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SEC Comment Letters
Company Responses
Letter Text
BioCardia, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
BioCardia, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
BioCardia, Inc.
Response Received
1 company response(s)
High - file number match
↓
BioCardia, Inc.
Response Received
1 company response(s)
High - file number match
↓
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
BioCardia, Inc.
Response Received
2 company response(s)
High - file number match
↓
↓
BioCardia, Inc.
Response Received
1 company response(s)
High - file number match
↓
BioCardia, Inc.
Response Received
3 company response(s)
High - file number match
↓
↓
↓
BioCardia, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-12-20
BioCardia, Inc.
Summary
Generating summary...
↓
Company responded
2022-12-20
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-10-15
BioCardia, Inc.
Summary
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↓
Company responded
2020-10-19
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-02-20
BioCardia, Inc.
Summary
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Company responded
2020-06-15
BioCardia, Inc.
Summary
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Company responded
2020-06-15
BioCardia, Inc.
Summary
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BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-12-17
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
9 company response(s)
High - file number match
SEC wrote to company
2005-03-09
BioCardia, Inc.
Summary
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Company responded
2005-03-23
BioCardia, Inc.
References: March 9, 2005
Summary
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Company responded
2007-01-24
BioCardia, Inc.
References: January 18, 2007
Summary
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Company responded
2009-01-30
BioCardia, Inc.
References: December 23, 2008
Summary
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Company responded
2009-06-04
BioCardia, Inc.
Summary
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Company responded
2010-08-12
BioCardia, Inc.
References: July 16, 2010
Summary
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Company responded
2017-06-28
BioCardia, Inc.
References: June 15, 2017
Summary
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Company responded
2017-07-20
BioCardia, Inc.
References: April 24, 2015 | July 13, 2017 | June 28, 2017
Summary
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Company responded
2017-08-08
BioCardia, Inc.
References: August 4, 2017
Summary
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Company responded
2019-12-05
BioCardia, Inc.
References: November 25, 2019
Summary
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BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-11-25
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2019-04-17
BioCardia, Inc.
Summary
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Company responded
2019-07-23
BioCardia, Inc.
Summary
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Company responded
2019-07-23
BioCardia, Inc.
Summary
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Company responded
2019-07-24
BioCardia, Inc.
Summary
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Company responded
2019-07-24
BioCardia, Inc.
Summary
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Company responded
2019-08-01
BioCardia, Inc.
Summary
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Company responded
2019-08-01
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-09-01
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2017-08-04
BioCardia, Inc.
Summary
Generating summary...
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Company responded
2017-08-25
BioCardia, Inc.
Summary
Generating summary...
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Company responded
2017-08-31
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-07-13
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-06-15
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2011-05-13
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2011-04-21
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2011-03-18
BioCardia, Inc.
Summary
Generating summary...
↓
Company responded
2011-04-11
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2011-02-25
BioCardia, Inc.
Summary
Generating summary...
↓
Company responded
2011-03-09
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-09-21
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2010-09-08
BioCardia, Inc.
Summary
Generating summary...
↓
Company responded
2010-09-09
BioCardia, Inc.
References: August 12,
2010 | August 25, 2010
Summary
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Company responded
2010-09-20
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-07-19
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-08-06
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2009-06-29
BioCardia, Inc.
References: April 15, 2009 | June 3, 2009
Summary
Generating summary...
↓
Company responded
2009-07-31
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-04-15
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-02-24
BioCardia, Inc.
References: December 23, 2008
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-12-23
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2007-01-26
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2007-01-18
BioCardia, Inc.
Summary
Generating summary...
BioCardia, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2005-07-08
BioCardia, Inc.
Summary
Generating summary...
↓
Company responded
2005-07-14
BioCardia, Inc.
References: July 8, 2005
Summary
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BioCardia, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2005-03-24
BioCardia, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-17 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2025-09-16 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2025-07-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2025-07-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2025-07-14 | SEC Comment Letter | BioCardia, Inc. | DE | 333-288592 | Read Filing View |
| 2025-05-05 | SEC Comment Letter | BioCardia, Inc. | DE | 333-286869 | Read Filing View |
| 2025-03-20 | SEC Comment Letter | BioCardia, Inc. | DE | 377-07792 | Read Filing View |
| 2024-08-29 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2024-08-29 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2024-08-16 | SEC Comment Letter | BioCardia, Inc. | DE | 333-281448 | Read Filing View |
| 2024-03-28 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2024-02-16 | SEC Comment Letter | BioCardia, Inc. | DE | 333-277059 | Read Filing View |
| 2023-12-01 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2023-11-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2023-11-14 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2023-10-24 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2022-12-20 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2022-12-20 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-10-19 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-10-15 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-06-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-06-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-02-20 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-12-17 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-12-05 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-11-25 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-08-01 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-08-01 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-07-24 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-07-24 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-07-23 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-07-23 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-04-17 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-09-01 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-08-31 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-08-25 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-08-08 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-08-04 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-07-20 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-07-13 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-06-28 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-06-15 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-05-13 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-04-21 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-04-11 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-03-18 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-03-09 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-02-25 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-09-21 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-09-20 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-09-09 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-09-08 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-08-12 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-07-19 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-08-06 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-07-31 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-06-29 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-06-04 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-04-15 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-02-24 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-01-30 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2008-12-23 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2007-01-26 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2007-01-24 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2007-01-18 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-07-14 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-07-08 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-03-24 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-03-23 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-03-09 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-14 | SEC Comment Letter | BioCardia, Inc. | DE | 333-288592 | Read Filing View |
| 2025-05-05 | SEC Comment Letter | BioCardia, Inc. | DE | 333-286869 | Read Filing View |
| 2025-03-20 | SEC Comment Letter | BioCardia, Inc. | DE | 377-07792 | Read Filing View |
| 2024-08-16 | SEC Comment Letter | BioCardia, Inc. | DE | 333-281448 | Read Filing View |
| 2024-02-16 | SEC Comment Letter | BioCardia, Inc. | DE | 333-277059 | Read Filing View |
| 2023-10-24 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2022-12-20 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-10-15 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-02-20 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-12-17 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-11-25 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-04-17 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-09-01 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-08-04 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-07-13 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-06-15 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-05-13 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-04-21 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-03-18 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-02-25 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-09-21 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-09-08 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-07-19 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-08-06 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-06-29 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-04-15 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-02-24 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2008-12-23 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2007-01-26 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2007-01-18 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-07-08 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-03-24 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-03-09 | SEC Comment Letter | BioCardia, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-17 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2025-09-16 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2025-07-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2025-07-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2024-08-29 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2024-08-29 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2024-03-28 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2023-12-01 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2023-11-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2023-11-14 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2022-12-20 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-10-19 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-06-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2020-06-15 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-12-05 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-08-01 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-08-01 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-07-24 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-07-24 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-07-23 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2019-07-23 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-08-31 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-08-25 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-08-08 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-07-20 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2017-06-28 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-04-11 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2011-03-09 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-09-20 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-09-09 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2010-08-12 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-07-31 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-06-04 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2009-01-30 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2007-01-24 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-07-14 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
| 2005-03-23 | Company Response | BioCardia, Inc. | DE | N/A | Read Filing View |
2025-09-17 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20250917_corresp.htm September 17, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Joshua Gorsky Re: BioCardia, Inc. Registration Statement on Form S-1 File No. 333-290283 Acceleration Request Requested Date: September 18, 2025 Requested Time: 9:00 a.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. hereby requests that its Registration Statement on Form S-1 (File No. 333-290283) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as we or our counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. This request shall supersede and replace any previously submitted request for accelerated effectiveness of the Registration Statement. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Austin D. March at (512) 338-5410. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Peter Altman, Ph.D., BioCardia, Inc. Austin D. March, Wilson Sonsini Goodrich & Rosati
2025-09-16 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20250916_corresp.htm September 16, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Joshua Gorsky Re: BioCardia, Inc. Registration Statement on Form S-1 File No. 333-290283 Acceleration Request Requested Date: September 17, 2025 Requested Time: 4:30 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. hereby requests that its Registration Statement on Form S-1 (File No. 333-290283) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as we or our counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Austin D. March at (512) 338-5410. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Peter Altman, Ph.D., BioCardia, Inc. Austin D. March, Wilson Sonsini Goodrich & Rosati
2025-07-15 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20250714_corresp.htm BioCardia, Inc. 320 Soquel Way Sunnyvale, California 94085 July 15, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549-3561 Attn: Joshua Gorsky Re: BioCardia, Inc. Registration Statement on Form S-3 Filed July 9, 2025 File No. 333-288592 Acceleration Request Requested Date: July 17, 2025 Requested Time: 4:30 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-288592) (the “Registration Statement”), be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Company may request by telephone to the staff of the Securities and Exchange Commission. The Company hereby authorizes Austin March of Wilson Sonsini Goodrich & Rosati, P.C., counsel for the Company, to make such request on the Company’s behalf. The Company requests that it be notified of the effectiveness of the Registration Statement by contacting Austin March at (512) 338-5410 or amarch@wsgr.com. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Peter Altman, BioCardia, Inc. Austin March, Esq., Wilson Sonsini Goodrich & Rosati, P.C.
2025-07-15 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20250714c_corresp.htm BioCardia, Inc. 320 Soquel Way Sunnyvale, California 94085 July 15, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549-3561 Attn: Joshua Gorsky Re: BioCardia, Inc. Registration Statement on Form S-3 Filed April 30, 2025 File No. 333-286869 Acceleration Request Requested Date: July 17, 2025 Requested Time: 4:30 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-286869) (the “Registration Statement”), be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Company may request by telephone to the staff of the Securities and Exchange Commission. The Company hereby authorizes Austin March of Wilson Sonsini Goodrich & Rosati, P.C., counsel for the Company, to make such request on the Company’s behalf. The Company requests that it be notified of the effectiveness of the Registration Statement by contacting Austin March at (512) 338-5410 or amarch@wsgr.com. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Peter Altman, BioCardia, Inc. Austin March, Esq., Wilson Sonsini Goodrich & Rosati, P.C.
2025-07-14 - UPLOAD - BioCardia, Inc. File: 333-288592
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 14, 2025 Peter Altman President and Chief Executive Officer BioCardia, Inc. 320 Soquel Way Sunnyvale, CA 94085 Re: BioCardia, Inc. Registration Statement on Form S-3 Filed July 9, 2025 File No. 333-288592 Dear Peter Altman: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Austin D. March </TEXT> </DOCUMENT>
2025-05-05 - UPLOAD - BioCardia, Inc. File: 333-286869
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 5, 2025 Peter Altman President and Chief Executive Officer BioCardia, Inc. 320 Soquel Way Sunnyvale, CA 94085 Re: BioCardia, Inc. Registration Statement on Form S-3 File No. 333-286869 Filed April 30, 2025 Dear Peter Altman: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Austin D. March </TEXT> </DOCUMENT>
2025-03-20 - UPLOAD - BioCardia, Inc. File: 377-07792
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 20, 2025 Peter Altman Chief Executive Officer BioCardia, Inc. 320 Soquel Way Sunnyvale, California 94085 Re: BioCardia, Inc. Draft Registration Statement on Form S-1 Submitted March 17, 2025 CIK No. 0000925741 Dear Peter Altman: Our initial review of your draft registration statement indicates that it fails to comply with the requirements of the Securities Act of 1933, the rules and regulations thereunder and the requirements of the form. More specifically, the draft registration statement does not include audited financial statements for the fiscal year ended December 31, 2024. We will provide more detailed comments relating to your registration statement following our review of a substantive amendment that addresses these deficiencies. Please contact Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Austin D. March </TEXT> </DOCUMENT>
2024-08-29 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20240828c_corresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28th Floor New York, NY 10022 August 29, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: BioCardia, Inc. Registration Statement on Form S-1, as amended File No: 333-281448 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P / Alliance Global Partners as Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 4:30pm Eastern Time on August 29, 2024 or as soon thereafter as practicable. Very truly yours, A.G.P / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2024-08-29 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20240828_corresp.htm August 29, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Daniel Crawford Re: BioCardia, Inc. Registration Statement on Form S-1 File No. 333-281448 Acceleration Request Requested Date: August 29, 2024 Requested Time: 4:30 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. hereby requests that its Registration Statement on Form S-1 (File No. 333-281448) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as we or our counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Austin D. March at (512) 338-5410. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Peter Altman, Ph.D., BioCardia, Inc. Austin D. March, Wilson Sonsini Goodrich & Rosati
2024-08-16 - UPLOAD - BioCardia, Inc. File: 333-281448
August 16, 2024
Peter Altman
President and Chief Executive Officer
BioCardia, Inc.
320 Soquel Way
Sunnyvale, California 94085
Re:BioCardia, Inc.
Registration Statement on Form S-1
Filed August 9, 2024
File No. 333-281448
Dear Peter Altman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Austin March, Esq.
2024-03-28 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20240328_corresp.htm BioCardia, Inc. 320 Soquel Way Sunnyvale, California 94085 March 28, 2024 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549-3561 Re: BioCardia, Inc. Registration Statement on Form S-3 Filed February 14, 2024 File No. 333-277059 Acceleration Request Requested Date: April 1, 2024 Requested Time: 4:30 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-277059) (the “Registration Statement”), be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Company may request by telephone to the staff of the Securities and Exchange Commission. The Company hereby authorizes Austin March of Wilson Sonsini Goodrich & Rosati, P.C., counsel for the Company, to make such request on the Company’s behalf. The Company requests that it be notified of the effectiveness of the Registration Statement by contacting Austin March at (512) 338-5410 or amarch@wsgr.com. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Peter Altman, BioCardia, Inc. Austin March, Esq., Wilson Sonsini Goodrich & Rosati, P.C.
2024-02-16 - UPLOAD - BioCardia, Inc. File: 333-277059
United States securities and exchange commission logo
February 16, 2024
Peter Altman
Chief Executive Officer
BioCardia, Inc.
320 Soquel Way
Sunnyvale, California 94085
Re:BioCardia, Inc.
Registration Statement on Form S-3
Filed February 14, 2024
File No. 333-277059
Dear Peter Altman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Austin March
2023-12-01 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20231129_corresp.htm BioCardia, Inc. 320 Soquel Way Sunnyvale, California 94085 December 1, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Cindy Polynice Re: BioCardia, Inc. Registration Statement on Form S-3 File No. 333-275099 Acceleration Request Requested Date: December 5, 2023 Requested Time: 4:30 p.m., Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-275099) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon thereafter as practicable, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with the Company’s counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Austin March at (512) 338-5410. [Signature page follows] Sincerely, BioCardia, Inc. /s/ Peter Altman Peter Altman President and Chief Executive Officer and Director cc: David McClung, BioCardia, Inc. Michael J. Danaher, Wilson Sonsini Goodrich & Rosati, P.C. Austin D. March, Wilson Sonsini Goodrich & Rosati, P.C.
2023-11-15 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20231114c_corresp.htm BioCardia, Inc. 320 Soquel Way Sunnyvale, California 94085 November 15, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Cindy Polynice Re: BioCardia, Inc. Registration Statement on Form S-3 File No. 333-275099 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on November 14, 2023, in which we requested the acceleration of the effective date of the above-referenced Registration Statement on Form S-3 for 4:00 p.m., on November 16, 2023, in accordance with Rule 461 under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the effective date. Please contact our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Michael J. Danaher at (650) 320-4625 if you have any questions or concerns regarding the foregoing. We appreciate your assistance in this matter. [Signature page follows] Sincerely, BioCardia, Inc. /s/ Peter Altman Peter Altman President and Chief Executive Officer and Director cc: David McClung, BioCardia, Inc. Michael J. Danaher, Wilson Sonsini Goodrich & Rosati, P.C. Austin D. March, Wilson Sonsini Goodrich & Rosati, P.C.
2023-11-14 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20231114_corresp.htm BioCardia, Inc. 320 Soquel Way Sunnyvale, California 94085 November 14, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Cindy Polynice Re: BioCardia, Inc. Registration Statement on Form S-3 File No. 333-275099 Acceleration Request Requested Date: November 16, 2023 Requested Time: 4:00 p.m. Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-275099) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon thereafter as practicable, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with the Company’s counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Michael J. Danaher at (650) 320-4625. [Signature page follows] Sincerely, BioCardia, Inc. /s/ Peter Altman Peter Altman President and Chief Executive Officer and Director cc: David McClung, BioCardia, Inc. Michael J. Danaher, Wilson Sonsini Goodrich & Rosati, P.C. Austin D. March, Wilson Sonsini Goodrich & Rosati, P.C.
2023-10-24 - UPLOAD - BioCardia, Inc.
United States securities and exchange commission logo
October 24, 2023
Dr. Peter Altman
President and Chief Executive Officer
BioCardia, Inc.
320 Soquel Way
Sunnyvale, California 94085
Re:BioCardia, Inc.
Registration Statement on Form S-3
Filed October 19, 2023
File No. 333-275099
Dear Dr. Peter Altman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael Danaher
2022-12-20 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20221220_corresp.htm December 20, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Re: BioCardia, Inc. Registration Statement on Form S-3 (File No. 333-268862) Acceleration Request Requested Date: Thursday, December 22, 2022 Requested Time: 4:30 P.M. Eastern Standard Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Austin D. March at (512) 338-5410. [Signature page follows] Securities and Exchange Commission December 20, 2022 Page 2 Sincerely, BIOCARDIA, INC. /s/ Peter Altman Peter Altman President and Chief Executive Officer Enclosures cc: David McClung, BioCardia, Inc. Michael J. Danaher, Brian Dillavou, and Austin D. March, Wilson Sonsini Goodrich & Rosati, P.C.
2022-12-20 - UPLOAD - BioCardia, Inc.
United States securities and exchange commission logo
December 20, 2022
Peter Altman
President and Chief Executive Officer
BioCardia, Inc.
320 Soquel Way
Sunnyvale, CA 94085
Re:BioCardia, Inc.
Registration Statement on Form S-3
Filed December 19, 2022
File No. 333-268862
Dear Peter Altman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Austin March
2020-10-19 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20201016_corresp.htm October 19, 2020 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-3720 Attention: Abby Adams Re: BioCardia, Inc. Registration Statement on Form S-3 Filed on October 9, 2020 File No. 333-249426 Acceleration Request Requested Date: Requested Time: October 20, 2020 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-249426) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Company or its counsel may request via telephone to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”). Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Nathan Robinson at (512) 338-5407 or via email at nrobinson@wsgr.com. [Signature page follows.] Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Nathan Robinson, Esq. Wilson Sonsini Goodrich & Rosati, Professional Corporation
2020-10-15 - UPLOAD - BioCardia, Inc.
United States securities and exchange commission logo
October 15, 2020
David McClung
Chief Financial Officer
BioCardia, Inc.
125 Shoreway Road, Suite B
San Carlos, California 94070
Re:BioCardia, Inc.
Registration Statement on Form S-3
Filed October 9, 2020
File No. 333-249426
Dear Mr. McClung:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nathan Robinson, Esq.
2020-06-15 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20200614b_corresp.htm A.G.P./Alliance Global Partners 590 Madison Avenue New York, New York 10022 June 15, 2020 VIA EDGAR U.S. Securities and Exchange Commission 100 F St., NE Washington, D.C. 20549 RE: BioCardia, Inc. (the “Company”) File No. 333-236404 Registration Statement on Form S-1 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P./Alliance Global Partners, as representative of the underwriters, hereby joins the request of the Company that the effective date of the above-referenced Registration Statement be accelerated so that it will become effective at 5:00 p.m. Eastern Time on June 16, 2020, or as soon thereafter as practicable. Pursuant to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter, who is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. Very truly yours, A.G.P./Alliance Global Partners By: Thomas Higgins /s/ Thomas Higgins Name: Thomas Higgins Title: Managing Director
2020-06-15 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20200614_corresp.htm June 15, 2020 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-3720 Attention: Ada D. Sarmento Re: BioCardia, Inc. Registration Statement on Form S-1 Filed on June 15, 2020 File No. 333-236404 Acceleration Request Requested Date: June 16, 2020 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-236404) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Company may request via telephone to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”). The Company hereby authorizes Nathan Robinson of Wilson Sonsini Goodrich & Rosati, Professional Corporation, counsel for the Company, to make such request on the Company’s behalf. The Company requests that it be notified of the effectiveness of the Registration Statement by telephone to Nathan Robinson of Wilson Sonsini Goodrich & Rosati, Professional Corporation at (512) 418-6483 or via email at nrobinson@wsgr.com. If notice of effectiveness is given by telephone, please also provide a copy of the Commission’s order declaring the Registration Statement effective to Nathan Robinson via facsimile at (512) 338-5499. Please direct any questions or comments regarding this acceleration request to Nathan Robinson at (512) 418-6483. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer
2020-02-20 - UPLOAD - BioCardia, Inc.
February 19, 2020
Peter Altman, Ph.D.
Chief Executive Officer
BioCardia, Inc.
125 Shoreway Road, Suite B
San Carlos, CA 94070
Re:BioCardia, Inc.
Registration Statement on Form S-1
Filed February 13, 2020
File No. 333-236404
Dear Dr. Altman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael J. Danaher, Esq.
2019-12-17 - UPLOAD - BioCardia, Inc.
December 17, 2019
David McClung
Chief Financial Officer
BioCardia, Inc.
125 Shoreway Road, Suite B
San Carlos, California 94070
Re:BioCardia, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed April 2, 2019
File No. 000-21419
Dear Mr. McClung:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-12-05 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20191204_corresp.htm December 5, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Rolf Sundwall and Sasha Parikh Re: BioCardia, Inc. Form 10-K for the Fiscal Year Ended December 31, 2018 Filed April 2, 2019 File No. 000-21419 Ladies and Gentlemen: BioCardia, Inc. (the “Company”) submits this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated November 25, 2019, relating to the Company’s Form 10-K for the fiscal year ended December 31, 2018 (File No. 000-21419) originally filed with the Commission on April 2, 2019 (the “2018 Form 10-K”). In this letter, the comment from the Staff has been recited in italicized, bold type, and the comment is followed by the Company’s response. Form 10-K for the Fiscal Year Ended December 31, 2018 ITEM 1. BUSINESS Cell Processing and Cell Delivery Product Platforms, page 6 1. You disclose that you "believe the Helix biotherapeutic delivery system is the world's safest and most efficient platform for cardiac therapeutic delivery." Although you disclose the Helix system has received regulatory approval for commercial use in Europe, it has only received FDA approval for investigational use in the United States. Because the Helix system has not received marketing approval from the FDA, it is premature to suggest or imply that it is safe or effective. Please provide to us draft disclosure for future periodic filings revising this or other similar statements accordingly. ■ 125 SHOREWAY ROAD, SUITE B SAN CARLOS, CA 94070 ■ PH: 650-226-0120 ▪ FAX: 650-631-3731 ■ WWW.BIOCARDIA.COM Securities and Exchange Commission December 5, 2019 Page 2 The Company’s statement that we “believe the Helix biotherapeutic delivery system is the world's safest and most efficient platform for cardiac therapeutic delivery” is based on a number of peer reviewed clinical papers by other groups using various delivery systems that was summarized in a 2018 peer reviewed poster presentation at the Transcatheter Therapeutics Conference, which included all of the referenced manuscripts. The accepted abstract for this presentation concludes: “With respect to safety, after 300 clinical cases, the Helix transendocardial delivery system compares favorably to biotherapeutic delivery systems in clinical trial use today. Procedural safety in a real world multicenter experience remains to be established for all biotherapeutic delivery systems.” With respect to efficiency of delivery, the Company has been involved in a number of preclinical studies, including peer reviewed publications which have shown the Helix system to have a greater efficiency of delivery as measured by the percentage of targeted therapeutic that remains at the target site after delivery, as compared with intracoronary artery infusion and other intramyocardial delivery approaches. For BioCardia’s CardiAMP cells, in a peer reviewed paper published in 2017, the Helix System’s efficiency of delivery was shown to be 18 times more efficient than delivery into the coronary arteries and 3 times more efficient than a comparable straight needle intramyocardial delivery approach. This paper concludes with the following statement: “The Helix transendocardial delivery system has the potential to improve local cell delivery and retention in cardiovascular cell based therapy, thus potentially improving clinical outcomes. Further studies are needed to characterize retention over time and quantify efficiency in an ischemic swine heart model and humans.” The Company has supplementally delivered to the Staff certain materials supporting these assertions. The Company did not assert the Helix is “effective.” This is terminology usually reserved for therapies, and the Helix is merely a delivery system for cardiac biotherapeutics. As neither the Helix intramyocardial biotherapeutic delivery system nor any biotherapeutic for intramyocardial delivery has received marketing approval from the FDA and based on the Staff’s comments, the Company proposes to replace the entire paragraph with the following in the Company’s 2019 10-K, with the revisions from original language made in italics: “Helix biotherapeutic delivery system - delivers therapeutics into the heart muscle with a penetrating helical needle from within the heart. We anticipate submitting Helix for approval in the United States as part of CardiAMP Cell Therapy System. The system is CE marked for commercial use in Europe and is under investigational use in the United States as part of our CardiAMP Cell Therapy System and CardiALLO Cell Therapy System development programs. The Company has published and presented data demonstrating that under investigational use, the Helix has performed favorably in comparison to other investigational biotherapeutic delivery approaches for delivery to the heart with respect to both safety of clinical procedures and efficiency of delivery of therapeutic agents in large animal studies. It has been used in more than 300 clinical procedures and is designed to be used in any catheterization laboratory in the world without the need for additional capital equipment. * * * * * ■ 125 SHOREWAY ROAD, SUITE B SAN CARLOS, CA 94070 ■ PH: 650-226-0120 ▪ FAX: 650-631-3731 ■ WWW.BIOCARDIA.COM Securities and Exchange Commission December 5, 2019 Page 3 Please direct your questions or comments to me at (650) 226-0123 or via email to dmcclung@BioCardia.com. Very truly yours, /s/ David McClung David McClung Chief Financial Officer cc: Peter Altman., CEO, BioCardia, Inc. Michael Danaher, Esq., and Nathan Robinson, Esq., Wilson Sonsini Goodrich & Rosati, Professional Corporation ■ 125 SHOREWAY ROAD, SUITE B SAN CARLOS, CA 94070 ■ PH: 650-226-0120 ▪ FAX: 650-631-3731 ■ WWW.BIOCARDIA.COM
2019-11-25 - UPLOAD - BioCardia, Inc.
November 25, 2019
David McClung
Chief Financial Officer
BioCardia, Inc.
125 Shoreway Road, Suite B
San Carlos, California 94070
Re:BioCardia, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed April 2, 2019
File No. 000-21419
Dear Mr. McClung:
We have reviewed your filing and have the following comment. In our comment, we
may ask you to provide us with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
ITEM 1. BUSINESS
Cell Processing and Cell Delivery Product Platforms, page 6
1.You disclose that you "believe the Helix biotherapeutic delivery system is the world's
safest and most efficient platform for cardiac therapeutic delivery." Although you
disclose the Helix system has received regulatory approval for commercial use in Europe,
it has only received FDA approval for investigational use in the United States. Because
the Helix system has not received marketing approval from the FDA, it is premature to
suggest or imply that it is safe or effective. Please provide to us draft disclosure for future
periodic filings revising this or other similar statements accordingly.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
FirstName LastNameDavid McClung
Comapany NameBioCardia, Inc.
November 25, 2019 Page 2
FirstName LastName
David McClung
BioCardia, Inc.
November 25, 2019
Page 2
You may contact Rolf Sundwall at 202-551-3105 or Sasha Parikh at 202-551-3627 if you
have questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-08-01 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20190731_corresp.htm July 31, 2019 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-3720 Attention: Jeffrey Gabor Re: BioCardia, Inc. Registration Statement on Form S-1 Filed on July 31, 2019 File No. 333-230779 Acceleration Request Requested Date: August 1, 2019 Requested Time: 4:30 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-230779) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Company may request via telephone to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”). The Company hereby authorizes Nathan Robinson of Wilson Sonsini Goodrich & Rosati, Professional Corporation, counsel for the Company, to make such request on the Company’s behalf. The Company requests that it be notified of the effectiveness of the Registration Statement by telephone to Nathan Robinson of Wilson Sonsini Goodrich & Rosati, Professional Corporation at (512) 338-5407 or via email at nrobinson@wsgr.com. If notice of effectiveness is given by telephone, please also provide a copy of the Commission’s order declaring the Registration Statement effective to Nathan Robinson via facsimile at (512) 338-5499. Please direct any questions or comments regarding this acceleration request to Nathan Robinson at (512) 338-5407. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Michael Danaher, Esq. Wilson Sonsini Goodrich & Rosati, Professional Corporation
2019-08-01 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20190731b_corresp.htm July 31, 2019 Securities and Exchange Commission 100 F. Street, NE Washington, D.C. 20549 Re: BioCardia, Inc. Registration Statement on Form S-1 File No. 333-230779 VIA EDGAR Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, Maxim Group LLC, as representative of the underwriters, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 4:30 p.m., Washington D.C. time, on Thursday, August 1, 2019, or as soon thereafter as practicable. The following is supplemental information supplied under Rule 418(a)(7) and Rule 460 under the Securities Act of 1933: (i) Date of preliminary prospectus: July 23, 2019. (ii) Dates of distribution: July 23, 2019 through the date hereof. (iii) Number of prospective underwriters and selected dealers to whom the preliminary prospectus was furnished: 12. (iv) Number of prospectuses so distributed: 540. The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. [Signature Page Follows] MAXIM GROUP LLC By: /s/ Clifford A. Teller Name: Clifford A. Teller Title: Executive Managing Director Head of Investment Banking
2019-07-24 - CORRESP - BioCardia, Inc.
CORRESP
1
filename1.htm
bcda20190724b_corresp.htm
July 24, 2019
Securities and Exchange Commission
100 F. Street, NE
Washington, D.C. 20549
Re: BioCardia, Inc.
Registration Statement on Form S-1
File No. 333-230779
VIA EDGAR
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence via EDGAR on July 23, 2019, in which we, Maxim Group LLC, as representative of the underwriters of the offering, joined the Company’s request for acceleration of the effective date of the above-referenced Registration Statement for Thursday, July 25, 2019, at 4:30 p.m., ET, or as soon thereafter as practicable. The Company is no longer requesting that such Registration Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date.
MAXIM GROUP LLC
By:
/s/ Clifford A. Teller
Name: Clifford A. Teller
Title: Executive Managing Director
Head of Investment Banking
2019-07-24 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20190724_corresp.htm July 24, 2015 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-3720 Attention: Jeffrey Gabor Re: BioCardia, Inc. Registration Statement on Form S-1 Filed on July 23, 2019 File No. 333-230779 Ladies and Gentlemen: BioCardia, Inc. (the “Company”) hereby respectfully requests withdrawal of its acceleration request filed on July 23, 2019 relating to its Registration Statement on Form S-1 (File No. 333-230779) (the “Registration Statement”). The Company is no longer requesting that such Registration Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date. If you have any questions regarding the foregoing, please contact our counsel, Nathan Robinson of Wilson Sonsini Goodrich and Rosati, Professional Corporation, at (512) 418-6483. Sincerely, BIOCARDIA, INC. By: /s/ David McClung Name: David McClung Title: Chief Financial Officer
2019-07-23 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20190723b_corresp.htm July 23, 2019 Securities and Exchange Commission 100 F. Street, NE Washington, D.C. 20549 Re: BioCardia, Inc. Registration Statement on Form S-1 File No. 333-230779 VIA EDGAR Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, Maxim Group LLC, as representative of the underwriters, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 4:30 p.m., Washington D.C. time, on Thursday, July 25, 2019, or as soon thereafter as practicable. The following is supplemental information supplied under Rule 418(a)(7) and Rule 460 under the Securities Act of 1933: (i) Date of preliminary prospectus: July 15, 2019. (ii) Dates of distribution: July 15, 2019 through the date hereof. (iii) Number of prospective underwriters and selected dealers to whom the preliminary prospectus was furnished: 12. (iv) Number of prospectuses so distributed: 470. The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. [Signature Page Follows] MAXIM GROUP LLC By: /s/ Clifford A. Teller Name: Clifford A. Teller Title: Executive Managing Director Head of Investment Banking
2019-07-23 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20190723_corresp.htm July 23, 2019 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-3720 Attention: Jeffrey Gabor Re: BioCardia, Inc. Registration Statement on Form S-1 Filed on July 23, 2019 File No. 333-230779 Acceleration Request Requested Date: July 25, 2019 Requested Time: 4:30 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-230779) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Company may request via telephone to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”). The Company hereby authorizes Nathan Robinson of Wilson Sonsini Goodrich & Rosati, Professional Corporation, counsel for the Company, to make such request on the Company’s behalf. The Company requests that it be notified of the effectiveness of the Registration Statement by telephone to Nathan Robinson of Wilson Sonsini Goodrich & Rosati, Professional Corporation at (512) 338-5407 or via email at nrobinson@wsgr.com. If notice of effectiveness is given by telephone, please also provide a copy of the Commission’s order declaring the Registration Statement effective to Nathan Robinson via facsimile at (512) 338-5499. Please direct any questions or comments regarding this acceleration request to Nathan Robinson at (512) 338-5407. Sincerely, BIOCARDIA, INC. By: /s/ David McClung David McClung Chief Financial Officer cc: Michael Danaher, Esq. Wilson Sonsini Goodrich & Rosati, Professional Corporation
2019-04-17 - UPLOAD - BioCardia, Inc.
April 17, 2019
Peter Altman, Ph.D.
President and Chief Executive Officer
BioCardia, Inc.
125 Shoreway Road, Suite B
San Carlos, CA 94070
Re:BioCardia, Inc.
Registration Statement on Form S-1
Filed April 9, 2019
File No. 333-230779
Dear Dr. Altman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Nathan Robinson, Esq.
2017-09-01 - UPLOAD - BioCardia, Inc.
Mail Stop 3030 September 1, 2017 Via E -mail Peter Altman Chief Executive Officer BioCardia, Inc. 125 Shoreway Road, Suite B San Carlos, California 94070 Re: BioCardia, Inc. Form 10 -K for the Fiscal Year Ended December 31, 2016 Filed March 30, 2017 File No. 000 -21419 Dear Dr. Altman : We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of the ir disclosure s, notwithstanding any review, comments, action or absence of action by the staff . Sincerely, /s/ Martin James Martin James Senior Assistant Chief Accountant Office of Electronics and Machinery
2017-08-31 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20170830_corresp.htm August 31, 2017 VIA EDGAR Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Russell Mancuso, Branch Chief, Office of Electronics and Machinery Brian Cascio, Accounting Branch Chief Julie Sherman Tom Jones Re: BioCardia, Inc. Registration Statement on Form S-3 Originally Filed on May 19, 2017 File No. 333-218124 Acceleration Request Requested Date: September 1, 2017 Requested Time: 2:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCardia, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-218124) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). Once the Registration Statement has been declared effective, please confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Lance E. Brady at (650) 565-3836 or emailing him at lbrady@wsgr.com. In connection with the acceleration request, the Company hereby acknowledges that: ● should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; ● the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and ● the Company may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, BioCardia, Inc. /s/ David McClung David McClung Vice President of Finance cc: Peter Altman, President and Chief Executive Officer Michael J. Danaher, Wilson Sonsini Goodrich & Rosati, P.C. Lance E. Brady, Wilson Sonsini Goodrich & Rosati, P.C.
2017-08-25 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20170824_corresp.htm 650 Page Mill Road Palo Alto, CA 94304-1050 PHONE 650.493.9300 FAX 650.493.6811 www.wsgr.com August 25, 2017 Via EDGAR and Overnight Delivery Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Russell Mancuso, Branch Chief, Office of Electronics and Machinery Brian Cascio, Accounting Branch Chief Julie Sherman Tom Jones Re: BioCardia, Inc. Amendment No. 2 to Registration Statement on Form S-3 Filed July 20, 2017 File No. 333-218124 Response dated August 8, 2017 Dear Mr. Mancuso: On behalf of our client, BioCardia, Inc. (the “Company”), we submit this letter in response to a telephonic conversation with the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) on August 23, 2017, during which we were informed that the Staff would have no further comments to the Company’s Amendment No. 2 to Registration Statement on Form S-3 (File No. 333-218124) filed with the Commission on July 20, 2017, or to the documents incorporated by reference therein (the “July Amended Registration Statement”). The Company is concurrently filing with this letter an amendment to the July Amended Registration Statement (the “August Amended Registration Statement”) for the sole purpose of filing an updated consent from the Company’s Independent Registered Public Accounting Firm as Exhibit 23.1 thereto. In addition, because the Company filed its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2017 with the Commission on August 14, 2017, the Company has updated the section titled “Information Incorporated by Reference” on page 30 of the July Amended Registration Statement to include such report. The Company has also updated the section titled “Ratio of Earnings to Fixed Charges” on page 6 of the July Amended Registration Statement and the accompanying “Computation of Ratio of Earnings to Fixed Charges” table on Exhibit 12.1 thereto to include relevant information for the six months ended June 30, 2017. For the convenience of the Staff, we are providing to the Staff by overnight delivery copies of this letter and the August Amended Registration Statement (including a version of the August Amended Registration Statement marked against the July Amended Registration Statement), in care of Mr. Mancuso. AUSTIN BEIJING BOSTON BRUSSELS HONG KONG LOS ANGELES NEW YORK PALO ALTO SAN DIEGO SAN FRANCISCO SEATTLE SHANGHAI WASHINGTON, DC WILMINGTON, DE U.S. Securities and Exchange Commission August 25, 2017 Page 2 *** Please direct any questions regarding the Company’s responses or the August Amended Registration Statement to me at (650) 493-9300 or mdanaher@wsgr.com. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Michael J. Danaher Michael J. Danaher cc: Peter Altman, President and CEO, BioCardia, Inc. David McClung, Vice President of Finance, BioCardia, Inc.
2017-08-08 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20170808_corresp.htm 650 Page Mill Road Palo Alto, CA 94304-1050 PHONE 650.493.9300 FAX 650.493.6811 www.wsgr.com August 8, 2017 Via EDGAR Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Russell Mancuso, Branch Chief, Office of Electronics and Machinery Brian Cascio, Accounting Branch Chief Julie Sherman Tom Jones Re: BioCardia, Inc. Amendment No. 2 to Registration Statement on Form S-3 Filed July 20, 2017 File No. 333-218124 Amendment No. 1 to Form 10-K for Fiscal Year Ended December 31, 2016 Filed July 20, 2017 File No. 000-21419 Response dated July 20, 2017 Dear Mr. Mancuso: On behalf of our client, BioCardia, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated August 4, 2017 and relating to the Company’s Amendment No. 2 to Registration Statement on Form S-3 (File No. 333-218124) filed with the Commission on July 20, 2017 (the “July Amended Registration Statement”) and Amendment No.1 to Form 10-K for the fiscal year ended December 31, 2016 (File No. 000-21419) filed with the Commission on July 20, 2017 (the “10-K Amendment”). In this letter, we have recited the comments from the Staff in bold italicized type and have followed each comment with the Company’s response. Capitalized terms used but not defined herein shall have the meanings ascribed thereto in the July Amended Registration Statement or the 10-K Amendment, as applicable. Except as otherwise specifically indicated, page references herein correspond to the page of the July Amended Registration Statement or the 10-K Amendment, as applicable. AUSTIN BEIJING BOSTON BRUSSELS HONG KONG LOS ANGELES NEW YORK PALO ALTO SAN DIEGO SAN FRANCISCO SEATTLE SHANGHAI WASHINGTON, DC WILMINGTON, DE U.S. Securities and Exchange Commission August 8, 2017 Page 2 Amendment No. 1 to Form 10-K for Fiscal Year Ended December 31, 2016 Security Ownership, page 36 1. From your response to prior comment 8, it appears that your beneficial ownership table does not include all named executive officers. Tell us the number of securities beneficially owned by each named executive officer not included in this table. In response to the Staff’s comment, the Company respectfully informs the Staff that, to the best of its knowledge, as of April 21, 2017, (i) Andrew Brooks (who resigned as the Chairman of the Board of Directors, Chief Executive Officer, Interim Chief Financial Officer and other positions with Tiger X on May 10, 2016) held zero shares of the Company’s common stock and (ii) Steven Rubin (who served as Interim Chief Executive Officer of Tiger X from May 10, 2016 until the completion of the Merger on October 24, 2016) held 342,822 shares of the Company’s common stock. Therefore, the total number of shares beneficially owned by “All directors and executive officers as a group,” when also including these former executive officers of Tiger X (a total of 14 persons), is 72,735,660 shares of the Company’s common stock, and the percentage of beneficial ownership is 15.57%. Exhibit 10.8 2. We note your response to prior comment 10. Tell us which exhibit sets forth the adjustment provisions mentioned in section 3 of exhibit 10.8. In response to the Staff’s comment, in August 2016, as consideration for consulting services provided pursuant to the Consulting Agreement filed as exhibit 10.8 to the Amended 10-K, OPKO was granted an option to purchase 259,592 shares of the Company’s common stock with an exercise price of $2.85 per share (the “OPKO Option”). The OPKO Option was pursuant to the Company’s 2016 Equity Incentive Plan and our 2016 Equity Incentive Plan Stock Option Agreement filed as exhibits 4.6 and 4.7, respectively, to Registration Statement on Form S-8 filed by us on February 8, 2017 that provide for adjustments to the number of underlying shares and exercise price in the event of a change in capitalization, including a stock split. In October 2016, a one-for-19.3678009 stock split of the Company’s common stock was implemented in connection with the Merger. Thus, following the stock split, the OPKO Option converted into 5,027,726 shares of the Company’s common stock with an exercise price of $0.15 per share. U.S. Securities and Exchange Commission August 8, 2017 Page 3 *** Please direct any questions regarding the Company’s responses to me at (650) 493-9300 or mdanaher@wsgr.com. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Michael J. Danaher Michael J. Danaher cc: Peter Altman, President and CEO, BioCardia, Inc. David McClung, Vice President of Finance, BioCardia, Inc.
2017-08-04 - UPLOAD - BioCardia, Inc.
Mail Stop 3030
August 4, 2017
Via E -mail
Peter Altman
Chief Executive Officer
BioCardia, Inc.
125 Shoreway Road, Suite B
San Carlos, California 94070
Re: BioCardia, Inc.
Amendment No. 2 to Registration Statement on Form S -3
Filed July 20, 2017
File No. 333 -218124
Amendment No. 1 to Form 10 -K for Fiscal Year Ended December 31, 2016
Filed July 20, 2017
File No. 000 -21419
Dear Dr. Altman :
We have reviewed the above -referenced filings and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your filings and providing the req uested
information. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your filings and the information you provi de in
response to these comments, we may have additional comments. Unless we note otherwise, our
references to prior comments are to comments in our July 13, 2017 letter.
Amendment No. 1 to Form 10 -K for Fiscal Year End ed December 31, 2016
Security Owne rship, page 36
1. From your response to prior comment 8, it appears that your beneficial ownership table
does not include all named executive officers. Tell us the number of securities
beneficially owned by each named executive officer not included in this table.
Exhibi t 10.8
2. We note your response to prior comment 10. Tell us which exhibit sets forth the
adjustment provisions mentioned in section 3 of exhibit 10.8.
Peter Altman
BioCardia, Inc .
August 4, 2017
Page 2
You may contact Julie Sherman at (202) 551 -3640 or Brian Cascio, Accounting Branch
Chief, at (202) 551-3676 if you have questions regarding comments on the financial statements
and related matters. Please contact Tom Jones at (202) 551 -3602 or me at (202) 551 -3617 with
any other questions.
Sincerely,
/s/ Russell Mancuso
Russell Mancuso
Branch Chief
Office of Electronics and Machinery
cc: Michael J. Danaher
2017-07-20 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20170720_corresp.htm 650 Page Mill Road Palo Alto, CA 94304-1050 PHONE 650.493.9300 FAX 650.493.6811 www.wsgr.com July 20, 2017 Via EDGAR and Overnight Delivery Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Russell Mancuso, Branch Chief, Office of Electronics and Machinery Brian Cascio, Accounting Branch Chief Julie Sherman Tom Jones Re: BioCardia, Inc. Amendment No. 1 to Registration Statement on Form S-3 Filed June 28, 2017 File No. 333-218124 Form 10-K for Fiscal Year Ended December 31, 2016 Response dated June 28, 2017 File No. 000-21419 Dear Mr. Mancuso: On behalf of our client, BioCardia, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated July 13, 2017 and relating to the Company’s Amendment No. 1 to Registration Statement on Form S-3 (File No. 333-218124) filed with the Commission on June 28, 2017 (the “June Amended Registration Statement”) and Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (File No. 000-21419) filed with the Commission on March 30, 2017 (the “2016 10-K”). The Company has also further revised the June Amended Registration Statement in response to the Staff’s comments in respect of the June Amended Registration Statement (the “July Amended Registration Statement”) and is filing concurrently with this letter (i) the July Amended Registration Statement, which reflects these revisions and updates and clarifies certain other information, (ii) an amendment to the 2016 10-K in order to provide additional or updated exhibits thereto and revisions to the disclosures therein (the “10-K Amendment”), (iii) and an amendment to the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2017, originally filed on May 11, 2017 (the “10-Q Amendment,” and together with the July Amended Registration Statement and the 10-K Amendment, the “Amended Filings”), in order to provide updated exhibits thereto. For the convenience of the Staff, we are providing to the Staff by overnight delivery copies of this letter and the Amended Filings (including a version of the July Amended Registration Statement marked against the June Amended Registration Statement), in care of Mr. Mancuso. AUSTIN BEIJING BOSTON BRUSSELS HONG KONG LOS ANGELES NEW YORK PALO ALTO SAN DIEGO SAN FRANCISCO SEATTLE SHANGHAI WASHINGTON, DC WILMINGTON, DE U.S. Securities and Exchange Commission July 20, 2017 Page 2 In this letter, we have recited the comments from the Staff in bold italicized type and have followed each comment with the Company’s response. Capitalized terms used but not defined herein shall have the meanings ascribed thereto in the July Amended Registration Statement, the 2016 10-K or 10-K Amendment, as applicable, or the 10-Q Amendment. Except as otherwise specifically indicated, page references herein correspond to the page of the July Amended Registration Statement, the 2016 10-K or the 10-K Amendment, as applicable, or the 10-Q Amendment. Amendment No. 1 to Registration Statement on Form S-3 Information Incorporated by Reference, page 30 1. Please specifically incorporate by reference the Form 8-K that you filed June 21, 2017. In response to the Staff’s comments, the Company has revised the disclosure on page 30 in the July Amended Registration Statement to include this Form 8-K in the Company’s list of filings incorporated by reference into the July Amended Registration Statement. Exhibits 2. We note your response to prior comment 2. Indentures covering the debt securities to be issued in a registration statement must be qualified at the time the registration statement relating to those debt securities becomes effective. File the indentures, not merely forms. The Company acknowledges the Staff’s comment and respectfully informs the Staff that the previously filed exhibits 4.2 and 4.4 to the July Amended Registration Statements are “qualified indentures” with respect to the Trust Indenture Act of 1939 (the “TIA”) and not merely “forms.” In compliance with the applicable provisions of the TIA and Rule 415 of Regulation C of the Securities Act of 1933, as amended (the “Securities Act”), these indentures remain “open ended” and provide a generic, non-specific description of the debt securities, and in connection with any takedown offering of debt securities, the Company will provide further details of such series of debt securities by filing both a supplemental indenture (as an exhibit to a Current Report on Form 8-K) and a prospectus supplement at the time such series is to be offered. The Company will also file a Form T-1 Statement of Eligibility prior to any applicable takedown offering. The Company respectfully directs the attention of the Staff to the Compliance and Disclosure Interpretations of the SEC regarding the Trust Indenture Act (last updated April 24, 2015), specifically section 201.04 under the heading “Interpretive Responses Regarding Particular Situations.” Furthermore, for the sake of clarity, the Company has revised its list of exhibits to strike the words “form of” from each of exhibits 4.2 and 4.4 in the July Amended Registration Statement. U.S. Securities and Exchange Commission July 20, 2017 Page 3 3. Revise the descriptions of exhibits 4.3 and 4.5 to reflect the substance of the second paragraph of your response to prior comment 2. In response to the Staff’s comments, the Company has revised the descriptions of exhibits 4.3 and 4.5 to provide the proper article and section references where such exhibits can be found within exhibits 4.2 and 4.4, respectively. Form 10-K for Fiscal Year Ended December 31, 2016 4. We may have further comment after you revise your Form 10-K as indicated in your responses, including your responses to prior comments 7, 12 and 21. The Company acknowledges the Staff’s comment and respectfully directs the Staff to review the 10-K Amendment and 10-Q Amendment, filed with the SEC on the date hereof. Business, page 1 5. Expand your response to prior comment 8 to address all identified parties, not merely those described on page 1. Also tell us whether your reference to the authors on pages 6 and 8 is intended to incorporate their conclusions by reference. The Company acknowledges the Staff’s comment and respectfully informs the Staff that all identified parties in the 2016 10-K have been compensated only on terms that were standard and customary in clinical study arrangements. For additional clarity, the Company has added into the 10-K Amendment the following sentence to the second full paragraph on page 2 of the 2016 10-K “As we engage in clinical trials of our therapeutic candidates, we have compensated and intend to compensate all parties performing the trials or studies (including all the parties identified in this Annual Report on Form 10-K) only on terms that are standard and customary in clinical study arrangements.” Regarding the references to authors on pages 6 and 8 of the 2016 10-K, the Company respectfully informs the Staff that these publications (and any conclusions contained therein) are not incorporated by reference, and the Company has added into the 10-K Amendment a footnote to the citations for these publications that explicitly clarifies that they are not incorporated by reference and provided for the sole purpose of directing the investing public to a more detailed review of the clinical results. 6. Expand your response to prior comment 9 to address all claims of safety and efficacy in your document. We note for example your disclosure at the top of page 6 regarding safety. If claims of safety and efficacy are appropriate under FDA rules only after a product has been cleared for sale, please revise your disclosure of claims regarding products that have not been so cleared. The Company acknowledges the Staff’s comment and respectfully reaffirms to the Staff that the references to “safety” and “efficacy” relate to discussions of the results of various clinical trials that have supported the safety and efficacy of the Company’s products. The Company has not and will not with the 10-K Amendment be marketing its products with any claims related to their safety and efficacy prior to obtaining FDA approval of such products. However, and to avoid confusion, the Company has revised certain disclosures in the 10-K Amendment, including the addition of language that the Company’s products “remain investigational,” and that “no claims regarding safety or efficacy can be made until the products are approved by the FDA.” U.S. Securities and Exchange Commission July 20, 2017 Page 4 Sales of a substantial number of shares of our Common Stock, page 59 7. Expand your response to prior comment 16 to tell us the specific date that sales in reliance on Rule 144 would be permitted by Rule 144(i) and that sales would be permitted under the lock-up agreement. The Company acknowledges the Staff’s comment and respectfully informs the Staff that the lock-up agreements executed in connection with the Merger (as defined in the 2016 10-K and 10-K Amendment) will expire one year after the effective time of the Merger, or October 24, 2017 (which is a correction to our response to comment #16 in our previous letter dated June 28, 2017, which stated October 26, 2017 as the expiration date for the lock-up agreements). Thus, those 286,566,412 shares of the Company’s common stock subject to the lock-up agreements would be free of any contractual obligations as of October 24, 2017. With respect to sales under Rule 144, no holder will be permitted to sell unregistered shares of the Company’s common stock pursuant to Rule 144 until October 27, 2017, on which date one year will have passed since the Company filed a Form 8-K containing all the “Form 10 information” and reflecting its status as an entity no longer described by Rule 144(i)(1)(i) as contemplated by Rule 144(i)(2). Executive Compensation, page 99 8. We note your response to prior comment 18. Please provide the disclosure required by Regulation S-K Item 402 for all individuals who served as the registrant’s principal executive officer during the last completed fiscal year and for each person who served as a director during any part of the last completed fiscal year. For guidance, see Regulation S-K Compliance and Disclosure Interpretation 127.01. The Company acknowledges the Staff’s comment and respectfully informs the Staff that the 10-K Amendment contains the disclosure required by Regulation S-K Item 402, as such requirements are modified for smaller reporting companies like the Company, with respect to all individuals who served as a director and/or a principal executive officer for the Company (or for the predecessor registrant, Tiger X Medical, Inc.). Security Ownership, page 99 9. When you revise your document as indicated in response to prior comment 19, please include the disclosure required by the last sentence of Regulation S-K Item 403(b). The Company acknowledges the Staff’s comment and respectfully informs the Staff that the 10-K Amendment contains the disclosure required by Regulation S-K Item 403(b), specifically referencing in the table footnotes the amount of shares with respect to which any person listed in the table has a right to acquire beneficial ownership. The Company confirms that no shares held by any person listed in the table have been “pledged” as security for any loan or other financial arrangement. U.S. Securities and Exchange Commission July 20, 2017 Page 5 Certain Relationships, page 99 10. When you revise your document as indicated in response to prior comment 20, please disclose the nature and type of consulting services contemplated by the agreement. Also disclose the nature and type of consulting that the related person provided you during the period that Item 404 requires you to address. The Company acknowledges the Staff’s comment and respectfully informs the Staff that the 10-K Amendment contains the additional information requested regarding the nature and type of consulting services contemplated by the agreement with OPKO Health, Inc., as well as the nature and type of consulting services provided by OPKO Health, Inc. to the Company during the fiscal year ended December 31, 2016. U.S. Securities and Exchange Commission July 20, 2017 Page 6 *** Please direct any questions regarding the Company’s responses or the Revised Registration Statement to me at (650) 493-9300 or mdanaher@wsgr.com. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Michael J. Danaher Michael J. Danaher cc: Peter Altman, President and CEO, BioCardia, Inc. David McClung, Vice President of Finance, BioCardia, Inc.
2017-07-13 - UPLOAD - BioCardia, Inc.
Mail Stop 3030
July 1 3, 2017
Via E -mail
Peter Altman
Chief Executive Officer
BioCardia, Inc.
125 Shoreway Road, Suite B
San Carlos, California 94070
Re: BioCardia, Inc.
Amendment No. 1 to Registration Statement on Form S -3
Filed June 28, 2017
File No. 333 -218124
Form 10 -K for Fiscal Year Ended December 31, 2016
Response dated June 28, 2017
File No. 000 -21419
Dear Dr. Altman :
We have reviewed your amended registration statement and your June 28, 2017 response
to our comment letter and have the following comments. In some of our comments, we may ask
you to provide us with information so we may better understand your disclosure.
Please respond to this lette r by amending your filings and providing the requested
information. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendme nt to your filings and the information you provide in
response to these comments, we may have additional comments. Unless we note otherwise, our
references to prior comments are to comments in our June 15, 2017 letter.
Amendment No. 1 to Registration S tatement on Form S -3
Information Incorporated by Reference, page 30
1. Please specifically incorporate by reference the Form 8 -K that you filed June 21, 2017.
Exhibits
2. We note your response to prior comment 2. Indentures covering the debt securities to be
issued in a registration statement must be qualified at the time the registration statement
relating to those debt securities becomes effective. File the indentures, not merely forms.
Peter Altman
BioCardia, Inc .
July 13, 2017
Page 2
3. Revise the descriptions of exhibits 4.3 and 4.5 to reflect the substance of the second
paragraph of your response to prior comment 2.
Form 10 -K for Fiscal Year Ended December 31, 2016
4. We may have further comment after you revise your Form 10 -K as indicated in your
responses, including your responses to prior comments 7, 12 and 21.
Business, page 1
5. Expand your response to prior comment 8 to address all identified parties, not merely
those described on page 1 . Also tell us whether you r reference to the authors on pages 6
and 8 is intended to incorporate their conclusions by reference.
6. Expand your response to prior comment 9 to address all claims of safety and efficacy in
your document. We note for example your disclosure at the top of page 6 regarding
safety. If claims of safety and efficacy are appropriate under FDA rules only after a
product has been cleared for sale, please revise your disclosure of claims regarding
products that have not been so cleared.
Sales of a substantial number of shares of our Common Stock, page 59
7. Expand your response to prior comment 16 to tell us the specifi c date that sales in
reliance on Rule 144 would be permitted by Rule 144(i) and that sales would be
permitted under the lock -up agreement.
Executive Compensation, page 99
8. We note your response to prior comment 18. Please p rovide the disclosure require d by
Regulation S -K Item 402 for all individuals who served as the registrant’s principal
executive officer during the last completed fiscal year and for each person who served as
a director during any part of the last completed fiscal year. For guidance, see Regulation
S-K Compliance and Disclosure Interpretation 127.01.
Security Ownership, page 99
9. When you revise your document as indicated in response to prior comment 19, please
include the disclosure required by the last sentence of Regulation S -K Item 403(b).
Certain Relationships, page 99
10. When you revise your document as indicated in response to prior comment 20, please
disclose the nature and type of consulting services contemplated by the agreement. Also
Peter Altman
BioCardia, Inc .
July 13, 2017
Page 3
disclose the nature and type of consulting that the related person provided you during the
period that Item 404 requires you to address.
You may contact Julie Sherman at (202) 551 -3640 or Brian Cascio, Accounting Branch
Chief, at (202) 551 -3676 if you have questions regarding comments on the financial statements
and related matters. Please contact Tom Jones at (202) 551 -3602 or me at (20 2) 551 -3617 with
any other questions.
Sincerely,
/s/ Russell Mancuso
Russell Mancuso
Branch Chief
Office of Electronics and Machinery
cc: Michael J. Danaher
2017-06-28 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm bcda20170627_corresp.htm 650 Page Mill Road Palo Alto, CA 94304-1050 PHONE 650.493.9300 FAX 650.493.6811 www.wsgr.com June 28, 2017 Via EDGAR and Overnight Delivery Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Russell Mancuso, Branch Chief, Office of Electronics and Machinery Brian Cascio, Accounting Branch Chief Julie Sherman Tom Jones Re: BioCardia, Inc. Registration Statement on Form S-3 Filed May 19, 2017 File No. 333-218124 Annual Report on Form 10-K for Fiscal Year Ended December 31, 2016 Filed March 30, 2017 File No. 000-21419 Dear Mr. Mancuso: On behalf of our client, BioCardia, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated June 15, 2017 and relating to the Company’s Registration Statement on Form S-3 (File No. 333-218124) filed with the Commission on May 19, 2017 (the “Registration Statement”) and Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (File No. 000-21419) filed with the Commission on March 30, 2017 (the “2016 10-K”). The Company has also revised the Registration Statement in response to the Staff’s comments in respect of the Registration Statement and is filing concurrently with this letter a revised Registration Statement (the “Revised Registration Statement”) which reflects these revisions and updates and clarifies certain other information. For the convenience of the Staff, we are providing to the Staff by overnight delivery copies of this letter and the Revised Registration Statement (including a version marked against the Registration Statement filed on May 19, 2017), in care of Mr. Mancuso. The Company also intends to file an amendment to the 2016 10-K (the “10-K Amendment”) in order to provide additional or updated exhibits thereto and revisions to the disclosures therein, to the extent as may be requested by the Staff following receipt of this letter. austin beijing brussels hong kong los angeles new york palo alto san diego san francisco seattle shanghai washington, dc wilmington, de U.S. Securities and Exchange Commission June 28, 2017 Page 2 In this letter, we have recited the comments from the Staff in bold italicized type and have followed each comment with the Company’s response. Capitalized terms used but not defined herein shall have the meanings ascribed thereto in the Revised Registration Statement or the 2016 10-K, as applicable. Except as otherwise specifically indicated, page references herein correspond to the page of the Revised Registration Statement or the 2016 10-K, as applicable. Form S-3 Common Stock, page 8 1. Address in your description of your common stock the vote required for removal of directors. In response to the Staff’s comment, the Company has revised the disclosure on page 8 in the Revised Registration Statement to include the required vote by holders of common stock to (i) remove a director or directors from the Company’s board of directors and (ii) amend the Company’s amended and restated bylaws. Exhibits 2. File the indentures, rather than forms of the indentures. Also include the information you indicate is included as exhibits 4.3 and 4.5. In response to the Staff’s comment, the Company advises the Staff that the Company has not entered into any agreement to offer or issue debt securities that will be governed by an indenture. Rather, to comply with the Trust Indenture Act of 1939, the Company has filed with the Registration Statement forms of indentures for both senior and subordinated debt securities in order to provide generic, non-specific descriptions of such debt securities, with details to be provided in a subsequent supplemental indenture at the time any series of debt securities are to be offered. Further, regarding exhibits 4.3 (the Form of Senior Debt Security) and 4.5 (the Form of Subordinate Debt Security), the Company advises the Staff that the information contained in Article 2, Sections 2.2 and 2.3 in each of the form indentures filed as exhibits 4.2 (with respect to senior debt securities) and 4.4 (with respect to subordinated debt securities) is sufficient to deem exhibits 4.3 and 4.5, respectfully, as having been included in the Registration Statement. U.S. Securities and Exchange Commission June 28, 2017 Page 3 Exhibit 5.1 3. Confirm that, with each take-down of securities on the registration statement, you will file an amended opinion of counsel that does not contain inappropriate assumptions or limitations. In response to the Staff’s comment, we and the Company confirm that an amended opinion of counsel will be filed with each take-down of securities under the Revised Registration Statement, once effective, and that all such opinions will not contain any inappropriate assumptions or limitations. 4. Reconcile the second paragraph which indicates that subscription rights do not underlie the Units with footnote (4) to the fee table of your registration statement. In response to the Staff’s comment, the legal opinion of Wilson Sonsini Goodrich & Rosati, P.C. (“WSGR”), filed as exhibit 5.1 to the Registration Statement (the “S-3 5.1 Opinion”), has been revised and filed with the Revised Registration Statement (such revised legal opinion to be referred to hereafter as the “Revised S-3 5.1 Opinion”), and such Revised S-3 5.1 Opinion makes clear that the Subscription Rights (as defined therein) do underlie the Units (as defined therein) as stated in the Registration Statement and Revised Registration Statement. 5. With regard to the equity securities, file an opinion that addresses the laws of the jurisdiction in which the registrant is organized. We note that the penultimate opinion of this exhibit addresses federal laws and the laws of New York, but the facing page of your registration statement indicates that you are incorporated in Delaware. We respectfully direct the attention of the Staff to the final paragraph on page 4 of the S-3 5.1 Opinion and Revised S-3 5.1 Opinion. The language confirms that the legal opinions provided therein address relevant laws from the State of Delaware (or more specifically, the Delaware General Corporation Law, defined therein as the “DGCL”). The legal opinions only address the laws of the State of New York as to the enforceability of the Debt Securities (as defined therein). U.S. Securities and Exchange Commission June 28, 2017 Page 4 Signatures 6. Include the registrant’s name in its signature as required by Form S-3. In response to the Staff’s comment, the Company has revised the signature page in the Revised Registration Statement to include the Company’s name, as the registrant and filer of the Revised Registration Statement. Form 10-K for Fiscal Year Ended December 31, 2016 Special Note, page i 7. You may not disclaim responsibility for your disclosure. Revise the penultimate sentence of the penultimate paragraph accordingly. In response to the Staff’s comment, the Company will remove this sentence from the “Special Note Regarding Forward-Looking Statements” or similar sections in all future reports to be filed with Commission or any other public disclosures. However, if the Staff requires the Company to amend the 2016 10-K to this effect, the Company will include language in its forthcoming10-K Amendment that the sentence in question (“Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements”) has been deleted. Business, page 1 8. Tell us whether you compensated any of the identified parties that conducted the studies that you describe in this filing. The Company acknowledges the Staff’s comment and respectfully informs the Staff that the parties identified as having conducted the studies described on page 1 of the 2016 10-K were compensated only on terms that were standard and customary in clinical study arrangements. The Company further intends to compensate the “Steering Committee” that is overseeing the current enrollment trial, which the Company is co-sponsoring. 9. If your proposed product has not been cleared for marketing by the FDA, tell us the authority on which you rely to indicate that the product is “safe” or “effective” as you do on pages 6, 8 and 9. The Company acknowledges the Staff’s comment and respectfully informs the Staff that the disclosures on the aforementioned pages of the 2016 10-K do not declare the product as “safe” or “effective” or having received any such determination from the FDA. Rather, the disclosures on these pages state only that the results of various trials have supported the findings of safety and efficacy with respect to the product and that the Company anticipates that future trials and studies (including the FDA accepted Phase III trial noted on page 7 of the 2016 10-K) will further these findings. While the final sentence of the third paragraph on page 8 (“Together, these findings supported that the direct injection of cellular grafts into damaged myocardium is safe and effective in the peri-infarct period.”) was included on page 91 of Amendment No. 2 to Form S-1 filed by BioCardia, Inc. on July 13, 2015 (the “July 2015 S-1/A”), the Company will replace this sentence in the forthcoming 10-K Amendment with the following: “Together, these findings demonstrated the safety of directly injecting cellular grafts into damaged myocardium during the peri-infarct period and provided signals of efficacy.” U.S. Securities and Exchange Commission June 28, 2017 Page 5 Product Overview, page 4 10. Tell us whether the studies have shown any material disadvantages or risks of your proposed products other than those mentioned in the fourth paragraph on page 5. The Company acknowledges the Staff’s comment and respectfully informs the Staff that there have been no material disadvantages or risks of the Company’s proposed products other than as disclosed in the aforementioned paragraph of the 2016 10-K. The Company notes further that the same disclosure was also provided on page 86 of the July 2015 S-1/A, and that the Staff had no comments relating to that disclosure at the time. 11. Clarify the difference between “post-acute myocardial infarction” mentioned on page 7 and the scope of your current IDE. We note your disclosure on page 4 that patients have been treated in post-acute infarction. The Company acknowledges the Staff’s comment to clarify the difference between “post-acute myocardial infarction” mentioned on page 7 of the 2016 10-K and the scope of the Company’s current IDE. The Company’s current IDE is the CardiAMP Heart Failure IDE, and the ongoing trial for this IDE (“CardiAMP HF”) is now entering the Phase III stage. This IDE is designed for patients suffering from chronic heart failure that is secondary to a myocardial infarction, or a heart attack. The CardiAMP cell therapy system is also being considered as part of treatments for patients in the immediate aftermath of a heart attack (i.e. “post-acute myocardial infarction (PMI) or “post-acute infarction,” which are equivalent terms here). The Company had used the CardiAMP’s Helix platform to deliver concentrated bone marrow cells for these types of patients in a Phase I study during 2016 (which took place in Europe), and as noted on page 7 of the 2016 10-K, the Company intends to submit a slightly modified IDE for trial (“CardiAMP PMI”) in the United States for these types of patients during 2017. U.S. Securities and Exchange Commission June 28, 2017 Page 6 Business Strategy, page 10 12. Disclose the existence of and reasons for material delays. For example, you disclose on page 10 that a trial is expected to have top-line results in 2019. However, BioCardia, Inc. disclosed on page 79 of Amendment No. 2 to Form S-1 filed on July 13, 2015 the anticipation of top-line trial results in the second half of 2017. The Company acknowledges the Staff’s comment and respectfully informs the Staff that the delays resulted from a lack of funding due to the failure of the Company to complete its initial public offering in 2015. Specifically, the disclosure on page 79 of the July 2015 S-1/A was conditioned on the assumption that the Company would complete its initial public offering and receive the necessary funding in order to complete its top-line trials during the second half of 2017. Without the necessary funding, the Company’s timeline and the implementation and execution of its business strategy were delayed by the additional time it took to raise money to fund the pivotal trial. The Company does not believe that any amendment to the disclosure on page 10 of the 2016 10-K is required; however, if the Staff deems that such amendment is necessary, the Company will add the following sentence after the last sentence in the first bullet point under the subheading, “Business Strategy”: “While we originally expected to commence this trial in the second half of 2015 and obtain results in the second half of 2017, delays in our obtaining necessary funding at the time resulted in our postponing the trial until December 2017.” Manufacturing, page 11 13. Tell us the status of your resolution of the observations from the February 2017 inspection. The Company respectfully informs the Staff that following the filing of the 2016 10-K, the observations from the February 2017 inspection have since been resolved to the satisfaction of the European notified body mentioned on page 11 of the 2016 10-K. Intellectual Property, page 11 14. We note your disclosure regarding patents expiring beginning in 2017. Provide us your analysis of the materiality of the patents that expire this year and in 2018-2019. The Company respectfully informs the Staff that out of the Company’s more than 50 issued U.S. patents to which it holds exclusive rights, five will expire during 2017, six will expire during 2018 and none will expire during 2019. The Company does not believe that any of the patents that are due to expire during this time period are material for the Company’s leading products or will have a material impact on the Company’s business or results of operations. U.S. Securities and Exchange Commission June 28, 2017 Page 7 The patent protection of biotherapeutics is complex and uncertain, page 51 15. Tell us why publication of information relating to your potential products may prevent you from enforcing patents as you mention in this risk factor. The Company respectfully informs the Staff that certain elements of the Company’s potential products are part of confidential, non-public trials and are not publicly disclosed. If the elements of the Company’s products were to be published before the Company obtains a patent or files a patent application, then others may be able to use the information to develop and apply for their own patent or patents, which if filed prior to the Company’s, could be superior in rights to any later filed Company patent under the “first inventor-to-file” system contemplated by the Leahy-Smith America Invents Act. Thus, the Company would be potentially unable to obtain or enforce patents relating to such products. Sales of a substantial number of shares of our common stock, page 59 16. Clarify the effect on sales if you were determined to have been an issuer described in Rule 144(i)(1)(i). In this regard, we note your reference on page 98 regarding your exclusion of information based on guidance in a Compliance and Disclosure Interpretation referring to transactions such as those in which the legal acquirer is a non-operating public shell. The Company acknowledges the Staff’s comment and respectfully informs the Staff that it believes pursuant to Rule 144(i)(2), holders of unregistered shares of the Company’s common stock wi
2017-06-15 - UPLOAD - BioCardia, Inc.
Mail Stop 3030 June 15, 2017 Via E -mail Peter Altman Chief Executive Officer BioCardia, Inc. 125 Shoreway Road, Suite B San Carlos, California 94070 Re: BioCardia, Inc. Registration Statement on Form S -3 Filed May 19, 2017 File No. 333 -218124 Form 10 -K for Fiscal Year Ended December 31, 2016 Filed March 30, 2017 File No. 000 -21419 Dear Dr. Altman : We have reviewed the above -referenced filings a nd have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your filings and providing the requested information. If you do not believe our comme nts apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filings and the information you provide in response to these comments, we may have additi onal comments. Form S -3 Common Stock, page 8 1. Address in your description of your common stock the vote required for removal of direc tors. Exhibits 2. File the indentures, rather than forms of the indentures. Also include the information you indicat e is included as exhibits 4.3 and 4.5. Peter Altman BioCardia, Inc . June 15, 2017 Page 2 Exhibit 5.1 3. Confirm that , with each take -down of securities on the registration statement, you will file an amended opinion of counsel that does not contain inappropriate assumptions or limitations. 4. Reconcile the second paragraph which indicates that subscription rights do not underlie the Unit s with footnote (4) to the fee table of your registration statement. 5. With regard to the equity securities, file an opinion that addresses the laws of the jurisdiction in which the registrant is organized. We note that the penultimate opinion of this exhibit addresses federal laws and the la ws of New York, but the facing page of your registration statement indicates that you are incorporated in Delaware. Signatures 6. Include the registrant’s name in its signature as required by Form S -3. Form 10 -K for Fiscal Year Ended December 31, 2016 Special Note, page i 7. You may not disclaim responsibility for your disclosure. Revise the penultimate sentence of the penultimate paragraph accordingly. Business, page 1 8. Tell us whether you compensated any of the identified parties that conducted the studies that you describe in this filing . 9. If you r proposed product has not been cleared for marketing by the FDA, tell us the authority on which you rely to indicate that the product is “safe” or “effective” as you do on pages 6, 8 an d 9. Product Overview, page 4 10. Tell us whether the studies have shown any material disadvantages or risks of your proposed products other than those mentioned in the fourth paragraph on page 5. 11. Clarify the difference between “post -acute myocardial in farction” mentioned on page 7 and the scope of your current IDE. We note your disclosure on page 4 that patients have been treated in post -acute infarction. Peter Altman BioCardia, Inc . June 15, 2017 Page 3 Business Strategy, page 10 12. Disclose the existence of and reasons for material delays. For example, you disclose on page 10 that a trial is expected to have top -line results in 2019. However, BioCardia, Inc. disclosed on page 79 of Amendment No. 2 to Form S -1 filed on July 13, 2015 the anticipation of top -line trial results in the second half of 2017. Manufacturing, page 11 13. Tell us the status of your resolution of the observations from the February 2017 inspection. Intellectual Property, page 11 14. We note your disclosure regarding patents expiring beginning in 2017. Provide us your analysis of the materiality of the patents that expire this year and in 2018 -2019 . The patent protection of biotherapeutics is complex and uncertain, page 51 15. Tell us why publication of information relating to your potential products may prevent you from enforcing patents as you mention in this ri sk factor. Sales of a substantial number of shares of our common stock, page 59 16. Clarify the effect on sales if you were determined to have been an issuer described in Rule 144(i)(1)(i). In this regard, we note your reference on page 98 regarding your exclusion of information based on guidance in a Compliance and Disclosure Interpretation referring to transactions such as those in which the legal acq uirer is a non - operating public shell. Item 10. Directors, Executive Officers and Corporate Governance, page 99 17. Provide information for the five -year period required by Regulation S -K Item 401. For example, we note your disclosure regarding Dr. Du ckers. Also, avoid vague disclosure such as statements that an executive was “with” an entity; we note for example, your disclosure regarding Mr. McClung. Peter Altman BioCardia, Inc . June 15, 2017 Page 4 Item 11. Executive Compensation, page 99 18. Provide the disclosure required by Regulation S -K Item 402 for all individuals who served as the registrant’s principal executive officer during the last completed fiscal year. We note for example the reference to Andrew Brooks and Steven Rubin in your Form 8-K filed May 11, 2016. Also, include director compensation for each person who served as a director during any part of the last completed fiscal year. Item 12. Security Ownership, page 99 19. Tell us why the last row of your beneficial ownership table inc ludes only 10 people given the number of directors and executive officers that you identify in the proxy statement. Also, show us how any omitted beneficial ownership affect s your calculation of the aggregate market value of common equity held by non -affiliates under General Instruction I.B.1 of Form S -3. Exhibits 20. File your agreement with OPKO Health mentioned on page 96. Also, provide us your analysis supporting your conclusion that Regulation S -K Item 404 does not require disclosure of this transa ction in the information incorpor ated as Item 13 of your Form 10-K. Exhibit s 31.1 and 31.2 21. Please amend to provide currently dated Certifications that include the internal control over financial reporting language in paragraph 4(b). For guidance, see Regulation S -K Compliance and Disclosure Interpretations, Section 215.02. This comment also app lies to your Form 10 -Q for the period ended March 31, 2017. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Peter Altman BioCardia, Inc . June 15, 2017 Page 5 You may contact Julie Sherman at (202) 551 -3640 or Brian Cascio, Accounting Branch Chief, at (202) 551 -3676 if you have questions regarding comments on the financial statements and related matters. Please contact Tom Jones at (202) 551 -3602 or me at (202) 551 -3617 with any other questions. Sincerely, /s/ Russell Mancuso Russell Mancuso Branch Chief Office of Electronics and Machinery cc: Michael J. Danaher
2011-05-13 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
May 13, 2011 Joshua B. Weingard Chief Legal Officer Cardo Medical, Inc. 7625 Hayvenhurst Avenue Suite 49 Van Nuys, California 91406
Re: Cardo Medical, Inc.
Preliminary Information Statement on Schedule 14C
Filed January 31, 2011
Annual Report on Form 10-K for the fiscal year
ended December 31, 2010 Filed March 31, 2011 File No. 0-21419
Dear Mr. Weingard:
We have completed our review of your filings. We remind you that our comments or
changes to disclosure in response to our co mments do not foreclose the Commission from
taking any action with respect to the filings and the company ma y not assert staff comments
as a defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States. We urge all persons who are responsible for the
accuracy and adequacy of the disclosure in the fi lings to be certain that the filings include the
information the Securities Exchange Act of 1934 and all applicable rules require.
S i n c e r e l y ,
A m a n d a R a v i t z
Assistant Director
2011-04-21 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
April 21, 2011 Joshua B. Weingard Chief Legal Officer Cardo Medical, Inc. 7625 Hayvenhurst Avenue Suite 49 Van Nuys, California 91406
Re: Cardo Medical, Inc.
Revised Preliminary Informat ion Statement on Schedule 14C
Filed April 11, 2011
File No. 0-21419
Dear Mr. Weingard:
We have reviewed your filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your
disclosure. Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response. If you do not believe our comments apply to your f acts and circumstances or do
not believe an amendment is required, please tell us why in your response.
After reviewing any amendment to your filing and the information you provide in
response to these comments, we may have additional comments.
The Arthrex Asset Sale, page 3
1. Given your disclosure on page 18 regarding re instatement of salaries, please disclose
here or under your “Use of Proceeds” di sclosure on page 5, as appropriate, the
amount of proceeds from the Arthrex and A ltus transactions that will be used for
payments to affiliates. In a subsequent section of your docum ent after the Summary,
please disclose the amount to be paid to each affiliate.
Joshua B. Weingard
Cardo Medical, Inc. April 21, 2011 Page 2 Why Was There No Vote Required, page 8
2. With a view toward clarified disclosu re, please tell us whether you obtained
shareholder vote for the Altus sale, even if not required. It is unclear whether you
used the shareholder vote regarding the spin e division that you mention at the bottom
of page 5 to engage in the Altus sale and, if so, how cl osing of the Altus sale was
consistent with Rule 14c-2(b).
Background of the Asset Sale, page 15
3. Please expand your response to prior co mment 6 to tell us why you have not
disclosed the “estimates, forecasts, plans and financial projections” mentioned in section 5.29 of the asse t purchase agreement.
Information Statement, page 25
4. We note the references in this section to correspondence, comme nts, communications
and requests from the SEC; however, members of the staff issued the comment letters
to you. Please revise to remove any im plication that the Commission itself has
reviewed your filing. Likewise, given th at the SEC did not issue the comments on
your filing and does not clear your responses to comments, please clarify how the
provisions of your amendment mentioned on page 26 will operate. Your revised
disclosure should not contain any implication that the SEC or its staff has or will (1)
approve or disapprove of your filing or tran sactions or (2) pass upon the adequacy or
accuracy of your disclosure.
Opinion of Inverness Advisors, page 28
5. Regarding your response to prior comment 9:
Please clarify the basis for your statement on page 30 that your forecasts reflected
the division’s performance “were it not to be sold to Arthrex.” In this regard, we
note the assumptions mentioned in the la st paragraph of your response to that
comment are not mentioned in your filing.
Please tell us why your projections on page 30 are only through 2013, yet
according to page 31, your advisor’s analysis was based on 20 years of
projections.
Joshua B. Weingard
Cardo Medical, Inc. April 21, 2011 Page 3 Discounted Cash Flow Analysis, page 34
6. Please disclose the compensation to the fina ncial advisor in connection with the sale
of your spine division.
Results of Operations and Financial Condition, page 55
7. We note that you discuss results of operations of the consolidated entity, including the
Reconstructive Division and the Spine Divi sion which were reported as discontinued
operations in the audited financial statemen ts for 2009 and 2010. Please tell us how
this presentation is appropriate under Item 303(a)(3) of Regulation S-K which states
that the discussion in this section should be of reported income from continuing
operations.
Pro Forma Unaudited Consolidated Financial Information, page 59
8. Please tell us why it is appr opriate under Article 11 of Re gulation S-X to present in
the pro forma balance sheet the use of proceeds from the asset sales to pay down outstanding notes payable. The pro forma adjustments should only give effect to
events that are directly attributable
to each specific transaction.
9. We see from page 59 that the purchase pric e for the Reconstructive Asset Sale will be
paid in cash on a quarterly basis for a term up to and including the 20th anniversary of
the closing date. Please tell us why y ou present all cash as being received upon
closing in the pro form a balance sheet.
10. As a related matter, we note that $900,000 of the proceeds from the Reconstructive
Asset Sale will be placed in escrow. Please tell us why you have not presented that
amount as restricted cash.
11. Regarding the pro forma statement of operations, we note that you present
discontinued operations. Under Instruction 1 to Article 11 of Regulation S-X, the
historical statement of income used in th e pro forma financial information should not
report operations of a segment that has been discontinued, extraordinary items, or the
cumulative effects of accounting changes. In this regard, if the histor ical statements of
income include such items, only the portion of the income statement through "income from continuing operations" (or the appropriate modification thereof) should be used
in preparing pro forma results. Please revise as appropriate.
Joshua B. Weingard
Cardo Medical, Inc. April 21, 2011 Page 4 Financial Statements
Report of Independent Registered Public Accounting Firm, page F-3
12. We see that Stonefield Josephs on, Inc. audited your financia l statements for the year
ended December 31, 2009. Please tell us who audited the reclassi fication adjustments
for discontinued operations that impacted the year ended December 31, 2009. In
addition, tell us why the audit reports do not address the recl assification adjustments.
We refer you to the PCAOB Staff Questions and Answers related to Adjustments to
Prior-Period Financial Statements Audite d by a Predecessor Auditor dated June 9,
2006.
Consolidated Statement of Operations, page F-5
13. Please revise to clarify if the loss from operations of disconti nued Reconstructive and
Spine Divisions is net of applicab le income taxes (benefit).
14. Please revise to also disclose net loss pe r share from continuing operations. Refer to
FASB ASC 260-10-50.
Note 1. Discontinued Operations, page F-8
15. We reference the statement that you do not expect any continuing cash flows to be
generated from the discontinued operations. Pl ease reconcile that statement with the
previous disclosure on page 59 that you exp ect to receive 5% royalty of future net
sales of the reconstructive products fo r 20 years after the closing date.
Subsequent Events, page F-20
16. Please tell us how you considered disclosing th e sale of the Spine Division that closed
on April 4, 2011 as a subsequent event. We see that the sale occurred before the
financial statements were reissued in the Schedule 14C. Refer to FASB ASC 855-10-
50-2. We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes the information the Securities
Exchange Act of 1934 and all applicable Exchan ge Act rules require. Since the company
and its management are in possession of all fact s relating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
Joshua B. Weingard
Cardo Medical, Inc. April 21, 2011 Page 5 In responding to our comments, please provi de a written statement from the company
acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
You may contact Kristin Lochhead at ( 202) 551-3664 or Brian Cascio, Accounting
Branch Chief, at (202) 551-3676 if you have que stions regarding comments on the financial
statements and related matters. Please contac t Tom Jones at (202) 551-3602 or me at (202)
551-3617 with any other questions.
S i n c e r e l y ,
R u s s e l l M a n c u s o
Branch Chief
cc (via fax): Esther L. Moreno
2011-04-11 - CORRESP - BioCardia, Inc.
CORRESP
1
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Akerman Senterfitt
One Southeast Third Avenue
25th Floor
Miami, Florida 33131
Tel: 305.374.5600
Fax: 305.374.5095
April 11, 2011
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, DC 20549
Re:
Cardo Medical, Inc.
Revised Preliminary Information Statement on Schedule 14C
Filed March 9, 2011
File No. 0-21419
Dear Mr. Mancuso:
On behalf of Cardo Medical, Inc. (the “Company”), we hereby respond to the Staff’s comment
letter, dated March 18, 2011, regarding the above-referenced revised preliminary information
statement on Schedule 14C. Please note that, for the Staff’s convenience, we have recited the
Staff’s comments in boldface type and provided our response to each comment immediately thereafter.
References to the “Revised Information Statement” used herein refer to the revised preliminary
information statement on Schedule 14C being filed in connection with this response letter.
General
1.
We reference the letter from the Division of Corporation Finance Chief Accountant’s Office
dated March 14, 2011. As previously requested, please revise to include the historical
financial statements of Cardo Medical, Inc. and the other information required by Item 14
of Schedule 14A. Please also include pro forma financial information required by Article
11 and Rule 8-05 of Regulation S-X reflecting the sale of the reconstructive division.
BOCA RATON DALLAS DENVER FORT LAUDERDALE JACKSONVILLE LAS VEGAS LOS ANGELES MADISON MIAMI NAPLES
NEW
YORK ORLANDO PALM BEACH TALLAHASSEE TAMPA TYSONS CORNER WASHINGTON, D.C. WEST PALM BEACH
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
April 11, 2011
Page 2
In response to the Staff’s comment, we have included the historical financial statements
on pages F-1 through F-21 of the Revised Information Statement and the other applicable
information relating to the Company required by Item 14 of Schedule 14A on pages 38-61
of the Revised Information Statement. We have also revised the disclosure on pages 59-61
of the Revised Information Statement to include the pro forma financial information
required by Article 11 and Rule 8-05 of Regulation S-X giving effect to the completed sale
of substantially all of the assets of the Spine Division and the pending sale of the
Reconstructive Division assets.
2.
As a related matter, we also reissue prior comment 2. Please note that if financial
statements as of a date on or after the date a component of your business has been disposed
of or has been classified as held for sale are required in a proxy statement, retrospective
reclassification of all prior periods to report the results of that component in
discontinued operations is required. Please refer to FASB ASC 205-20 for guidance on
reporting discontinued operations. In that regard, please tell us how you considered that
the historical financial statements of Cardo Medical, Inc. to be included in the Schedule
14C should be retroactively reclassified to show discontinued operations.
The Company’s historical financial statements for the years ended December 31, 2010 and
2009 that are included in the Revised Information Statement reflect the retrospective
reclassification of the appropriate prior periods to report the results of the
Reconstructive Division and the Spine Division in discontinued operations in accordance
with the guidance in FASB ASC 205-20.
3.
We note your response to prior comment 3; however, if your affiliated shareholders
approved a sale, you should inform investors of that development in the information
statement. Also clarify whether applicable state law requires additional shareholder vote
after you establish the terms of the sale of the spine
division, and disclose the substance of the last sentence of your response to prior
comment 3.
In response to the Staff’s comment, we have revised the disclosure on pages 5, 6, 8 and 13 of the
Revised Information Statement. In the Revised Information Statement, we have revised the
disclosure to reflect that we have closed the sale of substantially all of the Spine
Division assets. Subsequent to the Company’s filing of the initial preliminary
information statement on January 31, 2011 and the revised preliminary information
statement on March 9, 2011, the Company determined that it was in the best interests of
the Company to sell substantially all of the assets of the Spine Division before the
closing of the pending sale of the Reconstructive Division assets and that such sale did
not constitute a sale of substantially all of the Company’s assets overall. As a result,
the
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
April 11, 2011
Page 3
Company determined that it was not required to obtain stockholder approval for the
sale of substantially all of the assets of the Spine Division. If the Company sells any
remaining assets after the sale of the Reconstructive Division assets that constitute all
or substantially all of the Company’s assets, the Company will seek the written consent of
a majority of its stockholders if required pursuant to state law, in which case the
Company will prepare and send a separate information statement to its stockholders
providing the material information and terms of any such sale at least 20 calendar days
before its consummation.
A Note about Forward-Looking Statements, page 7
4.
Please expand your response to
prior comment 6 to address your
financial information as of
September 30, 2010.
In response to the Staff’s comment, we have revised the disclosure on page 7 of the
Revised Information Statement to delete the reference to the safe harbor.
Background of the Asset Sale, page 15
5.
We note your response to prior comment 7.
Reconcile the disclosure in the
penultimate paragraph on page 15 that a
fourth prospective purchaser submitted “a
preliminary indication of interest” on
December 3, 2010 with the disclosure in
the third paragraph on page 16 about “one
preliminary indication of interest”
received on December 21, 2010 and “three
preliminary indications of interest”
previously received.
In response to the Staff’s comment, we have revised the disclosure on page 16 of the
Revised Information Statement to clarify that the preliminary indications of interest
previously received that were referred to excluded that indication of interest which was
superseded by a specific proposal.
6.
We note your response to prior comment 8; however, it does not appear that you expanded
the references to your negotiations with Arthrex to disclose in greater detail the
negotiations that took place. For example, we note the following:
•
You continue to refer in the second paragraph on page 16 to Arthrex submitting a
“revised proposal” on December 22, 2010; however, you do not mention any other proposals
from Arthrex before that date. Please clarify when Arthrex submitted proposals before
December 22, 2010 and disclose the material revisions in the submitted proposals.
•
You continue to disclose in the third paragraph on page 16 that the board “decided to
continue negotiations with Arthrex” and in the fourth paragraph on page 16 that you
“continued to negotiate with Arthrex the terms and conditions.” However, you did not
expand the references to disclose in greater detail the negotiations that took place.
Please revise accordingly.
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
April 11, 2011
Page 4
In response to the Staff’s comment, we have revised the
disclosure on pages 15-17 of the
Revised Information Statement to provide more detail on the negotiations that took place.
Specifically, we have clarified that the revised proposal submitted by Arthrex on December
22, 2010 was actually Arthrex’s first proposal after the preliminary indication of
interest submitted by it on November 29, 2010 and we have explained the principal manner
in which Arthrex’s proposal differed from Arthrex’s preliminary indication of interest.
We have also disclosed the principal subjects of our negotiations with Arthrex after the
December 23, 2010 Board of Directors meeting.
Opinion of Inverness Advisors, page 27
7.
Regarding your response to prior comment 13:
•
Ensure that you have provided us a copy of all written materials that the financial
advisor presented to the board. We note the disclosure in the seventh paragraph on page 16
that the financial advisor made a presentation to the board on January 12, 2011; however,
it does not appear that you provided us a copy of any materials presented to the board on
that day. Please advise.
•
Provide the disclosure required by Item 14(b)(6) of Schedule 14A and Item 1015(b) of
Regulation M-A concerning the presentation on January 12, 2011.
In response to the Staff’s comment, the written materials that were provided by Inverness to
the Board of Directors in connection with the January 12, 2011 meeting of the Board of
Directors have been provided by the Company to the Staff under separate cover on a
confidential and supplemental basis pursuant to Rule 12b-4 under the Exchange Act. In
accordance with such rules, we respectfully requested that these materials be returned to us
promptly following completion of the Staff’s review thereof. By separate letter, we also
requested confidential treatment of these materials pursuant to the provisions of 17 C.F.R.
§200.83. Additionally, the Company is providing to the Staff under separate cover on a
confidential and supplemental basis pursuant to Rule 12b-4 under the Exchange act all other
written materials that Inverness provided to the Board. In accordance with such rules, we
respectfully request that these materials be returned to us promptly following completion of
the Staff’s review thereof. By separate letter, we also request confidential treatment of
these materials pursuant to the provisions of 17 C.F.R. §200.83.
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
April 11, 2011
Page 5
We do not believe the written materials that were provided by Inverness to the Board of
Directors or the related presentation that Inverness made to the Board of Directors in
connection with the January 12, 2011 meeting of the Board of Directors are materially related
to the sale of the Reconstructive Division assets. Accordingly, we do not believe any
additional disclosure about the January 12, 2011 presentation is required by Item 14(b)(6) of
Schedule 14A and Item 1015(b) of Regulation M-A. The transaction analyzed in the January 12,
2011 materials and presentation was materially different from the transaction that was
ultimately approved by the Board of Directors and the January 12, 2011 materials and
presentation were not relied upon by the Board of Directors in deciding to approve the
transaction. The January 12, 2011 materials and presentation analyzed the sale of the
Reconstructive Division assets and the Spine Division assets on a combined basis, while the
pending transaction relates to the sale of the Reconstructive Division assets only.
The January 12, 2011 materials and presentation did not include separate information on the
Reconstructive Division assets, such as a valuation of the Reconstructive Division assets on
a stand alone basis, that would be relevant to the transaction. If information from the
January 12, 2011 materials and presentation were included in the information statement, we
would be concerned that a stockholder would treat the information as germane to the pending
transaction when it is not and would therefore be misleading. Only the January 24, 2011
materials and presentation analyze the sale of the Reconstructive Division assets on a stand
alone basis, which is the pending transaction to which the Revised Information Statement
relates. Therefore, we do not believe an analysis of the Reconstructive Division assets and
the Spine Division assets on a combined basis to be material to the pending transaction in
this context. In light of the Staff’s comment, we have added
disclosure on pages 16-17 of
the Revised Information Statement to the effect that our Board of Directors did not rely on
the January 12, 2011 materials and presentation and have further clarified the differences
between the content of the January 12, 2011 and January 24, 2011 materials and presentations.
Additionally, the January 12, 2011 materials and presentation are not material in the context
of the completed sale of substantially all of the Company’s Spine Division assets. The
completed sale of substantially all of the Company’s Spine Division assets was a different
transaction with a different purchaser for different consideration (which did not include a
royalty payment component) from the transaction analyzed in the January 12, 2011 materials
which analyzed the sale of the Reconstructive Division assets and the Spine Division assets
on a combined basis and included a royalty payment as part of the purchase price for the assets of both divisions. The January 12, 2011 materials and presentation were not relied upon by
the Board of Directors in deciding to approve and consummate the sale of substantially all of
the assets of the Spine Division.
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
April 11, 2011
Page 6
We do not believe the additional written materials that were provided by Inverness to the
Board of Directors referenced above are materially related to the sale of the Reconstructive
Division assets. Accordingly, we do not believe any additional disclosure about these
materials is required by Item 14(b)(6) of Schedule 14A and Item 1015(b) of Regulation M-A.
These additional written materials provided to the Board were of an administrative nature,
updated the Board on the status of a potential transaction involving the Company’s assets or, in the case of the January 7, 2011 materials,
provided a royalty valuation analysis. The materials relating to the valuation analysis are
not materially related to the sale of the Reconstructive Division
assets for the same reasons discussed above in connection with the January 12, 2011
materials because the royalty valuation analysis was based on an analysis of the Reconstructive
Division assets and the Spine Division assets on a combined basis.
8.
We note your response to prior comment 14. However, the reference to the “letter is
solely for the information of the company’s Board of Directors in evaluating the
transaction” has not been deleted. Therefore, we reissue the comment.
In response to the Staff’s comment, we have revised the fairness opinion attached as Annex
C to the Revised Information Statement to delete “solely” from the opinion language that
was cited in Comment #8. We believe the remaining language is a correct statement in that
the opinion letter was for the information of the Company’s Board of Directors. The
deletion eliminates any suggestion in the opinion that stockholders cannot rely on the
opinion.
Discontinued Cash Flow Analysis, page 32
9.
We note your response to prior comment
16. Please demonstrate whether
disclosure of the results reflected in
the financial and operating forecasts,
to the extent they are not in line with
historic operating trends, is material
to shareholders to evaluate your
disclosure in this section.
For the reasons described below, we do not believe disclosure of the results reflected in
the financial and operating forecasts to be material to stockholders in their evaluation
of the disclosure in this section. That notwithstanding, we have included summary
disclosure on page 30 of th
2011-03-18 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
March 18, 2011 Joshua B. Weingard Chief Legal Officer Cardo Medical, Inc. 7625 Hayvenhurst Avenue Suite 49 Van Nuys, California 91406
Re: Cardo Medical, Inc.
Revised Preliminary Informat ion Statement on Schedule 14C
Filed March 9, 2011
File No. 0-21419
Dear Mr. Weingard:
We have reviewed your filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your
disclosure. Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response. If you do not believe our comments apply to your f acts and circumstances or do
not believe an amendment is required, please tell us why in your response.
After reviewing any amendment to your filing and the information you provide in
response to these comments, we may have additional comments. General
1. We reference the letter from the Division of Corporation Finance Chief Accountant’s
Office dated March 14, 2011. As previously requested, please revise to include the
historical financial statements of Cardo Medical, Inc. and the other information required
by Item 14 of Schedule 14A. Please also include pro forma financial information
required by Article 11 and Rule 8-05 of Re gulation S-X reflecting the sale of the
reconstructive division.
2. As a related matter, we also reissue prio r comment 2. Please note that if financial
statements as of a date on or after the date a component of your business has been
Joshua B. Weingard
Cardo Medical, Inc. March 18, 2011 Page 2
disposed of or has been clas sified as held for sale are required in a proxy statement,
retrospective reclassification of all prior periods to report the results of that component in
discontinued operations is required. Please refer to FASB ASC 205-20 for guidance on
reporting discontinued operations . In that regard, please tell us how you considered that
the historical financial statements of Cardo Me dical, Inc. to be included in the Schedule
14C should be retroactively reclassifi ed to show discontinued operations.
3. We note your response to prior comment 3; however, if your affiliated shareholders
approved a sale, you should inform investors of that development in the information statement. Also clarify whether applicable state law requires additi onal shareholder vote
after you establish the te rms of the sale of the spine divi sion, and disclose the substance
of the last sentence of your response to prior comment 3.
A Note about Forward-Looking Statements, page 7
4. Please expand your response to prior comment 6 to address your financial information as
of September 30, 2010.
Background of the Asset Sale, page 15
5. We note your response to prior comment 7. R econcile the disclosure in the penultimate
paragraph on page 15 that a fourth prospective purchaser submitted “a preliminary
indication of interest” on December 3, 2010 with the disclosure in the third paragraph on
page 16 about “one preliminary indication of interest” received on December 21, 2010
and “three preliminary indications of interest” previously received.
6. We note your response to prior comment 8; however, it does not appear that you
expanded the references to your negotiations with Arthrex to di sclose in greater detail the
negotiations that took place. For ex ample, we note the following:
You continue to refer in the second pa ragraph on page 16 to Arthrex submitting a
“revised proposal” on December 22, 2010; however, you do not mention any other proposals from Arthrex before that date. Please clarify when Arthrex
submitted proposals before December 22, 2010 and disclose the material revisions in the submitted proposals.
You continue to disclose in the third para graph on page 16 that the board “decided
to continue negotiations with Arthrex” and in the fourth paragraph on page 16 that
you “continued to negotiate with Arthre x the terms and conditions.” However,
you did not expand the references to disclose in greater de tail the negotiations that
took place. Please revise accordingly.
Joshua B. Weingard
Cardo Medical, Inc. March 18, 2011 Page 3 Opinion of Inverness Advisors, page 27
7. Regarding your response to prior comment 13:
Ensure that you have provided us a copy of all written materials that the financial
advisor presented to the board. We note the disclosure in the seventh paragraph
on page 16 that the financial advisor made a presentation to the board on January
12, 2011; however, it does not appear that you provided us a copy of any
materials presented to the board on that day. Please advise.
Provide the disclosure required by Item 14(b)(6) of Schedule 14A and Item
1015(b) of Regulation M-A concerni ng the presentation on January 12, 2011.
8. We note your response to prior comment 14. Ho wever, the reference to the “letter is
solely for the information of the compa ny’s Board of Directors in evaluating the
transaction” has not been deleted. Therefore, we reissue the comment.
Discounted Cash Flow Analysis, page 32
9. We note your response to prior comment 16. Pl ease demonstrate whet her disclosure of
the results reflected in the fina ncial and operating forecasts, to the extent they are not in
line with historic operating trends , is material to shareholders to evaluate your disclosure
in this section.
Voting Securities and Principal Holders Thereof, page 34
10. Please tell us why you did not update this di sclosure. In your re sponse, address (1)
whether the identified security holders acquired or disposed of shares since the date of the
table and (2) the filing date of the Form 4 reflecting the ownership information disclosed
in your table.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes the information the Securities
Exchange Act of 1934 and all applicable Exchan ge Act rules require. Since the company
and its management are in possession of all fact s relating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
Joshua B. Weingard
Cardo Medical, Inc. March 18, 2011 Page 4 In responding to our comments, please provi de a written statement from the company
acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
You may contact Kristin Lochhead at ( 202) 551-3664 or Brian Cascio, Accounting
Branch Chief, at (202) 551-3676 if you have que stions regarding comments on the financial
statements and related matters. Please contac t Tom Jones at (202) 551-3602 or me at (202)
551-3617 with any other questions.
S i n c e r e l y ,
R u s s e l l M a n c u s o
Branch Chief
cc (via fax): Esther L. Moreno, Esq.
2011-03-09 - CORRESP - BioCardia, Inc.
CORRESP
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Akerman Senterfitt
One Southeast Third Avenue
25th Floor
Miami, Florida 33131
Tel: 305.374.5600
Fax: 305.374.5095
March 9, 2011
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, DC 20549
Re:
Cardo Medical, Inc.
Preliminary Information Statement on Schedule 14C
Filed January 31, 2011
File No. 0-21419
Dear Mr. Mancuso:
On behalf of Cardo Medical, Inc. (the “Company”), we hereby respond to the Staff’s comment
letter, dated February 25, 2011, regarding the above-referenced Preliminary Information Statement
on Schedule 14C (the “Information Statement”). Please note that, for the Staff’s convenience, we
have recited the Staff’s comments in boldface type and provided our response to each comment
immediately thereafter.
General
1.
Please tell us your consideration of the need to include the historical financial
statements of Cardo Medical, Inc. and the other information required by Item 14 of Schedule
14A. Please also tell us why you have not included pro forma financial information
required by Article 11 and Rule 8-05 of Regulation S-X reflecting the sale of the
reconstructive division. We see that the preliminary information statement was filed due
to the sale or transfer of a substantial part of your assets.
BOCA RATON DALLAS
DENVER FORT LAUDERDALE JACKSONVILLE
LAS VEGAS LOS ANGELES MADISON
MIAMI NAPLES
NEW YORK ORLANDO PALM BEACH TALLAHASSEE TAMPA
TYSONS CORNER WASHINGTON, D.C. WEST PALM BEACH
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
March 9, 2011
Page 2
The Company respectfully does not agree that historical and pro forma financial statements
are required to be included in the Information Statement in the case of an information
statement relating to a sale of substantially all of the assets of a company where only
the target’s stockholders approve the transaction and such approval is obtained by a
written consent of a majority of the stockholders and no separate vote of the stockholders
is being solicited. When the Company prepared the Information Statement, it considered
the requirements of Schedule 14C, including Item 1 of Schedule 14C that provides:
“Furnish the information called for by all of the items of Schedule
14A of Regulation 14A (other than Items 1(c), 2, 4 and 5 thereof)
which would be applicable to any matter to be acted upon at the
meeting if proxies were to be solicited in connection with the
Meeting. Notes A, C, D and E to Schedule 14A are also applicable to
Schedule 14C.”
As part of its analysis, the Company considered Item 13 of Schedule 14A which requires
certain financial and other information be disclosed if action is to be taken with respect
to the authorization or issuance of any securities otherwise than for exchange for
outstanding securities of the registrant (Item 11) or if action is to be taken with
respect to the modification of any class of securities of the registrant, or the issuance
or authorization for issuance of securities of the registrant in exchange for outstanding
securities of the registrant (Item 12). The current transaction does not involve either
of the above described actions, so the Company concluded that the financial and other
information set forth in Item 13 was not required to be disclosed in the Information
Statement.
The Company considered Item 14 of Schedule 14A, including subsection (a) relating to the
applicability of that section that provides:
“If action is to be taken with respect to any of the following
transactions, provide the information required by this Item:
(1)
A merger or consolidation;
(2)
An acquisition of securities of another person;
(3)
An acquisition of any other going business or the assets of a
going business;
(4)
A sale or other transfer of all or any substantial part of
assets; or
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
March 9, 2011
Page 3
(5) A liquidation or dissolution.”
Notwithstanding, subsection (a) above governing the applicability of Item 14, the
Instructions to Item 14, and specifically Instruction 2 provides:
“2. (a) In transactions in which the consideration offered to
security holders consists wholly of cash, the information required
by paragraph (c)(1) of this Item for the acquiring company need not
be provided unless the information is material to an informed voting
decision (e.g., the security holders of the target company are
voting and financing is not assured).
(b) Additionally, if only the security holders of the target
company are voting:
i. The financial information in paragraphs (b)(8)-(11) of this Item
for the acquiring company and the target need not be provided; and
ii. The information in paragraph (c)(2) of this Item for the target
company need not be provided.
If, however, the transaction is a going-private transaction (as
defined by §240.13e-3), then the information required by paragraph
(c)(2) of this Item must be provided and to the extent that the
going-private rules require the information specified in paragraph
(b)(8)-(b)(11) of this Item, that information must be provided as
well.”
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
March 9, 2011
Page 4
Additionally, the Company considered the Division of Corporation Finance’s Financial Reporting
Manual, Topic 1140.3, Business Combinations, providing in relevant part:
Solicited
Shareholders
Consideration
Financial Statements
Target only
Cash only
Financial statements of
the target are not
required in the proxy
statement since security
holders are presumed to
have access to information
about their company,
unless it is a going
private transaction. See
Instruction 2(b) to Item
14 of Schedule 14A.
Financial statements of
the acquirer are not
required unless the
information is material to
an informed voting
decision (e.g., acquirer
financing is not assured).
See Instruction 2(a) to
Item 14 of Schedule 14A.
. . . .
No pro forma information
is required.
The current transaction involves a sale or other transfer of all or any substantial part
of the assets of the Company. In the current transaction, the stockholders of the
acquiring company (Arthrex) are not voting on this transaction and a majority of the
stockholders (58%) of the target company (Cardo Medical) have consented to the transaction
prior to the filing of the preliminary Information Statement. The stockholders of the
Company have access to information about the Company in the Company’s publicly filed
documents, including its reports on Form 8-K, 10-Q and 10-K. This is not a going private
transaction. As disclosed in the Information Statement, the Company will continue to be a
public company and the Company’s common stock will continue to trade on the OTC Bulletin
Board. The Company is receiving the consideration described in the Information Statement
and the stockholders of the Company are not receiving any consideration. The purchase
price of the proposed asset sale is to be paid wholly in cash and there is no contingency
related to a potential lack of financing.
The financial statements of the acquiring company would not be material to an informed
voting decision because the majority of the Company’s stockholders acted by written
consent on January 24, 2011 to approve the proposed transaction prior to the filing of the
Information Statement. Therefore, pursuant to Instruction 2(a) of Item 14, the financial
information required by paragraph (c)(1) of Item 14 is not required for an informed voting
decision. Additionally, pursuant to Instruction 2(b) to Item 14, the financial
information required in paragraphs (b)(8)-(11) and (c)(2) of Item 14 are not required
because only the security holders of the target company were required to approve the
transaction. Finally, this is not a going-private transaction and thus the financial
statements required by the foregoing paragraphs would not apply.
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
March 9, 2011
Page 5
The Company also considered the requirements under Item 15 of Schedule 14A assuming that
the transaction constituted the disposition of any property. Under Item 15, no historical
financial statements or pro forma financial information is required.
The Company also considered the Staff’s interpretive guidance in Question 6 of the
Division of Corporation Finance’s Manual of Publicly Available Telephone Interpretations,
Third Supplement (July 2001):
Question 6
Q: What financial statements should be filed with proxy materials
soliciting votes with respect to the sale or other transfer of all
or any substantial part of assets? See Item 14(a)(4) of Schedule
14A.
A: The registrant should provide its financial information pursuant
to Item 14(c)(1) of Schedule 14A. In addition, if authorization is
sought from security holders for disposition of a significant
business, unaudited financial statements of that business should be
provided in the proxy materials for the same periods as are required
for the registrant, along with pro forma information. The staff’s
position concerning these financial statements is not affected by
the adoption of the new rules.
The Company did not believe the above interpretive guidance applied to the Information
Statement and the transaction on the basis that the Information Statement did not
constitute proxy materials soliciting the votes of stockholders with respect to the sale
of all or substantially all of the Company’s assets.
Lastly, the Company believed it had provided information to its stockholders that
constituted the material and relevant financial impact of the transaction in the
Information Statement when it provided the following disclosure under “Summary—Structure
of the Company After the Asset Sale”:
“After completion of the Asset Sale, the Company will hold:
•
cash and cash equivalents in the approximate amount of
$11.3 million, excluding $900,000 held in escrow;
•
accounts receivable in the approximate amount of
$450,000; and
•
the limited liability company interests of Cardo
Medical, LLC.
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
March 9, 2011
Page 6
After the Asset Sale, our ongoing operations will consist of our
Spine Division operations, the collection of accounts receivable,
the collection of royalty payments pursuant to the terms of the
Asset Purchase Agreement, and the payment of any liabilities.”
If the Staff believes that we should expand this narrative discussion in the Information
Statement to include additional items or considerations regarding the financial impact of
the transaction, we would gladly consider such request and revise the Information
Statement to provide additional disclosure.
Alternatively, if the Staff disagrees with the Company’s position set forth above, the
Company is simultaneously pursuing a request for a waiver from the Office of the Chief
Accountant with respect to providing financial statements for the year ended December 31,
2010 which have not been issued and are not publicly available. The Company in such
waiver request is requesting the Staff to permit it to provide the historical financial
statements for the years ended December 31, 2009 and 2008 and the financial statements for
the nine months ended September 30, 2010.
2.
As a related matter, please note that if financial statements as of a date on or after the
date a component of your business has been disposed of or has been classified as held for
sale are required in a proxy statement, retrospective reclassification of all prior periods
to report the results of that component in discontinued operations is required. Please
refer to FASB ASC 205-20 for guidance on reporting discontinued operations. In that
regard, please tell us how you considered that the historical financial statements of Cardo
Medical, Inc, to be included in the Schedule 14C should be retroactively reclassified to
show discontinued operations.
Please see our response to Comment #1.
Spine Division Sale, page 3
3.
Please tell us whether you plan to send another information statement with the material
information regarding the spine division sale 20 days before the spine division sale. See
Rule 14c-2(b). Cite all authority on which you rely, including any relevant authority
regarding whether applicable state law permits you to consider a transaction approved by
shareholders when you have not determined the terms of that transaction.
In light of the Staff’s comment, we have determined to revise the Information Statement to
remove the resolution acted upon by written consent of a majority of our stockholders
providing the following, “authorized, as soon as practicable after the closing
contemplated by the asset purchase agreement, Cardo Medical to sell all of the assets of
its Spine Division on terms and conditions to be determined by the Board of Directors of
Cardo Medical.” The Company will prepare and send a separate information statement
providing the material information regarding the Spine Division sale at least 20 calendar
days before its consummation if the Company determines that such sale constitutes a sale
of substantially all of its assets under Delaware law.
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
March 9, 2011
Page 7
The Asset Sale, page 3
4.
Please expand the fourth bullet point on pages 3 and 9 and the section entitled “Use of
Proceeds” on page 4 to quantify the amount of proceeds to be paid to each of your officers
and directors. For example, are any of the proceeds to be used to pay accrued salaries of
your officers? Also, please quantify the amount of your proceeds to be paid to other
related parties. For example, we note the disclosure on page 10 of your latest Form 10-Q
that you issued a promissory note to the brother of your chief executive officer.
In response to the Staff’s comment, we have revised the
disclosure on pages 3-5, 10 and 19
of the Information Statement.
Structure of the Company After the Asset Sale, page 5
5.
Please expand the appropriate section to disclose who will be your officers and directors:
•
after the sale of your reconstructive division; and
•
after the sale of your spine division.
In response to the Staff’s comment, we have revised the
disclosure on pages 5 and 20 of
the Information Statement.
A Note about Forward-Looking Statements, page 6
6.
We note your reference to penny stock in your latest Form 10-K. The safe harbor you cite
in the second sentence excludes penny stock issuers. Please do not invoke a safe harbor
that is not applicable.
In our Form 10-K for the year ended December 31, 2009 and filed on March 31, 2010, we
provided in a risk factor that our common stock may be a penny stock in certain
circumstances and disclosed the risks associated with a “penny stock” characterization.
In response to the Staff’s comment, we respectfully advise the Staff that we have reviewed
Rule 3a51-1 promulgated under the Securities Exchange Act of 1934, as amended, which
states that “penny stock” shall mean any equity security other than a security whose
issuer has:
Russell Mancuso
Branch Chief
United States Securities and Exchange Commission
March 9, 2011
Page 8
1.
Net tangible assets (i.e., total assets less intangible assets and liabilities)
in excess of $2,000,000, if the issuer has been in continuous operation for at least
three years, or $5,000,000, if the issuer has been in continuous operations for less
than three years; or
2.
Av
2011-02-25 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
February 25, 2011
Via Facsimile and U.S. Mail
Joshua B. Weingard Chief Legal Officer Cardo Medical, Inc. 7625 Hayvenhurst Avenue Suite 49 Van Nuys, California 91406
Re: Cardo Medical, Inc.
Preliminary Information Statement on Schedule 14C
Filed January 31, 2011
File No. 0-21419
Dear Mr. Weingard:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response. If you do not believe our comments apply to your f acts and circumstances or do
not believe an amendment is required, please tell us why in your response.
After reviewing any amendment to your filing and the information you provide in
response to these comments, we may have additional comments. General
1. Please tell us your consideration of the need to include the historical financial statements
of Cardo Medical, Inc. and th e other information required by Item 14 of Schedule 14A.
Please also tell us why you have not include d pro forma financial information required by
Article 11 and Rule 8-05 of Regulation S-X reflecting the sale of the reconstructive
division. We see that the preliminary informa tion statement was filed due to the sale or
transfer of a substantial pa rt of your assets.
Joshua B. Weingard
Cardo Medical, Inc. February 25, 2011 Page 2
2. As a related matter, please note th at if financial statements as of a date on or after the date
a component of your business has been disposed of or has been classified as held for sale
are required in a proxy statement, retrospectiv e reclassification of all prior periods to
report the results of that component in discont inued operations is required. Please refer to
FASB ASC 205-20 for guidance on reporting discontinued oper ations. In that regard,
please tell us how you considered that the historical financial statements of Cardo
Medical, Inc. to be included in the Schedul e 14C should be retroac tively reclassified to
show discontinued operations.
Spine Division Sale, page 3
3. Please tell us whether you plan to send anot her information statement with the material
information regarding the spine division sale 20 days before the spine division sale. See
Rule 14c-2(b). Cite all authority on whic h you rely, including any relevant authority
regarding whether applicable state law perm its you to consider a transaction approved by
shareholders when you have not determined the terms of that transaction.
The Asset Sale, page 3
4. Please expand the fourth bullet point on pages 3 and 9 and the secti on entitled “Use of
Proceeds” on page 4 to quantify the amount of proceeds to be pa id to each of your
officers and directors. For example, are any of the proceeds to be used to pay accrued
salaries of your officers? Also, please quan tify the amount of your pr oceeds to be paid to
other related parties. For example, we note the disclosure on page 10 of your latest Form
10-Q that you issued a promisso ry note to the brother of your chief executive officer.
Structure of the Company Af ter the Asset Sale, page 5
5. Please expand the appropriate section to disclose who will be your officer s and directors:
after the sale of your rec onstructive division; and
after the sale of your spine division.
A Note about Forward-Looking Statements, page 6
6. We note your reference to penny stock in your latest Form 10-K. The safe harbor you
cite in the second sentence ex cludes penny stock issuers. Please do not invoke a safe
harbor that is not applicable.
Joshua B. Weingard
Cardo Medical, Inc. February 25, 2011 Page 3
Background of the Asset Sale, page 14
7. Please reconcile the disclosure in the penulti mate paragraph on page 14 regarding three
preliminary indications of interest with the disclosure in the first paragraph on page 15
regarding four preliminary indications of interest.
8. Please expand the references on page 15 to your negotiations with Arth rex to disclose in
greater detail the negotiations that took place, why the structure of the transaction was
changed and how the purchase price was dete rmined. Include a description of the
negotiation of the agreements with affiliates.
9. Please tell us, with a view to disclosu re, whether the purchase price for only the
reconstructive division was greater than th e amounts in the indications of interest
mentioned in the third paragraph on page 15.
10. Please tell us, with a view to disclosure, wh ether you have begun to ne gotiate the sale of
your spine division with any of the three or four parties from whom you received
indications of interest or otherwise.
Reasons for the Asset Sale and the Spine Division Sale, page 16
11. Please provide greater specificity regardi ng the reasons for the transactions. For
example:
When did you reduce your workforce? By what amount? Why?
What led to the conclusion that you are unable to raise funds?
How did payments to related persons affect the decision?
How did the “Special Factors” mentioned in the next subsection affect your reasons
for the transactions?
Opinion of Inverness Advisors, page 24
12. Please clarify how Inverness’ January 12, 2011 analysis mentioned on page 15 differed
from the January 24 analysis.
13. Provide us a copy of all written materials that the financial advisor pr ovided to the board.
Joshua B. Weingard
Cardo Medical, Inc. February 25, 2011 Page 4
14. We note the limitation on reliance by share holders in the last full paragraph on the
penultimate page of the opinion attached as Annex C. The limitation should be deleted
because it is inconsistent with the disclo sures relating to the opinion. Otherwise:
Disclose the basis for the financial advisor’ s belief that shareholders cannot rely upon
the opinion to support any claims against the financial advisor aris ing under state law,
such as the inclusion of an express discla imer in the financial advisor’s engagement
letter with you.
Describe any applicable state-law authority regarding the availability of such a
potential defense. In the absence of appli cable state-law authority, disclose that the
availability of such a defense will be resolved by a court of competent jurisdiction.
Disclose that resolution of the question of th e availability of such a defense will have
no effect on the rights and responsibilities of the board of direct ors under applicable
state law.
Disclose that the availability of such a state-law defense to the financial advisor
would have no effect on the rights and respons ibilities of ei ther the financial advisor
or the board of directors under the federal securities laws.
15. We note the disclaimer in the first para graph on page 26 that Inverness assumed no
responsibility relating to the forecasts. While it may be accep table to include qualifying
language concerning subjective an alyses, it is inappropriate to disclaim responsibility for
statements made in the document. Please revise.
16. We note your disclosure that Inverness us ed the projections provided by you in its
analyses. Please provide us your analysis as to whether disclosure of the projections may
be material to a shareholder in evaluating your disclosure.
17. Refer to the last sentence of the penultimate paragraph on page 30. With a view toward
clarified disclosure, please tell us with specificity the nature of the services that Inverness and its affiliates have provi ded you, the dates of those services, the amount you paid for
those services, and the nature of any ag reement to provide future services.
18. We note the statement in the penultimate se ntence of the last full paragraph on the
penultimate page of Annex C regarding Inverne ss’ prior written consent. If true, please
disclose that Inverness has consented to the use of the opinion in this document and to
your summary of the opinion as it appear s in your information statement.
Joshua B. Weingard
Cardo Medical, Inc. February 25, 2011 Page 5
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing incl udes the information the Securities Exchange Act
of 1934 and all applicable Exchange Act ru les require. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In responding to our comments, please provi de a written statement from the company
acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
You may contact Kristin Lochhead at ( 202) 551-3664 or Brian Cascio, Accounting
Branch Chief, at (202) 551-3676 if you have que stions regarding comments on the financial
statements and related matters. Please contac t Tom Jones at (202) 551-3602 or me at (202)
551-3617 with any other questions.
S i n c e r e l y ,
R u s s e l l M a n c u s o
Branch Chief
2010-09-21 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
September 21, 2010
Derrick Romine Chief Financial Officer Cardo Medical, Inc. 9701 Wilshire Blvd., Suite 1100 Beverly Hills, CA 90212
Re: Form 10-K for the fiscal year ended December 31, 2009
Filed September 29, 2008
File No. 000-21419
Dear Mr. Romine:
We have completed our review of your Form 10-K and related filings
and do not, at this time, ha ve any further comments.
Sincerely,
Brian Cascio Accounting Branch Chief
Cc: Joshua Weingar d, Chief Legal Officer
2010-09-20 - CORRESP - BioCardia, Inc.
CORRESP
1
filename1.htm
September 20, 2010 Letter
9701 Wilshire Blvd., Suite 1100 Beverly Hills, CA 90212
T 310-274-2036
F 310-271-2632
E info@CardoMedical.com
September 20, 2010
VIA EDGAR
Mr. Brian Cascio
Accounting Branch Chief
United States Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Cardo Medical, Inc.
Form 10-K for the fiscal year ended December 31, 2009
Filed March 31, 2010
Dear Mr. Cascio,
In connection with our response letter, dated September 9, 2010, to the United States Securities and Exchange Commission's
comment letter, dated August 25, 2010, Cardo Medical, Inc. (the "Company") acknowledges the following:
the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
Staff comments or changes to disclosure in response to Staff comments do not foreclose the
Commission from taking any action with respect to the filing; and
the Company may not assert staff comments as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United States.
CARDO MEDICAL, INC.
By: /s/ Derrick Romine
Derrick Romine
Chief Financial Officer
2010-09-09 - CORRESP - BioCardia, Inc.
CORRESP
1
filename1.htm
September 9, 2010 Letter
9701 Wilshire Blvd., Suite 1100 Beverly Hills, CA 90212
T 310-274-2036
F 310-271-2632
E info@CardoMedical.com
September 9, 2010
VIA EDGAR
Mr. Brian Cascio
Accounting Branch Chief
United States Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549-4631
Re: Cardo Medical, Inc.
Form 10-K for the fiscal year ended December 31, 2009
Filed March 31, 2010
Dear Mr. Cascio,
This letter is in response to the Staff's comment letter dated August 25, 2010, regarding the above-referenced
Form 10-K for Cardo Medical, Inc. (the "Company", "Cardo", "we",
"us" or "our"). Please note that, for the Staff's convenience, we have recited the Staff's comments in
boldface type and provided our response to each comment immediately thereafter.
For 10-K for the fiscal year ended December 31, 2009
1. We note your response to prior
comment 1. Please tell us how you determined that the family members and business associates of Dr. Brooks mentioned in
your response are affiliates of the company as that term is defined in Rule 12b-2. In this regard, it is not clear what impact the
lock-up agreements mentioned in your response would have on your calculation, given that it appears the securities each
person or class of persons you mention is voting common equity. Cite all authority on which you rely. Also, we note from
your response that you applied the same market value calculation when you filed your Form 10-K. To the extent that these
shareholders are appropriately determined to be your affiliates, please tell us how you determined that you continued
to be eligible to use Form S-3 at the time you filed that Form S-3 or when you filed your Form 10-K.
Because the measurement date used for determining smaller reporting
company status (June 30, 2009) differs from the dates used to determine public float for Form S-3 eligibility purposes, the
Company was eligible to report as a smaller reporting company for purposes of the Form 10-K, and also eligible to use Form
S-3 at the time of filing the registration statement and at the time of our Section 10(a)(3) update.
We filed our Registration Statement on Form S-3 on February 8, 2010. In accordance with the
instruction to Section I.B.1. of the General Instructions of Form S-3 and Question 116.06 of the Compliance and Disclosure
Interpretations relating to Securities Act Forms, in calculating the aggregate market value of the voting and non-voting
common equity held by non-affiliates, we selected the closing price of our common stock as of a date (December 21, 2009)
within 60 days prior to February 8, 2010, the date of filing the Form S-3, and multiplied that
by the number of shares of common stock outstanding held by non-affiliates as of February 8, 2010. Please see the calculation below:
Total shares issued and outstanding as of February 8, 2010
230,293,141
Less: Dr. Andrew Brooks
61,823,189
Michael Kvitnitsky
28,916,654
Derrick Romine
677,941
Frost Gamma Investments Trust
33,250,911
Thomas Morgan
7,855,616
Ronald Richards
667,205
Subbarao Uppaluri
396,592
Steven Rubin
102,821
Aggregate family/business associates
17,358,062
Total non-affiliate shares
79,244,150
Closing share price on December 21, 2009
$
1.80
Aggregate market value of common equity
held by non-affiliates
$
142,639,470
In accordance with Question 116.07 of the Compliance and Disclosure Interpretations relating to
Securities Act Forms, we reassessed our Form S-3 eligibility in connection with the filing of our Form 10-K on March 31, 2010
which constituted a Section 10(a)(3) update of our shelf registration statement. Consistent with this interpretation, in
calculating the aggregate market value of the voting and non-voting common equity held by non-affiliates, we selected the
closing price of our common stock as of a date (February 10, 2010) within 60 days prior to March 31, 2010, the date of filing
the Form 10-K, and multiplied that by the number of shares of common stock outstanding held by non-affiliates as of March
31, 2010. Please see the calculation below:
Total shares issued and outstanding as of March 31, 2010
230,293,141
Less: Dr. Andrew Brooks
61,823,189
Michael Kvitnitsky
28,916,654
Derrick Romine
677,941
Frost Gamma Investments Trust
33,250,911
Thomas Morgan
7,855,616
Ronald Richards
667,205
Subbarao Uppaluri
396,592
Steven Rubin
102,821
Aggregate family/business associates
17,358,062
Total non-affiliate shares
79,244,150
Closing share price on February 10, 2010
$
0.96
Aggregate market value of common equity
held by non-affiliates
$
76,074,384
In contrast, as provided in our response, dated August 12, 2010, to Comment #1, the aggregate
market value of the voting and non-voting common equity held by non-affiliates as of June 30, 2009 was below $75 million.
The calculation as of the last business day of the registrant's most recently completed second fiscal quarter is required by the
facing sheet of Form 10-K as it relates to the determination of whether the registrant meets the definition of "large
accelerated filer," "accelerated filer" or "smaller reporting company" in accordance with Rule 12b-2 of
the Exchange Act and is not determinative of whether the registrant remains S-3 eligible in accordance with the look-back
provisions discussed above.
As discussed with the Staff on August 30, 2010 and as set forth in our response, dated August 12,
2010, to Comment #1, the Company has consistently applied the same methodology and approach in determining to exclude
shares held by family members and business associates of Dr. Andrew Brooks (our Chairman and Chief Executive Officer)
from the calculation of the aggregate market value of our common stock held by non-affiliates. The determination of affiliate
status under Rule 12b-2 of the Exchange Act and Rules 144 and 145(d) of the Securities Act is not a bright-line test and
instead requires a factual assessment as acknowledged by the SEC in numerous no-action letters. Additionally, the note to
the facing sheet of Form 10-K also recognizes that a company may calculate the aggregate market value of the common
stock held by non-affiliates on the basis of assumptions reasonable under the circumstances. As a result, we excluded
shares held by our officers, directors, and 5% or greater stockholders as well as shares held by family members and business
associates of Dr. Andrew Brooks (our Chairman and Chief Executive Officer), which shares were acquired in connection with
our initial merger transaction or in our June 30, 2009 private placement, and which stockholders each delivered a two-year
lock-up agreement with respect to these shares. We viewed these shares as not in the public float for at least the term of the
lock-up agreements (which expired on August 29, 2010). Additionally, we made the reasonable assumption under the
circumstances that the shares held by family members and business associates of Dr. Andrew Brooks should be deemed to
be indirectly controlled by or under common control with Dr. Andrew Brooks. Consequently, we believe we have taken the
more conservative approach to the calculation of the aggregate market value of the common stock held by non-affiliates and
we have been consistent in applying this methodology and approach.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of
Operations, page 35
Liquidity and Capital Resources, page 41
2. We reference your response to prior comment 4 that your
finished goods products have a shelf life ranging from 8 to 10 years and that your base-level inventories are projected to be
consumed between the 1st quarter to the 4th quarter of 2011. Please tell us what you mean by
base-level inventories and if there is some inventory that will not be consumed in the next twelve months. In this regard, tell
us how you considered that a portion of your inventory should be recorded as long-term in your balance sheet.
In an orthopedic implant operation, the surgeon does not know the exact size of the implant needed
for the patient prior to physically incising the area and making a visual assessment. As a result, it is necessary for our
representative to have on-hand all possible sizes and configurations for each surgery. Further, our representative must have
on-hand a second set of implants so that a replacement item is immediately available in the event the initially selected implant
somehow becomes exposed to a non-sterile environment. As such, base-level inventory consists of a minimum of two
complete sets of all possible inventory components for a single surgery.
In addition, replacement inventory must be in sufficient quantity to avoid delays in the scheduling of
surgeries. In "min-max" inventory parlance, base-level inventory would be considered the "min" or
minimum necessary to conduct orderly business. We only manufacture replacement inventory when the individual sizes of
components become depleted, approaching the base-level.
When we make decisions about what quantities to manufacture, we use our sales forecasts, as well
as historical trends for each particular size and configuration to determine what quantities will be adequate to keep inventory
above the base-level and to expedite implant replenishment. We do not manufacture inventory unless we expect to sell it
within the next twelve months; however, due to the variability of demand for any particular size or component, it is possible
that a particular implant may not be used during the year after manufacture.
While it is not possible to know exactly when and how much of a particular size or component will be
used, at each balance sheet date we perform an assessment of slow moving, excess and obsolete inventory based on
historic trends and sales projections. Such assessment is performed at the individual part number level, so each component
and size is assessed separately. We also perform it on the inventory overall. Such assessments have consistently shown that
the inventory overall is not impaired, and it will sell within one year. On the part-by-part level, though, we find that sometimes
we have inventory on hand that exceeds the historical annual sales level for that part, although it does not exceed expected
sales for the next twelve months.
Our assessment considers each inventory part number as a whole, which includes work-in-progress
("WIP"). Due to our multi-step manufacturing process, WIP is a significant portion of our inventory balances. Part
of the decision regarding when to begin manufacturing replacements is based on the need for sufficient time for the
manufacturing process. This process can take as few as 12 weeks and as many as 18 weeks depending on vendor capacity
and backlog. If our inventory assessment only contemplated finished goods the projected consumption periods would be
accelerated and all such inventories would be consumed within twelve months of the balance sheet date.
Accounting Standards Codification ("ASC") 210-10, Balance Sheet, provides a broad
definition of current assets as "resources commonly identified as those that are reasonably expected to be realized in
cash or sold or consumed during the normal operating cycle of the business." However, ASC 210-10-45-1 states that
"Current assets generally include all of the following: .b. Inventories of merchandise, raw materials, goods in process,
finished goods, operating supplies, and ordinary maintenance material and parts." We note that within this section, a
distinction is made regarding certain of the items such as receivables from employees and prepaid expenses such that these
items would be bifurcated if they extended beyond a year; however, no such distinction is made for inventory.
We also note that while we do not present our financial statements in accordance with International
Financial Reporting Standards ("IFRS"), International Accounting Standard 1, Presentation of Financial
Statements, (Para. 59) states that "assets and liabilities that are part of the normal operating cycle (e.g., inventories and
trade receivables and trade payables) are classified as current assets and current liabilities even when they are expected to
be realized or settled more than one year after the balance-sheet date." In light of the expected convergence of U.S.
GAAP with IFRS, occasionally we also look to IFRS when there is ambiguity in U.S. GAAP.
Regulation S-X, Rule 502, item 6 "Inventories." also makes no distinction between current
and non-current inventory. And in fact, if we were to bifurcate the inventory, the disclosure required by Rule 502 might prove
confusing as the footnote disclosure would not agree to the current or non-current inventory captions on the face of the
balance sheet.
Finally, we noted that we made the decision to manufacture the parts based on expected usage at
that time, and we believe that over time, that usage estimate will be accurate. In other words, in a particular period usage of
Part A might be greater than expected, and Part B might be less than expected. However in the subsequent period, usage
trends will likely reverse to get us to our historical averages.
But the most important consideration was whether a bifurcated presentation would provide decision
usefulness to the users of the financial statements. And using this standard, together with the fact patterns and technical
references above, we concluded it was not appropriate to bifurcate a small portion of certain sizes of certain parts of inventory
to non-current.
The above notwithstanding, going forward, we will continue to assess the need to reclassify such
inventory to non-current, particularly if the amounts involved become significant.
In connection with responding to the Commission's comments, we acknowledge the following:
the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
Staff comments or changes to disclosure in response to Staff comments do not foreclose the
Commission from taking any action with respect to the filing; and
the Company may not assert staff comments as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United States.
We believe the responses provided above fully address the Staff's comments. If you have any
questions, please call me at (310) 274-2036.
Sincerely,
/s/ Derrick Romine
Derrick Romine
Chief Financial Officer
Cardo Medical, Inc.
2010-09-08 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
August 25, 2010
VIA U.S. MAIL and FACSIMILE (310) 271-2632
Derrick Romine Chief Financial Officer Cardo Medical, Inc. 9701 Wilshire Blvd., Suite 1100 Beverly Hills, CA 90212
Re: Form 10-K for the fiscal year ended December 31, 2009
Filed September 29, 2008
File No. 000-21419
Dear Mr. Romine:
We have reviewed your response dated August 12, 2010 and related filings and
have the following comments. In some of our comments, we may ask you to provide us with information so we may be tter understand your disclosure.
Please respond to this letter within te n business days by providing the requested
information or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstan ces, please tell us why in
your response.
After reviewing the information you provide in response to these comments, we
may have additional comments.
Derrick Romine
Cardo Medical, Inc.
August 25, 2010 Page 2
Form 10-K for the fiscal year ended December 31, 2009
1. We note your response to prior comment 1. Please tell us how you determined that
the family members and business associ ates of Dr. Brooks mentioned in your
response are affiliates of the company as that term is defined in Rule 12b-2. In this
regard, it is not clear what impact the lock-up agreements mentioned in your response
would have on your calculation, given that it appears the securities each person or
class of persons you mention is voting comm on equity. Cite all authority on which
you rely. Also, we note from your response that you applied the same market value
calculation when you filed your Form 10-K. To the extent that these shareholders are
appropriately determined to be your affilia tes, please tell us how you determined that
you continued to be eligible to use Form S-3 at the time you filed that Form S-3 or
when you filed your Form 10-K.
Item 7. Management’s Discussion and Analys is of Financial Condition and Results of
Operations, page 35
Liquidity and Capital Resources, page 41
2. We reference your response to prior co mment 4 that your finished goods products
have a shelf life ranging from 8 to 10 year s and that your base-l evel inventories are
projected to be consumed between the 1st quarter to the 4th quarter of 2011. Please
tell us what you mean by base -level inventories and if th ere is some inventory that
will not be consumed in the next twelve months. In this regard, tell us how you
considered that a portion of your inventory should be recorded as long-term in your
balance sheet.
**********
You may contact Kristin Lochhead at ( 202) 551-3664 or me at (202) 551-3676 if
you have questions regarding comments on the financial statements and related matters.
If you have other questions, please contact Louis Rambo at (202) 551-3289 or Geoff
Kruczek at (202) 551-3641.
Sincerely,
Brian Cascio Accounting Branch Chief
Cc: Joshua Weingar d, Chief Legal Officer
2010-08-12 - CORRESP - BioCardia, Inc.
CORRESP
1
filename1.htm
August 12, 2010 Letter
9701 Wilshire Blvd., Suite 1100 Beverly Hills, CA 90212
T 310-274-2036
F 310-271-2632
E info@CardoMedical.com
August 12, 2010
VIA EDGAR
Mr. Brian Cascio
Accounting Branch Chief
United States Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549-4631
Re: Cardo Medical, Inc.
Form 10-K for the fiscal year ended December 31, 2009
Filed March 31, 2010
Form 10-Q for the fiscal quarter ended March 31, 2010
File No. 000-21419
Dear Mr. Cascio,
This letter is in response to the Staff's comment letter dated July 16, 2010, regarding the
above-referenced Form 10-K and 10-Q for Cardo Medical, Inc. (the "Company", "Cardo",
"we", "us" or "our"). Please note, on July 28, 2010, we requested, and were granted,
an extension to submit our response until August 13, 2010. Please note that, for the Staff's convenience, we have
recited the Staff's comments in boldface type and provided our response to each comment immediately thereafter.
For 10-K for the fiscal year ended December 31, 2009
1. Please demonstrate to us how you determined the
aggregate market value of common equity held by non-affiliates disclosed here. Show us all calculations. Include in your
response, at a minimum: (1) the price of your common equity on
the last business day of your quarter ended June 30, 2009; (2) the number of shares outstanding on that date; and (3)
the identities of each affiliate who held your common equity on that date and the amount of common equity each affiliate
held.
We calculated our June 30, 2009 non-affiliate market value using the closing share price of our
common stock as quoted on the OTCBB on that date of $1.25. The total outstanding shares on that date was
203,360,271 and the total outstanding shares included in the non-affiliate calculation was 54,712,244. For purposes of
this calculation we excluded shares held by our officers, directors, and 5% or greater stockholders, as well as shares
held by family members and business associates of Dr. Andrew Brooks (our Chairman and Chief Executive Officer),
which shares were acquired in connection with our initial merger transaction or in our June 30, 2009 private placement,
and which stockholders each delivered a two-year lock-up agreement with respect to these shares. We view these
shares as not in the public float for at least the term of the lock-up agreements (which expire on August 29, 2010) and
determined that it was appropriate to exclude these shares from the non-affiliate market value calculation. We have
consistently applied this approach to our non-affiliate market value calculation when we initially filed our Registration
Statement on Form S-3 on February 8, 2010 and when our Form S-3 was amended by the filing of our Annual Report on
Form 10-K on March 31, 2010.
The calculation for June 30, 2009 is provided below. Also below are the names of our executive
officers, directors, and 5% stockholders and their respective holdings at June 30, 2009. We have not included the names
of family and associates of Dr. Brooks whose shares were excluded from the non-affiliate market value calculation;
however, their aggregate holdings at June 30, 2009 are noted.
Total shares issued and outstanding
203,360,271
Less: Dr. Andrew Brooks
(61,823,189)
Michael Kvitnitsky
(28,916,654)
Derrick Romine
(677,941)
Frost Gamma Investments Trust
(30,965,196)
Thomas Morgan
(7,855,616)
Ronald Richards
(667,205)
Subbarao Uppaluri
(338,967)
Steven Rubin
(45,197)
Aggregate family/business associates
(17,358,062)
Total non-affiliate shares
54,712,244
Closing share price, June 30, 2009
$1.25
Aggregate market value of common equity
held by non-affiliates
$
68,390,305
Item I. Business, page 1
Third-Party Reimbursement, page 12
2. Please tell us, and revise future filings to disclose, whether third-party
payors currently reimburse healthcare providers for procedures involving your products.
Our payor relationship is directly with the hospital and we do not receive payment from third-party payors.
Our products are sold directly to hospitals and or distributors. Healthcare providers are reimbursed by
third-party insurance payors for the professional component of the procedure. Healthcare providers are not reimbursed
from third-party payors for the cost of our products sold to the hospitals and or distributors.
We have noted your comment and will ensure the information above is integrated into the third-party
reimbursement discussion in future filings.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of
Operations, page 35
Liquidity and Capital Resources, page 41
3. We reference the disclosure that one of your most
significant uses of cash related to the build-up of inventory. In this regard, we see that inventory significantly increased
from $942,000 at December 31, 2008 to $3.2 million at December 31, 2009. Please tell us why inventory has
substantially increased at December 31, 2009. Future filings should include a discussion of the underlying reasons for
and the impact of significant changes in financial condition, including investments in inventory and capital expenditures.
Refer to Item 303 of Regulation S-K.
We have noted your comment and will expand future disclosures to
provide additional detail regarding the underlying reasons for and the impact of significant changes in financial condition
including significant build-ups of inventory. Our discussion related to this matter will be expanded in our Form 10-Q for
the quarterly period ended June 30, 2010 and in future filings, substantially as follows:
In order to meet our projected revenue objectives for the remainder of 2010 and 2011 it is
necessary to accumulate certain minimum required levels of inventory at hospitals and with distributors and sales
personnel. Further, additional sets of instrument trays are needed to ensure such trays are available at every surgical
location. Consequently, significant cash is used in operating and financing activities to meet our inventory needs. In
order to achieve our growth objectives, we are considering different strategies, including organic sales increases with
new and existing health care facilities and growth through acquisitions. As a result, we are evaluating and we will
continue to evaluate other companies and businesses for potential synergies that would add value to our existing
operations.
4. As a related matter, please also tell us how you determined that none of your inventory is impaired at
December 31, 2009.
Our finished goods products have a long shelf-life, ranging from 8 to
10 years. As noted above in our response to comment #3, certain minimum required levels of every size per product are
needed in order to participate in a surgery. If a surgical procedure requires three inventory products, our operating room
representative is required to have on hand two sets of every available size for those three products, which may be up to
120 inventory items per single surgery. Because we service several hospitals in multiple geographic locations we must
maintain significant quantities of inventory in finished goods for immediate replenishment.
On a quarterly basis we evaluate our inventory balances to determine the quarter in which we
expect our inventory to be consumed. Our evaluation is dependent upon future sales projections. All of our base-level
inventories are projected to be consumed between the 1st quarter of 2011 and the 4th
quarter of 2011. We do not have any inventory items in stock that are no longer available for sale; therefore, we do not
have any obsolete inventory. Although the infrequently used larger sizes are slower moving inventory items, as the
expected number of surgeries increase over time, the likelihood of these items being consumed also increases. At such
time that management believes a significant amount of slow moving inventory items are not likely to be used in
surgeries, we will establish a reasonable inventory reserve.
Consolidated Financial Statements
Note 7. Vertebron Transaction, page 54
5. We also see that the transaction to acquire Vertebron did not meet the definition
of a business combination and was accounted for as an asset purchase. Please provide the basis in the accounting
literature for your accounting treatment and tell us why the transaction does not represent the acquisition of a business
which should be accounted for under FASB ASC 805.
The Company performed an analysis of the accounting literature in
FASB ASC 805 in order to determine whether the Vertebron transaction met the definition of a business combination. As
indicated in ASC 805, the transaction would not qualify as a business combination if the acquired assets did not
constitute a business. ASC 805 indicates that "a business consists of inputs and processes applied to those inputs
that have the ability to create outputs." Based on several factors, including the layoff of Vertebron's entire
workforce, the dissolution of its management team, and uncooperative vendors, customers and distributors, it was
determined that there were no inputs or processes included in the acquired asset set, and therefore such asset set did
not constitute a business. In fact, the only remaining assets acquired of any value were inventories. Consequently, we
concluded that the Vertebron transaction was not a business combination. See Exhibit A to this response letter
for our analysis at the time of the transaction.
6. In this regard, we reference the statement on page 5 that you acquired all intellectual
property rights owned by Vertebron. Please tell us how you determined the allocation of the purchase price and the
reason this was allocated entirely to inventory with no allocation to any intangible assets.
At the date of the Vertebron transaction, there were other market
participants who were selling virtually the same products offered by Vertebron. None of the products or technologies
owned by Vertebron possessed any technological advantages over current spinal market products nor were they
particularly unique. Further, prior to the Vertebron transaction, Cardo had already received 510(k) approvals from the
FDA to use approximately 90% of the technologies owned by Vertebron. In addition, we had acquired a licensing
agreement to sell Vertebron's products. Thus, it was not necessary for us to acquire the intellectual property to continue
selling the product or have it manufactured for us. Furthermore, since others were already selling products that were
ostensibly the same, there was little or no value of the intellectual property in the market as a whole.
We acquired the Vertebron asset set in an open-bid bankruptcy auction. The fact that our bid
was highest and the replacement cost of the inventory far exceeded our bid price, further evidences the minimal value
attributed to the intellectual property. The value of the Vertebron asset set was the inventory, which was discounted
significantly compared to the prices for which we would ordinarily purchase it. Therefore, we allocated the entire $1.3
million purchase price to inventory.
Item 15. Exhibits. Financial Statement Schedules. page
67
7.
Given the disclosure on page 22 of the registration statement on Form S-3 you
filed on February 8, 2010 about incorporating your future filings by reference, it appears you were required to file your
auditor's consent as an exhibit to your annual report on Form 10-K. See Regulation S-K Item 601(b)(23). Please amend
your Form 10-K accordingly or file that consent as an exhibit to an appropriate Exchange Act filing, as appropriate.
In response to the Staff comment, and in accordance with our
conversation with the Staff regarding this matter, we filed the inadvertently omitted consent under cover of Form 8-K on
August 12, 2010.
Form 10-Q for the fiscal quarter ended March 31, 2010
Condensed Consolidated Financial Statements
Note 1. Summary of Significant Accounting Policies, page 4
8. In future filings please provide a more substantive discussion of management's plan
to continue to raise capital and generate positive cash flows from operations, including the related uncertainties and
anticipated cash requirements over the next 12 months. You should also address your plans to address profitable
operations. The disclosure should include a viable plan that would allow you to continue as a going concern for at least
12 months following the date of the financial statements.
We have noted your comment and we will expand future disclosures
to provide additional detail regarding the status of our plans to address profitable operations. Our discussion related to
this matter will be expanded in our Form 10-Q for the quarterly period ended June 30, 2010 and in future filings,
substantially as follows:
As reflected in the accompanying financial statements, the Company had losses from operations
of $2,937,000 and negative cash flows from operations of $2,593,000 during the six months ended June 30, 2010, an
accumulated deficit of $14,102,000 and limited cash to fund its future operations.
Management anticipates that the Company will sustain losses through the fourth quarter of 2010 and require additional
capital to supplement operations.
Thus far, the Company has been able
to finance its operating losses through a series of equity issuances. Nevertheless,
there is no assurance that the
Company will be able to finance any future operating losses and as such, there is substantial doubt about the
Company's ability to continue as a going concern. Management is actively seeking various sources of financing;
however, there are no assurances that any such financing can be obtained on favorable terms, if at all. Management is
closely monitoring its operating costs to conserve cash until additional funds become available through financing or
operating activities.
9. In addition, please tell us how you considered the going concern matters in your
assessment of the recoverability of goodwill and long lived assets.
The financial statement footnotes included in our Form 10-K for the
year ended December 31, 2009 indicate that Cardo's goodwill and long-lived assets are assessed for impairment
annually at the end of the fourth quarter. The going concern matters, which were considered in our impairment analysis
at December 31, 2009, had not changed significantly between the filing of the December 31, 2009 Form 10-K and the
March 31, 2010 Form 10-Q. Although our internal financial forecasts, which were an integral part of the annual
assessment, were modified to reflect up-to-date information, the results continued to reflect positive cash flows and
profitable operations within a reasonable period of time. Accordingly, our management determined that no events or
changes in circumstances during the quarter ended March 31, 2010, or through the date of filing the corresponding Form
10-Q, warranted an interim assessment of the carrying values of its goodwill or long-lived assets.
In connection with responding to the Commission's comments, we
acknowledge the following:
the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
Staff comments or changes to disclosure in response to Staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the Company may not assert staff comments as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United States.
We believe the responses provided above fully address the Staff's comments. If you have any
que
2010-07-19 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
July 16, 2010
VIA U.S. MAIL and FACSIMILE (310) 271-2632
Derrick Romine Chief Financial Officer Cardo Medical, Inc. 9701 Wilshire Blvd., Suite 1100 Beverly Hills, CA 90212
Re: Form 10-K for the fiscal year ended December 31, 2009
Filed September 29, 2008
Form 10-Q for the fiscal quarter ended March 31, 2010
File No. 000-21419
Dear Mr. Romine:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us w ith information so we may better understand
your disclosure.
Please respond to this letter within te n business days by providing the requested
information or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstan ces, please tell us why in
your response.
After reviewing the information you provide in response to these comments, we
may have additional comments.
Derrick Romine
Cardo Medical, Inc.
July 16, 2010 Page 2 Form 10-K for the fiscal year ended December 31, 2009
1. Please demonstrate to us how you determined the aggregate market value of common equity held by non-affiliates disclosed here. Show us all calculations. Include in your response, at a minimum: (1) the price of your common equity on
the last business day of your quarter ended June 30, 2009; (2) the number of shares outstanding on that date; and (3) the identities of each affiliate who held your common equity on that date and th e amount of common equity each affiliate
held.
Item 1. Business, page 1
Third-Party Reimbursement, page 12
2. Please tell us, and revise future filings to disclose, whether third-party payors currently reimburse healthcar e providers for procedures involving your products.
Item 7. Management’s Discussion and Analys is of Financial Condition and Results of
Operations, page 35
Liquidity and Capital Resources, page 41
3. We reference the disclosure that one of your most significant us es of cash related
to the build-up of inventory. In this regard, we see th at inventory significantly
increased from $942,000 at December 31, 2008 to $3.2 million at December 31,
2009. Please tell us why inventory has substantially increased at December 31,
2009. Future filings should include a discussion of the underlying reasons for and the impact of significant changes in fina ncial condition, includ ing investments in
inventory and capital expenditures. Refer to Item 303 of Regulation S-K.
4. As a related matter, please also tell us how you determined that none of your
inventory is impaired at December 31, 2009.
Consolidated Financial Statements
Note 7. Vertebron Transaction, page 54
5. We also see that the transaction to acqui re Vertebron did not meet the definition
of a business combination and was accounted for as an asset purchase. Please
provide the basis in the accounting lite rature for your accounting treatment and
tell us why the transaction does not repr esent the acquisition of a business which
should be accounted for under FASB ASC 805.
Derrick Romine
Cardo Medical, Inc.
July 16, 2010 Page 3
6. In this regard, we reference the st atement on page 5 that you acquired all
intellectual property rights owned by Vertebron. Please tell us how you
determined the allocation of the purchase price and the reason this was allocated
entirely to inventory with no allocation to any intangible a
Item 15. Exhibits, Financial Statement Schedules, page 67
7. Given the disclosure on page 22 of th e registration statement on Form S-3 you
filed on February 8, 2010 about incorporati ng your future filings by reference, it
appears you were required to file your a uditor’s consent as an exhibit to your
annual report on Form 10-K. See Regulati on S-K Item 601(b)(23). Please amend
your Form 10-K accordingly or file that consent as an exhibit to an appropriate Exchange Act filing, as appropriate.
Form 10-Q for the fiscal quarter ended March 31, 2010
Condensed Consolidated Financial Statements
Note 1. Summary of Significant Accounting Policies, page 4
8. In future filings please provide a more substantive discussion of management’s
plan to continue to raise capital and ge nerate positive cash flows from operations,
including the related uncertainties and an ticipated cash requirements over the next
12 months. You should also address your plans to address profitable operations.
The disclosure should include a viable plan that would allow you to continue as a
going concern for at least 12 months following the date of the financial
statements.
9. In addition, please tell us how you consid ered the going concern matters in you
assessment of the recoverability of goodwill and long-lived assets.
**********
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes the information the Securities
Exchange Act of 1934 and all applicable Exch ange Act rules require. Since the company
and its management are in possession of all f acts relating to a company’s disclosure, they
are responsible for the accuracy and adequacy of the disclosures they have made.
Derrick Romine
Cardo Medical, Inc. July 16, 2010 Page 4
In responding to our comments, please provi de a written statement from the company
acknowledging that:
• the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
• the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any person under the federal secu rities laws of the
United States. You may contact Kristin Lochhead at ( 202) 551-3664 or me at (202) 551-3676 if
you have questions regarding comments on the financial statements and related matters.
If you have other questions, please contact Louis Rambo at (202) 551-3289 or Geoff
Kruczek at (202) 551-3641.
Sincerely,
Brian Cascio Accounting Branch Chief
Cc: Joshua Weingar d, Chief Legal Officer
2009-08-06 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
August 5, 2009
Derrick Romine Chief Financial Officer Cardo Medical, Inc. 8899 Beverly Blvd., Suite 619 Los Angeles, CA 90048
Re: Cardo Medical, Inc.
Form 10-K for the fiscal year ended December 31, 2008
Filed March 31, 2009
Form 10-K for the fiscal year ended June 30, 2008 Filed September 29, 2008 File No. 000-21419
Dear Mr. Romine:
We have completed our review of your Forms 10-K and related filings
and do not, at this time, have any further comments. S i n c e r e l y , B r i a n C a s c i o A c c o u n t i n g B r a n c h C h i e f
2009-07-31 - CORRESP - BioCardia, Inc.
CORRESP 1 filename1.htm July 31, 2009 Letter 9701 Wilshire Blvd., Suite 1100, Beverly Hills, CA 90212 Phone (310) 274-2036 Fax (310) 271-2632 Email info@CardoMedical.com July 31, 2009 In connection with its response to the United States Securities and Exchange Commission's comment letter, dated June 26, 2009, Cardo Medical, Inc. (the "Company") acknowledges the following: the Company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. CARDO MEDICAL, INC. By: /s/ Derrick Romine Derrick Romine Chief Financial Officer
2009-06-29 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
June 26, 2009
VIA U.S. MAIL and FACSIMILE (818) 780-6677
Derrick Romine Chief Financial Officer Cardo Medical, Inc. 8899 Beverly Blvd., Suite 619
Los Angeles, CA 90048
Re: Cardo Medical, Inc.
Form 10-K for the fiscal year ended December 31, 2008
Filed March 31, 2009
Form 10-Q for the fiscal quarter ended March 31, 2009 File No. 000-21419
Dear Mr. Romine:
We have reviewed your response dated June 3, 2009 and related filings and have
the following comments. We have limited our review to only your financial statements
and related disclosures and will make no fu rther review of your documents. Where
indicated, we think you should revise your document in response to these comments, however, if you disagree, we would be pleased to consider your explanation as to why a revision is not necessary. Please be as detailed as necessary in your explanation.
Please understand that the purpose of our review process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Mr. Romine
Cardo Medical, Inc.
June 26, 2009 Page 2
General
1. We see that in your resp onse letter dated June 3, 2009, you provided the requested
representations from the company’s outsi de counsel, Akerma n Senterfitt. In
connection with responding to our comments, please provide, in writing, a
statement from the company acknowledging that:
· the company is responsible for the adequacy and accuracy of the disclosure in
the filing;
· staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking a ny action with respect to the filing;
and
· the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any pers on under the federal s ecurities laws of
the United States.
Form 10-K for the fiscal year ended December 31, 2008
Share Based Payment, page 49
2. We reference your response to prior co mment 7 in our letter dated April 15, 2009.
Please revise future filings to clarif y how you determine historical volatility,
similar to your response.
Note 7. Accin Transaction, page 54
3. We note your response to prior comment 11 in our letter dated April 15, 2009.
Please address the following comments to help us understand your accounting for
the transaction:
· Please tell us the basis for the “neg otiated value of Accelerated” of $10
million. Discuss whether there were a ny valuations performed to support the
negotiated value of the business.
· Please tell us the nature of the comm on ownership between Accin and Cardo.
That is, discuss whether Cardo and Accin are under common control.
· Discuss the business reasons for distributing the $3.75 million to Accin commensurate with the formation of A ccelerated. Discuss why the option to
Mr. Romine
Cardo Medical, Inc.
June 26, 2009 Page 3
purchase the remaining interests in Accelerated was valued at $3.75 million
(37.5% of the negotiated va lue of the company).
Acquisition of Non-Controll ing Interests, page 55
4. We see the discussion of your subsidia ries Uni Knee LLC and Cervical Xpand
LLC and the acquisition of the minority in terests during 2008. Please tell us who
the joint venture partner was for Uni and Cervical, including whether they were a
related party and/or under common control. Discuss when these joint ventures
were formed and how you recorded the formation.
5. Please tell us your accounting treatment fo r the acquisition of the non-controlling
interest in Accelerated a nd your basis in US GAAP for this accounting treatment.
If Accin and Cardo are under common control, tell us why th e acquisition of the
non-controlling interest should not be record ed at historical cost with any excess
of the purchase price over the transferors’ historical cost being recorded as a
capital transaction. Refer to EITF Issue 02-05 and 90-5, SAB Topic 5G,
paragraph D11 – D12 of SFAS 141, and Technical Bulletin 85-5.
6. In addition, tell us how you determined the $6.25 million purchase price and
explain the basis for assigning that value to the non-controlling interest acquired.
Please also tell us how you determined the value of the intangible assets recorded,
including significant estimates and assumptions used, and why you believe that
the entire amount recorded is recoverable.
Form 10-Q for the fiscal quarter ended March 31, 2009
Condensed Consolidated Financial Statements
7. Please tell us how you have complied with the guidance in SFAS 160 with regard to the non-controlli ng interests outstanding at Ma rch 31, 2008 and for the three
months ended March 31, 2008. Please note th at the presentation and disclosure
requirements of SFAS 160 should be app lied retrospectively for all periods
presented and impact the presentation of non-controlling interests in the balance
sheet and statement of operations. Refer to paragraphs 38 – 39 and A3 – A7 of SFAS 160.
Item 4. Evaluation of Disclosure C ontrols and Procedures, page 20
8. We see that you provided management’s assessment of the effectiveness of your
internal controls over financial reporting as of March 31, 2009. As we note that you are only required by Item 308 and 308( T) of Regulation S-K to provide
management's assessment of the effec tiveness of your internal control over
Mr. Romine
Cardo Medical, Inc. June 26, 2009 Page 4
financial reporting as of the end of your mo st recent fiscal year , please tell us why
this was provided for the interim period and whether an assessment was performed as of March 31, 2009.
As appropriate, please respond to these co mments within 10 business days or tell
us when you will provide us with a response. Please furnish a cover letter with your
response that keys your responses to our comments and provides any requested
information. Detailed cover le tters greatly facilitate our re view. Please understand that
we may have additional comments after re viewing your responses to our comments.
You may contact me at (202) 551-3676 or Kristin Lochhead at (202) 551-3664 if
you have questions. In this regard, please do not hesitate to contact Martin James,
Senior Assistant Chief Accountant, at (202) 551-3671 with any other questions.
Sincerely,
Brian Cascio Accounting Branch Chief
2009-06-04 - CORRESP - BioCardia, Inc.
CORRESP
1
filename1.htm
June 3, 2009 Letter
Denver
One Southeast Third Avenue
Fort Lauderdale
25th Floor
Jacksonville
Miami, Florida 33131-1714
Los Angeles
Madison
www.akerman.com
Miami
New York
305 374 5600 tel 305 374 5095 fax
Orlando
Tallahassee
Tampa
Tysons Corner
Michael Francis
Washington, DC
305 982 5581
West Palm Beach
michael.francis@akerman.com
June 3, 2009
VIA EDGAR
Brian Cascio
Accounting Branch Chief
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549-6010
Re: Cardo Medical, Inc.
Form 10-K for the fiscal year ended December 31, 2008
Filed March 31, 2009
Form 10-Q/A for the quarterly period ended September 30, 2008
File No. 000-21419
Dear Mr. Cascio:
On behalf of Cardo Medical, Inc. ("Cardo" or the "Company"), we hereby respond to the Staff's
comment letter, dated April 15, 2009, regarding the above-referenced Form 10-K and 10-Q/A. Please note that, for the Staff's convenience,
we have recited the Staff's comments in boldface type and provided our response to each comment immediately thereafter.
Form 10-K for the fiscal year ended December 31, 2008
Critical Accounting Policies and Estimates, page 37
Please note that the discussion of critical accounting policies and estimates should present
your analysis of the uncertainties involved in applying a principle at a given time or the variability that is reasonably likely to result from its
application
Mr. Brian Cascio
Accounting Branch Chief
June 3, 2009
Page 2
over time. You should address specifically why your accounting estimates or assumptions bear the risk of change. Equally
important, you should address the questions that arise once the critical accounting estimate or assumption has been identified, by analyzing,
to the extent material, such factors as how you arrived at the estimate, how accurate the estimate/assumption has been in the past, how
much the estimate/assumption has changed in the past, and whether the estimate/assumption is reasonably likely to change in the future. In
future filings, please consider providing a more detailed discussion of the critical estimates and assumptions involved in assessing goodwill
and intangible assets for impairment as well as in determining the fair value of stock based awards.
We have reviewed our policy for identifying and describing critical accounting policies and estimates. In future
filings, we will provide a more detailed description and analysis of our critical accounting policies and estimates, including events and
circumstances surrounding the estimate or assumption, its historical accuracy and whether it is likely to change in the future.
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm, page 42
In accordance with Rule 2-02(a), please have your auditors revise future reports of independent registered
public accounting firm to indicate the city and state where the report was issued.
We have noted this and will ensure the proper information is presented in future filings.
Consolidated Statements of Shareholders' Equity and Non-Controlling Interests, page 45
We see that you have included non-controlling interest within your schedule of
consolidated statement of shareholder's equity. Please tell us the basis for your presentation and how this complies with the requirements of
Rule 3-04 of Regulation S-X.
Rule 3-04 of Regulation S-X requires an analysis of the changes in each caption of stockholders' equity and non-
controlling interests presented in the balance sheets shall be given in a note or separate statement. This analysis shall be presented in the
form of a reconciliation of the beginning balance to the ending balance for each period for which an income statement is required to be filed
with all significant reconciling items described by appropriate captions with contributions from and distribution to owners shown separately.
We note that the disclosure for non-controlling interests required by Rule 3-04 is the same as that for
components of shareholders' equity. Furthermore, during 2008 we purchased all
Mr. Brian Cascio
Accounting Branch Chief
June 3, 2009
Page 3
the non-controlling interests, so they have been converted to
Cardo equity and we no longer need to present the reconciliation in future periods.
We presented the reconciliation within the statement of shareholders' equity based on the aforementioned.
Alternatively, we could have presented the reconciliation of non-controlling interests in a separate statement or footnote. However, we believe
we are complying with Rule 3-04 and the presentation is not misleading.
In 2009 we will move this disclosure to the footnote as follows;
NOTE X - ACQUISITION OF NON-CONTROLLING INTERESTS
As a result of the aforementioned, the changes in non-controlling interests during 2008 were as follows.
(in thousands)
Balance at December 31, 2007
$ 634
Acquisition of non-controlling interest of Uni
(15)
Acquisition of non-controlling interest of Cervical
20
Acquisition of non-controlling interest of Accelerated
(787)
Net loss
148
Balance at December 31, 2008
$ -
We reference a cash distribution to Accin Corporation shareholders of $6,201 in the consolidated statement of
cash flows for the fiscal year ended December 31, 2008. Please tell us how this distribution is presented in the statement of
stockholder's equity.
On May 21, 2007, (1) Cardo contributed $3.75 million to Accelerated Innovation, Inc. ("Accelerated")
and (2) Accin Corporation ("Accin") contributed all of its net business assets to Accelerated. In exchange for this contribution,
Cardo got 37.5% of the ownership interests in Accelerated and Accin got the remaining 62.5% of the ownership interests of Accelerated.
We performed the required analysis in Statement of Financial Reporting Standards ("SFAS") No. 141,
"Business Combinations" (see response to comment 11 below), and determined that Accelerated should be consolidated into
Cardo as a result of this transaction.
Concurrent with the above transaction, on May 21, 2007, the $3.75 million contributed by Cardo was distributed out of
Accelerated into Accin for distribution to Accin shareholders.
Mr. Brian Cascio
Accounting Branch Chief
June 3, 2009
Page 4
Since Accelerated was consolidated into Cardo, the distribution of $3.75 million
was a capital distribution and it was recorded in the statement of stockholders equity.
Alternatively, instead of contributing the money to Accelerated for distribution to Accin, when Cardo exercised its
option to acquire the non-controlling interest of Accelerated, it purchased the interest directly from Accin.
The cash distribution of $6,201 in 2008 to the shareholders of Accin Corporation was a payment made by Cardo
directly to Accin to exercise its option to acquire the 62.5% non-controlling interest of Accelerated, which was owned by Accin. The payment
to acquire these non-controlling interests was made directly to Accin, a non-consolidated entity. As such, it did not go through Accelerated,
and was not a capital distribution and does not appear in the statement of stockholders' equity.
This option exercise and consequent acquisition of the non-controlling interest of Accelerated was accounted for
using the purchase accounting method in accordance with SFAS No. 141. The financial statements reflect the allocation of the purchase
price to the net assets acquired based on their fair values at the acquisition date.
Note 1, Summary of Significant Accounting Policies, page 47
Other Assets, page 49
We see from page 39 that you recognize amortization of capitalized license fees within selling, general and
administrative expenses. Since the license fees relate to marketing and distributing a manufacturer's products, please tell us how you
considered that the amortization of license fees should be recorded within cost of sales.
Our business model contemplates the development and offering of a full line of orthopedic implant devices. In
fact, it is critical for us to have a complete line in order to attract distributors to represent us to the customers. One of the products we need for
our line is not internally developed, but rather developed and manufactured by a third party, which also sells the product.
We could sell this product using the third party's branding; however in order to present a full line of Cardo products,
we paid a license fee to the third party to re-brand the product with the Cardo name. Such rebranding has nothing to do with the cost of the
product we're selling. It is solely to build our brand and add to the Cardo-branded product line.
The license payment had nothing to do with our purchasing of product from the counterparty. We did, and continue to
purchase the product at the standard cost. There is no difference in cost as a result of the license fee.
Mr. Brian Cascio
Accounting Branch Chief
June 3, 2009
Page 5
Consequently, this is a sales and marketing cost and we have recorded the amortization of the license fees within
selling, general and administrative expenses.
Goodwill and Other Intangible Assets, page 49
Please tell us and expand future filings to make more detailed and specific disclosure about how you identify
and measure goodwill impairment. Discuss how your policy considers paragraphs 19 - 22 of SFAS 142 and the two-step impairment test
and how you measure fair value for purposes of this exercise. Please also expand to address the reporting unit concept, how you identified
reporting units and how you allocated goodwill to those reporting units. Please disclose significant estimates and assumptions used in your
analysis. In addition, tell us how you concluded that the remaining goodwill and other intangible assets are recoverable at December 31,
2008.
We Identify and Measure Goodwill Impairment
In accordance with paragraphs 19-22 of SFAS No. 142, the first step of the Company's goodwill impairment test
compares the fair value of a reporting unit with its carrying amount, including goodwill. If the fair value of a reporting unit exceeds its carrying
amount, goodwill of the reporting unit is considered not impaired, thus the second step of the impairment test is unnecessary. If the carrying
amount of a reporting unit exceeds its fair value, the second step of the goodwill impairment test shall be performed to measure the amount
of impairment loss, if any. The second step of the goodwill impairment
test compares the implied fair value of reporting unit goodwill with the carrying amount of that goodwill. If the carrying amount of reporting
unit goodwill exceeds the implied fair value of that goodwill, an impairment loss shall be recognized in an amount equal to that excess. The
loss recognized cannot exceed the carrying amount of goodwill. After a goodwill impairment loss is recognized, the adjusted carrying amount
of goodwill shall be its new accounting basis. Subsequent reversal of a previously recognized goodwill impairment loss is prohibited once the
measurement of that loss is completed.
We Measure Fair Value
With the assistance of an independent valuation firm, we measure fair value using the discounted cash flow
method.
Determination of Reporting Units
Cardo commercializes its reconstructive joint devices through its Cardo Reconstructive ("Recon") division
and its spine devices through its Cardo Spine ("Spine") division. The chief decision maker regarding these divisions is Michael
Kvitnitsky. The Division Managers are John Kuczynski for the Recon division and Joe Simpson for the Spine division.
Mr. Brian Cascio
Accounting Branch Chief
June 3, 2009
Page 6
The customers for all the products are the hospitals who pay for them, and hospitals use products from either or both
of the divisions. The hospitals approve all devices to be used in the hospital, but the individual doctors make the decisions about which device
to use.
Doctors operating within the hospitals are either reconstructive surgeons or spine surgeons. These doctors specialize
such that a reconstructive surgeon does not do spine surgery and a spine surgeon does not do reconstructive surgery. As such, the industry
is divided into two subgroups: reconstructive surgery devices and spine devices.
Following is a diagram of the structure of Cardo.
The testing for impairment was conducted at the reporting unit, or component level, which is one level below the
operating unit. In Cardo's case, the operating units, or segments, are the Reconstructive and Spine product lines. The reporting units are
one level below that. In the case of the Reconstructive Division, the reporting units are the knee and hip products. For the Spine Division,
the reporting units are the licensed and internally developed products (including Cervical Xpand LLC). Following is a diagram of our reporting
units.
Mr. Brian Cascio
Accounting Branch Chief
June 3, 2009
Page 7
Allocation of Goodwill to Reporting Units
Goodwill was generated when Cardo acquired Uni-Knee LLC and Cervical Xpand LLC ("Cervical"). As
Cardo is still a very small company, it was clear which reporting units to allocate goodwill to. The goodwill resulting from the acquisition of
Uni-Knee LLC belongs in the Knee reporting unit; and the goodwill resulting from the acquisition of Cervical belongs in the Internally
Developed reporting unit under the Spine segment.
Significant Estimates and Assumptions
When preparing the discounted cash flow projections, we estimated future revenues based on the number of doctors
we thought we could reasonably expect to use our products, multiplied by the average number of products that the doctors currently using our
products use.
The cost of goods sold and other operating expenses were estimated based on our own experience in the immediate
future, and industry averages in the intermediate and long range future. Accounts receivable and inventory levels were based on sales, as
these accounts typically increase and decrease proportional to revenue.
Mr. Brian Cascio
Accounting Branch Chief
June 3, 2009
Page 8
The Cervical goodwill assessment assumed that since the submission of its product under rule 510(k) to the FDA was
rejected, the only alternative to commercialize the Cervical product was to undergo clinical trials. In order to do this, we estimated it would
cost $1.5 million to redesign it and $25 million to conduct all phases of clinical trials.
Remaining Goodwill and Other Intangible and Long Lived Assets
In accordance with SFAS No. 144, "Accounting for Impairment or Disposal of Long Lived Assets," and with
the assistance of a third party valuation firm, we tested the other intangible and long lived assets by comparing the sum of the undiscounted
cash flows stemming from the long lived asset to its carrying value. Based on this analysis, it was determined that the other long lived assets
were not impaired.
Furthermore, since the fair value of the equity of the knee reporting unit was higher than its carrying value, we
determined the goodwill allocated to the knee reporting unit was not impaired.
Finally, ostensibly as a result of the FDA's rejection of our 510(k) application and the requirement to conduct clinical
trials in order to bring the spine product to market, we determined that the goodwill associated with the Cervical acquisition had been
impaired. Accordingly, we recorded an impairment charge of $1,457,014.
Share Based Payment, page 49
We note that you base your historical volatility on the Dow Jones index of small
cap medical device companies in addition to an index of similarly situated public companies. Please explain to us how you use the index in
calculating hi
2009-04-15 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
April 15, 2009
VIA U.S. MAIL and FACSIMILE (818) 780-6677
Derrick Romine Chief Financial Officer Cardo Medical, Inc. 8899 Beverly Blvd., Suite 619
Los Angeles, CA 90048
Re: Cardo Medical, Inc.
Form 10-K for the fiscal year ended December 31, 2008
Filed March 31, 2009
Form 10-Q/A for the quarterly period ended September 30, 2008
File No. 000-21419
Dear Mr. Romine:
We have reviewed your response date d March 16, 2009 and related filings and
have the following comments. We have limited our review to only your financial
statements and related disclosures and will make no further review of your documents.
Where indicated, we think you should revise your document in response to these
comments, however, if you disagree, we would be pleased to consider your explanation
as to why a revision is not necessary. Pl ease be as detailed as necessary in your
explanation.
Please understand that the purpose of our review process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Mr. Romine
Cardo Medical, Inc.
April 15, 2009 Page 2 Form 10-K for the fiscal year ended December 31, 2008
Critical Accounting Policies and Estimates, page 37
1. Please note that the discussion of criti cal accounting policies and estimates should
present your analysis of th e uncertainties involved in a pplying a principle at a
given time or the variability that is reasonably likely to result from its application
over time. You should address specifically why your accounting estimates or assumptions bear the risk of change. Equally important, you should address the
questions that arise once the critical accounting estimate or assumption has been
identified, by analyzing, to the extent ma terial, such factors as how you arrived at
the estimate, how accurate the estimate/assumption has been in the past, how much the estimate/assumption has cha nged in the past, and whether the
estimate/assumption is reasonably likely to change in the future. In future filings,
please consider providing a more detailed discussion of the critical estimates and
assumptions involved in assessing goodwill and intangible assets for impairment
as well as in determining the fair value of stock based awards.
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm, page 42
2. In accordance with Rule 2-02(a), please have your auditors revise future reports
of independent registered public accounti ng firm to indicate the city and state
where the report was issued.
Consolidated Statements of Shareholders’ E quity and Non-Controlling Interests, page 45
3. We see that you have included non-control ling interest within your schedule of
consolidated statement of sh areholder’s equity. Please tell us the basis for your
presentation and how this complies with the requirements of Rule 3-04 of
Regulation S-X.
4. We reference a cash distribution to Accin Corporation shareholders of $6,201 in
the consolidated statement of cash flows for the fiscal year ended December 31, 2008. Please tell us how this distribution is presented in the statement of stockholder’s equity.
Note 1. Summary of Significan t Accounting Policies, page 47
Other Assets, page 49
5. We see from page 39 that you recognize amortization of capitalized license fees
within selling, general and administrative e xpenses. Since the lic ense fees relate
Mr. Romine
Cardo Medical, Inc.
April 15, 2009 Page 3
to marketing and distributing a manufactur er’s products, please tell us how you
considered that the amortiza tion of license fees should be recorded within cost of
sales.
Goodwill and Other Intangible Assets, page 49
6. Please tell us and expand future filings to make more detailed and specific disclosure about how you identify and measure goodwill impairment. Discuss how your policy considers paragraphs 19 – 22 of SFAS 142 and the two-step impairment test and how you measure fair value for purposes of this exercise.
Please also expand to address the reporting unit concept, how you identified reporting units and how you allocated goodw ill to those reporting units. Please
disclose significant estimates and assump tions used in your analysis. In addition,
tell us how you concluded that the remaining goodwill and other intangible assets are recoverable at December 31, 2008.
Share Based Payment, page 49
7. We note that you base your historical volatility on the Dow Jones index of small
cap medical device companies in addition to an index of simila rly situated public
companies. Please explain to us how you us e the index in calculating historical
volatility. For example, discuss how that index is comparable to your company by
explaining how this index contains hist orical volatilities of similar entities
following a comparable period in their live s. Tell us how the expected volatility
used in your stock-based compensation calculations complies with the guidance
of paragraphs A31-A34 of SFAS 123(R) and question 6 of SAB Topic 14.D.1.
Revenue Recognition, page 50
8. We reference the disclosure that revenue is recognized when title and risk of loss
pass to the customer, which is generally on the day of surgery. In your response
and in future filings, please expand to describe the terms and conditions of
product sales in sufficient detail to indicate how your revenue recognition
treatment complies with SAB Topic 13. The policy should also address, where
significant, customer acceptance, return pol icies, post-sale obligations, warranties,
credits and discounts, rebates, price protection or simila r privileges and how these
impact revenue recognition. Future fili ngs should address how your policy differs
for both end-users and distributors.
Research and Development Costs, page 50
9. We see that you recorded in-process rese arch and development in the acquisition
of the minority interest of Accelerated. Please expand future filings to include
disclosure about the nature of the acquired technology and how the fair value was
Mr. Romine
Cardo Medical, Inc.
April 15, 2009 Page 4
determined. Please make some disclosure about the state of completion at acquisition and the extent of effort necessary to complete the in-process
project(s), including costs. Disclose whether the technology was brought to
fruition, and if not, disclose why not.
10. As a related matter, in future filings cr itical accounting policies should discuss the
following related to in-process research and development, as applicable:
⋅ Nature of projects acquired;
⋅ Summary of values assigned to IPR&D by technology / product
⋅ Status of the development of the work at acquisition date;
⋅ Nature and timing of remaining effo rts for completion, including estimated
completion date;
⋅ Value and risks of the purchased R&D;
⋅ How periods subsequent to the acquisition have been affected by completion of the project and intr oduction of the technology.
Note 7. Accin Transaction, page 54
11. Please explain to us in greater detail the transaction which resulted in the acquisition of Accelerated. In your response, please address the following
comments:
⋅ Discuss why Cardo received only 37.5% of the ownership interests of
Accelerated when they contributed $ 3,750 in cash to the venture while Accin
only contributed business assets with a net book value of $867.
⋅ Discuss why the capital transactions of Accelerated are recorded on Cardo’s books from inception. For example, we see that the contribution of Accin’s
net assets and the distribution to Accin was recorded within the consolidated
statement of shareholder’s equity. Discuss the nature of the line item
“contribution of net assets of Accin” on the statement of stockholder’s equity
and reconcile the amounts to this footnote.
⋅ Discuss why the $3,750 contribution by Ca rdo was distributed by Accelerated
to Accin. For example, explain whethe r this distribution diluted any of
Accin’s ownership intere sts in Accelerated.
⋅ Discuss how you determined that Cardo obtained control of Accelerated such
that their cash contribution of $3,750 (which was distributed to Accin)
constituted a business combination and as a result Cardo should consolidated
Accelerated. Tell us the accounting l iterature that you consulted and the
specifics of the transaction that led you to the conclu sion. Please also tell us
Mr. Romine
Cardo Medical, Inc.
April 15, 2009 Page 5
how you considered FIN 46(R) in determining who should consolidate Accelerated.
⋅ Discuss what section under SAB Topic 5 you referred to in determining that
the assets should be record ed at Accin’s historical cost basis. Discuss the
nature of the common ownership of Accin, Accelerated and Carodo and how
that impacted your conclusion.
⋅ Discuss the nature of the net assets th at Accin contributed to Accelerated.
⋅ Tell us why you are providing pro forma information as if Accin and Cardo
were consolidated at the beginning of 2007. It appears as though Accin is the
other joint venture partner in th e ownership of Accelerated.
Future filings should also be revise d to address the above comments, as
appropriate.
Note 8. Acquisition of Non-C ontrolling Interests, page 55
12. Please revise future filings to include all of the disclosures required by paragraphs 52 and 54 of SFAS 141.
Item 9A (T). Controls and Procedures, page 62
13. We note the material weaknesses identified at December 31, 2008 and included
within the discussion of your internal control over financial reporting. Please
revise future filings to disclose in greater detail the nature of the material weaknesses identified in your disclosure. In addition, please disclose when the
material weaknesses were id entified, by whom they were identified and when the
material weaknesses first began.
Form 10-Q/A for the quarterly period ended September 30, 2008
Exhibits 31.1 and 31.2
14. We note that you omitted the language in paragraph 4 of Item 601(b)(31)(i) of
Regulation S-K that refers to internal c ontrol over financial reporting. Please file
an amendment to the Form10-Q/A to incl ude certifications that include all the
required paragraphs. You may file an a bbreviated amendment that includes a
cover page, explanatory note, signature page and paragr aphs 1, 2, 4 and 5 of the
certification.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under
Mr. Romine
Cardo Medical, Inc. April 15, 2009 Page 6 the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, please provide, in writing, a statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
You may contact me at (202) 551-3676 or Kristin Lochhead at (202) 551-3664 if
you have questions. In this regard, please do not hesitate to contact Martin James,
Senior Assistant Chief Accountant, at (202) 551-3671 with any other questions.
Sincerely,
Brian Cascio Accounting Branch Chief
2009-02-24 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
February 24, 2009
VIA U.S. MAIL and FACSIMILE (818) 780-6677
Derrick Romine Chief Financial Officer Cardo Medical, Inc. 8899 Beverly Blvd., Suite 619
Los Angeles, CA 90048
Re: Form 10-K for the fiscal year ended June 30, 2008
Filed September 29, 2008
File No. 000-21419
Dear Mr. Romine:
We have reviewed your response dated January 30, 2009 and related filings and
have the following comments. We have limited our review of your filing to the
disclosures pertaining to the evaluation of your internal c ontrol over financial reporting.
Specifically, we have reviewed your filing to determine if you conducted the evaluation of your internal control over financial repor ting, as required by Exchange Act Rules 13a-
15 and 15d-15, and provided an assessment and a conclusion as to th e effectiveness of
your internal control over financial reporting, as required by Item 308T(a) of Regulations
S-K. Where indicated, we think you should revise your document in response to these
comments, however, if you disagree, we would be pleased to consider your explanation
as to why a revision is not necessary. Pl ease be as detailed as necessary in your
explanation.
Please understand that the purpose of our review process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Mr. Romine
Cardo Medical, Inc.
February 24, 2009 Page 2 Form 10-K/A for the fiscal year ende d June 30, 2008 filed on February 2, 2009
Item 9A(T) Controls and Procedures, page 3
1. We note that in your amended 10-K your management has again concluded that
disclosure controls and proce dures were effective as of th e end of the fiscal year.
In our letter dated December 23, 2008, we asked you to consider whether
management's failure to provide its re port on internal control over financial
reporting impacts its conclusion regarding the effectiveness of your disclosure
controls and procedures as of the end of th e fiscal year. Please tell us the factors
you considered and highlight for us those factors that supported your conclusion.
In particular, please explain how you considered the definition of disclosure controls and procedures provi ded in Rule 13a-15(e), whic h indicates that effective
controls and procedures would ensure that information required to be disclosed by
the issuer is recorded, pro cessed, summarized and reported
within the time
periods specified in the Commission’s rules and forms. In addition, as discussed
in Compliance and Disclosure Inte rpretation 115.02, which you can find at
http://www.sec.gov/divisions/corpf in/guidance/regs-kinterp.htm , failure to file
management's report on Internal Control over Financial Reporting rendered your annual report materially deficient and also rendered the company not timely or
current in its Exchange Act Reporting. In light of these facts, please explain how
you could conclude that disc losure controls and proce dures were effective.
Alternatively, please further amend the 10-KSB to disclose management's revised conclusion on the effectiveness of your di sclosure controls and procedures, i.e.,
that DC&P were not effective as of the end of the fiscal year.
2. Please revise the language used in your disclosure concerning changes in your internal control over financial repor ting to indicate whether there was any
change
to your internal control over financial re porting that has materially affected, or
that is reasonably likely to materially affect, your internal control over financial
reporting, consistent with the languag e used in amended Item 308(c) of
Regulation S-K.
Exhibit 31.1, 31.2 and 32
3. Please revise to include the certifications of your chief executive officer and chief
financial officer as a separate exhibit to your Form 10-K/A, as required by Item 601(b)(31) of Regulation S-K rather than within the 10-K/A document.
Mr. Romine
Cardo Medical, Inc. February 24, 2009 Page 3 You may contact Kristin Lochhead at (202) 551-3664 or me at (202) 551-3671 if you have questions.
Sincerely, Martin F. James Senior Assistant Chief Accountant
2009-01-30 - CORRESP - BioCardia, Inc.
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
<PAGE>
Judith Kenney & Associates, P.A.
Law Offices 2001 Biscayne Boulevard, Suite 3402
Miami, Florida 33137
Telephone (305) 572-1020
Facsimile (305) 572-1085
e-mail jkenney@jkpalaw.com
January 30, 2009
VIA EDGAR
Martin F. James
Senior Assistant Chief Accountant
United Sates Securities and Exchange Commission
Division of Corporation Finance
Washington, D.C. 20549-7010
Re: Form 10-K for the fiscal year ended June 30, 2008
Filed September 29, 2008
File No. 000-21419
Dear Mr. James:
On behalf of Cardo Medical, Inc. (the "Company"), I am responding to the
Staff's comment letter, dated December 23, 2008, regarding the above-
referenced Form 10-K. For your convenience, we have incorporated the staff's
comments below, and our response follows each comment.
Form 10-K for the fiscal year ended June 30, 2008
-------------------------------------------------
Item 9A(T) Controls and Procedures, page 8
Comment 1.
It appears that your management has performed an assessment of
disclosure controls and procedures (DCP) but it does not appear that your
management has concluded on its assessment of internal control over financial
reporting (ICFR) as of June 30, 2008. Since you were required to file or
filed an annual report for the prior fiscal year, it appears you are required
to report on your management's assessment of internal control over financial
reporting. Note that DCP and ICFR require two separate and distinct
assessments and conclusions.
If your management has not yet performed its assessment, we ask that you
complete your evaluation and amend your filing within 30 calendar days to
provide the required management's report on internal control over financial
reporting. Alternatively, please revise to provide a clear conclusion on
your assessment of ICFR as of June 30, 2008 in compliance with Section 404(a)
of the Sarbanes-Oxley Act.
1
<PAGE>
United States Securities and Exchange Commission
January 30, 2009
Page 2
In performing your evaluation, you may find the following documents
helpful: The Commission's release "Amendments to Rules Regarding
Management's Report on Internal Control Over Financial Reporting"
(Securities Act Release 8809/Financial Reporting Release 76). You can find
this release at: http://www.sec.gov/rules/final/2007/33-8809/pdf; the
Commission's release "Commission Guidance Regarding Management's Report on
Internal Control Over Financial Reporting Under Section 13(a) or 15(d) of the
Securities Exchange Act of 1934" (Securities Act Release 8010/Financial
Reporting Release 77). You can find this release at:
http://sec.gov/rules/interp/2007/33-8810.pdf; and the "Sarbanes-Oxley Section
404-A Guide for Small Business" brochure at:
(http://www.sec.gov/info/smallbus/404guide.shtml).
Please note that the failure to perform management's assessment
adversely affects the company's and its shareholders' ability to avail
themselves of rules and forms that are predicated on the current or timely
filing of Exchange Act reports. For further information regarding these
impacts, please see Compliance and Disclosure Interpretation 115.02, which
you can find at http://www.sec.gov/divisions/corpfin/guidance/regs-
kinterp.htm.
In addition, please evaluate whether management's failure to perform or
complete its report on internal control over financial reporting impacts its
conclusions regarding the effectiveness of your disclosure controls and
procedures as of the end of the fiscal year covered by the report and, as
appropriate, revise your conclusion of the effectiveness of disclosure
controls and procedures at June 30, 2008. In particular, please consider the
definition of disclosure controls and procedures provided in Rule 13a-15(e),
which indicates that effective controls and procedures would ensure that
information required to be disclosed by the issuer is recorded, processed,
summarized and reported within the time periods specified in the Commission's
rules and forms. In addition, as discussed in Compliance and Disclosure
Interpretation 115.02, which you can find at
http://www.sec.gov/divisions/corpfin/guidance/regs-kinterp.htm, failure to
file management's report on Internal Control over Financial Reporting
rendered your annual report materially deficient and also rendered the
company not timely or current in its Exchange Act Reporting.
Response to Comment 1
We have today filed Amendment No. 1 to the Company's Annual Report on
Form 10-K for the year ended June 30, 2008 (the "Amendment"). Although the
Company's principal executive officer and principal financial officer
conducted an evaluation of the Company's internal control over financial
reporting ("ICFR") as of June 30, 2008, we failed to include the Company's
conclusion that its ICFR was effective. We stated in the original Form 10-K
that "No material weaknesses in our internal control over financial reporting
were identified." The Amendment contains the appropriate conclusion.
2
<PAGE>
United States Securities and Exchange Commission
January 30, 2009
Page 3
Comment 2.
Please revise the language in your disclosure concerning changes in
your internal control over financial reporting to indicate whether there was
any change to your internal control over financial reporting that has
materially affected, or that is reasonably likely to materially affect, your
internal control over financial reporting, consistent with the language used
in amended Item 308(c) of Regulation S-K.
Response to Comment 2.
We have also revised the language in the paragraph regarding the absence
of significant changes in the Company's ICFR to include changes that
"materially affected, or are reasonably likely to materially affect" the
Company's ICFR.
*****************************************************************************
We believe that the Amendment addresses the Staff's comments and
corrects our prior omissions. The Company's acknowledgment is attached
hereto as Appendix A.
Very truly yours,
/s/Judith Kenney
---------------------------------
3
<PAGE>
Appendix A
I, Andrew Brooks, Chief Executive Officer of Cardo Medical, Inc. (the
"Company"), do hereby acknowledge that:
The Company is responsible for the adequacy and accuracy
of the disclosure in the filing;
Staff comments or changes to disclosure in response to staff
comments do not foreclose the Commission from taking any
action with respect to the filing; and
The Company may not assert staff comments as a defense in
any proceeding initiated by the Commission or any person
under the federal securities laws of the United States.
Date: January 28, 2009 /s/ Andrew Brooks
--------------------------
Andrew Brooks
Chief Executive Officer
4
</TEXT>
</DOCUMENT>
2008-12-23 - UPLOAD - BioCardia, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
December 23, 2008
VIA U.S. MAIL and FACSIMILE (818) 780-6677
Derrick Romine Chief Financial Officer Cardo Medical, Inc. 8899 Beverly Blvd., Suite 619
Los Angeles, CA 90048
Re: Form 10-K for the fiscal year ended June 30, 2008
Filed September 29, 2008
File No. 000-21419
Dear Mr. Romine:
We have reviewed your filing and have the following comments. We have
limited our review of your filing to the disclo sures pertaining to the evaluation of your
internal control over financial reporting. Sp ecifically, we have reviewed your filing to
determine if you conducted the evaluation of your internal cont rol over financial
reporting, as required by Exchange Act Ru les 13a-15 and 15d-15, and provided an
assessment and a conclusion as to the effectiv eness of your internal control over financial
reporting, as required by Item 308T(a) of Regul ations S-K. Where indicated, we think
you should revise your document in response to these comments, however, if you disagree, we would be pleased to consider your explanation as to why a revision is not
necessary. Please be as detailed as necessary in your explanation.
Please understand that the purpose of our review process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Mr. Romine
Cardo Medical, Inc.
December 23, 2008 Page 2 Form 10-K for the fiscal year ended June 30, 2008
Item 9A(T) Controls and Procedures, page 8
1. It appears that your management has pe rformed an assessment of disclosure
controls and procedures (DCP) but it doe s not appear that your management has
concluded on its assessment of internal control over financial reporting (ICFR) as of June 30, 2008. Since you were required to file or filed an annual report for the
prior fiscal year, it appears you are re quired to report on your management’s
assessment of internal control over financ ial reporting. Note that DCP and ICFR
require two separate and distin ct assessments and conclusions.
If your management has not yet performed its assessment, we ask that you complete your evaluation and amend your filing within 30 calendar days to provide the required management's repor t on internal control over financial
reporting. Alternatively, please revise to provide a clear conclusion on your
assessment of ICFR as of June 30, 2008 in compliance with S ection 404(a) of the
Sarbanes-Oxley Act. In performing your evaluation, you may find the following documents helpful:
the Commission’s release Amendments to Rules Regarding
Management’s Report on Internal Control Over Financial Reporting
(Securities Act Release 8809/Financ ial Reporting Release 76). You
can find this release at: http://www.sec.gov/rules/final/2007/33-8809.pdf
;
the Commission’s release Commission Guidance Regarding
Management’s Report on Internal Control Over Financial Reporting
Under Section 13(a) or 15(d) of the Securities Exchange Act of 1934
(Securities Act Release 8010/Financ ial Reporting Release 77). You
can find this release at
http://sec.gov/rules/interp/2007/33-8810.pdf ; and
the “Sarbanes-Oxley Section 404 – A Guide for Small Business” brochure at: ( http://www.sec.gov/info/smallbus/404guide.shtml
).
Please note that the failure to perform management’s assessment adversely affects
the company’s and its shareholders ability to avail themselves of rules and forms
that are predicated on the current or ti mely filing of Exchange Act reports. For
further information regarding these impacts, please see Compliance and Disclosure Interpretation 115.02, which you can find at http://www.sec.gov/divisions/corpf in/guidance/regs-kinterp.htm
.
Mr. Romine
Cardo Medical, Inc.
December 23, 2008 Page 3
In addition, please evaluate whether management’s failure to perform or complete its report on internal control over fina ncial reporting impacts its conclusions
regarding the effectiveness of your disclosure controls and procedures as of the
end of the fiscal year covered by the report and, as appropriate, revise your conclusion of the effectiveness of disclosu re controls and procedures at June 30,
2008. In particular, please consider the definition of disclosure controls and
procedures provided in Rule 13a-15(e), whic h indicates that effective controls and
procedures would ensure that information required to be disclosed by the issuer is
recorded, processed, summarized and reported within the time periods specified in
the Commission’s rules and forms. In addition, as discussed in Compliance and
Disclosure Interpretation 115.02, which you can find at http://www.sec.gov/divisions/corpfin/guidanc e/regs-kinterp.htm, failure to file
management's report on Internal Control over Financial Reporting rendered your annual report materially deficient and also rendered the company not timely or
current in its Exchange Act Reporting.
2. Please revise the language used in your disclosure concerning changes in your internal control over financial reporting to indicate whether there was any change
to your internal control over financial reporting that has materially affected
, or
that is reasonably likely to materially affect , your internal control over financial
reporting, consistent with the languag e used in amended Item 308(c) of
Regulation S-K.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, please provide, in writing, a statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
Mr. Romine
Cardo Medical, Inc. December 23, 2008 Page 4
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
You may contact Kristin Lochhead at (202) 551-3664 or me at (202) 551-3671 if you have questions.
Sincerely, Martin F. James Senior Assistant Chief Accountant
2007-01-26 - UPLOAD - BioCardia, Inc.
Mail Stop 4561 January 26, 2007 Roy Israel 990 Stewart Avenue First Floor Garden City, NY 11530 Re: ClickNsettle.com, Inc. Form 10-KSB for Fiscal Year Ended June 30, 2006 Form 10-QSB for Fiscal Qu arter Ended September 30, 2006 File No. 000-21419 Dear Mr. Israel: We have completed our review of your Form 10-KSB and related filings and do not, at this time, have any further comments. You may contact Yolanda Crittendon, Sta ff Accountant, at (202) 551-3472 or the undersigned at (202) 551-3413 if you have questions. Sincerely, Cicely LaMothe Accounting Branch Chief
2007-01-24 - CORRESP - BioCardia, Inc.
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
clickNsettle.com, Inc.
990 Stewart Avenue, 1st Floor
Garden City, NY 11530
January 24, 2007
Filed Via Edgar
---------------
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington D.C. 20549
Attention: Ms. Yolanda Crittendon
Staff Accountant
Mail Stop 4561
RE: clickNsettle.com, Inc.
Form 10-KSB for Fiscal Year Ended June 30, 2006
Form 10-QSB for Fiscal Quarter Ended September 30, 2006
File No. 000-21419
Dear Ms. Crittendon:
This letter sets forth the response of clickNsettle.com, Inc. (the "Company") to
the comment received from the Staff of the Securities and Exchange Commission by
letter dated January 18, 2007.
Item 8A - Controls and Procedures
1. We noted that you evaluated disclosure controls and procedures
within 90 days prior to the filing date for the year ended June 30,
2006 and the period ended September 30, 2006. Advise us on how you
comply with the requirements in Item 307 of Regulation S-B to
conclude on the effectiveness as of the end of the period covered by
the report, or revise accordingly.
Response to Above Comment:
1. We did in fact evaluate our disclosure controls and procedures as of
the end of both periods. That is, our evaluation was performed as of
June 30, 2006 and as of September 30, 2006, respectively. As such,
we were in full compliance with the requirements in Item 307 of
Regulation S-B. Going forward, effective with our filing of Form
10-QSB for the quarterly period ended December 31, 2006, we will
ensure that our response to this item, Controls and Procedures, will
be more specific. That is, we anticipate our response to be as
follows:
<PAGE>
CONTROLS AND PROCEDURES
Our disclosure controls and procedures are designed to ensure that
material information relating to the Company are made known to our Chief
Executive Officer ("CEO"), Chief Financial Officer ("CFO") and others in the
Company involved in the preparation of this quarterly report, by others within
the Company. Our CEO and CFO have reviewed our disclosure controls and
procedures as of December 31, 2006 and have concluded that they are effective.
There have been no significant changes in our internal controls or other factors
that could significantly affect our internal controls subsequent to December 31,
2006, the last date they were reviewed by our CEO and CFO.
The Company hereby acknowledges the following:
o the Company is responsible for the adequacy and accuracy of
the disclosure in the Form 10-KSB and the Form 10-QSB filings;
o staff comments or changes to disclosures in response to staff
comments do not foreclose the Commission from taking any
action with respect to the filings; and
o the Company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
If you have any questions or comments concerning the above, please do not
hesitate to contact me at 516-941-3222. My direct fax number is 516-213-7600.
Also, please update your records to use my direct fax number as the Company's
fax going forward.
Very truly yours,
/s/ Patricia Giuliani-Rheaume
-----------------------------
Patricia Giuliani-Rheaume
Vice President, Chief Financial Officer & Treasurer
cc: Robert S. Matlin, Kirkpatrick & Lockhart Preston Gates Ellis LLP
</TEXT>
</DOCUMENT>
2007-01-18 - UPLOAD - BioCardia, Inc.
Mail Stop 4561 January 18, 2007 Roy Israel 990 Stewart Avenue First Floor Garden City, NY 11530 Re: ClickNsettle.com, Inc. Form 10-KSB for Fiscal Year Ended June 30, 2006 Form 10-QSB for Fiscal Qu arter Ended September 30, 2006 File No. 000-21419 Dear Mr. Israel: We have reviewed your filings and have the following comments. We have limited our review to only your financial stat ements and related disclosures and do not intend to expand our review to other portions of your docum ents. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as deta iled as necessary in your expl anation. In some of our comments, we may ask you to provide us in formation so we may better understand your disclosure. After reviewing this inform ation, we may or may not raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Item 8 – Changes in and disagreements w ith accountants on accounting and financial disclosure, page 11 Item 8A – Controls a nd Procedures, page 11 1. We noted that you evaluated disclosure c ontrols and procedures within 90 days prior to the filing date for the year ended June 30, 2006 and the period ended September 30, 2006. Advise us on how you comply with the requirements in Item 307 of Regulation S-B to conclude on the effectiveness as of the end of the period covered by the report, or revise accordingly. * * * * Roy Israel ClickNsettle.com, Inc. January 18, 2007 Page 2 As appropriate, please respond to these co mments within 10 business days or tell us when you will provide us with a response. Detailed cover letters gr eatly facilitate our review. Please file your cover letter on E DGAR. Please understa nd that we may have additional comments after reviewin g your responses to our comments. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings reviewed by the staff to be certain that they have provided all information investors require for an info rmed decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our comments, please provide, in writing, a statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filings; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filings or in response to our comments on your filings. You may contact Yolanda Crittendon, Sta ff Accountant, at (202) 551-3472 or the undersigned at (202) 551-3413 if you have questions. Sincerely, Cicely LaMothe Accounting Branch Chief
2005-07-14 - CORRESP - BioCardia, Inc.
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
clickNsettle.com, Inc.
990 Stewart Avenue, 1st Floor
Garden City, NY 11530
July 14, 2005
Filed Via Edgar
United States Securities and Exchange Commission
Division of Corporate Finance
100 F Street, NE
Washington D.C. 20549
Attention: Mr. Matthew Maulbeck
Staff Accountant
Mail Stop 4561
RE: clickNsettle.com, Inc.
Form 8-K
Filed 6/30/05
File No. 0-21419
Dear Mr. Maulbeck:
This letter sets forth the responses of clickNsettle.com, Inc. (the "Company")
to the comments received from the Staff of the Securities and Exchange
Commission by letter dated July 8, 2005.
Form 8-K filed June 30, 2005
1. Please revise the Form to state whether the former accountant
resigned, declined to stand for re-election or was dismissed, and
the specific date, as required by Item 304(a)(1)(i) of Regulation
S-B. It is not sufficient to state that you and your former auditors
"mutually decided to terminate their relationship" as that wording
is unclear to a reader.
Response to Comment 1:
We have filed an amendment to the Form 8-K whereby we provided the requested
information as set forth above. Specifically, the 4th sentence of the first
paragraph under Item 4.01 of the Form 8-K/A states:
<PAGE>
As the Company no longer has an operating business, Grant Thornton LLP
("Grant Thornton") resigned as the Company's independent registered public
accounting firm on June 28, 2005.
The Company hereby acknowledges the following:
o the Company is responsible for the adequacy and accuracy of
the disclosure in the Form 8-K/A filing;
o staff comments or changes to disclosures in response to staff
comments do not foreclose the Commission from taking any
action with respect to the filing; and
o the Company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
If you have any questions or comments concerning the above, please do not
hesitate to contact me at 516-941-3222. My direct fax number is 516-213-7600.
Also, please update your records to use my direct fax number as the Company's
fax going forward.
Very truly yours,
/s/ Patricia Giuliani-Rheaume
-----------------------------
Patricia Giuliani-Rheaume
Vice President, Chief Financial Officer & Treasurer
cc: Robert S. Matlin, Thelen Reid & Priest LLP
</TEXT>
</DOCUMENT>
2005-07-08 - UPLOAD - BioCardia, Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 4561
July 8, 2005
VIA U.S. MAIL AND FAX (516) 829-4386
Ms. Patricia Giuliani-Rheaume
Chief Financial Officer and Vice President
clickNsettle.com, Inc.
990 Stewart Avenue
First Floor
Garden City, NY 11530
Re: clickNsettle.com, Inc.
Item 4.01 Form 8-K
Filed June 30, 2005
File No. 0-21419
Dear Ms. Giuliani-Rheaume:
We have reviewed your filing and have the following comment.
Where indicated, we think you should revise your document in
response
to this comment. If you disagree, we will consider your
explanation
as to why our comment is inapplicable or a revision is
unnecessary.
Please be as detailed as necessary in your explanation. After
reviewing this information, we may raise additional comments.
Please understand that the purpose of our review process
is
to assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comment or on any other
aspect
of our review. Feel free to call me at the telephone number
listed
at the end of this letter.
Form 8-K filed June 30, 2005
1. Please revise the Form to state whether the former accountant
resigned, declined to stand for re-election or was dismissed, and
the
specific date, as required by Item 304(a)(1)(i) of Regulation S-
B.
It is not sufficient to state that you and your former auditors
"mutually decided to terminate their relationship" as that wording
is
unclear to a reader.
File an amendment under cover of Form 8-K/A and include the
Item 4.01 designation, including the letter from the former
accountant filed as an Exhibit 16. Please note that your former
accountants should make it clear within the Exhibit 16 letter that
it
is in reference to your amended Form 8-K.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filing to be certain that the
filing includes all information required under the Securities
Exchange Act of 1934 and that they have provided all information
investors require for an informed investment decision. Since the
company and its management are in possession of all facts relating
to
a company`s disclosure, they are responsible for the accuracy and
adequacy of the disclosures they have made.
In connection with responding to our comments, please
provide,
in writing, a statement from the company acknowledging that:
* the company is responsible for the adequacy and accuracy of the
disclosure in the filing;
* staff comments or changes to disclosure in response to staff
comments do not foreclose the Commission from taking any action
with
respect to the filing; and
* the company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in our review of your filing or in
response to our comments on your filing.
Please provide the supplemental information requested above
within 5 business days from the date of this letter. The
supplemental information should be filed as correspondence on
EDGAR.
The amendment requested should be filed as promptly as possible
and
should be reviewed by the former accountants. The letter required
by
Exhibit 16 should cover any revised disclosures.
Any questions regarding the above should be directed to me at
(202)
551-3466.
Sincerely,
Matthew Maulbeck
Staff Accountant
??
??
??
??
clickNsettle.com, Inc.
July 8, 2005
Page 1
</TEXT>
</DOCUMENT>
2005-03-24 - UPLOAD - BioCardia, Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
March 24, 2005
VIA USMAIL and FAX (516) 794-8518
Mail Stop 0409
Ms. Patricia Giuliani-Rheaume
Vice President, Chief Financial Officer and Treasurer
clickNsettle.com, Inc.
990 Stewart Avenue, Suite 140
Garden City, NY 11530
Re: clickNsettle.com, Inc.
Form 10-KSB for the year ended 6/30/2004
File No. 000-21419
Dear Ms. Patricia Giuliani-Rheaume:
We have completed our review of your Form 10-KSB and related
filings and do not, at this time, have any further comments.
Sincerely,
Kathleen Collins
Branch Chief
??
??
??
??
</TEXT>
</DOCUMENT>
2005-03-23 - CORRESP - BioCardia, Inc.
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
clickNsettle.com, Inc.
990 Stewart Avenue, 1st Floor
Garden City, NY 11530
March 23, 2005
United States Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549
Attention: Mr. Wilson K. Lee
Staff Accountant
Division of Corporation Finance
RE: clickNsettle.com, Inc.
Form 10-KSB for the year ended 6/30/04
File No. 000-21419
Dear Mr. Lee:
This is in response to your letter dated March 9, 2005. Specifically, you posed
the following question:
Note 14 - Subsequent Event, page F-24
1. The Company states "The Board of Directors is negotiating the terms
of an asset purchase agreement with the present Chief Executive
Officer of the Company, whereby he, or companies owned by him, would
assume the assets and liabilities of the ADR business of the Company
and its future commitments." Tell us how you considered paragraphs
30 and 41 to 44 of SFAS 144 in determining whether to categorize the
assets of the ADR business as held for sale and whether to classify
the sale of this business as discontinued operations. Tell us how
you applied this guidance at year-end June 30, 2004 as well as at
the quarters ended September 30, 2004 and December 31, 2004 or
revise your financial statements accordingly.
Our response:
We considered the guidance in paragraph 30 of SFAS 144 in determining whether to
classify the assets of the ADR business as held for sale and whether to classify
the sale of
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this business as a discontinued operation. Paragraph 30 states that all of the
criteria enumerated in items (a) through (f) must be met for the assets to be
classified as held for sale. We do not believe that all such criteria were met
until January 13, 2005. We will present the assets, liabilities and results of
operations of the ADR business as a discontinued operation in the financial
statements of the Company as of and for the quarter and nine months ending March
31, 2005.
More specifically, we considered the following in our evaluation of each of the
criteria set forth in paragraph 30:
a) Management, having the authority to approve the action, commits to a plan to
sell the asset (disposal group).
Prior to June 30, 2004, Management and the Board of Directors had been
discussing the financial status of the ADR business as business volume had been
declining and it appeared that this trend was continuing. In an effort to review
all possibilities, the Company made a press release in July 2004 that it was
exploring strategic alternatives. In response thereto, the Company did receive
inquiries as to a possible sale of the ADR business. However, no decision was
made to sell the business at that time. In fact, at a Board of Directors'
meeting held on August 13, 2004, Management and the Board specifically
considered various alternatives. The scenarios presented included (1) continue
to run the ADR business as is; (2) liquidate the Company; (3) continue to run
the Company but with significant changes which were aimed at reducing costs; or
(4) sell the ADR business and then have the Company pursue another operating
business. No decision was made to sell the ADR business until August 24, 2004.
However, even at that time, the sale was subject to entering into a definitive
agreement and the receipt of a fairness opinion. A fairness opinion was not
obtained until October 15, 2004 and a definitive agreement was not signed until
October 18, 2004. Furthermore, the transaction required shareholder approval.
Such shareholder approval was obtained at the Company's Annual Meeting on
January 13, 2005. Up until that time, Management and the Board was prepared to
continue to operate the ADR business in the event that the transaction was not
approved.
b) The asset (disposal group) is available for immediate sale in its present
condition subject to only terms that are usual and customary for sales of such
assets (disposal groups).
The sale of the ADR business involved the sale of assets as well as the
assumption of liabilities, most notably the assumption of lease commitments.
Such lease commitments included leases of office space in Great Neck, New York
and in Brooklyn, New York among others. In order to affect the sale, the Company
had to be released from these obligations and the leases had to be assigned and
assumed by the Buyer. Although such releases were not obtained from the
landlords until January 2005, it is feasible that they could have been obtained
earlier and thereby, this criterion would have been satisfied.
c) An active program to locate a buyer and other actions required to complete
the plan to sell the asset (disposal group) have been initiated.
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Management and the Board issued a press release in July 2004 which stated
that the Company was exploring strategic alternatives which included but was not
restricted to the sale of the ADR business. The Board did set a deadline for
bids for the Company to be received by 5pm on August 3, 2004. However, the Board
still had not determined that the strategic alternative to be selected was
limited to the sale of the ADR business. Also, even though the Board approved
the Asset Purchase Agreement which was signed on October 18, 2004, such
agreement contained a clause that the Company retained the right to have a
so-called "fiduciary out" to allow the Company to terminate the Asset Purchase
Agreement.
d) The sale of the asset (disposal group) is probable and transfer of the asset
(disposal group) is expected to qualify for recognition as a completed sale,
within one year, except as permitted by paragraph 31.
Per the above, the sale was only deemed probable after shareholder
approval had been obtained on January 13, 2005. In order to approve the sale, a
majority of the outstanding shares entitled to vote had to be cast affirmatively
rather than a majority of the votes cast. Accordingly, in order to obtain
approval for the transaction, over 50% of all outstanding shares had to be cast
in favor thereof. Management and the Board of Directors and affiliates thereof
owned 44.5% of the shares. With respect to the remaining 55.5% of the shares
outstanding, Management had no ability to predict what percentage would vote in
the affirmative, or, of even greater significance, what percentage of the 55.5%
would actually be voted. Due to the nature of this proposal, brokers were not
able to vote on behalf of the underlying security holder. Such security holder
had to vote him/herself. As such, the outcome of the vote was difficult to
forecast and the result was uncertain.
In the final analysis, Management's view as to the uncertainty of the
shareholders to actively cast their votes was accurate in that 42.6% of the
outstanding shares did not cast their votes. This figure only needed to be
slightly higher to reach 50% and the transaction would not have passed as a
majority of the outstanding shares had to be cast affirmatively.
From a purely mathematical perspective, if 44.5% of the shares
(representing those shares owned by Management and the Board of Directors and
affiliates thereof) were subtracted from the final number of votes cast, 43.4%
of the remaining non-controlled shares which were actively voted needed to be
cast in the affirmative in order to approve the sale. Although the final vote
tally reflected that 55.8% of the outstanding shares voted in favor of the
transaction, due to the uncertainty involved, approval was not probable until it
occurred.
e) The asset (disposal group) is being actively marketed for sale at a price
that is reasonable in relation to its current fair value.
Per response to item c) above, the sale of the ADR business was not
determined to be the sole course of action in exploring strategic alternatives.
With respect to determining a reasonable price, no determination had been made
as to the reasonableness of such price until an independent investment firm
completed its study and reported to Management and the Board of Directors on
October 15, 2004.
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f) Actions required to complete the plan indicate that it is unlikely that
significant changes to the plan will be made or that the plan will be withdrawn.
Per the above, it was not deemed unlikely that changes would have been
made concerning the proposed transaction as it was subject to shareholders'
approval and as the Company retained the right to have a so-called "fiduciary
out" to allow the Company to terminate the Asset Purchase Agreement should a
better transaction be presented prior to the closing of the sale.
In summary, we believe that all of the criteria as specified in paragraph 30 of
SFAS 144 were not achieved until shareholder approval was obtained on January
13, 2005. As a result, in preparing our financial statements for the quarter
ended December 31, 2004, we applied the guidance specified in paragraph 33 of
SFAS 144. That is, if the criteria in paragraph 30 are met after the balance
sheet date but before issuance of the financial statements, a long-lived asset
shall continue to be classified as held and used in those financial statements
when issued.
For the quarterly and nine-month period ending March 31, 2005, we intend to
present our financial statements in accordance with paragraphs 42 and 43 of SFAS
144, which will be to present the assets and liabilities and results of
operations as discontinued operations for all periods presented.
If you have any questions or comments concerning the above, please do not
hesitate to contact me at 516-794-8950 ext.143. My direct fax number is
516-213-7600.
Very truly yours,
/s/ Patricia Giuliani-Rheaume
-----------------------------
Patricia Giuliani-Rheaume
Vice President, Chief Financial Officer & Treasurer
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2005-03-09 - UPLOAD - BioCardia, Inc.
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<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
March 9, 2005
Mail Stop 0409 and FAX (516) 794-8518
Ms. Patricia Giuliani-Rheaume
Vice President, Chief Financial Officer and Treasurer
clickNsettle.com, Inc.
990 Stewart Avenue, Suite 140
Garden City, NY 11530
Re: clickNsettle.com, Inc.
Form 10-KSB for the year ended 6/30/2004
File No. 000-21419
Dear Ms. Patricia Giuliani-Rheaume:
We have reviewed your filing and have the following
comments.
We have limited our review to only the issues addressed below and
will make no further review of your documents. As such, all
persons
who are responsible for the adequacy and accuracy of the
disclosure
are urged to be certain that they have included all information
required pursuant to the Securities Exchange Act of 1934.
Where indicated, we think you should revise your document in
response to these comments. If you disagree, we will consider
your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
FORM 10-KSB FOR THE YEAR ENDED JUNE 30, 2004
Financial Statements and Notes
Note 14 - Subsequent Event, page F-24
1. The Company states "The Board of Directors is negotiating the
terms of an asset purchase agreement with the present Chief
Executive
Officer of the Company, whereby he, or companies owned by him,
would
assume the assets and liabilities of the ADR business of the
Company
and its future commitments." Tell us how you considered
paragraphs
30 and 41 to 44 of SFAS 144 in determining whether to categorize
the
assets of the ADR business as held for sale and whether to
classify
the sale of this business as discontinued operations. Tell us how
you applied this guidance at year-end June 30, 2004 as well as at
the
quarters ended, September 30, 2004 and December 31, 2004 or revise
your financial statements accordingly.
* * * *
As appropriate, please respond to these comments within 10
business days or tell us when you will provide us with a response.
Please furnish a cover letter with your amendment that keys your
responses to our comments and provides any requested supplemental
information. Detailed cover letters greatly facilitate our
review.
Please file your cover letter on EDGAR. Please understand that we
may have additional comments after reviewing your responses to our
comments.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings reviewed by the staff to
be
certain that they have provided all information investors require
for
an informed decision. Since the company and its management are in
possession of all facts relating to a company`s disclosure, they
are
responsible for the accuracy and adequacy of the disclosures they
have made.
In connection with responding to our comments, please
provide,
in writing, a statement from the company acknowledging that
* the company is responsible for the adequacy and accuracy of the
disclosure in the filings;
* staff comments or changes to disclosure in response to staff
comments do not foreclose the Commission from taking any action
with
respect to the filings; and
* the company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in our review of your filings or
in
response to our comments on your filings.
You may contact Wilson K. Lee, at (202) 824-5535 or me, at
(202)
942-2814 if you have questions.
Sincerely,
Kathleen Collins
Accounting Branch Chief
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clickNsettle.com, Inc.
March 9, 2005
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