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Letter Text
Nuwellis, Inc.
Response Received
2 company response(s)
Medium - date proximity
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Nuwellis, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-11-22
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-08-21
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-08
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
10 company response(s)
High - file number match
SEC wrote to company
2024-01-26
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2023-09-27
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2022-09-15
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2021-06-14
Nuwellis, Inc.
Summary
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Company responded
2021-06-30
Nuwellis, Inc.
References: June 28, 2021
Summary
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Nuwellis, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-06-28
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-08-12
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-06-04
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-05-05
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-04-17
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2019-12-13
Nuwellis, Inc.
Summary
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Company responded
2019-12-20
Nuwellis, Inc.
References: December 13, 2019
Summary
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Nuwellis, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-12-27
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-02-05
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
1 company response(s)
High - file number match
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SEC wrote to company
2018-05-22
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Nuwellis, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Nuwellis, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Nuwellis, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Nuwellis, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Nuwellis, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2016-12-28
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2013-02-06
Nuwellis, Inc.
Summary
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Company responded
2013-02-08
Nuwellis, Inc.
References: February 5, 2013
Summary
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Nuwellis, Inc.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2012-07-27
Nuwellis, Inc.
Summary
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Company responded
2012-07-30
Nuwellis, Inc.
References: July 27, 2012
Summary
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Nuwellis, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-02-16
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2011-10-27
Nuwellis, Inc.
Summary
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Company responded
2011-12-16
Nuwellis, Inc.
References: October 27, 2011
Summary
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Company responded
2011-12-29
Nuwellis, Inc.
References: December 23, 2011
Summary
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Company responded
2012-02-01
Nuwellis, Inc.
References: January 6, 2012
Summary
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Nuwellis, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-01-06
Nuwellis, Inc.
Summary
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Nuwellis, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-12-23
Nuwellis, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-05 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2025-06-05 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2025-04-17 | SEC Comment Letter | Nuwellis, Inc. | DE | 377-07886 | Read Filing View |
| 2024-12-20 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-11-22 | SEC Comment Letter | Nuwellis, Inc. | DE | 333-283283 | Read Filing View |
| 2024-09-04 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-08-21 | SEC Comment Letter | Nuwellis, Inc. | DE | 333-281563 | Read Filing View |
| 2024-07-08 | SEC Comment Letter | Nuwellis, Inc. | DE | 333-280647 | Read Filing View |
| 2024-07-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-02-14 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-02-14 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-02-09 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-02-09 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-01-26 | SEC Comment Letter | Nuwellis, Inc. | DE | 333-276562 | Read Filing View |
| 2023-09-29 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2023-09-29 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2023-09-27 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2022-10-11 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2022-10-11 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2022-09-15 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-07-01 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-06-30 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-06-28 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-06-21 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-06-14 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-08-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-08-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-08-12 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-06-05 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-06-04 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-05-06 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-05-05 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-04-17 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-01-23 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-01-23 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-12-27 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-12-27 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-12-20 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-12-13 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-03-06 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-03-06 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-02-05 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2018-05-22 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2018-05-21 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-04-18 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-04-18 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-03-20 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2016-12-30 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2016-12-30 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2016-12-28 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2013-02-13 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2013-02-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2013-02-06 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-08-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-08-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-08-01 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-07-30 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-07-27 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-16 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-14 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-13 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-01 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-01-06 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2011-12-29 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2011-12-23 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2011-12-16 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2011-10-27 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-17 | SEC Comment Letter | Nuwellis, Inc. | DE | 377-07886 | Read Filing View |
| 2024-11-22 | SEC Comment Letter | Nuwellis, Inc. | DE | 333-283283 | Read Filing View |
| 2024-08-21 | SEC Comment Letter | Nuwellis, Inc. | DE | 333-281563 | Read Filing View |
| 2024-07-08 | SEC Comment Letter | Nuwellis, Inc. | DE | 333-280647 | Read Filing View |
| 2024-01-26 | SEC Comment Letter | Nuwellis, Inc. | DE | 333-276562 | Read Filing View |
| 2023-09-27 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2022-09-15 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-06-28 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-06-14 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-08-12 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-06-04 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-05-05 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-04-17 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-12-27 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-12-13 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-02-05 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2018-05-22 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2016-12-28 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2013-02-06 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-07-27 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-16 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-01-06 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2011-12-23 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2011-10-27 | SEC Comment Letter | Nuwellis, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-05 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2025-06-05 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-12-20 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-09-04 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-07-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-04-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-02-14 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-02-14 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-02-09 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2024-02-09 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2023-09-29 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2023-09-29 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2022-10-11 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2022-10-11 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-07-01 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-06-30 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2021-06-21 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-08-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-08-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-06-05 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-05-06 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-01-23 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2020-01-23 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-12-27 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-12-20 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-03-06 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2019-03-06 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2018-05-21 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-04-18 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-04-18 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2017-03-20 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2016-12-30 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2016-12-30 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2013-02-13 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2013-02-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-08-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-08-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-08-01 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-07-30 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-14 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-13 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-08 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2012-02-01 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2011-12-29 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
| 2011-12-16 | Company Response | Nuwellis, Inc. | DE | N/A | Read Filing View |
2025-06-05 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm Ladenburg Thalmann & Co. Inc. 640 Fifth Avenue, 4 th Floor New York, New York 10019 June 5, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Washington, DC 20549 Re: Nuwellis, Inc. Registration Statement on Form S-1 (Registration No. 333-287663) Concurrence in Acceleration Request Ladies and Gentlemen: Ladenburg Thalmann & Co. Inc. (“ Ladenburg ”), as representative of the underwriters for the referenced offering, hereby concurs in the request by Nuwellis, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:00 p.m. (Eastern Time), or as soon as practicable thereafter, on June 6, 2025, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering. Very truly yours, LADENBURG THALMANN & CO. INC. By: /s/ Nicholas Stergis Name: Nicholas Stergis Title: Managing Director
2025-06-05 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm June 5, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Nicholas O’Leary Re: Nuwellis, Inc. Registration Statement on Form S-1 File No. 333-287663 Acceleration Request Requested Date: June 6, 2025 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company” ) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-287663) (the “Registration Statement” ) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman LLP, counsel to the Company, to make such request on its behalf. Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702. [Signature page follows] **** Sincerely, Nuwellis, Inc. By: /s/ John L. Erb John L. Erb Interim Chief Executive Officer cc: Neil P. Ayotte, Nuwellis, Inc. Robert B. Scott, Nuwellis, Inc. Phillip D. Torrence, Honigman LLP Jessica M. Herron, Honigman LLP Michael F. Nertney, Ellenoff Grossman & Schole LLP Thomas Fugnitti, Ellenoff Grossman & Schole LLP
2025-04-17 - UPLOAD - Nuwellis, Inc. File: 377-07886
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 17, 2025 John Erb Interim President and Chief Executive Officer Nuwellis, Inc. 12988 Valley View Road Eden Prairie, MN 55344 Re: Nuwellis, Inc. Draft Registration Statement on Form S-1 Submitted April 11, 2025 CIK No. 0001506492 Dear John Erb: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. 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 Nicholas O'Leary at 202-551-4451 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Jessica M. Herron, Esq. </TEXT> </DOCUMENT>
2024-12-20 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
December 20, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1, as amended
File No. 333-283283
Acceleration Request
Requested Date:
December 20, 2024
Requested Time:
4:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company”) hereby respectfully requests that the above-referenced
Registration Statement on Form S-1, as amended (File No. 333-283283) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable
thereafter, 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. The Company hereby authorizes each of Phillip D.
Torrence and Jessica M. Herron of Honigman LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone
at (269) 337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By:
/s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
Robert B. Scott, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
2024-11-22 - UPLOAD - Nuwellis, Inc. File: 333-283283
November 22, 2024
Nestor Jaramillo, Jr.
Chief Executive Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, MN 55344
Re:Nuwellis, Inc.
Registration Statement on Form S-1
Filed November 15, 2024
File No. 333-283283
Dear Nestor Jaramillo Jr.:
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 Juan Grana at 202-551-6034 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Jessica M. Herron, Esq.
2024-09-04 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
September 4, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1/A
File No. 333-281563
Acceleration Request
Requested Date:
September 6, 2024
Requested Time:
4:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement on Form S-1, as amended (File No. 333-281563) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of
Honigman LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313)
465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By:
/s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
Robert B. Scott, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
2024-08-21 - UPLOAD - Nuwellis, Inc. File: 333-281563
August 21, 2024
Nestor Jaramillo
Chief Executive Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, MN 55344
Re:Nuwellis, Inc.
Registration Statement on Form S-1
Filed August 15, 2024
File No. 333-281563
Dear Nestor Jaramillo:
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 Nicholas O'Leary at 202-551-4451 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Jessica M. Herron, Esq.
2024-07-08 - UPLOAD - Nuwellis, Inc. File: 333-280647
July 8, 2024
Nestor Jaramillo
President and Chief Executive Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:Nuwellis, Inc.
Registration Statement on Form S-3
Filed July 1, 2024
File No. 333-280647
Dear Nestor Jaramillo:
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 Robert Augustin at 202-551-8483 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Jessica M. Herron
2024-07-08 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
July 8, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention:
Robert Augustin
Re:
Nuwellis, Inc.
Registration Statement on Form S-3
File No. 333-280647
Acceleration Request
Requested Date: July 9, 2024
Requested Time: 4:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the ”Company”) hereby requests that the above-referenced Registration Statement on Form S-3
(File No. 333-280647) (the ”Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman
LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602.
Very truly yours,
/s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
Nuwellis, Inc.
cc:
Phillip D. Torrence
Jessica M. Herron
(Honigman LLP)
2024-04-22 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
April 22, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1, as amended
File No. 333-276562
Withdrawal of Acceleration Request
Ladies and Gentlemen:
Reference is made to our letter filed as correspondence via EDGAR on April 17, 2024 (the “Acceleration Request”), in which we requested the acceleration of the effective date of the above-referenced Registration Statement on Form S-1, as amended (File No. 333-276562) (the “Registration Statement”). 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 direct any questions with respect to the withdrawal of the Acceleration Request of the Registration Statement to Jessica M. Herron
of Honigman LLP, counsel to the Company, by telephone at (313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By: /s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
Robert B. Scott, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Tracy Buffer, Lowenstein Sandler LLP
2024-04-22 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
Roth Capital Partners, LLC
888 San Clemente Drive
Newport Beach, CA 92660
April 22, 2024
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuwellis, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-276562)
Ladies and Gentlemen:
In connection with the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of
1933, as amended (the “Act”), Roth Capital Partners, LLC, as placement agent, hereby joins in the request of the Company that the effective date of such registration statement be accelerated to 5:00 p.m. (Eastern time) on April 24, 2024, or as soon
thereafter as practicable.
In making this request the undersigned acknowledges that it is aware of its obligations under the Act as they relate
to the public offering of securities pursuant to the registration statement.
[Signature Page Follows]
Very truly yours,
ROTH CAPITAL PARTNERS, LLC,
By:
/s/ Aaron M. Gurewitz
Name:
Aaron M. Gurewitz
Title:
President & Head of Investment Banking
2024-04-22 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
April 22, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1
File No. 333-276562
Acceleration Request
Requested Date:
April 24, 2024
Requested Time:
5:00 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1
(File No. 333-276562) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman
LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269)
337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By:
/s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
Robert B. Scott, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Tracy Buffer, Lowenstein Sandler LLP
2024-04-22 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
April 22, 2024
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuwellis, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-276562)
Ladies and Gentlemen:
In connection with the above-captioned registration statement, the undersigned placement agent hereby requests the withdrawal of its acceleration
request dated April 17, 2024.
Very truly yours,
ROTH CAPITAL PARTNERS, LLC
By: /s/ Aaron M. Gurewitz
Name: Aaron M. Gurewitz
Title: President & Head of Investment Banking
2024-04-17 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
Roth Capital Partners, LLC
888 San Clemente Drive
Newport Beach, CA 92660
April 17, 2024
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E. Washington, D.C. 20549
Re:
Nuwellis, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-276562)
Ladies and Gentlemen:
In connection with the above-captioned registration statement, and pursuant to Rule 461
under the Securities Act of 1933, as amended (the “Act”), Roth Capital Partners, LLC, as placement agent, hereby joins in the request of the Company that the effective date of such registration statement be accelerated to 5:00 p.m. (Eastern time) on
April 18, 2024, or as soon thereafter as practicable.
In making this request the undersigned acknowledges that it is aware of its obligations
under the Act as they relate to the public offering of securities pursuant to the registration statement.
[Signature
Page Follows]
Very truly yours,
ROTH CAPITAL PARTNERS, LLC,
By:
/s/ Aaron M. Gurewitz
Name:
Aaron M. Gurewitz
Title:
President & Head of Investment Banking
2024-04-17 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
April 17, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1
File No. 333-276562
Acceleration Request
Requested Date:
April 18, 2024
Requested Time:
5:00 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-276562) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman LLP, counsel to the Company, to make such request on its
behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or,
in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By:
/s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
Robert B. Scott, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Tracy Buffer, Lowenstein Sandler LLP
2024-02-14 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
February 14, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1, as amended
File No. 333-276562
Withdrawal of Acceleration Request
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence via EDGAR on February 9, 2024, in which we requested the acceleration of the effective date of the above-referenced
registration statement on Form S-1, as amended (the “Registration Statement”), for February 12, 2024, at 5:00 p.m. Eastern Time, or as soon as thereafter possible in accordance with Rule 461 under the
Securities Act of 1933, as amended (the “Securities Act”).
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 direct any questions or comments concerning this request to Aaron M. Schleicher, Esq. of Sullivan & Worcester LLP, counsel to the placement agents, at +1 (212) 660 3034.
[Signature Page to Follow]
Very truly yours,
LAKE STREET CAPITAL MARKETS, LLC
By:
/s/ Michael Townley
Name: Michael Townley
Title: Head of Investment Banking
MAXIM GROUP LLC
By:
/s/ Clifford A. Teller
Name: Clifford A. Teller
Title: Co-President
[Signature Page to Withdrawal of Acceleration Request]
2024-02-14 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
February 14, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1, as amended
File No. 333-276562
Withdrawal of Acceleration Request
Ladies and Gentlemen:
Reference is made to our letter filed as correspondence via EDGAR on February 9, 2024 (the “Acceleration Request”), in which we requested the acceleration of the effective date of the above-referenced Registration Statement on Form S-1, as amended (File No.
333-276562) (the “Registration Statement”). 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 direct any questions with respect to the withdrawal of the Acceleration Request of the Registration Statement to
Jessica M. Herron of Honigman LLP, counsel to the Company, by telephone at (313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By: /s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
Robert B. Scott, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Aaron M. Schleicher, Sullivan & Worcester LLP
2024-02-09 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
February 9, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1
File No. 333-276562
Acceleration Request
Requested Date:
February 12, 2024
Requested Time:
5:00 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement
on Form S-1 (File No. 333-276562) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of
Honigman LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone
at (269) 337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By: /s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
Robert B. Scott, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Aaron M. Schleicher, Sullivan & Worcester LLP
2024-02-09 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
February 9, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1, as amended
File No: 333-276562
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933,
as amended (the “Securities Act”), Lake Street Capital Markets, LLC and Maxim Group LLC, as placement agents for the proposed offering, hereby join the request of Nuwellis, Inc. (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
Monday, February 12, 2024, or as soon thereafter as practicable.
Pursuant to Rule 460 of the General Rules and Regulations of the Commission under the Securities Act, please be advised that there will be distributed to each underwriter, dealer or agent, who is reasonably anticipated
to participate in the distribution of the securities in this offering, as many copies of the preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned is aware of its obligations under the provisions of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, including the delivery requirements contained in such Rule, in connection with the
above-referenced issue.
Very truly yours,
LAKE STREET CAPITAL MARKETS, LLC
By:
/s/ Michael Townley
Name: Michael Townley
Title: Head of Investment Banking
MAXIM GROUP LLC
By:
/s/ Clifford A. Teller
Name: Clifford A. Teller
Title: Co-President
cc:
David E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron M. Schleicher, Esq., Sullivan & Worcester LLP
2024-01-26 - UPLOAD - Nuwellis, Inc. File: 333-276562
United States securities and exchange commission logo
January 25, 2024
Nestor Jaramillo
Chief Executive Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:Nuwellis, Inc.
Registration Statement on Form S-1
Filed January 18, 2024
File No. 333-276562
Dear Nestor Jaramillo:
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 Robert Augustin at 202-551-8483 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Phillip D. Torrence
2023-09-29 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
September 29, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Jessica Ansart
Re:
Nuwellis, Inc.
Registration Statement on Form S-1
File No. 333-274610
Acceleration Request
Requested Date:
September 29, 2023
Requested Time:
4:01 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on
Form S-1 (File No. 333-274610) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman
LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone
at (269) 337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By: /s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
Robert B. Scott, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Aaron M. Schleicher, Sullivan & Worcester LLP
2023-09-29 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
September 29, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention: Jessica Ansart
Re:
Nuwellis, Inc.
Registration Statement on Form S-1, as amended
File No: 333-274610
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations of
the U.S. Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities Act”), Lake Street Capital Markets, LLC and Maxim Group LLC, as placement agents for the proposed offering, hereby join the request of Nuwellis, Inc. (the “Company”) that the effective date of the above-referenced Registration
Statement be accelerated so that it will become effective at 4:01 p.m. Eastern Time on Friday, September 29, 2023, or as soon thereafter as practicable.
Pursuant to Rule 460 of the General Rules and Regulations of the Commission under the Securities Act, please be advised that there will be
distributed to each underwriter, dealer or agent, who is reasonably anticipated to participate in the distribution of the securities in this offering, as many copies of the preliminary prospectus as appears to be reasonable to secure adequate
distribution of the preliminary prospectus.
The undersigned is aware of its obligations under the
provisions of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, including the delivery requirements contained in such Rule, in connection with the above-referenced issue.
Very truly yours,
LAKE STREET CAPITAL MARKETS, LLC
By:
/s/ Michael Townley
Name: Michael Townley
Title: Head of Investment Banking
MAXIM GROUP LLC
By:
/s/ Clifford A. Teller
Name: Clifford A. Teller
Title: Co-President
cc: Aaron M. Schleicher, Esq., Sullivan &
Worcester LLP
Shu Wei, Esq., Sullivan & Worcester LLP
2023-09-27 - UPLOAD - Nuwellis, Inc.
United States securities and exchange commission logo
September 27, 2023
Nestor Jaramillo, Jr.
Chief Executive Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:Nuwellis, Inc.
Registration Statement on Form S-1
Filed September 21, 2023
File No. 333-274610
Dear Nestor Jaramillo:
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 Jessica Ansart at 202-551-4511 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Phillip Torrence
2022-10-11 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
October 11, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Dillon Hagius
Re:
Nuwellis, Inc.
Registration Statement on Form S-1
File No. 333-267368
Acceleration Request
Requested Date:
October 12, 2022
Requested Time:
5:01 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-267368) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman LLP, counsel to the
Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at
(313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
Nuwellis, Inc.
By: /s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
cc:
Neil P. Ayotte, Nuwellis, Inc.
George Montague, Nuwellis, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Michael F. Nertney, Ellenoff Grossman & Schole LLP
Thomas Fugnitti, Ellenoff Grossman & Schole LLP
2022-10-11 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
Ladenburg Thalmann & Co. Inc.
640 Fifth Avenue, 4th Floor
New York, New York 10019
October 11, 2022
VIA FACSIMILE AND EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
Re:
Nuwellis, Inc.
Registration Statement on Form S-1 (Registration No. 333-267368)
Concurrence in Acceleration Request
Ladies and Gentlemen:
Ladenburg Thalmann & Co. Inc. (“Ladenburg”),
as representative of the underwriters for the referenced offering, hereby concurs in the request by Nuwellis, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:01 p.m. (Eastern Time), or as soon as
practicable thereafter, on October 12, 2022, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering.
Very truly yours,
LADENBURG THALMANN & CO. INC.
By:
/s/ Nicholas Stergis
Name: Nicholas Stergis
Title: Managing Director
2022-09-15 - UPLOAD - Nuwellis, Inc.
United States securities and exchange commission logo
September 15, 2022
Nestor Jaramillo, Jr.
Chief Executive Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, MN 55344
Re:Nuwellis, Inc.
Registration Statement on Form S-1
Filed September 9, 2022
File No. 333-267368
Dear Mr. Jaramillo:
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: Phillip D. Torrence, Esq.
2021-07-01 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
July 1, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention:
Tom Kluck
Celeste M. Murphy
Re:
Nuwellis, Inc.
Registration Statement on Form S-3/A
File No. 333-256797
Acceleration Request
Requested Date:
July 2, 2021
Requested Time:
9:00 A.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Nuwellis, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3/A
(File No. 333-256797) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman
LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602.
Very truly yours,
/s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
Nuwellis, Inc.
cc:
Phillip D. Torrence
Jessica M. Herron
(Honigman LLP)
2021-06-30 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
June 30, 2021
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F. Street, N.E.
Washington, D.C. 20549
Attention:
Tom Kluck
Celeste M. Murphy
Re:
Nuwellis, Inc.
Amendment No. 1 to Registration Statement on Form S-3
Filed June 21, 2021
File No. 333-256797
Dear Mr. Kluck and Ms. Murphy:
This letter, which is being submitted on behalf of Nuwellis, Inc. (“Nuwellis” or the “Company”),
responds to the comment of the staff of the Securities and Exchange Commission to Amendment No. 1 to the Company’s Registration Statement on Form S-3 (File No. 333-256797), originally filed on June 4, 2021 and amended on June 21, 2021 (“Amendment No. 1”) contained in your letter, dated June 28, 2021 (the “Comment Letter”).
For your convenience, we have included the text of the applicable comment from the Comment Letter in bold immediately before our response.
Amendment No. 1 to Registration Statement on Form S-3
General
1.
We note your response to comment 1 and your revised disclosure on the cover page of the prospectus that, “[you] have not offered any securities pursuant to General Instruction I.B.6 of Form S-3 during the prior
12 calendar month period that ends on and includes the date of this prospectus.” We further note that you filed a 424 prospectus on March 17, 2021 for a firm commitment offering of your common stock for $18 million that was on a shelf
registration statement on Form S-3. Please reconcile your disclosure or advise.
The aggregate market value of the Company’s outstanding voting and nonvoting common equity computed pursuant to General Instruction I.B.6. of Form S-3 exceeded $75 million subsequent to the Company’s Securities Act Section 10(a)(3) update in
2020. As a result, pursuant to Instruction 3 to General Instruction I.B.6. of Form S-3, this lifted the one third limitation on sales specified in General Instruction I.B.6(a) and the prior registration statement was then considered to be filed
pursuant to General Instruction I.B.1. for subsequent sales, including the March 17, 2021 offering. Specifically, on August 3, 2020, the Company’s stock price closed at $30.00 per share, which was prior to the Company’s 1-for-30 reverse stock split
on October 16, 2021. As of that date, the Company was no longer subject to and limited by General Instruction I.B.6 of Form S-3 as our public float was in excess of $75 million. As a result, the firm commitment offering filed by the Company on
March 17, 2021, prior to filing its Annual Report on Form 10-K on March 25, 2021, was offered pursuant to General Instruction I.B.1.
Please contact Phillip D. Torrence at (269) 337-7702 or ptorrence@honigman.com or Jessica M. Herron at (313) 465-7602 or jherron@honigman.com
if you have any comments or questions about this letter.
Very truly yours,
/s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
Nuwellis, Inc.
cc:
Phillip D. Torrence
Jessica M. Herron
(Honigman LLP)
2
2021-06-28 - UPLOAD - Nuwellis, Inc.
United States securities and exchange commission logo
June 28, 2021
Nestor Jaramillo, Jr
President and Chief Executive Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:Nuwellis, Inc.
Amendment No. 1 to Registration Statement on Form S-3
Filed June 21, 2021
File No. 333-256797
Dear Mr. Jaramillo:
We have reviewed your amended registration statement and have the following comment.
Please respond to this letter by amending your registration statement and providing the requested
information. If you do not believe our comment applies 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 registration statement and the information you
provide in response to this comment, we may have additional comments. Our reference to the
prior comment is to the comment in our June 14, 2021 letter.
Amendment No. 1 to Registration Statement on Form S-3
General
1.We note your response to comment 1 and your revised disclosure on the cover page of the
prospectus that, "[you] have not offered any securities pursuant to General Instruction
I.B.6 of Form S-3 during the prior 12 calendar month period that ends on and includes the
date of this prospectus." We further note that you filed a 424 prospectus on March 17,
2021 for a firm commitment offering of your common stock for $18 million that was on a
shelf registration statement on Form S-3. Please reconcile your disclosure or advise.
Please contact Tom Kluck at 202-551-3233 or Celeste Murphy at 202-551-3257 with any
questions.
Sincerely,
FirstName LastNameNestor Jaramillo, Jr
Comapany NameNuwellis, Inc.
June 28, 2021 Page 2
FirstName LastName
Nestor Jaramillo, Jr
Nuwellis, Inc.
June 28, 2021
Page 2
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence
2021-06-21 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
June 21, 2021
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F. Street, N.E.
Washington, D.C. 20549
Attention:
Tom Kluck
Celeste M. Murphy
Re:
Nuwellis, Inc.
Registration Statement on Form S-3
Filed June 4, 2021
File No. 333-256797
Dear Mr. Kluck and Ms. Murphy:
Nuwellis, Inc. (“Nuwellis” or the “Company”)
today filed Amendment No. 1 (“Amendment No. 1”) to its Registration Statement on Form S-3 (File No. 333-256797), originally filed on June 4, 2021 (“Original Registration Statement”). This letter, which is being submitted on behalf of Nuwellis, responds to the comment of the staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) to the Original Registration Statement contained in your letter, dated June 14, 2021 (the “Comment Letter”).
For your convenience, we have included the text of the applicable comment from the Comment Letter in bold immediately before our response.
Form S-3 filed June 4, 2021
General
1.
Based on publicly available information, it appears that the aggregate market value of your common equity
held by non-affiliates during the 60 days prior to the date of filing of the registration statement was not $75 million or more, as required by General Instruction I.B.1 of Form S-3. Please advise. To the extent you intend to rely on
General Instruction I.B.6 to Form S-3 for limited primary offerings, please disclose on the prospectus cover page the information called for by Instruction 7 to General Instruction I.B.6. Please also confirm to us your understanding of
the size limitations for offerings made under General Instruction I.B.6.
In response to the Staff´s comment, the Company has revised the prospectus cover page to disclose the information required by Instruction 7 to General
Instruction I.B.6. The Company acknowledges the Staff’s comment and confirms its understanding of the size limitations for offerings made under General Instruction I.B.6.
We hope that the foregoing, and the revisions to the Original Registration Statement set forth in Amendment No. 1, have been responsive to the Staff’s
comment.
Please contact Phillip D. Torrence at (269) 337-7702 or ptorrence@honigman.com or Jessica M. Herron at (313) 465-7602 or jherron@honigman.com if you have
any comments or questions about this letter.
Very truly yours,
/s/ Nestor Jaramillo, Jr.
Nestor Jaramillo, Jr.
President and Chief Executive Officer
Nuwellis, Inc.
cc:
Phillip D. Torrence
Jessica M. Herron
(Honigman LLP)
2021-06-14 - UPLOAD - Nuwellis, Inc.
United States securities and exchange commission logo
June 14, 2021
Nestor Jaramillo, Jr
President and Chief Executive Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:Nuwellis, Inc.
Registration Statement on Form S-3
Filed June 4, 2021
File No. 333-256797
Dear Mr. Jaramillo:
We have limited our review of your registration statement to those issues we have
addressed in our comment. Please respond to this letter by amending your registration statement
and providing the requested information. If you do not believe our comment applies 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 registration statement and the information you
provide in response to this comment, we may have additional comments.
Form S-3 filed June 4, 2021
General
1.Based on publicly available information, it appears that the aggregate market value of
your common equity held by non-affiliates during the 60 days prior to the date of filing of
the registration statement was not $75 million or more, as required by General Instruction
I.B.1 of Form S-3. Please advise. To the extent you intend to rely on General
Instruction I.B.6 to Form S-3 for limited primary offerings, please disclose on the
prospectus cover page the information called for by Instruction 7 to General
Instruction I.B.6. Please also confirm to us your understanding of the size limitations for
offerings made under General Instruction I.B.6.
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 LastNameNestor Jaramillo, Jr
Comapany NameNuwellis, Inc.
June 14, 2021 Page 2
FirstName LastName
Nestor Jaramillo, Jr
Nuwellis, Inc.
June 14, 2021
Page 2
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.
Please contact Tom Kluck at 202-551-3233 or Celeste Murphy at 202-551-3257 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence
2020-08-17 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
August 17, 2020
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Chris Edwards
Re:
CHF Solutions, Inc.
Registration Statement on Form S-1
File No. 333-241454
Acceleration Request
Requested Date:
August 18, 2020
Requested Time:
5:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, CHF Solutions, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-241454) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman LLP, counsel to the
Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at
(313) 465-7602 or, in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
CHF Solutions, Inc.
By: /s/ John Erb
John Erb
Chief Executive Officer
cc:
Thomas Lynch, CHF Solutions, Inc.
Claudia Drayton, CHF Solutions, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Michael F. Nertney, Ellenoff Grossman & Schole LLP
Matthew McCullough, Ellenoff Grossman & Schole LLP
2020-08-17 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
Ladenburg Thalmann & Co. Inc.
277 Park Avenue, 26th Floor
New York, New York 10172
August 17, 2020
VIA FACSIMILE AND EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
Re:
CHF SOLUTIONS, INC.
Registration Statement on Form S-1 (Registration No. 333-241454)
Concurrence in Acceleration Request
Ladies and Gentlemen:
Ladenburg Thalmann & Co. Inc. (“Ladenburg”),
as representative of the underwriters for the referenced offering, hereby concurs in the request by CHF Solutions, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:30 p.m. (Eastern Time), or as soon as
practicable thereafter, on August 18, 2020, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering.
Very truly yours,
LADENBURG THALMANN & CO. INC.
By:
/s/ Nicholas Stergis
Name: Nicholas Stergis
Title: Managing Director
2020-08-12 - UPLOAD - Nuwellis, Inc.
United States securities and exchange commission logo
August 11, 2020
John Erb
Chief Executive Officer
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:CHF Solutions, Inc.
Registration Statement on Form S-1
Filed August 6, 2020
File No. 333-241454
Dear Mr. Erb:
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 Chris Edwards at (202) 551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence
2020-06-05 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
June 5, 2020
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Jason L. Drory
Re:
CHF Solutions, Inc.
Registration Statement on Form S-1
File No. 333-238811
Acceleration Request
Requested Date:
June 8, 2020
Requested Time:
5:00 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, CHF Solutions, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-238811) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman LLP, counsel to the Company, to make
such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or,
in her absence, Philip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
CHF Solutions, Inc.
By: /s/ John Erb
John Erb
Chief Executive Officer
cc:
Thomas Lynch, CHF Solutions, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
2020-06-04 - UPLOAD - Nuwellis, Inc.
United States securities and exchange commission logo
June 4, 2020
Thomas P. Lynch
Chief Legal and Compliance Officer
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:CHF Solutions, Inc.
Registration Statement on Form S-1
Filed May 29, 2020
File No. 333-238811
Dear Mr. Lynch:
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 L. Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence
2020-05-06 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
May 6, 2020
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Irene Paik
Re:
CHF Solutions, Inc.
Registration Statement on Form S-1
File No. 333-237911
Acceleration Request
Requested Date:
May 8, 2020
Requested Time:
5:00 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, CHF Solutions, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-237911) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman LLP, counsel to the
Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at
(313) 465-7602 or, in her absence, Philip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
CHF Solutions, Inc.
By: /s/ John Erb
John Erb
Chief Executive Officer
cc:
Thomas Lynch, CHF Solutions, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
2020-05-05 - UPLOAD - Nuwellis, Inc.
United States securities and exchange commission logo
May 5, 2020
John Erb
Chief Executive Officer
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:CHF Solutions, Inc.
Registration Statement on Form S-1
Filed April 29, 2020
File No. 333-237911
Dear Mr. Erb:
We have limited our review of your registration statement to the issue we have addressed
in our comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 registration statement and the information you
provide in response to this comment, we may have additional comments.
Registration Statement on Form S-1 filed April 29, 2020
Exhibits
1.We note that in Exhibit 5.1, counsel only opines on 1,794,906 of the 6,726,506 shares of
common stock registered. Please have counsel amend the legal opinion to opine on all of
the shares of common stock registered.
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.
FirstName LastNameJohn Erb
Comapany NameCHF Solutions, Inc.
May 5, 2020 Page 2
FirstName LastName
John Erb
CHF Solutions, Inc.
May 5, 2020
Page 2
Please contact Irene Paik at 202-551-6553 or Celeste Murphy at 202-551-3257 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence, Esq.
2020-04-17 - UPLOAD - Nuwellis, Inc.
April 16, 2020
John L. Erb
Chief Executive Officer
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie, MN 55344
Re:CHF Solutions, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed April 1, 2020
File No. 001-35312
Dear Mr. Erb:
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
cc: Jessica M. Herron, Esq.
2020-01-23 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
Ladenburg Thalmann & Co. Inc.
999 Vanderbilt Beach Road, Suite 200
Naples, Florida 34108
January 23, 2020
VIA FACSIMILE AND EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
Re:
CHF SOLUTIONS, INC.
Registration Statement on Form S-1 (Registration No. 333-235385)
Concurrence in Acceleration Request
Ladies and Gentlemen:
Ladenburg Thalmann & Co. Inc. (“Ladenburg”),
as representative of the underwriters for the referenced offering, hereby concurs in the request by CHF Solutions, Inc. that the effective date of the above-referenced registration statement be accelerated to 9:15 a.m. (Eastern Time), or as soon as
practicable thereafter, on January 24, 2020, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering.
Very truly yours,
LADENBURG THALMANN & CO. INC.
By:
/s/ Nicholas Stergis
Name: Nicholas Stergis
Title: Managing Director
2020-01-23 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
January 23, 2020
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Irene Paik
Re:
CHF Solutions, Inc.
Registration Statement on Form S-1
File No. 333-235385
Acceleration Request
Requested Date:
January 24, 2020
Requested Time:
9:15 A.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, CHF Solutions, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-235385) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman LLP, counsel to the Company, to make
such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or,
in her absence, Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
CHF Solutions, Inc.
By: /s/ John Erb
John Erb
Chief Executive Officer
cc:
Thomas Lynch, CHF Solutions, Inc.
Claudia Drayton, CHF Solutions, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
Michael F. Nertney, Ellenoff Grossman & Schole LLP
Matthew McCullough, Ellenoff Grossman & Schole LLP
2019-12-27 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
December 27, 2019
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Irene Paik
Re:
CHF Solutions, Inc.
Registration Statement on Form S-1
File No. 333-235658
Acceleration Request
Requested Date:
December 30, 2019
Requested Time:
4:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, CHF Solutions, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-235658) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman LLP, counsel to the Company, to make such request on its
behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or,
in her absence, Philip D. Torrence of Honigman LLP by telephone at (269) 337-7702.
[Signature page follows]
****
Sincerely,
CHF Solutions, Inc.
By: /s/ John Erb
John Erb
Chief Executive Officer
cc:
Thomas Lynch, CHF Solutions, Inc.
Phillip D. Torrence, Honigman LLP
Jessica M. Herron, Honigman LLP
2019-12-27 - UPLOAD - Nuwellis, Inc.
December 27, 2019
John Erb
Chief Executive Officer
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:CHF Solutions, Inc.
Registration Statement on Form S-1
Filed December 20, 2019
File No. 333-235658
Dear Mr. Erb:
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 Irene Paik at 202-551-6553 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip Torrence, Esq.
2019-12-20 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
December 20, 2019
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F. Street, N.E.
Washington, D.C. 20549
Attention:
Paul Fischer
Celeste M. Murphy
Re:
CHF Solutions, Inc.
Registration Statement on Form S-1
Filed December 6, 2019
File No. 333-235385
Dear Mr. Fischer and Ms. Murphy:
CHF Solutions, Inc. (“CHF Solutions” or the “Company”) today filed Amendment No. 1 (“Amendment No. 1”) to its Registration Statement on Form S-1 (File No. 333-235385), originally filed on December 6, 2019 (“Original Registration Statement”). This letter, which is being submitted on behalf of CHF Solutions, responds to the comment of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to the Original Registration Statement contained in your letter, dated December 13, 2019 (the “Comment Letter”).
For your convenience, we have included the text of the applicable comment from the Comment Letter in bold immediately before our response.
Registration Statement on Form S-1 Filed December 6, 2019
Choice of Forum, page 68
1.
We note that your forum selection provision identifies the Court of Chancery of the Stateof Delaware as the exclusive forum for certain
litigation, including any “derivative action.” Please disclose whether this provision applies to actions arising under the Securities Act or the Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates exclusive
federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for federal and state
courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. If the provision applies to Securities Act claims, please revise your prospectus to state that there is
uncertainty as to whether a court would enforce such provision and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. If the provision does not apply to actions arising under the
Securities Act or Exchange Act, please also tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities Act or Exchange Act.
In response to the Staff´s comment, CHF Solutions has added a new risk factor in Amendment No. 1 to clarify that the Company’s exclusive forum provision
in the Company’s Fourth Amended Certificate of Incorporation does not apply to claims arising under the federal securities laws and the rules and regulations thereunder, including the Securities Act and the Exchange Act, and to identify the risks
and other potential impacts of the exclusive forum provision on investors.
For the Staff’s convenience, the full text of the new risk factor included in Amendment No. 1 is copied below:
“Our Fourth Amended and Restated Certificate of Incorporation, as amended, provides that, unless we consent in writing to
the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a
favorable judicial forum for disputes with us or our directors, officers, or employees.
Our Fourth Amended and Restated Certificate of Incorporation, as amended, provides that, unless we consent in writing to the selection of an alternative forum, the Court of
Chancery of the State of Delaware will be the exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware
General Corporation Law; or any action asserting a claim against us that is governed by the internal affairs doctrine. This choice of forum provision does not preclude or contract the scope of exclusive federal or concurrent jurisdiction for any
actions brought under the Securities Act or the Exchange Act. Accordingly, our exclusive forum provision will not relieve us of our duties to comply with the federal securities laws and the rules and regulations thereunder, and our stockholders
will not be deemed to have waived our compliance with these laws, rules and regulations.
Any person or entity purchasing or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consented to these provisions. These
exclusive-forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum of its choosing for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us and our directors,
officers and other employees.
If a court were to find the choice of forum provision contained in our Fourth Amended and Restated Certificate of Incorporation, as amended, to be inapplicable or unenforceable in
an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition. Even if we are successful in defending against these claims,
litigation could result in substantial costs and be a distraction to management and other employees.”
The Company has also added a description of the exclusive forum provision to a subsection, titled “Choice of Forum,” in Amendment No. 1, titled
“Description of Securities,” to clearly and prominently describe the provision for investors. For the Staff’s convenience, the full text of the subsection is copied below:
“Choice of Forum
Our Fourth Amended and Restated Certificate of Incorporation, as amended, provides that, unless we consent in writing to the selection of an alternative forum, the Court of
Chancery of the State of Delaware will be the exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware
General Corporation Law; or any action asserting a claim against us that is governed by the internal affairs doctrine. These provisions would not apply
to suits brought to enforce a duty or liability created by the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction. Our Fourth Amended and Restated Certificate of Incorporation, as amended, will further provide that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a
cause of action arising under the Securities Act, subject to applicable law. Any person or entity purchasing or otherwise acquiring any interest in our securities shall be deemed to have notice of and consented to these provisions. Our exclusive
forum provision will not relieve us of our duties to comply with the federal securities laws and the rules and regulations thereunder, and our stockholders will not be deemed to have waived our compliance with these laws, rules and regulations.
The provisions of the Delaware General Corporation Law, our Fourth Amended and Restated Certificate of Incorporation, as amended, and our Second Amended and Restated Bylaws could
have the effect of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the price of our common stock that often result from actual or rumored hostile takeover attempts. These
provisions may also have the effect of preventing changes in our management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.”
Additionally, to help the Company’s stockholders understand the scope of the exclusive forum selection clause going forward, the Company will include
disclosure in its future periodic filings to clarify that the exclusive forum selection provision in its Fourth Amended and Restated Certificate of Incorporation, as amended, does not preclude or contract the scope of exclusive federal or
concurrent jurisdiction for any actions brought under the federal securities laws and the rules and regulations thereunder, including the Securities Act and the Exchange Act.
We hope that the foregoing, and the revisions to the Original Registration Statement set forth in Amendment No. 1, have been responsive to the Staff’s
comments.
Please contact Phillip D. Torrence at (269) 337-7702 or ptorrence@honigman.com or Jessica M. Herron at (313) 465-7602 or jherron@honigman.com
if you have any comments or questions about this letter.
Very truly yours,
/s/ John L. Erb
John L. Erb
Chief Executive Officer
CHF Solutions, Inc.
cc:
Phillip D. Torrence
Jessica M. Herron
(Honigman LLP)
2019-12-13 - UPLOAD - Nuwellis, Inc.
December 13, 2019
John Erb
Chief Executive Officer
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie, MN 55344
Re:CHF Solutions, Inc.
Registration Statement on Form S-1
Filed December 6, 2019
File No. 333-235385
Dear Mr. Erb:
We have limited our review of your registration statement to those issues we have
addressed in our comment. Please respond to this letter by amending your registration statement
and providing the requested information. If you do not believe our comment applies 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 registration statement and the information you
provide in response to this comment, we may have additional comments.
Registration Statement on Form S-1, filed on December 6, 2019
Choice of Forum, page 68
1.We note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any "derivative
action." Please disclose whether this provision applies to actions arising under the
Securities Act or the Exchange Act. In that regard, we note that Section 27 of the
Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any
duty or liability created by the Exchange Act or the rules and regulations thereunder, and
Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts
over all suits brought to enforce any duty or liability created by the Securities Act or the
rules and regulations thereunder. If the provision applies to Securities Act claims, please
revise your prospectus to state that there is uncertainty as to whether a court would
enforce such provision and investors cannot waive compliance with the federal securities
laws and the rules and regulations thereunder. If the provision does not apply to actions
arising under the Securities Act or Exchange Act, please also tell us how you will inform
FirstName LastNameJohn Erb
Comapany NameCHF Solutions, Inc.
December 13, 2019 Page 2
FirstName LastName
John Erb
CHF Solutions, Inc.
December 13, 2019
Page 2
investors in future filings that the provision does not apply to any actions arising under the
Securities Act or Exchange Act.
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.
Please contact Paul Fischer at 202-551-3415, or Celeste M. Murphy, Legal Branch Chief,
at 202-551-3257 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip Torrence, Esq.
2019-03-06 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
Ladenburg Thalmann & Co. Inc.
999 Vanderbilt Beach Road, Suite 200
Naples, Florida 34108
March 6, 2019
VIA FACSIMILE AND EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Washington, DC 20549
Re:
CHF SOLUTIONS, INC.
Registration Statement on Form S-1 (Registration No. 333-229102)
Concurrence in Acceleration Request
Ladies and Gentlemen:
Ladenburg Thalmann & Co. Inc. (“Ladenburg”), as
representative of the underwriters for the referenced offering, hereby concurs in the request by CHF Solutions, Inc. that the effective date of the above-referenced registration statement be accelerated to 4:30 p.m. (Eastern Time), or as soon as
practicable thereafter, on March 7, 2019, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering.
Very truly yours,
LADENBURG THALMANN & CO. INC.
By:
/s/ Nicholas Stergis
Name: Nicholas Stergis
Title: Managing Director
2019-03-06 - CORRESP - Nuwellis, Inc.
CORRESP
1
filename1.htm
March 6, 2019
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Heather Percival
Re:
CHF Solutions, Inc.
Registration Statement on Form S-1
File No. 333-229102
Acceleration Request
Requested Date:
March 7, 2019
Requested Time:
4:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, CHF Solutions, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-229102) (the “Registration
Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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. The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Jessica M. Herron of Honigman LLP, counsel to the Company, to make such request on its
behalf.
Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman LLP by telephone at (313) 465-7602 or,
in her absence, Meredith Ervine of Honigman LLP by telephone at (616) 649-1942.
[Signature page follows]
****
Sincerely,
CHF Solutions, Inc.
By: /s/ John Erb
John Erb
Chief Executive Officer
cc:
Claudia Drayton, CHF Solutions, Inc.
Phillip D. Torrence, Honigman LLP
Meredith Ervine, Honigman LLP
Jessica M. Herron, Honigman LLP
Michael F. Nertney, Ellenoff Grossman & Schole LLP
Matthew McCullough, Ellenoff Grossman & Schole LLP
2019-02-05 - UPLOAD - Nuwellis, Inc.
February 5, 2019
John L. Erb
Chief Executive Officer
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re:CHF Solutions, Inc.
Registration Statement on Form S-1
Filed December 31, 2018
File No. 333-229102
Dear Mr. Erb:
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 Heather Percival at 202-551-3498 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Meredith Ervine
2018-05-22 - UPLOAD - Nuwellis, Inc.
Mail Stop 3030 May 21 , 2018 Via E -mail John L. Erb Chief Executive Officer CHF Solutions, Inc. 12988 Valley View Road Eden Prairie, MN 55344 Re: CHF Solutions, Inc. Registration Statement on Form S-3 Filed May 11, 2018 File No. 333-224881 Dear Mr. Erb : 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 Caleb French at (202) 551 -6947 with any questions. Sincerely, /s/ Caleb French for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Phillip D. Torrence, Esq. Honigman Miller Schwartz and Cohn LLP
2018-05-21 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm May 21, 2018 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Caleb French Re: CHF Solutions, Inc. Registration Statement on Form S-3 File No. 333-224881 Acceleration Request Requested Date: May 23, 2018 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, CHF Solutions, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-224881) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Jessica M. Herron of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman Miller Schwartz and Cohn LLP by telephone at (313) 465-7602. Sincerely, CHF Solutions, Inc. /s/ John Erb John Erb Chief Executive Officer cc: Claudia Drayton, CHF Solutions, Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Jessica M. Herron, Honigman Miller Schwartz and Cohn LLP
2017-11-17 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm Ladenburg Thalmann & Co. Inc. 999 Vanderbilt Beach Road, Suite 200 Naples, Florida 34108 November 17, 2017 VIA FACSIMILE AND EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: CHF SOLUTIONS, INC. Registration Statement on Form S-1 (Registration No. 333-221010) Concurrence in Acceleration Request Ladies and Gentlemen: Ladenburg Thalmann & Co. Inc. (“Ladenburg”), as representative of the underwriters for the referenced offering, hereby concurs in the request by CHF Solutions, Inc. that the effective date of the above-referenced registration statement be accelerated to 4:15 p.m. (Eastern Time), or as soon as practicable thereafter, on November 21, 2017, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering. Very truly yours, LADENBURG THALMANN & CO. INC. By: /s/ Nicholas Stergis Name: Nicholas Stergis Title: Managing Director
2017-11-17 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm November 17, 2017 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Heather Percival Re: CHF Solutions, Inc. Registration Statement on Form S-1 File No. 333-221010 Acceleration Request Requested Date: November 21, 2017 Requested Time: 4:15 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, CHF Solutions, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-221010) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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”). The Company hereby authorizes each of Phillip D. Torrence and Jessica M. Herron of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. The Company hereby acknowledges that: · should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; 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. Please confirm the effectiveness of the Registration Statement with Jessica M. Herron of Honigman Miller Schwartz and Cohn LLP by telephone at (313) 465-7602. [Signature page follows] **** Sincerely, CHF Solutions, Inc. /s/ John Erb John Erb Chief Executive Officer cc: Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Jessica M. Herron, Honigman Miller Schwartz and Cohn LLP Michael F. Nertney, Ellenoff Grossman & Schole LLP Matthew McCullough, Ellenoff Grossman & Schole LLP
2017-04-18 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm Ladenburg Thalmann & Co. Inc. 999 Vanderbilt Beach Road, Suite 200 Naples, Florida 34108 April 18, 2017 VIA FACSIMILE AND EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: SUNSHINE HEART, INC. Registration Statement on Form S-1 (Registration No. 333-216841) Concurrence in Acceleration Request Ladies and Gentlemen: Ladenburg Thalmann & Co. Inc. (“Ladenburg”), as representative of the underwriters for the referenced offering, hereby concurs in the request by Sunshine Heart, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:00 p.m. (Eastern Time), or as soon as practicable thereafter, on April 18, 2017, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering. Very truly yours, LADENBURG THALMANN & CO. INC. By: /s/ Nicholas Stergis Name: Nicholas Stergis Title: Managing Director
2017-04-18 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm April 18, 2017 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Tim Buchmiller Re: Sunshine Heart, Inc. Registration Statement on Form S-1 File No. 333-216841 Acceleration Request Requested Date: April 18, 2017 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Sunshine Heart, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-216841) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Jessica Herron of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. The Company hereby acknowledges that: · should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; 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. Please confirm the effectiveness of the Registration Statement with Meredith Ervine of Honigman Miller Schwartz and Cohn LLP by telephone at (616) 649-1942. [Signature page follows] **** Sincerely, SUNSHINE HEART, INC. /s/ John Erb John Erb Chief Executive Officer cc: Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Jessica Herron, Honigman Miller Schwartz and Cohn LLP Joseph A. Smith, Ellenoff Grossman & Schole LLP Michael F. Nertney, Ellenoff Grossman & Schole LLP
2017-03-20 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm March 20, 2017 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Heather Percival Re: Sunshine Heart, Inc. Registration Statement on Form S-1 File No. 333-216053 Acceleration Request Requested Date: March 21, 2017 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Sunshine Heart, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-215112) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Jessica Herron of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. 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 filing 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. Please confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman Miller Schwartz and Cohn LLP by telephone at (269) 337-7702. [Signature page follows] **** Sincerely, SUNSHINE HEART, INC. /s/ JOHN L. ERB John L. Erb Chairman, President and Chief Executive Officer cc: Claudia Drayton, Sunshine Heart, Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Jessica Herron, Honigman Miller Schwartz and Cohn LLP
2016-12-30 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm December 30, 2016 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Tom Jones Amanda Ravitz Re: Sunshine Heart, Inc. Registration Statement on Form S-1 File No. 333-215112 Acceleration Request Requested Date: January 3, 2017 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Sunshine Heart, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-215112) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Jessica Herron of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. 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 filing 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. Please confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman Miller Schwartz and Cohn LLP by telephone at (269) 337-7702. [Signature page follows] **** Sincerely, SUNSHINE HEART, INC. /s/ JOHN L. ERB John L. Erb Chairman, President and Chief Executive Officer cc: Claudia Drayton, Sunshine Heart, Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Jessica Herron, Honigman Miller Schwartz and Cohn LLP
2016-12-30 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm December 30, 2016 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Tom Jones Amanda Ravitz Re: Sunshine Heart, Inc. Registration Statement on Form S-1 File No. 333-215112 Acceleration Request Requested Date: December 30, 2016 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Sunshine Heart, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-215112) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, 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”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Jessica Herron of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. 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 filing 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. Please confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman Miller Schwartz and Cohn LLP by telephone at (269) 337-7702. [Signature page follows] **** Sincerely, SUNSHINE HEART, INC. /s/ JOHN L. ERB John L. Erb Chairman, President and Chief Executive Officer cc: Claudia Drayton, Sunshine Heart, Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Jessica Herron, Honigman Miller Schwartz and Cohn LLP
2016-12-28 - UPLOAD - Nuwellis, Inc.
Mail Stop 3030
December 28, 2016
Via E -mail
John Erb
Chief Executive Officer
Sunshine Heart, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Re: Sunshine Heart, Inc.
Registration Statement on Form S-1
Filed December 15, 2016
File No. 333 -215112
Dear M r. Erb:
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 Tom Jones at (202) 551 -3602 with any questions.
Sincerely,
/s/ Tom Jones for
Amanda Ravitz
Assistant Director
Office of Electronics and Machinery
cc: Phillip D. Torrence, Esq.
2013-02-13 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm 12988 VALLEY VIEW ROAD EDEN PRAIRIE, MN 55344 February 13, 2013 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Mail Stop 4561 Attention: Russell Mancuso, Legal Branch Chief Tim Buchmiller, Senior Attorney Re: Sunshine Heart, Inc. Registration Statement on Form S-1 filed February 13, 2013 File No. 333-186259 Acceleration Request Requested Date: February 13, 2013 Requested Time: 4:00 P.M. Eastern Time Dear Mr. Mancuso and Mr. Buchmiller: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Sunshine Heart, Inc., a Delaware corporation (the “Company”), hereby requests that the above-referenced Registration Statement on Form S-l (File No. 333-186259) (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”) (the “Registration Statement Acceleration Request”). Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Honigman Miller Schwartz and Cohn LLP, by calling Phillip D. Torrence at (269) 337-7702. In connection with the Registration Statement Acceleration Request, the Company hereby acknowledges that: · should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement on Form S-l effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement on Form S-l; · the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement on Form S-l; 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, /S/ JEFFREY MATHIESEN Jeffrey Mathiesen Chief Financial Officer Sunshine Heart, Inc. cc: David A. Rosa, Sunshine Heart, Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Jeffrey Kuras, Honigman Miller Schwartz and Cohn LLP 2
2013-02-08 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm 12988 VALLEY VIEW ROAD EDEN PRAIRIE, MN 55344 February 8, 2013 VIA EDGAR AND OVERNIGHT DELIVERY Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Mail Stop 4561 Attention: Russell Mancuso, Legal Branch Chief Tim Buchmiller, Senior Attorney Re: Sunshine Heart, Inc. Form S-1 filed January 28, 2013 (the “Initial Registration Statement”) File No. 333-186259 Dear Mr. Mancuso and Mr. Buchmiller: On behalf of Sunshine Heart, Inc., a Delaware corporation (the “Registrant”) and pursuant to the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we have filed with the Securities and Exchange Commission (the “SEC”) an Amendment No. 1 to a Registration Statement on Form S-1 (the “Amended S-1”). Such filing was prepared in response to the comments of the SEC’s staff (the “Staff”) as set forth in a comment letter dated February 5, 2013. In order to facilitate the Staff’s review of the Amended S-1, wherever practicable all disclosures which were not completed in the prior filing of the Initial Registration Statement have been completed. In addition, all disclosures have been updated to the latest practicable date. The action taken by, or the response of, the Registrant with respect to each comment contained in your February 5, 2013 comment letter is set forth below. For convenience of the Staff, the Staff’s comments have been included in their entirety followed by the Registrant’s response. Capitalized terms used but not defined herein shall have the meanings for such terms that are set forth in the Amended S-1. SEC STAFF COMMENT 1. Please update your filing to include the disclosures required by Regulation S-K Item 402 for your last completed fiscal year. REGISTRANT’S RESPONSE We have updated the Amended S-1 to include the disclosures required by Regulation S-K Item 402 for the Registrant’s last completed fiscal year. SEC STAFF COMMENT 2. Please include the information required by Regulation S-K Item 601(b)(101) as an exhibit to your filing. REGISTRANT’S RESPONSE We have included the information required by Regulation S-K Item 601(b)(101) as an exhibit to the Amended S-1. SEC STAFF COMMENT 3. Please include all required undertakings in the form required by Regulation S-K Item 512. For example, you have omitted the undertakings required by Regulation S-K Item 512(a)(6). Also, it is unclear whether you are attempting to provide the undertakings in Regulation S-K Item 512(a)(5)(i), and if so, why you have included only a part of the language in that Item. REGISTRANT’S RESPONSE The Registrant intentionally omitted the undertaking required by Regulation S-K Item 512(a)(6) as these undertakings apply to primary offerings and initial distributions of securities. Here, the offering of securities to be registered is a secondary offering, as the initial distribution to the selling shareholder will take place in a private offering exempt from registration requirements. Similarly, the Registrant included the undertakings provided in Regulation S-K Item 512(a)(5)(i)(A), which applies to a prospectus filed pursuant to Rule 424(b)(3) (and is applicable here), but not the undertakings provided in Regulation S-K Item 512(a)(5)(i)(B), which applies to a prospectus filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) (and are not applicable here). Finally, the Registrant inadvertently included the undertakings provided in Regulation S-K Item 512(e), which is inapplicable as the Registrant has not specifically incorporated by reference in the prospectus all or any part of the annual report to security holders meeting the requirements of Rule 14a-3 or Rule 14c-3 under the Exchange Act. 2 As reflected in the above information, our documents have been amended in response to these comments. In connection with the response to the Staff’s comments, all persons responsible for the filing of this document hereby acknowledge that: · should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; 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. Finally, the Registrant further confirms that it will furnish a letter at the time it requests acceleration of the effective date of the registration statement acknowledging the statements set forth in the Staff’s comment letter. We hope that the foregoing has been responsive to the Staff’s comments. If you would like to discuss any of the responses to the Staff’s comments or if you would like to discuss any other matters, please contact Phillip D. Torrence, Esq. of Honigman Miller Schwartz and Cohn LLP, our outside securities counsel at (269) 337-7702. Thank you. Sincerely, /S/ JEFFREY MATHIESEN Jeffrey Mathiesen Chief Financial Officer Sunshine Heart, Inc. cc: David A. Rosa, Sunshine Heart, Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Jeffrey Kuras, Honigman Miller Schwartz and Cohn LLP 3
2013-02-06 - UPLOAD - Nuwellis, Inc.
February 5, 2013 Via E -mail David A. Rosa Chief Executive Officer Sunshine Heart, Inc. 12988 Valley View Road Eden Prairie, MN 55344 Re: Sunshine Heart, Inc. Registration Statement on Form S-1 Filed January 28, 2013 File No. 333 -186259 Dear M r. Rosa : We have limited our review of your registration statement to those issues we have addressed in our 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 registration statement and providing the requested information. Where you do not believe our comments apply to your facts and circumst ances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. 1. Please update your filing to in clude the disclosures required by Regulation S -K Item 402 for your last completed fiscal year . 2. Please include the information required by Regula tion S-K Item 601(b)(101) as an exhibit to your filing . 3. Please include all required undertakings in the form required by Regulation S -K Item 512. For example, you have omitted the undertakings required by Regulation S -K Ite m 512(a)(6) . Also, it is unclear whether you are attempting to provide the undertakings in Regulation S -K Item 512(a)(5) (i), and if so, why you have included only a part of the language in that Item . 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 Secur ities David A. Rosa Sunshine Heart, Inc. February 5, 2013 Page 2 Act of 1933 and all applicable Securities Act rules require. 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 . Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant t o delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effect iveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceler ation of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Tim Buchmiller at (202) 551 -3635 or me at (202) 551-3617 with any questions. Sincerely, /s/ Russell Mancuso Russell Mancuso Branch Chief cc: Phillip D. Torrence , Esq . Honigman Miller Schwartz and Cohn LLP
2012-08-08 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm SUNSHINE HEART, INC. 12988 Valley View Road Eden Prairie, Minnesota 55344 August 8, 2012 BY EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form S-1 File No. 333-182727 Request for Acceleration of Effectiveness Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Sunshine Heart, Inc. (the “Company”) hereby respectfully requests that the effective date of the above-captioned Registration Statement (the “Filing”) be accelerated so that it will be declared effective at 4:00 p.m. Eastern Time on Thursday, August 9, 2012 or as soon thereafter as possible. The Company acknowledges that: (i) should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission, acting pursuant to delegated authority, declare the Filing effective, such declaration does not foreclose the Commission from taking any action with respect to the Filing; (ii) the action of the Commission or the staff of the Commission, acting pursuant to delegated authority, in declaring the Filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Filing; and (iii) 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. Please contact Jonathan Zimmerman of Faegre Baker Daniels LLP with any questions or comments at (612) 766-8419. Thank you for your assistance with this filing. Sincerely yours, SUNSHINE HEART, INC. By: /s/ Jeffrey Mathiesen Jeffrey Mathiesen Chief Financial Officer
2012-08-08 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm [CANACCORD GENUITY INC. LETTERHEAD] August 8, 2012 BY EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form S-1 File No. 333-182727 Request for Acceleration of Effectiveness Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), the undersigned, as representative of the several underwriters, hereby joins Sunshine Heart, Inc. (the “Company”) in requesting that the effective date of the Company’s above-referenced Registration Statement on Form S-1, as amended, be accelerated so that the Registration Statement will be declared effective on August 9, 2012, at 4:00 p.m., Eastern time, or as soon thereafter as practicable. The undersigned wishes to inform you that, pursuant to Rule 460 under the Act, it will provide to each underwriter and dealer who it is reasonably anticipated will be invited to participate in the offering of shares of the Company’s common stock pursuant to the Registration Statement as many copies of the Preliminary Prospectus, dated August 1, 2012, as appears to be reasonable to secure adequate distribution of such Preliminary Prospectus. The undersigned also wishes to advise you that approximately 200 copies of the Preliminary Prospectus have been distributed between August 1, 2012 and August 7, 2012 to prospective underwriters, institutional investors and others. The undersigned, as representative of the several underwriters, is, and each underwriter and dealer has advised the undersigned that it is, aware of its obligations under Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Sincerely yours, Canaccord Genuity Inc. As representative of the several underwriters CANACCORD GENUITY INC. By: /s/ Matthew C. Steere Name: Matthew C. Steere Title: Managing Director
2012-08-01 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm JONATHAN R. ZIMMERMAN jon.zimmerman@faegrebd.com (612) 766-8419 August 1, 2012 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, NE Washington, DC 20549-3561 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form S-1 (File No. 333-182727) (the “Registration Statement”) Ladies and Gentlemen: On behalf of Sunshine Heart, Inc. (the “Company”), we are transmitting Amendment No. 2 to the Registration Statement (the “Amendment”) in a clean version and two copies of the Amendment in a version marked to show changes from Amendment No. 1 to the Registration Statement. In response to verbal comments to the Registration Statement received from the Commission’s staff (the “Staff”) on July 31, 2012, the Company revised pages 4 through 6 of the Amendment to delete the charts that disclose detailed results of the Company’s feasibility trial. The Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in the filing, (ii) 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 (iii) 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. Please do not hesitate to call me at 612-766-8419 if you have any questions or comments regarding the foregoing or if we can be of service in facilitating your review of this filing. Sincerely, /s/ Jonathan R. Zimmerman Jonathan R. Zimmerman Enclosures cc: Tim Buchmiller, Securities and Exchange Commission (w/ encl.) David Rosa, Chief Executive Officer, Sunshine Heart, Inc. (w/out encl.) Jeffrey Mathiesen, Chief Financial Officer, Sunshine Heart, Inc. (w/out encl.)
2012-07-30 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm JONATHAN R. ZIMMERMAN jon.zimmerman@faegrebd.com (612) 766-8419 July 30, 2012 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, NE Washington, DC 20549-3561 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form S-1 (File No. 333-182727) (the “Registration Statement”) Ladies and Gentlemen: On behalf of Sunshine Heart, Inc. (the “Company”), we are transmitting the following responses of the Company to the comments of the Commission’s staff (the “Staff”) as set forth in the letter of Amanda Ravitz, Assistant Director, dated July 27, 2012 (the “Comment Letter”) to the Registration Statement filed with the Securities and Exchange Commission on July 17, 2012 (the “Initial Filing”). We have enclosed for your reference two courtesy copies of Amendment No. 1 to the Registration Statement (the “Amendment”) in a clean version and two copies of the Amendment in a version marked to show changes from the Initial Filing. The responses herein were provided to this firm by the Company. In this letter, we have recited the comment from the Staff in italicized, bold type and have followed the comment with the Company’s response in regular type. References in this letter to we, our or us mean the Company or its advisors, as the context may require. All references to page numbers in the Company’s responses refer to page numbers in the Amendment. Prospectus Cover Page 1. We note you have not included the number of shares of common stock to be offered. Please note that this is not information which you can exclude from your registration statement in reliance on Securities Act Rule 430A. Refer to Compliance and Disclosure Interpretation (Securities Act Rules) 227.02. Please revise your prospectus to include this information. Company Response: The prospectus has been revised to include the number of shares to be offered. 2. We note your disclosure that you are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. Please revise your prospectus to state your election under Section 107(b) of the JOBS Act: · if you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or · if you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures. Also, please supplementally provide us with any written materials that you or anyone authorized to do so on your behalf provides in reliance on Section 5(d) of the Securities Act to potential investors that are qualified institutional buyers or institutional accredited investors. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offerings. Company Response: The Company has elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. The Company has added disclosure to the risk factor beginning on page 29 of the Registration Statement explaining that this election allows the Company to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies and explaining that, as a result of this election, the Company’s financial statements may not be comparable to companies that comply with public company effective dates. Similar disclosure has been added on page 38 of the Registration Statement discussing the Company’s critical accounting policies. The Company respectfully advises the Staff that it has not provided, and has not authorized anyone on its behalf to provide, any written materials in reliance on Section 5(d) of the Securities Act to potential investors that are qualified institutional buyers or institutional accredited investors. Similarly, the investment banks participating in the offering have advised the Company that they have not published or distributed any research reports about the Company in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the JOBS Act. Graphics 3. Please remove any depictions of products from which you have not derived a material amount of sales. To the extent that you have derived a material amount of sales from the depicted product please: · tell us whether the depicted product is a prototype or if you could currently sell that product as depicted. If any aspects of your device, such as the driver, are not available in the form factor depicted, please make that clear; and · revise your graphics to indicate, if true, that your product is in the development stage and has not received FDA approval. 2 Company Response: The Company has removed in the inside front cover graphic included in the Initial Filing and replaced it with the Company’s logo. Prospectus Summary 4. We note your disclosure that you are pursuing necessary regulatory approvals in the United States and Europe. We also note your recent press releases regarding the completion of a two year follow-up of one patient from your feasibility trial and the receipt of CE Mark approval in Europe. Please revise your disclosure as appropriate. Company Response: The Company has revised its disclosure throughout the Registration Statement disclosing that it received CE Mark approval in July 2012 and has revised its disclosure on pages 6 and 49 disclosing that it completed a two-year follow-up of one patient from the Company’s feasibility trial. 5. Your disclosure appears to indicate that your extra-aortic approach may have competitive advantages over existing intra-aortic methods of pumping assistance in that your product does not come into contact with the patient’s blood thereby avoiding clotting issues and ongoing treatment with anti-coagulants. Given that the novel aspect of your product is that it comes into direct contact with the aorta, please balance your disclosure with any possible risks associated with your product physically coming into contact with and pumping that aorta, such as aortic aneurysms, tears or dissections, or clot or plaque displacements, etc., which could be caused by your product. As appropriate, please also revise your risk factors. Company Response: The Company has revised pages 3 and 48 of the Registration Statement to disclose that there is a risk of infection in connection with implantation of the Company’s system and the risk of erosion of the aortic wall or an aortic rupture exists if a patient contracts a sternal infection and continues to use the Company’s system. The Company also revised its disclosure in the Summary, Business and Risk Factors sections to highlight that its system has been implanted in a limited number of patients to date and the potential competitive disadvantages and risks associated with use of its system are not fully known at this time. The Company respectfully advises the Staff that the results from the Company’s clinical activities to date, including its feasibility trial and animal trials, have not revealed a risk of aortic aneurysms, tears or dissections in connection with use of the Company’s product in the absence of an infection of the sternum or any other risks that are not discussed in the Registration Statement. 6. It appears that the insertion of your device would require surgery under general anesthesia whereas other competing products could be done in a catheterization laboratory with local anesthesia. If true, please balance your disclosure with the advantages and disadvantages of your products versus those of your competitors in terms of the insertion and removal of your product versus those of your competitors. As appropriate, please also revise your risk factors. Company Response: The Company respectfully advises the Staff that all of the products with which the Company believes it competes and that the Company is aware of are required, like the Company’s system, to be implanted in an operating room using a surgical procedure that requires general anesthesia. The Company is aware of one competitor conducting a trial for a product treating Class III heart failure that can be implanted percutaneously. However, the Company understands that only patients who have suffered a heart attack within 60 days preceding implantation are eligible to have the product implanted. The Company’s clinical trial protocol excludes patients who have suffered a heart attack within 90 days of enrollment from eligibility, and the Company’s system is designed to target patients with chronic heart failure symptoms rather than to address 3 acute cardiac situations. The Company therefore believes that the requirement to surgical implant its system in a procedure using general anesthesia is similar to the procedure required for products that treat the Company’s target patient population and does not represent a competitive disadvantage. 7. Please tell us whether you have any information about your financial position or results during your last completed quarter that would be material to your investors. Also, update your response to this comment as of the date you request that the registration statement be declared effective. Company Response: The Company has revised the Registration Statement to include financial information as of and for the three- and six-month periods ended June 30, 2012. Clinical Development, page 4 8. We note the disclosure in your charts in this section. Please revise or add textual disclosure that describes in clear every day terms what the information presented in the charts should mean to an investor who may be unfamiliar with this type of statistical presentation. Company Response: The Company has added textual disclosure to pages 4 and 49 of the Registration Statement to provide additional detail on the information presented in the applicable charts. The Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in the filing, (ii) 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 (iii) 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. Please do not hesitate to call me at 612-766-8419 if you have any questions or comments regarding the foregoing or if we can be of service in facilitating your review of this filing. Sincerely, /s/ Jonathan R. Zimmerman Jonathan R. Zimmerman Enclosures cc: Tim Buchmiller, Securities and Exchange Commission (w/ encl.) David Rosa, Chief Executive Officer, Sunshine Heart, Inc. (w/out encl.) Jeffrey Mathiesen, Chief Financial Officer, Sunshine Heart, Inc. (w/out encl.) 4
2012-07-27 - UPLOAD - Nuwellis, Inc.
July 27, 2012 Via E -mail David A. Rosa Chief Executive Officer Sunshine Heart, Inc. 12988 Valley View Road Eden Prairie , MN 55344 Re: Sunshine Medical, Inc. Registration Statement on Form S-1 Filed July 17, 2012 File No. 333 -182727 Dear M r. Rosa : We have limited our review of your registration statement to those issues we have addressed in our 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 registration statement and providing the requested information. Where 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 registration statement and the information you provide in response to these comments, we may have additional comments. Prospectus Cove r Page 1. We note you have not included the number of shares of common stock to be offered. Please note that this is not information which you can exclude from your registration statement in reliance on Securities Act Rule 430A . Refer to Compliance and Dis closure Interpretation (Securities Act Rules) 227.02. Please revise your prospectus to include this information. 2. We note your disclosure that you are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. Please revise your prospectus to state your election under Section 107(b) of the JOBS Act: if you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), include a statement that the electi on is irrevocable; or David A. Rosa Sunshine Heart, Inc. July 27, 2012 Page 2 if you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or r evised accounting standards that have different effective dates for public and private companies until those standar ds apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be co mparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures. Also, p lease supplementally provide us with any written materials that you or anyone authorized to do so on your behalf provide s in reliance on Section 5(d) of the Securities Act to potential investors that are qualified institutional buyers or institutional accredited investors. Similarly, please supplementally provide us with any research reports about you th at are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. Graphics 3. Please remove any depictions of products from which you have not derived a material amount of sales. To the extent that you have derived a material amount of sales from the depicted product please: tell us whether the depicted product is a prototype or if you could currently sell that product as depicted. If any aspects of your device, such as the driver, are not available in the form factor depicted, please make that clear; and revise your graphics to indicate, if true, that your product is in the deve lopment stage and has not received FDA approval. Prospectus Summary 4. We note your disclosure that you are pursuing necessary regulatory approvals in the United States and Europe. We also note your recent press releases regarding the completion of a two y ear follow -up of one patient from your feasibility trial and the receipt of CE Mark approval in Europe. Please revise your disclosure as appropriate . 5. Your disclosure appears to indicate that your extra -aortic approach may have competitive advantages over existing intra -aortic methods of pumping assistance in that your product does not come into contact with the patient’s blood thereby avoiding clotting issues and ongoing treatment with anti -coagulants. Given that the novel aspect of your product is that it comes into direct contact with the aorta, please balance your disclosure with any possible risks associated with your product physically coming into contact with and pumping the aorta, such as aortic aneurisms, tears or dissections, or clot or plaque displacements, etc., which could be caused by your product. As appropriate, please also revise your risk factors. David A. Rosa Sunshine Heart, Inc. July 27, 2012 Page 3 6. It appears that the insertion of your device would require surgery under general anesthesia whereas other competing products could be done in a catheterization laboratory with local anesthesia. If true, please balance your disclosure with the advantages and disadvantages of your products versus those of your competitors in terms of the insertion and removal of your product versus those of your competitors. As appropriate, please also revise your risk factors. 7. Please tell us whether you have any information about your financial position or results during your last completed quarter that would be material to your investors. Also, update your response to this comment as of the date you request that the registration statement be declared effective. Clinical Development , page 4 8. We note the disclosure in your charts in this section. Please revise or add textual disclosure that describes in clea r every day terms what the information presented in the charts should mean to an investor who may be unfamiliar with this type of statistical presentation. 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 Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are resp onsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff , acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the de claration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation David A. Rosa Sunshine Heart, Inc. July 27, 2012 Page 4 of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1 934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may con tact Tim Buchmiller at (202) 551 -3635 or me at (202) 551-3528 with any questions. Sincerely, /s/ Tim Buchmiller for Amanda Ravitz Assistant Director cc: Jonathan R. Zimmerman , Esq . Matthew R. Kuhn, Esq. Faegre Baker Daniels LLP
2012-02-16 - UPLOAD - Nuwellis, Inc.
February 16, 2012 Via E-Mail Jeffrey Mathiesen Chief Financial Officer Sunshine Heart, Inc. 12988 Valley View Road Eden Prairie, Minnesota55344 Re: Sunshine Heart, Inc. Form 10 Filed September 30, 2011 File No. 001-35312 Dear Mr. Mathiesen: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Daniel Morris for Amanda Ravitz Assistant Director cc (by e-mail): Matthew R. Kuhn -- Faegre Baker Daniels LLP
2012-02-14 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm SUNSHINE HEART, INC. 12988 Valley View Road Eden Prairie, Minnesota 55344 February 14, 2012 VIA EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, NE Washington, DC 20549-3561 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form 10 (File No. 001-35312) (the “Registration Statement”) Ladies and Gentlemen: Sunshine Heart, Inc. (the “Company”) is transmitting with this letter Amendment No. 5 to the Registration Statement. In response to verbal comments to the Registration Statement received from the Commission’s staff (the “Staff”) on February 10, 2012, the Company revised the narrative description below the Summary Compensation Table. The Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in the filing, (ii) 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 (iii) 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. Please do not hesitate to call me or Matt Kuhn of Faegre Baker Daniels LLP at 612-766-8134 if you have any questions or comments regarding the foregoing or if the Company can be of service in facilitating your review of this filing. Sincerely, SUNSHINE HEART, INC. /s/ Jeffrey Mathiesen Jeffrey Mathiesen
2012-02-13 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm SUNSHINE HEART, INC. 12988 Valley View Road Eden Prairie, Minnesota 55344 February 13, 2012 Via Edgar and Facsimile Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549-3561 Attn: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form 10 File No. 001-35312 Dear Ms. Ravitz: Reference is made to the above-captioned Registration Statement. We hereby request that the effective date of the above-captioned Registration Statement be accelerated so that it will be declared effective at 5:00 p.m. Eastern Time on February 14, 2012, pursuant to Section 12(d) of the Securities Exchange Act of 1934, as amended, and Rule 12d1-2 thereunder. Sunshine Heart, Inc. (the “Company”) acknowledges that: (i) should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission, acting pursuant to delegated authority, declare the filing effective, such declaration does not foreclose the Commission from taking any action with respect to the filing; (ii) the action of the Commission or the staff of the Commission, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and (iii) 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. Please contact Matt Kuhn of Faegre Baker Daniels LLP with any questions or comments at (612) 776-8134. Thank you for your assistance with this filing. SUNSHINE HEART, INC. By: /s/ Jeffrey Mathiesen Jeffrey Mathiesen Chief Financial Officer
2012-02-08 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm MATTHEW R. KUHN MKuhn@faegrebd.com (612) 766-8134 February 8, 2012 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, NE Washington, DC 20549-3561 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form 10 (File No. 001-35312) (the “Registration Statement”) Ladies and Gentlemen: On behalf of Sunshine Heart, Inc. (the “Company”), we are transmitting Amendment No. 4 to the Registration Statement (the “Amendment”) in a clean version and two copies of the Amendment in a version marked to show changes from Amendment No. 3 to the Registration Statement. In response to verbal comments to the Registration Statement received from the Commission’s staff (the “Staff”) on February 7, 2012, the Company revised pages 33 and 34 of the Amendment to clarify that the periods to which the narrative disclosure applies is the applicable calendar year. As indicated in footnote 2 to the Summary Compensation Table, the Company historically has awarded incentive compensation to its named executive officers based on their performance during calendar years, rather than the Company’s fiscal years, which historically ended on June 30. The Amendment clarifies the narrative disclosure relating to the Summary Compensation Table by specifying “calendar year” prior to each year referenced in the discussion. The Company also confirms to the Staff that each portion marked “intentionally omitted” in Exhibit 10.17 to the Registration Statement is marked as such in the agreement executed by the Company and the other party thereto. All portions of the agreement that the Company omitted from its filing with the Commission pursuant to a request for confidential treatment but that are included in the original agreement are marked with a “***” as indicated in Exhibit 10.17 filed with the Commission. The Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in the filing, (ii) 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 (iii) 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. Please do not hesitate to call me at 612-766-8134 if you have any questions or comments regarding the foregoing or if we can be of service in facilitating your review of this filing. Sincerely, /s/ Matthew R. Kuhn Matthew R. Kuhn Enclosures cc: Allicia Lam, Staff Attorney, Securities and Exchange Commission (w encl.) Daniel Morris, Special Counsel, Securities and Exchange Commission (w/out encl.) David Rosa, Chief Executive Officer, Sunshine Heart, Inc. (by e-mail; w/out encl.) Jeffrey Mathiesen, Chief Financial Officer, Sunshine, Inc. (by e-mail; w/out encl.) 2
2012-02-01 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm MATTHEW R. KUHN MKuhn@faegrebd.com (612) 766-8134 February 1, 2012 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, NE Washington, DC 20549-3561 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form 10 (File No. 001-35312) (the “Registration Statement”) Ladies and Gentlemen: On behalf of Sunshine Heart, Inc. (the “Company”), we are transmitting the following responses of the Company to the comments of the Commission’s staff (the “Staff”) as set forth in the letter of Amanda Ravitz, Assistant Director, dated January 6, 2012 (the “Comment Letter”). We have enclosed for your reference two courtesy copies of Amendment No. 3 to the Registration Statement (the “Amendment”) in a clean version and two copies of the Amendment in a version marked to show changes from Amendment No. 2 to the Registration Statement. The responses herein were provided to this firm by the Company. In this letter, we have recited the comment from the Staff in italicized, bold type and have followed the comment with the Company’s response in regular type. References in this letter to we, our or us mean the Company or its advisors, as the context may require. All references to page numbers in the Company’s responses refer to page numbers in the Amendment. Clinical Development, page 2 1. We note your disclosure that you have not yet implanted any additional patients permitted by the FDA. Please revise to clarify whether you plan on implanting the 20 additional patients and adding the two centers, and if so, when you plan on doing so. Please also clarify if these additional patients and two centers would be part of the “pivotal trial.” Company Response: The Company has not implanted any additional patients, and currently does not have plans to implant any additional patients, permitted by the FDA’s April 2011 approval. If the Company implants any additional patients permitted by this approval, the patients would be part of the Company’s feasibility trial and would not be included in the results for the Company’s planned pivotal trial. The additional centers approved by the FDA in April 2011 for the feasibility trial might participate in the Company’s planned pivotal trial, but the protocol for the planned pivotal trial remains subject to FDA approval and the inclusion of any particular center in the pivotal trial cannot be determined with certainty at this time. Please see the additional disclosure on this matter on page 2. Manufacturers and Suppliers, page 3 2. We note your response to prior comment 5. However, given your disclosure that, in the short term, each of your suppliers is material to your operations, please tell us whether you have any agreements with your suppliers and if so, how these agreements are not material. In addition, please expand your risk factor disclosure to reflect your reliance on single source suppliers. Company Response: The Company revised page 3 to clarify that, while critical components of its product are supplied through single sources, the Company believes it could find alternative suppliers for each component without materially interrupting production of the Company’s product at current levels. The Company believes there is one exception to the foregoing description. The Company identified that exception on page 3 and filed a copy of the Company’s agreement with that supplier as an exhibit to the Amendment and requested confidential treatment for portions thereof. The Company further respectfully advises the Staff that, with respect to the components used in the Company’s product other than the balloon, the Company previously has obtained such components from sources other than the Company’s current supplier or previously has manufactured the component itself. Based on its relationship with prior suppliers and the Company’s prior manufacturing experience, the Company has identified alternative supply sources that would allow it, if necessary, to obtain supplies of all components other than the balloon from sources other than current suppliers without materially interrupting the Company’s business. The Company further respectfully advises the Staff that the Company’s supply agreements that are not filed as exhibits to the Amendment do not contain minimum purchase obligations or similar financial commitments of the Company, and therefore if the Company decided or needed to source the applicable components from persons that currently are not providing components to the Company, the Company could do so without triggering a material financial obligation. The Company revised page 10 of its risk factor disclosure to state that the Company does not second source any components of its product. Executive Compensation, page 33 3. Please update your executive compensation disclosure for the fiscal year ended December 31, 2011. Company Response: In response to the Staff’s comment, the Company has revised the executive compensation disclosure for the Company’s six-month fiscal year ended December 31, 2011 (the “Stub Year”). Consistent with Regulation S-K Compliance and Disclosure Interpretation 217.05, the summary compensation table in the Amendment includes compensation information for the 12-month fiscal year ended June 30, 2011 and for the Stub Year for the Company’s named executive officers for the Stub Year. Similarly, the director compensation table in the Amendment also includes compensation information for the 12-month fiscal year ended June 30, 2011 and for the Stub Year for the individuals who served as directors of the Company during the Stub Year. 4. We note your response to prior comment 9. Please provide us with your analysis as to whether the company benchmarks the salaries of Dr. Peters and Debra Kridner. See Regulation S-K Compliance and Disclosure Interpretation 118.05. If the company does benchmark these salaries, please identify the component companies that make up the compensation peer group and the basis for selecting the peer group. Company Response: The Company respectfully advises the Staff that the Company’s Board of Directors is responsible for determining Dr. Peters’ and Ms. Kridner’s compensation, including base salaries, on an annual basis. The Board makes this determination based in part on the salary recommendation prepared by the chief executive officer. The Board does not consult compensation data about other companies as a reference point on which — either wholly or in part — to base, justify or provide a framework for compensation decisions regarding Dr. Peters or Ms. Kridner. While the chief executive officer might evaluate compensation paid to other executives as one factor when formulating compensation recommendations to the Board, the Board 2 members do not consider any information regarding third party compensation practices that the chief executive officer might consult when formulating his recommendations. The Company further respectfully advises the Staff that the Company’s chief executive officer uses any data he collects about third-party compensation practices as one factor that is neither dominant nor binding in his process of recommending compensation he subjectively believes is appropriate. The chief executive officer is free to give no weight to any information he might choose to consult. The Company also notes for the Staff that the Company is a smaller reporting company as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended. Pursuant to the Commission’s scaled disclosure requirements, the Company is not obligated to provide disclosure under Item 402(b)(2)(xiv) of Regulation S-K, to which Regulation S-K Compliance and Disclosure Interpretation 118.05 relates. Based on the factors described above, the Company believes its disclosure in the Amendment satisfies its obligation under Item 402(o) of Regulation S-K to provide a narrative description of any material factors necessary to an understanding of the information described in the Summary Compensation Table, and, in any event, that further disclosure under Item 402(b)(2)(xiv) of Regulation S-K and Compliance and Disclosure Interpretation 118.05 would not be necessary if they were applicable. The Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in the filing, (ii) 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 (iii) 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. Please do not hesitate to call me at 612-766-8134 if you have any questions or comments regarding the foregoing or if we can be of service in facilitating your review of this filing. Sincerely, /s/ Matthew R. Kuhn Matthew R. Kuhn Enclosures cc: Allicia Lam, Staff Attorney, Securities and Exchange Commission (w encl.) Daniel Morris, Special Counsel, Securities and Exchange Commission (w/out encl.) David Rosa, Chief Executive Officer, Sunshine Heart, Inc. (w/out encl.) Jeffrey Mathiesen, Chief Financial Officer, Sunshine, Inc. (w/out encl.) 3
2012-01-06 - UPLOAD - Nuwellis, Inc.
January 6, 2012
Via E-Mail
Jeffrey Mathiesen Chief Financial Officer Sunshine Heart, Inc. 7651 Anagram Drive Eden Prairie, Minnesota 55344
Re: Sunshine Heart, Inc.
Amendment No. 2 to Form 10
Filed December 29, 2011 File No. 001-35312
Dear Mr. Mathiesen:
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 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 circumstances or do not believe an am endment is appropriate, 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 ma y have additional comments.
Clinical Development, page 2
1. We note your disclosure that you have not yet implanted any additional patients
permitted by the FDA. Please revise to clarify whether you plan on implanting the 20
additional patients and adding the two centers , and if so, when you plan on doing so.
Please also clarify if these additional patie nts and two centers would be part of the
“pivotal trial.”
Manufacturers and Suppliers, page 3
2. We note your response to prior comment 5. Howe ver, given your disc losure that, in the
short term, each of your suppliers is material to your operations, please tell us whether
you have any agreements with your suppliers and if so, how these agreements are not
material. In addition, please e xpand your risk factor disclosure to reflect your reliance on
single source suppliers.
Jeffrey Mathiesen Sunshine Heart, Inc. January 6, 2012 Page 2
Executive Compensation, page 33
3. Please update your executive compensation di sclosure for the fiscal year ended
December 31, 2011.
4. We note your response to prior comment 9. Plea se provide us with your analysis as to
whether the company benchmarks the salaries of Dr. Peters and Debra Kridner. See
Regulation S-K Compliance and Disclosure In terpretation 118.05. If the company does
benchmark these salaries, please identify th e component companies that make up the
compensation peer group and the basi s for selecting the peer group.
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 include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e. 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 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 David Burt on at (202) 551-3626 or L ynn Dicker, the accounting
reviewer, at (202) 551-3616 if you have questions regarding comments on the financial
statements and related matters. Please contact Allicia Lam at (202) 551-3316 or Daniel Morris,
Special Counsel, at (202) 551- 3314 with any other questions.
Sincerely,
/s/ Daniel Morris for
Amanda Ravitz Assistant Director
cc (by e-mail): Matthew R. Kuhn -- Faegre & Benson LLP
2011-12-29 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm MATTHEW R. KUHN MKuhn@faegre.com (612) 766-8134 December 29, 2011 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, NE Washington, DC 20549-3561 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form 10 (File No. 001-35312) (the “Registration Statement”) Ladies and Gentlemen: On behalf of Sunshine Heart, Inc. (the “Company”), we are transmitting the following responses of the Company to the comments of the Commission’s staff (the “Staff”) as set forth in the letter of Amanda Ravitz, Assistant Director, dated December 23, 2011 (the “Comment Letter”). We have enclosed for your reference two courtesy copies of Amendment No. 2 to the Registration Statement (the “Amendment”) in a clean version and two copies of the Amendment in a version marked to show changes from Amendment No. 1 to the Registration Statement. The responses herein were provided to this firm by the Company. In this letter, we have recited the comment from the Staff in italicized, bold type and have followed the comment with the Company’s response in regular type. References in this letter to we, our or us mean the Company or its advisors, as the context may require. All references to page numbers in the Company’s responses refer to page numbers in the Amendment. Overview, page 1 1. We note your response to prior comment 10. Please revise the summary to include disclosure that all revenue during 2009 and 2010 was derived from your feasibility clinical trials. Company Response: The Company revised page 1 to disclose that all of its revenue for the years ended December 31, 2010 and 2009 was derived solely from sales in conjunction with its feasibility clinical trial. Our Product, page 2 2. Expand your discussion of the adverse consequences if your product is turned off for extended periods of time. In addition, please clarify whether use of the product, including turning it off and on, requires a visit to a medical facility. Company Response: The Company revised page 2 to disclose that, in addition to the potential return of a patient’s prior heart failure symptoms, a patient could experience a loss of any improvement in the patient’s condition resulting from use of the C-Pulse System or worsening of the patient’s heart failure symptoms compared to when the patient began receiving treatment if the C-Pulse System is not used as instructed. The Company is unable to provide any more specific information regarding the potential adverse consequences of turning the C-Pulse System off for extended periods of time because the particular response of a person to non-compliant use of the Company’s product varies from patient to patient. The Company also revised page 2 to clarify that patients are not required to visit a medical facility when turning the C-Pulse System on or off. Clinical Development, page 3 3. We note your response to prior comment 6. Please revise the second-to-last paragraph of this section to disclose the anticipated end date of the IDE study. Company Response: The Company revised the paragraph cited in the Staff’s comment to disclose that the anticipated end date of its IDE study is in 2015. Sales and Marketing, page 3 4. Please disclose the anticipated timetable for the expansion of your sales into Europe and throughout the world. Company Response: In response to the Staff’s comment, the Company revised page 3 to disclose that it expects to begin sales in Europe in the middle of 2012 and to clarify that expansion in Europe beyond the initial countries targeted, or in other parts of the world, is subject to uncertainties. Due to these uncertainties, the Company has not established anticipated timetables for expansion beyond the countries in Europe where it intends to initially commence sales. Manufacturers and Suppliers, page 3 5. We note that you do not have any material long-term agreements with your suppliers. However, please revise to clarify whether you have any suppliers on which you materially rely. Company Response: In response to the Staff’s comment, the Company revised this section to clarify that all critical components of the Company’s product are single sourced and therefore any unwillingness or inability of a supplier to provide a component of the Company’s product would interrupt and adversely affected the Company’s business. The Company further added disclosure that, in light of these facts, the Company materially relies on each of its suppliers in the short term. Competition, page 4 6. We note your response to prior comment 9. Please revise to disclose that the potential disadvantages of the C-Pulse System are not fully known. Company Response: In response to the Staff’s comment, the Company revised its disclosure to state that the potential competitive disadvantages of the Company’s product are not fully known. 2 Properties, page 27 7. We note your revised disclosure in this section. Please continue to provide updated disclosure with your subsequent amendments. In this regard, we note that you anticipate moving your operations in late December 2011. Company Response: On page 27, the Company updated its disclosure to reflect that relocation of the Company’s headquarters is expected to be completed in January 2012. Summary Compensation Table, page 33 8. Given your disclosure in the last paragraph on page 33 that your employment agreement with Mr. Rosa provides for a salary of $250,000, please provide additional disclosure clarifying why the summary compensation table indicates that Mr. Rosa received $280,000 in base salary in 2011. Company Response: As disclosed on page 33, Mr. Rosa’s employment agreement provided him with a base salary of $250,000, subject to annual review of the Company’s board of directors. The Company entered into its employment agreement with Mr. Rosa on November 1, 2009. In connection with subsequent annual reviews, the Company’s board of directors has increased Mr. Rosa’s annual base salary to be greater than the $250,000 per year initially agreed upon with Mr. Rosa. The Company revised page 33 to disclose Mr. Rosa’s current annual base salary. The $280,000 amount included in the Summary Compensation Table with respect to Mr. Rosa represents the amount of salary earned by Mr. Rosa for the Company’s most recently completed fiscal year based on his base salary as in effect throughout that period. 9. We note your response to prior comment 15. With a view to disclosure, please describe for us the nature and extent of your chief executive officer’s consultation of certain publicly available information. For instance, please tell us the type of information that the chief executive officer consulted and how this information served as a “reference point.” Company Response: In response to the Staff’s comment, the Company revised its disclosure on page 34 to disclose that the publicly available information consulted by the Company’s chief executive officer consisted of proxy statements filed with the Commission and that he used the information gathered to confirm that the salaries he recommends for the Company’s other named executive officers is not, in his opinion, significantly above or below the salaries of persons occupying similar positions at the companies included in the information so gathered. 3 Please do not hesitate to call me at 612-766-8134 if you have any questions or comments regarding the foregoing or if we can be of service in facilitating your review of this filing. Sincerely, /s/ Matthew R. Kuhn Matthew R. Kuhn Enclosures cc: Allicia Lam, Staff Attorney, Securities and Exchange Commission (w encl.) Daniel Morris, Special Counsel, Securities and Exchange Commission (w/out encl.) David Rosa, Chief Executive Officer, Sunshine Heart, Inc. (w/out encl.) Jeffrey Mathiesen, Chief Financial Officer, Sunshine, Inc. (w/out encl.) 4
2011-12-23 - UPLOAD - Nuwellis, Inc.
December 23, 2011 Jeff Mathiesen Chief Financial Officer Sunshine Heart, Inc. 7651 Anagram Drive Eden Prairie, Minnesota Re: Sunshine Heart, Inc. Amendment No. 1 to Form 10 Filed December 16, 2011 File No. 001-35312 Dear Mr. Mathiesen: 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 fact s and circumstances or do not believe an amendment is appropriate, pl ease tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. Overview, page 1 1. We note your response to prior comment 10. Please revise the summary to include disclosure that all revenu e during 2009 and 2010 was deri ved from your feasibility clinical trials. Our Product, page 2 2. Expand your discussion of the adverse conse quences if your product is turned off for extended periods of time. In a ddition, please clarify whether us e of the product, including turning it off and on, requires a visit to a medical facility. Jeff Mathiesen Sunshine Heart, Inc. December 23, 2011 Page 2 Clinical Development, page 2 3. We note your response to prior comment 6. Plea se revise the second- to-last paragraph of this section to disclose the anti cipated end date of the IDE study. Sales and Marketing, page 3 4. Please disclose the anticipated timetable for the expansion of your sales into Europe and throughout the world. Manufacturers and Suppliers, page 3 5. We note that you do not have any material l ong-term agreements with your suppliers. However, please revise to clarify wh ether you have any suppliers on which you materially rely. Competition, page 4 6. We note your response to prior comment 9. Plea se revise to disclose that the potential disadvantages of the C-Pulse System are not fully known. Properties, page 27 7. We note your revised disclosure in this section. Please continue to provide updated disclosure with your subsequent amendments. In this regard, we note that you anticipate moving your operations in late December 2011. Summary Compensation Table, page 33 8. Given your disclosure in the last paragraph on page 33 that your employment agreement with Mr. Rosa provides for a salary of $250,000, please provide additional disclosure clarifying why the summary compensation ta ble indicates that Mr. Rosa received $280,000 in base salary in 2011. 9. We note your response to prior comment 15. With a view to disclosure, please describe for us the nature and extent of your chie f executive officer’s c onsultation of certain publicly available information. For instance, please tell us the type of information that the chief executive officer consulted and how this information served as a “reference point.” 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 include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are Jeff Mathiesen Sunshine Heart, Inc. December 23, 2011 Page 3 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 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 David Burt on at (202) 551-3626 or Lynn Dicker at (202) 551-3616 if you have questions regarding comments on the fina ncial statements and related matters. Please contact Allicia Lam at (202) 551-3316 or Dani el Morris, Special Counsel, at (202) 551-3314 with any other questions. Sincerely, /s/ Daniel Morris for Amanda Ravitz Assistant Director cc (by e-mail): Matthew R. Kuhn -- Faegre & Benson LLP
2011-12-16 - CORRESP - Nuwellis, Inc.
CORRESP 1 filename1.htm MATTHEW R. KUHN MKuhn@faegre.com (612) 766-8134 December 16, 2011 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, NE Washington, DC 20549-3561 Attention: Amanda Ravitz, Assistant Director Re: Sunshine Heart, Inc. Registration Statement on Form 10 (File No. 001-35312) (the “Registration Statement”) Ladies and Gentlemen: On behalf of Sunshine Heart, Inc. (the “Company”), we are transmitting the following responses of the Company to the comments of the Commission’s staff (the “Staff”) as set forth in the letter of Amanda Ravitz, Assistant Director, dated October 27, 2011 (the “Comment Letter”). We have enclosed for your reference two courtesy copies of Amendment No. 1 to the Registration Statement (the “Amendment”) in a clean version and two copies of the Amendment in a version marked to show changes from the initial filing of the Registration Statement. The responses herein were provided to this firm by the Company. In this letter, we have recited the comment from the Staff in italicized, bold type and have followed the comment with the Company’s response in regular type. References in this letter to we, our or us mean the Company or its advisors, as the context may require. All references to page numbers in this letter refer to page numbers in the Amendment. General 1. Please note that the Form 10 goes effective by lapse of time 60 days after the original filing date, pursuant to Section 12(g)(1) of the Securities Exchange Act of 1934. Upon the expiration of this 60-day time period, you will be subject to the reporting requirements under Section 13(a) of the Securities Exchange Act of 1934. In such event, we will continue to review your filing until all of our comments have been addressed. If this filing was made voluntarily, you should consider withdrawing it prior to the effective date if comments remain outstanding. You could then refile when you are prepared to resolve the comments. If so, please file your request for withdrawal before the automatic effectiveness date. Company Response: The securities being registered by the Amendment are to be listed on the Nasdaq Capital Market national securities exchange, and therefore the Company believes that such securities are being registered pursuant to Section 12(b) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) and not Section 12(g) of the Exchange Act. Section 12(d) of the Exchange Act states that any securities registered under Section 12(b) of the Exchange Act will become effective thirty days after the receipt by the Commission of a certification by the exchange that the securities have been approved for listing or within such shorter period of time as the Commission may determine. Market Data, page i 2. With regard to third party data referenced throughout, please provide copies of these industry publications, surveys, and other sources of statistics, clearly marking the relevant sections of these reports. Also, please tell us whether these materials were prepared at your request or in connection with the registration statement. Company Response: Please see the enclosed binder of supporting documentation, which is appropriately referenced to the statements in the Amendment that this material supports. None of these materials were prepared at our request or in connection with the Registration Statement. Item 1 — Business, page 1 3. Please revise this section to describe the distribution methods for your products, whether you manufacture your products, sources and availability of raw materials and the names of principal suppliers. In this regard, we note your risk factor, “We depend on a limited number of manufacturers and suppliers…” on page 10. In addition, revise to describe the terms of any material agreements. Company Response: In response to the Staff’s comment, the Company revised page 3 to describe the distribution methods for its products, to clarify that the Company does not manufacture its products and to provide the material information relating to the Company’s suppliers and the availability of new materials. Our Product, page 2 4. Please revise to describe in greater detail how your product will be used. For example, we note your statement that your product may be turned on or off at any time allowing the patient intervals of freedom to perform certain activities. Please revise your disclosure to discuss whether the product is expected to be used all the time or for certain hours and whether the product can be used at home by a patient or whether use of your product requires a visit to a medical facility. Please also revise to disclose specifically the types of activities which are allowable and the restrictions on activities when the product is turned on or off. Company Response: In response to the Staff’s comment, the Company revised page 2 to include further details regarding use of the Company’s product. 2 5. We note that your product is implanted between the patient’s ribs and sternum. Please reconcile the implantation of the device with your statements that the device “does not directly contact the patient’s blood.” Company Response: In response to the Staff’s comment, the Company revised the Registration Statement to clarify that the Company’s product, when implanted, remains outside the patient’s vascular system. Clinical Development, page 2 6. We note your statements on page 2 that you have completed enrollment in your feasibility clinical trial. Please revise to discuss any results from the current feasibility study and the status of the study. If you have conducted other clinical trials, please revise to discuss the dates and results of those clinical trials, as well. In addition, please discuss the status of your IDE application, including the remaining hurdles to approval. Company Response: In response to the Staff’s comment, the Company revised its disclosure to include information regarding the results of the feasibility trial and included further details regarding the IDE application. 7. We note also your statement on page 1 that you are seeking CE Mark approval for your product and that you anticipate that you will obtain approval in early 2012. Please revise to describe the status of your CE Mark approval, the steps you have taken to seek CE Mark approval and the steps which still need to be taken before approval. Company Response: In response to the Staff’s comment, the Company revised its disclosure on pages 1 and 3 to include additional details regarding the CE Mark process. Sales and Marketing, page 3 8. Please revise to clarify the “initial steps” you have taken to develop a network of physicians and clinics in Europe. Company Response: In response to the Staff’s comment, the Company revised this section on page 3 to delete the reference to “initial steps” taken to develop a network of physicians and clinics in Europe and to include more information regarding the Company’s plans and efforts to date to commercialize its product in Europe. Competition, page 4 9. We note that your disclosure describes only the perceived advantages of your product relative to the competition. Please also describe the competitive disadvantages of your product relative to other products used at the same or earlier stages of heart failure. If you are unable to identify the disadvantages, add appropriate disclosure stating that the efficacy of your product, including potential competitive disadvantages, is not known. Company Response: In response to the Staff’s comment, the Company revised its disclosure on page 4 to disclose that the efficacy of its product, including any potential competitive disadvantages, is not known. 3 Comparison of Year Ended December 31, 2010 to Year Ended December 31, 2009 Revenue, page 26 10. Please revise to clarify whether all of the revenues earned during the years ended December 31, 2010 and December 31, 2009 resulted from your feasibility clinical trial. Company Response: In response to the Staff’s comment, the Company revised its disclosure to clarify that all of the revenue during 2009 and 2010 was derived solely from sales of the C-Pulse System to hospitals and clinics under contract in conjunction with the Company’s feasibility trial. Sources of Liquidity, page 27 11. We note that your current funds are sufficient to continue your operations “into 2012.” Please specify when you expect to require additional funds and describe the course of action you propose to take in order to obtain additional financing. Company Response: In response to the Staff’s comment, the Company revised this section on page 27 to specify that it expects its current funds will be sufficient to fund the Company’s operations through substantially all of the first half of 2012 and the Company expects to obtain additional financing when needed through sales of its common stock or other securities. Item 5 — Beneficial Owners of More than Five Percent of our Common Stock, page 29 12. Please revise to identify the natural persons with voting or investment power over the shares beneficially owned by entities listed in the table. Company Response: In response to the Staff’s comment, the Company revised the footnotes to the table on page 29 to identify the natural persons with voting or investment power over the shares beneficially owned by entities listed in the table. Directors and Executive Officers, page 29 13. Please revise the table to include Nicholas Callinan’s position as Chairman of the Board. Company Response: In response to the Staff’s comment, the Company revised the table on page 29 to include Nicholas Callinan’s position as Chairman of the Board. Directors, page 30 14. Please revise Paul Buckman’s biography to describe briefly the principal business of Pathway Medical Technologies, Inc. Please also revise to specify the dates when Dr. Mark Harvey and Donal O’Dwyer served as directors of the entities listed in their respective biographies. Company Response: In response to the Staff’s comment, the Company revised the biographies of Mr. Buckman, Dr. Harvey, and Mr. O’Dwyer to include the information noted above. 4 Item 6 — Executive Compensation, page 33 15. Please revise to describe how the board set the salary of Dr. Peters and Debra Kridner, given that there are no employment agreements with these individuals. Company Response: In response to the Staff’s comment, the Company revised page 34 to include a description of the process undertaken by the Company to set the salary of Dr. Peters and Debra Kridner. Related Party Transactions, page 37 16. We note section 2 of Exhibit 10.15. Please revise to describe in greater detail the services that WSP provides. Additionally, please revise to clarify that this agreement requires that Williams Peter serve as your Medical Director and Chief Technical Officer. Company Response: In response to the Staff’s comment, the Company revised its disclosure to clarify that the agreement requires that Dr. Peters serve as our Medical Director and Chief Technical Officer and that we make payments to WSP rather than directly to Dr. Peters for his services in those capacities. Item 9 — Market Price of and Dividends…, page 37 17. We note your disclosure that 235,634,277 shares of your common stock may be sold by your existing stockholders without restrictions under Rule 144. Please revise to clarify whether this number includes those shares owned by your affiliates. Company Response: In response to the Staff’s comment, the Company revised page 38 to clarify that the number of shares specified does not include shares owned by the Company’s affiliates. Common Stock, page 49 18. We note your statement that you are authorized to issue up to 196,000,000 shares of common stock. However, we note Article IV.A of your Articles of Incorporation which states that you are authorized to issue 1,960,000,000 shares of common stock. Please revise. Company Response: The Company revised the number of authorized shares. Financial Statements, page F-1 Note 4. Income Taxes, page F-12 19. We note your disclosures regarding the recognition of a $670,000 tax benefit in 2010 as a result of your foreign subsidiary’s R&D tax credit rebate. With a view toward enhanced disclosure, please explain to us in greater detail the nature of the rebate and the circumstances surrounding your recognition of it only during that period. Tell us what your expectations are for future rebates considering anticipated increases in research and development expenses and expected continued losses. Company Response: In response to the Staff’s comment, the Company revised Note 4 on page F-13 to include greater details regarding the tax credit rebate and to explain the Company’s expectations for future tax credit rebates. 5 Exhibits 20. Please tell us why you have not filed your lease agreements for your corporate headquarters in Eden Prairie, Minnesota and your office space in St. Leonards, New South Wales, Australia. Company Response: In response to the Staff’s comment, the Company filed as exhibits with the Amendment its lease agreements for properties in Minnesota and the office space in St. Leonards, New South Wales, Australia. Please do not hesitate to call me at 612-766-8134 if you have any questions or comments regarding the foregoing or if we can be of service in facilitating your review of this filing. Sincerely, /s/ Matthew R. Kuhn Matthew R. Kuhn Enclosures cc: Allicia Lam, Staff Attorney, Securities and Exchange Commission (w/out encl.) Daniel Morris, Special Counsel, Securities and Exchange Commission (w/out encl.) David Rosa, Chief Executive Officer, Sunshine Heart, Inc. (w/out encl.) Jeffrey Mathiesen, Chief Financial Officer, Sunshine, Inc. (w/out encl.) 6
2011-10-27 - UPLOAD - Nuwellis, Inc.
October 27, 2011 Jeff Mathiesen Chief Financial Officer Sunshine Heart, Inc. 7651 Anagram Drive Eden Prairie, Minnesota Re: Sunshine Heart, Inc. Form 10 Filed September 30, 2011 File No. 001-35312 Dear Mr. Mathiesen: 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 by amendi ng your filing, 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 circ umstances or do not believe an amendment is appropriate, 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 ma y have additional comments. General 1. Please note that the Form 10 goes effective by lapse of time 60 days after the original filing date, pursuant to Section 12(g)(1) of the Securities Exchange Act of 1934. Upon the expiration of this 60-day time peri od, you will be subject to the reporting requirements under Section 13(a) of the Securiti es Exchange Act of 1934. In such event, we will continue to review your filing until all of our comments have been addressed. If this filing was made voluntarily, you should cons ider withdrawing it prior to the effective date if comments remain outstanding. You could then refile when you are prepared to resolve the comments. If so, please file your request for withdrawal before the automatic effectiveness date. Market Data, page i 2. With regard to third party data referenced throughout, please provide copies of these industry publications, surveys, and other sources of statistics, clearly marking the relevant Jeff Mathiesen Sunshine Heart, Inc. October 27, 2011 Page 2 sections of these reports. Al so, please tell us whether these materials were prepared at your request or in connection with the registration statement. Item 1 – Business, page 1 3. Please revise this section to describe the distribution methods for your products, whether you manufacture your products, sources and ava ilability of raw materials and the names of principal suppliers. In this regard, we note your risk factor, “We depend on a limited number of manufacturers and s uppliers…” on page 10. In add ition, revise to describe the terms of any material agreements. Our Product, page 2 4. Please revise to describe in greater detail how your product will be used. For example, we note your statement that your product may be turned on or off at any time allowing the patient intervals of freedom to perfor m certain activities. Please revise your disclosure to discuss whether th e product is expected to be us ed all the time or for certain hours and whether the product can be used at home by a patient or whether use of your product requires a visit to a medical facility. Please also revise to disclose specifically the types of activities which are allowable and the restrictions on activities when the product is turned on or off. 5. We note that your product is implanted between the patient’s ribs and sternum. Please reconcile the implantation of the device with your statements that the device “does not directly contact th e patient’s blood.” Clinical Development, page 2 6. We note your statements on page 25 that you have completed enrollment in your feasibility clinical trial. Please revise to discuss any results from the current feasibility study and the status of the study. If you have conducted other clinical trials, please revise to discuss the dates and results of those clinical trials, as well. In addition, please discuss the status of your IDE app lication, including the remaini ng hurdles to approval. 7. We note also your statement on page 1 that you are seeking CE Mark approval for your product and that you anticipate that you will obtain approval in early 2012. Please revise to describe the status of your CE Mark appr oval, the steps you have taken to seek CE Mark approval and the steps which still need to be taken before approval. Sales and Marketing, page 3 8. Please revise to clarify the “initial steps” you have taken to de velop a network of physicians and clinics in Europe. Jeff Mathiesen Sunshine Heart, Inc. October 27, 2011 Page 3 Competition, page 4 9. We note that your disclosure describes onl y the perceived advantages of your product relative to the competition. Please also desc ribe the competitive disadvantages of your product relative to other products used at the same or earlier stages of heart failure. If you are unable to identify the disadvantages, a dd appropriate disclosure stating that the efficacy of your product, including potentia l competitive disadvantages, is not known. Comparison of Year Ended December 31, 2010 to Year Ended December 31, 2009 Revenue, page 26 10. Please revise to clarify wh ether all of the revenues earned during the years ended December 31, 2010 and December 31, 2009 resulted fr om your feasibility clinical trial. Sources of Liquidity, page 27 11. When note that your current funds are sufficien t to continue your operations “into 2012.” Please specify when you expect to require ad ditional funds and describe the course of action you propose to take in order to obtain additional financing. Item 5 – Beneficial Owners of More than Five Percent of ou r Common Stock, page 29 12. Please revise to identify the natural persons with voting or inve stment power over the shares beneficially owned by entities listed in the table. Directors and Executive Officers, page 29 13. Please revise the table to include Nicholas Ca llinan’s position as Chairman of the Board. Directors, page 30 14. Please revise Paul Buckman’s biography to de scribe briefly the principal business of Pathway Medical Technologies, Inc. Please al so revise to specify the dates when Dr. Mark Harvey and Donal O’Dwyer served as directors of the entities listed in their respective biographies. Item 6 – Executive Compensation, page 33 15. Please revise to describe how the board set th e salary of Dr. Peters and Debra Kridner, given that there are no employment agreements with these individuals. Jeff Mathiesen Sunshine Heart, Inc. October 27, 2011 Page 4 Related Party Transactions, page 37 16. We note section 2 of Exhibit 10.15. Please revise to describe in greate r detail the services that WSP provides. Additionally, please revise to clarify that this agreement requires that Williams Peter serve as your Medical Di rector and Chief Technical Officer. Item 9 – Market Price of and Dividends…, page 37 17. We note your disclosure that 235,634,277 shares of your common stock may be sold by your existing stockholders without restrictions under Rule 14 4. Please revise to clarify whether this number includes those shares owned by your affiliates. Common Stock, page 49 18. We note your statement that you are aut horized to issue up to 196,000,000 shares of common stock. However, we note Article IV.A of your Articles of Incorporation which states that you are authorized to is sue 1,960,000,000 shares of common stock. Please revise. Financial Statements, page F-1 Note 4. Income Taxes, page F-12 19. We note your disclosures regarding the r ecognition of a $670,000 tax benefit in 2010 as a result of your foreign subsidiary’s R&D tax cr edit rebate. With a view toward enhanced disclosure, please explain to us in greater detail the nature of the rebate and the circumstances surrounding your recognition of it only during that pe riod. Tell us what your expectations are for future rebates considering anticipated increases in research and development expenses and e xpected continued losses. Exhibits 20. Please tell us why you have not filed your lease agreements for your corporate headquarters in Eden Prairie, Minnesota and your office space in St. Leonards, New South Wales, Australia. 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 include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. 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. Jeff Mathiesen Sunshine Heart, Inc. October 27, 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 David Burton at (202) 551-3626 or Lynn Di cker, accounting reviewer, at (202) 551-3616 if you have questions regard ing comments on the financial statements and related matters. Please cont act Allicia Lam at (202) 551-33 16 or Daniel Morris, Special Counsel, at (202) 551-3314 w ith any other questions. Sincerely, /s/ Daniel Morris for Amanda Ravitz Assistant Director cc (by e-mail): Matthew R. Kuhn -- Faegre & Benson LLP