Loaded from persisted store.
Save this research path
Create a free accountSave this ticker search and return to the same filing timeline in one click. You can also create alerts for new SEC correspondence after signing up.
How to read this research view
A quick starting pointThreads
All Filings
SEC Comment Letters
Company Responses
Letter Text
enVVeno Medical Corp
Response Received
1 company response(s)
High - file number match
↓
enVVeno Medical Corp
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-10-31
enVVeno Medical Corp
Summary
UPLOAD · 2023-10-31
Generating summary...
↓
Company responded
2023-11-01
enVVeno Medical Corp
Summary
CORRESP · 2023-11-01
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
High - file number match
↓
Company responded
2023-08-21
enVVeno Medical Corp
Summary
CORRESP · 2023-08-21
Generating summary...
enVVeno Medical Corp
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-05-16
enVVeno Medical Corp
Summary
UPLOAD · 2022-05-16
Generating summary...
enVVeno Medical Corp
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-08-10
enVVeno Medical Corp
Summary
UPLOAD · 2020-08-10
Generating summary...
↓
Company responded
2020-08-10
enVVeno Medical Corp
Summary
CORRESP · 2020-08-10
Generating summary...
↓
Company responded
2022-05-11
enVVeno Medical Corp
Summary
CORRESP · 2022-05-11
Generating summary...
enVVeno Medical Corp
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-05-06
enVVeno Medical Corp
Summary
UPLOAD · 2022-05-06
Generating summary...
enVVeno Medical Corp
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2020-12-28
enVVeno Medical Corp
Summary
UPLOAD · 2020-12-28
Generating summary...
↓
Company responded
2021-02-03
enVVeno Medical Corp
Summary
CORRESP · 2021-02-03
Generating summary...
↓
Company responded
2021-02-03
enVVeno Medical Corp
Summary
CORRESP · 2021-02-03
Generating summary...
↓
Company responded
2021-02-04
enVVeno Medical Corp
Summary
CORRESP · 2021-02-04
Generating summary...
↓
Company responded
2021-02-05
enVVeno Medical Corp
Summary
CORRESP · 2021-02-05
Generating summary...
↓
Company responded
2021-02-05
enVVeno Medical Corp
Summary
CORRESP · 2021-02-05
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-11-12
enVVeno Medical Corp
Summary
UPLOAD · 2020-11-12
Generating summary...
↓
Company responded
2020-11-27
enVVeno Medical Corp
Summary
CORRESP · 2020-11-27
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-09-24
enVVeno Medical Corp
Summary
UPLOAD · 2020-09-24
Generating summary...
↓
Company responded
2020-10-20
enVVeno Medical Corp
Summary
CORRESP · 2020-10-20
Generating summary...
enVVeno Medical Corp
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-08-13
enVVeno Medical Corp
Summary
UPLOAD · 2020-08-13
Generating summary...
enVVeno Medical Corp
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-07-08
enVVeno Medical Corp
Summary
UPLOAD · 2020-07-08
Generating summary...
↓
Company responded
2020-07-15
enVVeno Medical Corp
Summary
CORRESP · 2020-07-15
Generating summary...
↓
Company responded
2020-07-15
enVVeno Medical Corp
Summary
CORRESP · 2020-07-15
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-06-19
enVVeno Medical Corp
Summary
UPLOAD · 2020-06-19
Generating summary...
↓
Company responded
2020-06-22
enVVeno Medical Corp
Summary
CORRESP · 2020-06-22
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2020-04-14
enVVeno Medical Corp
Summary
UPLOAD · 2020-04-14
Generating summary...
↓
Company responded
2020-04-15
enVVeno Medical Corp
Summary
CORRESP · 2020-04-15
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2019-05-28
enVVeno Medical Corp
Summary
UPLOAD · 2019-05-28
Generating summary...
↓
Company responded
2019-06-10
enVVeno Medical Corp
Summary
CORRESP · 2019-06-10
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
High - file number match
Company responded
2019-04-25
enVVeno Medical Corp
Summary
CORRESP · 2019-04-25
Generating summary...
↓
SEC wrote to company
2019-05-21
enVVeno Medical Corp
Summary
UPLOAD · 2019-05-21
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-06-18
enVVeno Medical Corp
Summary
UPLOAD · 2018-06-18
Generating summary...
↓
Company responded
2018-06-18
enVVeno Medical Corp
Summary
CORRESP · 2018-06-18
Generating summary...
enVVeno Medical Corp
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2018-05-25
enVVeno Medical Corp
Summary
CORRESP · 2018-05-25
Generating summary...
enVVeno Medical Corp
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2018-05-25
enVVeno Medical Corp
Summary
CORRESP · 2018-05-25
Generating summary...
enVVeno Medical Corp
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2017-12-13
enVVeno Medical Corp
Summary
UPLOAD · 2017-12-13
Generating summary...
↓
Company responded
2017-12-14
enVVeno Medical Corp
Summary
CORRESP · 2017-12-14
Generating summary...
↓
Company responded
2017-12-18
enVVeno Medical Corp
Summary
CORRESP · 2017-12-18
Generating summary...
↓
Company responded
2017-12-18
enVVeno Medical Corp
Summary
CORRESP · 2017-12-18
Generating summary...
↓
Company responded
2018-02-08
enVVeno Medical Corp
Summary
CORRESP · 2018-02-08
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-11-17
enVVeno Medical Corp
Summary
UPLOAD · 2017-11-17
Generating summary...
↓
Company responded
2017-12-05
enVVeno Medical Corp
Summary
CORRESP · 2017-12-05
Generating summary...
enVVeno Medical Corp
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-10-04
enVVeno Medical Corp
Summary
UPLOAD · 2017-10-04
Generating summary...
↓
Company responded
2017-11-03
enVVeno Medical Corp
Summary
CORRESP · 2017-11-03
Generating summary...
enVVeno Medical Corp
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2017-09-06
enVVeno Medical Corp
Summary
CORRESP · 2017-09-06
Generating summary...
enVVeno Medical Corp
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-03-13
enVVeno Medical Corp
Summary
UPLOAD · 2017-03-13
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-14 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2025-03-10 | SEC Comment Letter | enVVeno Medical Corp | DE | 333-285474 | Read Filing View |
| 2023-11-01 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2023-10-31 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2023-08-21 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2023-08-07 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2022-05-16 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2022-05-11 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2022-05-06 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-05 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-05 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-04 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-03 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-03 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-12-28 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-11-27 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-11-12 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-10-20 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-09-24 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-08-13 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-08-10 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-08-10 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-07-15 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-07-15 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-07-08 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-06-22 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-06-19 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-04-15 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-04-14 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2019-06-10 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2019-05-28 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2019-05-21 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2019-04-25 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-06-18 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-06-18 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-05-25 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-05-25 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-02-08 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-18 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-18 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-14 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-13 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-05 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-11-17 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-11-03 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-10-04 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-09-06 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-03-13 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-10 | SEC Comment Letter | enVVeno Medical Corp | DE | 333-285474 | Read Filing View |
| 2023-10-31 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2023-08-07 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2022-05-16 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2022-05-06 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-12-28 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-11-12 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-09-24 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-08-13 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-08-10 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-07-08 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-06-19 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-04-14 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2019-05-28 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2019-05-21 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-06-18 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-13 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-11-17 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-10-04 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-03-13 | SEC Comment Letter | enVVeno Medical Corp | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-14 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2023-11-01 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2023-08-21 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2022-05-11 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-05 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-05 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-04 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-03 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2021-02-03 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-11-27 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-10-20 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-08-10 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-07-15 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-07-15 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-06-22 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2020-04-15 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2019-06-10 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2019-04-25 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-06-18 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-05-25 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-05-25 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2018-02-08 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-18 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-18 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-14 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-12-05 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-11-03 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
| 2017-09-06 | Company Response | enVVeno Medical Corp | DE | N/A | Read Filing View |
2025-03-14 - CORRESP - enVVeno Medical Corp
CORRESP 1 filename1.htm ENVVENO MEDICAL CORPORATION 70 Doppler Irvine, California 92618 March 14, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Re: enVVeno Medical Corporation Registration Statement on Form S-3 Filed February 28, 2025 File No. 333-285474 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, enVVeno Medical Corporation hereby requests acceleration of effectiveness of the above referenced Registration Statement so that it will become effective at 5:30 p.m. EST on Friday, March 14, 2025, or as soon as thereafter practicable. Very truly yours, /s/ Robert Berman Robert Berman Chief Executive Officer cc: Ellenoff Grossman & Schole LLP
2025-03-10 - UPLOAD - enVVeno Medical Corp File: 333-285474
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 10, 2025 Robert A. Berman Chief Executive Officer enVVeno Medical Corporation 70 Doppler Irvine, California 92618 Re: enVVeno Medical Corporation Registration Statement on Form S-3 Filed February 28, 2025 File No. 333-285474 Dear Robert A. Berman: 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 Conlon Danberg at 202-551-4466 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Matthew Bernstein, Esq. </TEXT> </DOCUMENT>
2023-11-01 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
ENVVENO
MEDICAL CORPORATION
70
Doppler
Irvine,
California 92618
November
1, 2023
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
DC 20549
Re:
enVVeno
Medical Corporation
Registration
Statement on Form S-3
Filed
October 26, 2023
File
No. 333-275187
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, enVVeno Medical Corporation, hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will become effective at 4:00 p.m. EST on Friday, November 3, 2023, or as soon
as thereafter practicable.
Very
truly yours,
/s/
Robert Berman
Robert
Berman
Chief
Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2023-10-31 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
October 31, 2023
Robert A. Berman
Chief Executive Officer
enVVeno Medical Corporation
70 Doppler
Irvine, California 92618
Re:enVVeno Medical Corporation
Registration Statement on Form S-3
Filed October 26, 2023
File No. 333-275187
Dear Robert A. Berman:
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 Conlon Danberg at 202-551-4466 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Matthew Bernstein, Esq.
2023-08-21 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
ENVVENO
MEDICAL CORPORATION
70
Doppler
Irvine,
California 92618
August
21, 2023
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
DC 20549
Attn:
Jane Park
Re:
enVVeno
Medical Corporation
Registration
Statement on Form S-3
Filed
July 31, 2023, as amended
File
No. 333-273546
Dear
Ms. Park:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, enVVeno Medical Corporation, hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will become effective at 4:30 p.m. EST on Wednesday, August 23, 2023, or as
soon as thereafter practicable.
Very
truly yours,
/s/
Robert Berman
Robert
Berman
Chief
Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2023-08-07 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
August 7, 2023
Robert Berman
Chief Executive Officer
enVVeno Medical Corporation
70 Doppler
Irvine, California 92618
Re:enVVeno Medical Corporation
Registration Statement on Form S-3
Filed July 31, 2023
File No. 333-273546
Dear Robert Berman:
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 Jane Park at 202-551-7439 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Matthew Bernstein, Esq.
2022-05-16 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
May 16, 2022
Craig Glynn
Chief Financial Officer
enVVeno Medical Corporation
70 Doppler
Irvine, California 92618
Re:enVVeno Medical Corporation
Form 10-K for the Fiscal Year Ended December 31, 2021
Filed March 28, 2022
File No. 001-38325
Dear Mr. Glynn:
We have completed our review of your filings. 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
2022-05-11 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
enVVeno
Medical Corporation
70
Doppler
Irvine,
California 92618
May
11, 2022
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Tara Harkins
Re:
enVVeno Medical
Corporation
Form 10-K for the Fiscal
Year Ended December 31, 2021
Filed March 28, 2022
File No. 001-38325
Dear
Ms. Harkins,
On
behalf of enVVeno Medical Corporation (the “Company”) we hereby transmit the Company’s response to the letter
received by us from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”),
dated May 6, 2022, regarding the Company’s Form 10-K for the Fiscal Year Ended December 31, 2021. For the Staff’s convenience,
we have repeated below the Staff’s comment in bold, and have followed such comment with the Company’s response.
Form
10-K for the Fiscal Year Ended December 31, 2021
Exhibits
1.
We note the certifications provided in Exhibits 31.1 and 31.2 do not include paragraph 4(b) referring to internal control over financial
reporting after the end of the transition period that allows these omissions. Please amend the filing to provide revised certifications.
You may file an abbreviated amendment that is limited to the cover page, explanatory note, signature page and paragraphs 1, 2, 4 and
5 of the certification. Refer to Exchange Act Rule 13a-14(a) and Item 601(b)(31) of Regulation S-K. This comment also applies to your
Form 10-Q for the quarter ended March 31, 2022.
The
Staff is advised that concurrently with this response, the Company has filed amendments to its Form 10-K for the fiscal year ended December
31, 2021 and Form 10-Q for the fiscal quarter ended March 31, 2022 to incorporate revised certifications.
We
thank the Staff for its review of the foregoing. If you have further comments, we ask that you forward them by electronic mail to our
counsel, Matthew Bernstein, Esq. at mbernstein@egsllp.com or by telephone at (212) 370-1300.
Very truly yours,
/s/
Craig Glynn
Craig
Glynn
Chief
Financial Officer
cc:
Matthew Bernstein, Esq.
Ellenoff Grossman & Schole LLP
2022-05-06 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
May 6, 2022
Craig Glynn
Chief Financial Officer
enVVeno Medical Corporation
70 Doppler
Irvine, California 92618
Re:enVVeno Medical Corporation
Form 10-K for the Fiscal Year Ended December 31, 2021
Filed March 28, 2022
File No. 001-38325
Dear Mr. Glynn:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
FirstName LastNameCraig Glynn
Comapany NameenVVeno Medical Corporation
May 6, 2022 Page 2
FirstName LastName
Craig Glynn
enVVeno Medical Corporation
May 6, 2022
Page 2
Form 10-K for the Fiscal Year Ended December 31, 2021
Exhibits
1.We note the certifications provided in Exhibits 31.1 and 31.2 do not
include paragraph 4(b) referring to internal control over financial reporting after the end of
the transition period that allows these omissions. Please amend the filing to provide
revised certifications. You may file an abbreviated amendment that is limited to the cover
page, explanatory note, signature page and paragraphs 1, 2, 4 and 5 of the certification.
Refer to Exchange Act Rule 13a-14(a) and Item 601(b)(31) of Regulation S-K. This
comment also applies to your Form 10-Q for the quarter ended March 31, 2022.
In closing, 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.
You may contact Tara Harkins at (202) 551-3639 or Kevin Kuhar, Accounting Branch
Chief, at (202) 551-3662 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-02-05 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
February
5, 2021
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Margaret Schwartz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
File
No. 333-251528
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc. hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will be declared effective at 5:30 p.m., Eastern Time, on Monday, February
8, 2021, 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.
Very truly yours,
/s/
Robert A. Berman
By:
Robert
A. Berman
Title:
Chief
Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2021-02-05 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
February
5, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Margaret Schwartz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1, as amended
File
No. 333-251528
Ladies
and Gentlemen:
As
representative of the underwriters of the proposed public offering of securities of Hancock Jaffe Laboratories, Inc. (the “Company”),
we hereby join the Company’s request that the effective date of the above-referenced Registration Statement on Form S-1
be accelerated so that it will be declared effective at 5:30 p.m., Eastern Time, on Monday, February 8, 2021, 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.
Pursuant
to Rule 460 under the Act, we, as representative of the underwriters, wish to advise you that there will be distributed to each
underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the
proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The
undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters
and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended.
[Remainder
of Page Intentionally Left Blank]
Very
truly yours,
Ladenburg
Thalmann & Co. Inc.
By:
/s/
Nicholas Stergis
Name:
Nicholas Stergis
Title:
Managing Director, Investment Banking
2021-02-04 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
February
4, 2021
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Margaret Schwartz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
File
No. 333-251528
Ladies
and Gentlemen:
On
February 3, 2021, Hancock Jaffe Laboratories, Inc. (the “Company”) requested acceleration of the effective date of
the above-referenced Registration Statement so that it would become effective at 5:30 p.m. on Thursday, February 4, 2021 or as
soon thereafter as practicable. We hereby withdraw such request.
Very truly yours,
/s/
Robert A. Berman
By:
Robert
A. Berman
Title:
Chief
Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2021-02-03 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
February
3, 2021
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Margaret Schwartz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
File
No. 333-251528
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc. hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will be declared effective at 5:30 p.m., Eastern Time, on Thursday,
February 4, 2021, 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.
Very
truly yours,
/s/
Robert A. Berman
By: Robert A.
Berman
Title:
Chief Executive Officer
cc:
Ellenoff Grossman & Schole
LLP
2021-02-03 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
February
3, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Margaret Schwartz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
File
No. 333-251528
Ladies
and Gentlemen:
As
representative of the underwriters of the proposed public offering of securities of Hancock Jaffe Laboratories, Inc. (the “Company”),
we hereby join the Company’s request that the effective date of the above-referenced Registration Statement on Form S-1
be accelerated so that it will be declared effective at 5:30 p.m., Eastern Time, on Thursday, February 4, 2021, 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.
Pursuant
to Rule 460 under the Act, we, as representative of the underwriters, wish to advise you that there will be distributed to each
underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the
proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The
undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters
and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended.
[Remainder
of Page Intentionally Left Blank]
Very
truly yours,
Ladenburg
Thalmann & Co. Inc.
By:
/s/
Nicholas Stergis
Name:
Nicholas Stergis
Title:
Managing Director, Investment Banking
2020-12-28 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
December 28, 2020
Robert Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, California 92618
Re:Hancock Jaffe Laboratories, Inc.
Registration Statement on Form S-1
Filed December 21, 2020
File No. 333-251528
Dear Mr. Berman:
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 Margaret Schwartz at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matthew Bernstein, Esq.
2020-11-27 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
November
27, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporate Finance
100
F Street, N.E.
Mail
Stop 4628
Washington,
DC 20549
Attn:
Alan Campbell
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
Filed
November 6, 2020
File
No. 333-249942
Dear
Mr. Campbell:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc. hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will become effective at 4:00 p.m. EST on Monday, November 30, 2020,
or as soon as thereafter practicable.
Very
truly yours,
/s/
Robert A. Berman
By:
Robert A. Berman
Title:
Chief Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2020-11-12 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
November 12, 2020
Robert A. Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, California 92618
Re:Hancock Jaffe Laboratories, Inc.
Registration Statement on Form S-1
Filed November 6, 2020
File No. 333-249942
Dear Mr. Berman:
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 Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matthew Bernstein, Esq.
2020-10-20 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
October
20, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporate Finance
100
F Street, N.E.
Mail
Stop 4628
Washington,
DC 20549
Attn:
Abby Adams
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-3
Filed
September 17, 2020
File
No. 333-248865
Dear
Ms. Adams:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc. hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will become effective at 4:30 p.m. EST on Thursday, October 22, 2020,
or as soon as thereafter practicable.
Very
truly yours,
/s/
Robert A. Berman
By:
Robert A. Berman
Title:
Chief Executive Officer
cc: Ellenoff Grossman & Schole LLP
2020-09-24 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
September 24, 2020
Robert A. Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, California 92618
Re:Hancock Jaffe Laboratories, Inc.
Registration Statement on Form S-3
Filed September 17, 2020
File No. 333-248865
Dear Mr. Berman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matthew Bernstein, Esq.
2020-08-13 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
August 13, 2020
Robert Berman
Chief Executive Officer and Director
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, CA 92618
Re:Hancock Jaffe Laboratories, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed July 24, 2020
File No. 001-38325
Dear Mr. Berman:
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: Matthew Bernstein
2020-08-10 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
August 7, 2020
Robert Berman
Chief Executive Officer and Director
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, CA 92618
Re:Hancock Jaffe Laboratories, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed July 24, 2020
File No. 001-38325
Dear Mr. Berman:
We have reviewed your filing and have the following comment. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Preliminary Proxy Statement filed July 24, 2020
Proposal No. 1: The Authorized Share Proposal, page 8
1.We note one of the reasons listed for the proposal to increase the number of authorized
shares is that the company does not have a sufficient amount of authorized shares to issue
additional stock in connection with a potential merger between the company and Catheter
Precision, Inc., as described in a non-binding letter of intent between the parties, dated
May 22, 2020. No further information is provided regarding this transaction and the letter
of intent has not been filed as a material agreement to date. Note A to Schedule 14A
provides that where a solicitation of security holders is for the purpose of approving the
authorization of additional securities which are to be used to acquire another specified
company, and the registrants' security holders will not have a separate opportunity to vote
upon the transaction, the solicitation to authorize the securities is also a solicitation with
respect to the acquisition. Under those facts, information required by Items 11, 13 and 14
shall be furnished. Please advise us whether the company's shareholders will have a
FirstName LastNameRobert Berman
Comapany NameHancock Jaffe Laboratories, Inc.
August 7, 2020 Page 2
FirstName LastName
Robert Berman
Hancock Jaffe Laboratories, Inc.
August 7, 2020
Page 2
separate opportunity to vote on the Catheter Precision transaction. If not, please revise the
proxy statement to include the additional disclosure required.
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.
You may contact Laura Crotty at (202) 551-7614 or Joe McCann at (202) 551-6262.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-08-10 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
CA 92618
August
10, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Laura Crotty
Re:
Hancock
Jaffe Laboratories, Inc.
Preliminary
Proxy Statement on Schedule 14A
Filed
July 24, 2020
File
No. 001-38325
Dear
Ms. Crotty,
Hancock
Jaffe Laboratories, Inc. (the “Company”) hereby transmits its response to the comment letter received from
the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”)
on August 7, 2020 regarding the Preliminary Proxy Statement on Schedule 14A filed by the Company on July 24, 2020 (the “Proxy”).
For the Staff’s convenience, the Company has repeated below the Staff’s comment in bold, and has followed such comment
with the Company’s response.
Preliminary
Proxy Statement filed July 24, 2020
Proposal
No. 1: The Authorized Share Proposal, page 8
1.
We
note one of the reasons listed for the proposal to increase the number of authorized shares is that the company does not have
a sufficient amount of authorized shares to issue additional stock in connection with a potential merger between the company
and Catheter Precision, Inc., as described in a non-binding letter of intent between the parties, dated May 22, 2020. No further
information is provided regarding this transaction and the letter of intent has not been filed as a material agreement to
date. Note A to Schedule 14A provides that where a solicitation of security holders is for the purpose of approving the authorization
of additional securities which are to be used to acquire another specified company, and the registrants' security holders
will not have a separate opportunity to vote upon the transaction, the solicitation to authorize the securities is also a
solicitation with respect to the acquisition. Under those facts, information required by Items 11, 13 and 14 shall be furnished.
Please advise us whether the company's shareholders will have a separate opportunity to vote on the Catheter Precision transaction.
If not, please revise the proxy statement to include the additional disclosure required.
In
the event that the Company signs a definitive merger agreement with Catheter Precision, Inc. (“Catheter Precision”),
the Company intends to file a registration statement on Form S-4, which will include a proxy statement/prospectus. The Company
contemplates that such proxy statement/prospectus will constitute (i) a prospectus of the Company under Section 5 of the Securities
Act of 1933, as amended, with respect to the shares of common stock of the Company to be issued to stockholders of Catheter Precision
pursuant to the merger and (ii) a proxy statement for the Company’s stockholders under Section 14(a) of the Securities Exchange
Act of 1934, as amended, in connection with a special meeting of the Company’s stockholders (the “Special Meeting”).
At the Special Meeting, the Company’s stockholders will be asked to approve the issuance of shares of the Company’s
common stock in the merger. Therefore, the Company’s stockholders will have a separate opportunity to vote on matters related
to the potential merger transaction with Catheter Precision that is described in the non-binding letter of intent between the
Company and Catheter Precision dated May 22, 2020.
**************
Securities
and Exchange Commission
August
10, 2020
Page
2
The
Company thanks the Staff for its review of the foregoing. If you have further comments, the Company asks that you forward them
by electronic mail to its counsel, Matthew Bernstein, Esq. at mbernstein@egsllp.com or by telephone at (212) 370-1300.
Very
truly yours,
/s/
Robert Berman
Robert
Berman
Chief
Executive Officer
cc:
Matthew
Bernstein, Esq.
Ellenoff
Grossman & Schole LLP
2020-07-15 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
July
15, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporate Finance
100
F Street, N.E.
Mail
Stop 4628
Washington,
DC 20549
Attn:
Christopher Edwards
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
Filed
July 13, 2020
File
No. 333-239658
Dear
Mr. Edwards:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc. hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will become effective at 5:00 p.m. EST on Thursday, July 16, 2020, or
as soon as thereafter practicable.
Very
truly yours,
/s/
Robert A. Berman
By:
Robert
A. Berman
Title:
Chief
Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2020-07-15 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
LADENBURG
THALMANN & CO. INC.
999
Vanderbilt Beach Road, Suite 200
Naples,
Florida 34108
July
15, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hancock
Jaffe Laboratories, Inc. Registration Statement on Form S-1 (File No. 333-239658) originally filed July 2, 2020, as amended.
Requested
Date: July 16, 2020
Requested
Time: 5:00 PM Eastern Time
Ladies
and Gentlemen:
In
connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended
(the “Act”), we, as representative of the several underwriters, hereby join in the request of Hancock Jaffe Laboratories,
Inc. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 5:00 p.m.,
Eastern Time (US), on July 16, 2020, or at such later time as the Company or its outside counsel, Ellenoff Grossman & Schole
LLP, may request via a telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission.
Pursuant
to Rule 460 under the Act, we wish to advise you that the underwriters have distributed as many copies of the Preliminary Prospectus
dated July 13, 2020 to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution
of the preliminary prospectus.
The
undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating
underwriters that they have complied and will comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
***
Sincerely,
LADENBURG THALMANN & CO. INC.
By:
/s/
Nicholas Stergis
Nicholas
Stergis
Managing
Director
[Signature
Page to Underwriter Acceleration Request Letter]
2020-07-08 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
July 8, 2020
Robert A. Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, California 92618
Re:Hancock Jaffe Laboratories, Inc.
Registration Statement on Form S-1
Filed July 2, 2020
File No. 333-239658
Dear Mr. Berman:
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: David Selengut, Esq.
2020-06-22 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
June
22, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporate Finance
100
F Street, N.E.
Mail
Stop 4628
Washington,
DC 20549
Attn:
Tim Buchmiller
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
Filed
June 15, 2020
File
No. 333-239195
Dear
Mr. Buchmiller:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc. hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will become effective at 4:30 p.m. EST on Tuesday, June 23, 2020, or
as soon as thereafter practicable.
Very truly yours,
/s/
Robert A. Berman
By:
Robert A. Berman
Title:
Chief Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2020-06-19 - UPLOAD - enVVeno Medical Corp
United States securities and exchange commission logo
June 18, 2020
Robert A. Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, California 92618
Re:Hancock Jaffe Laboratories, Inc.
Registration Statement on Form S-1
Filed June 15, 2020
File No. 333-239195
Dear Mr. Berman:
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 Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Barry I. Grossman, Esq.
2020-04-15 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
April
15, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporate Finance
100
F Street, N.E.
Mail
Stop 4628
Washington,
DC 20549
Attn:
Ada D. Sarmento
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-3
Filed
April 7, 2020
File
No. 333- 237592
Dear
Ms. Sarmento:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc., hereby requests acceleration of
effectiveness of the above referenced Registration Statement so that it will become effective at 4:30 p.m. EST on Thursday,
April 16, 2020, or as soon as thereafter practicable.
Very
truly yours,
/s/
Robert A. Berman
By:
Robert A. Berman
Title:
Chief Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2020-04-14 - UPLOAD - enVVeno Medical Corp
April 14, 2020
Robert A. Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, CA 92618
Re:Hancock Jaffe Laboratories, Inc.
Registration Statement on Form S-3
Filed April 7, 2020
File No. 333-237592
Dear Mr. Berman:
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: Barry I. Grossman, Esq.
2019-06-10 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
HANCOCK
JAFFE LABORATORIES, INC.
70
Doppler
Irvine,
California 92618
June
10, 2019
VIA
EDGAR
U.S.
Securities and Exchange Commission
Office
of Financial Services
100
F Street, N.E.
Mail
Stop 4628
Washington,
DC 20549
Attn:
Tom Jones
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
Filed
June 7, 2019
File
No. 333-232035
Dear
Mr. Jones:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc., hereby requests acceleration of effectiveness
of the above referenced Registration Statement so that it will become effective at 5:00 p.m. EST on Tuesday, June 11, 2019, or
as soon as thereafter practicable.
Very
truly yours,
/s/
Robert A. Berman
Robert
A. Berman
Chief
Executive Officer
cc:
Ellenoff
Grossman & Schole LLP
2019-05-28 - UPLOAD - enVVeno Medical Corp
May 28, 2019
Robert A. Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, California 92168
Re:Hancock Jaffe Laboratories, Inc.
Draft Registration Statement on Form S-1
Submitted May 15, 2019
CIK No. 0001661053
Dear Mr. Berman:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours 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 Thomas Jones at 202-551-3602 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Barry I. Grossman, Esq.
2019-05-21 - UPLOAD - enVVeno Medical Corp
April 4, 2019
Robert A. Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, CA 92618
Re:Hancock Jaffe Laboratories, Inc.
Registration Statement on Form S-1
Filed March 29, 2019
File No. 333-230598
Dear Mr. Berman:
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 Michael Fay at 202-551-3812 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: David Selengut, Esq.
2019-04-25 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
CA 92618
April
25, 2019
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
Filed
March 29, 2019
File
No. 333-230598
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc. (the “Registrant”)
hereby requests acceleration of effectiveness of the above referenced Registration Statement on Form S-1 so that it will become
effective at 4:30 p.m., Eastern time, on Monday, April 29, 2019, or as soon as thereafter as is practicable.
Very
truly yours,
/s/
Robert A. Berman
Robert
A. Berman
President
and Chief Executive Officer
cc:
Ellenoff Grossman & Schole LLP
2018-06-18 - UPLOAD - enVVeno Medical Corp
June 18, 2018
Robert A. Berman
Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
70 Doppler
Irvine, California 92618
Re:Hancock Jaffe Laboratories, Inc.
Registration Statement on Form S-1
Filed June 12, 2018
File No. 333-225570
Dear Mr. Berman:
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 Tim Buchmiller at (202) 551-3635 with any questions.
Division of Corporation Finance
Office of Electronics and Machinery
cc: Michael A. Hedge, Esq.
2018-06-18 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
June
18, 2018
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Amanda Ravitz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
File
No. 333-225570
Request
for Acceleration
Acceleration
Request
Request
Date: June 20, 2018
Request
Time: 4:00 p.m. Eastern Time (or as soon thereafter as practicable)
Dear
Ms. Ravitz:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc., a Delaware corporation
(the “Registrant”), hereby respectfully requests that the Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-1 (File No. 333-225570), to become effective
at 4:00 p.m. Eastern Time on June 20, 2018, or as soon thereafter as practicable, or at such later time as the Registrant or its
counsel may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes K&L Gates LLP,
counsel to the Registrant, to orally modify or withdraw this request for acceleration.
The
Registrant requests that it be notified of such effectiveness by a telephone call to Michael A. Hedge at (949) 623-3519, or in
his absence, Jason C. Dreibelbis at (949) 623-3543.
Sincerely,
HANCOCK
JAFFE LABORATORIES, INC.
By:
/s/
Robert A. Berman
Robert
A. Berman
Chief
Executive Officer
cc:
Yury
Zhivilo, Hancock Jaffe Laboratories, Inc.
Bill
Abbott, Hancock Jaffe Laboratories, Inc.
Michael
A. Hedge, K&L Gates LLP
2018-05-25 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
May 25, 2018
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Amanda Ravitz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
File
No. 333-220372
Request
for Acceleration
Acceleration
Request
Request
Date: May 30, 2018
Request
Time: 4:30 p.m. Eastern Time (or as soon thereafter as practicable)
Dear
Ms. Ravitz:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc., a Delaware corporation
(the “Registrant”), hereby respectfully requests that the Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-1 (File No. 333-220372), to become effective
at 4:30 p.m. Eastern Time on May 30, 2018, or as soon thereafter as practicable, or at such later time as the Registrant
or its counsel may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes K&L
Gates LLP, counsel to the Company, to orally modify or withdraw this request for acceleration.
The
Registrant requests that it be notified of such effectiveness by a telephone call to Michael A. Hedge at (949) 623-3519, or in
his absence, Alexa M. Ekman at (949) 623-3603.
Sincerely,
HANCOCK
JAFFE LABORATORIES, INC.
By:
/s/
Robert A. Berman
Robert
A. Berman
Chief Executive Officer
cc:
Yury Zhivilo, Hancock Jaffe Laboratories,
Inc.
Bill
Abbott, Hancock Jaffe Laboratories, Inc.
Michael
A. Hedge, K&L Gates LLP
2018-05-25 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Network
1 Financial Securities, Inc.
2 Bridge Avenue, Suite 241
Red Bank, NJ 07701
May
25, 2018
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Amanda Ravitz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
File
No. 333-220372
Request
for Acceleration
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), we, as the sole
underwriter (the “Underwriter”), hereby join in the request of Hancock Jaffe Laboratories, Inc. (the “Registrant”),
for the acceleration of the effective date of the Registrant’s Registration Statement on Form S-1 (File No. 333-220372)
(as amended, the “Registration Statement”), relating to a public offering of shares of the Registrant’s units,
each unit consisting of one share of our common stock, par value $0.00001 per share, and a common stock purchase warrant to purchase
one share of the Registrant’s common stock, so that the Registration Statement may be declared effective on Wednesday,
May 30, 2018 at 4:30 p.m. Eastern Time, or as soon thereafter as practicable. The undersigned, as Representatives, confirms
that they are aware of their obligations under the Securities Act.
In
connection with the Registration Statement, pursuant to Rule 460 under the Securities Act, we wish to advise you that, between
May 22, 2018 and the date hereof, 250 copies of the Registrant’s Preliminary Prospectus, dated May 22, 2018,
were distributed to investors, prospective underwriters and dealers and others.
The
undersigned, as Representatives, hereby advise you that they have complied and will continue to comply, and that they have been
informed by the participating underwriters and dealers that they have complied and will comply, with the provisions of Rule 15c2-8
promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above proposed offering.
Very
truly yours,
NETWORK
1 FINANCIAL SECURITIES, INC.
Acting
severally on behalf of itself and the several underwriters
By:
NETWORK
1 FINANCIAL SECURITIES, INC.
By:
/s/
Damon Testaverde
Name:
Damon
Testaverde
Title:
Managing
Director
2018-02-08 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
February
8, 2018
VIA
EDGAR
Amanda
Ravitz
Assistant
Director
United
States Securities and Exchange Commission
Office
of Electronics and Machinery
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hancock Jaffe Laboratories, Inc.
Amendment No. 4 to Registration Statement
on Form S-1
Filed January 26, 2018
File No. 333-220372
Dear
Ms. Ravitz:
Hancock
Jaffe Laboratories, Inc., a Delaware corporation (the “Company”), hereby provides the following information
in response to the oral comment received from the staff (the “Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) on February 7, 2018 to Amendment No. 4 to the Registration Statement
on Form S-1 (File No. 333-220372) filed on January 26, 2018 (“Amendment No. 4”). The Company’s
response is preceded by a reproduction of the Staff’s oral comment in italics.
1.
How were the 2018 note investors made aware
of the opportunity to invest in the company and please identify any pre-existing relationships between these investors and
the company.
Company
Response: During the period from June 15, 2017 through December 7, 2017, the Company received proceeds of approximately $2,750,500
pursuant to the issuance of certain convertible promissory notes (the “2017 Financing”). Alexander Capital,
L.P. (“Alexander”) acted as the placement agent for the 2017 Financing.
During
the period from September 1, 2017 and December 6, 2017, the Company issued 253,792 shares of its Series B Preferred Stock, par
value $0.00001 per share (the “Series B Financing”). Newbridge Securities Corporation (“Newbridge”)
acted as the Company’s placement agent for the Series B Financing.
During
the period from January 5, 2018 through January 16, 2018, the Company received net proceeds of approximately $2,603,750 pursuant
to the issuance of certain convertible promissory notes (the “2018 Financing”). Alexander acted as the placement
agent for the 2018 Financing.
Alexander
has informed the Company that the purchasers in the 2018 Financing (the “Purchasers”) had a pre-existing relationship
with Black River Wealth Management Ltd. (“Black River”), an affiliate of Newbridge, which itself holds securities
of the Company. The Purchasers were privately solicited based on their relationships with Alexander or its representatives.
Amanda
Ravitz
Page
2 of 2
Should
you have any questions or require any additional information, please contact Hancock Jaffe Laboratories, Inc., attention William
Abbott, by phone at (949) 387-9279, or by e-mail at billabbott@hjlinc.com.
Sincerely,
/s/ Benedict Broennimann, M.D.
Benedict Broennimann, M.D.
Co-Chief Executive Officer
Hancock Jaffe Laboratories, Inc.
Cc:
Tim Buchmiller, U.S. Securities and Exchange
Commission
Tom Jones, U.S. Securities and Exchange Commission
Gary Todd, U.S. Securities and Exchange Commission
Jeanne Bennett, U.S. Securities and Exchange
Commission
William Abbott, Hancock Jaffe Laboratories,
Inc.
Michael Hedge, K&L Gates LLP
2017-12-18 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
December
18, 2017
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Amanda
Ravitz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1/A
File
No. 333-220372
Withdrawal
of Request for Acceleration
Dear
Ms. Ravitz:
Reference
is made to the letter of Hancock Jaffe Laboratories, Inc., a Delaware corporation (the “Registrant”),
filed as correspondence via EDGAR on December 18, 2017, in which the Registrant requested the acceleration of the effective date
of the above-referenced Registration Statement for Tuesday, December 19, 2017, at 4:30 p.m. Eastern Time, in accordance with Rule
461 under the Securities Act of 1933, as amended. The Registrant is no longer requesting that such Registration Statement be declared
effective at this time and the Registrant hereby formally withdraws its request for acceleration of the effective date. The
Registrant will submit an acceleration request letter requesting that such Registration Statement be declared effective at a different
time.
Sincerely,
HANCOCK
JAFFE LABORATORIES, INC.
By:
/s/
Steven A. Cantor
Steven
A. Cantor
Co-Chief
Executive Officer
cc:
Benedict
Broennimann, M.D., Hancock Jaffe Laboratories, Inc.
Bill
Abbott, Hancock Jaffe Laboratories, Inc.
Michael
A. Hedge, K&L Gates LLP
2017-12-18 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
December
18, 2017
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn: Amanda
Ravitz
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
File
No. 333-220372
Request
for Acceleration
Acceleration
Request
Request
Date: December 19, 2017
Request
Time: 4:30 p.m. Eastern Time (or as soon thereafter as practicable)
Dear
Ms. Ravitz:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Hancock Jaffe Laboratories, Inc., a Delaware corporation
(the “Registrant”), hereby respectfully requests that the Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-1 (File No. 333-220372), to become effective
at 4:30 p.m. Eastern Time on December 19, 2017, or as soon thereafter as practicable, or at such later time as the Registrant
or its counsel may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes K&L
Gates LLP, counsel to the Company, to orally modify or withdraw this request for acceleration.
The
Registrant requests that it be notified of such effectiveness by a telephone call to Michael A. Hedge at (949) 623-3519, or in
his absence, Alexa M. Ekman at (949) 623-3603.
Sincerely,
HANCOCK
JAFFE LABORATORIES, INC.
By:
/s/
Steven A. Cantor
Steven
A. Cantor
Co-Chief
Executive Officer
cc:
Benedict
Broennimann, M.D., Hancock Jaffe Laboratories, Inc.
Bill
Abbott, Hancock Jaffe Laboratories, Inc.
Michael
A. Hedge, K&L Gates LLP
2017-12-14 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
December
14, 2017
Via
EDGAR and Courier
Amanda
Ravitz
Assistant
Director
United
States Securities and Exchange Commission
Office
of Electronics and Machinery
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hancock
Jaffe Laboratories, Inc.
Amendment
No. 2 to Registration Statement on Form S-1/A
Filed
December 5, 2017
File
No. 333-220372
Dear
Ms. Ravitz:
Hancock
Jaffe Laboratories, Inc., a Delaware corporation (the “Company”), hereby provides the following information
in response to the comments received from the staff (the “Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) in its letter to the Company dated December 13, 2017 (the “Comment
Letter”). The Company’s responses are preceded by a reproduction of the Staff’s comment in italics as
set forth in the Comment Letter.
In
addition, the Company is concurrently filing an amended Registration Statement on Form S-1 (as amended, the “Registration
Statement”).
We
are subject to certain negative covenants set forth in the Notes, page 12
1.
Clarify
if the material covenants mentioned in the second paragraph of this risk factor are the same as the negative covenants described
in the first paragraph of this risk factor. Please also make similar disclosure in the fifth paragraph on page 60. If there
are different material covenants, please disclose those in an appropriate location in your prospectus.
Company
Response: The Company acknowledges the Staff’s comment and has revised its disclosure on pages 12 and
60 of the Registration Statement accordingly.
Amanda Ravitz
Page 2 of 2
Use
of Proceeds, page 48
2.
File
as an exhibit the note issued to Leman Cardiovascular S.A. Also, tell us how you intend to satisfy your remaining obligations
under that note and revise your disclosure as appropriate. Disclose under “Liquidity and Capital Resources” whether
you believe that the net proceeds from your offering after intended uses, together with the cash generated from operations
and your current cash and cash equivalents, will be sufficient to meet your anticipated operating liquidity and capital resources
requirements for at least the twelve months following your offering.
Company
Response: The Company acknowledges the Staff’s comment and has filed the note issued to Leman Cardiovascular S.A.
as Exhibit 10.35 to the Registration Statement, and has revised its disclosure on pages 48 and 60 of the Registration
Statement accordingly.
Should
you have any questions or require any additional information, please contact Hancock Jaffe Laboratories, Inc., attention Bill
Abbott, by phone at (949) 387-9279, or by e-mail at billabbott@hjlinc.com.
Sincerely,
/s/
Benedict Broennimann, M.D.
Benedict
Broennimann, M.D.
Co-Chief
Executive Officer
Hancock
Jaffe Laboratories, Inc.
Cc:
Tim
Buchmiller, U.S. Securities and Exchange Commission
Tom
Jones, U.S. Securities and Exchange Commission
Gary
Todd, U.S. Securities and Exchange Commission
Jeanne
Bennett, U.S. Securities and Exchange Commission
Bill
Abbott, Hancock Jaffe Laboratories, Inc.
Michael
Hedge, K&L Gates LLP
2017-12-13 - UPLOAD - enVVeno Medical Corp
Mail Stop 3030 December 1 3, 2017 Via E -mail Benedict Broennimann, M.D. Co-Chief Executive Officer Hancock Jaffe Laboratories, Inc. 70 Doppler Irvine, California 92618 Re: Hancock Jaffe Laboratories, Inc. Amendment No. 2 to Registration Statement on Form S -1 Filed December 5, 2017 File No. 333 -220372 Dear Dr. Broennimann : We have reviewed your amended registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our November 17, 2017 letter. We are subject to certain negative covenants set forth in the Notes, page 12 1. Clarify if the material covenants mentioned in the second paragraph of this risk factor are the same as the negative covenants described in the first paragraph of this risk factor. Please also make similar disclosure in the fifth paragraph on page 60. If there are different material covenants, please disclose those in an appropriate location in your prospectus. Use of Proceeds, page 48 2. File as an exhibit the note issued to Leman Cardiovascular S.A. Also, tell us how you intend to satisfy your remaining obligat ions under that note and revise your disclosure as appropriate. Disclose under “Liquidity and Capital Resources” whether you believe that Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. December 1 3, 2017 Page 2 the net proceeds from your offering after intended uses, together with the cash generated from operations and your cu rrent cash and cash equivalents, will be sufficient to meet your anticipated operating liquidity and capital resources requirements for at least the twelve months following your offering. You may contact J eanne Bennett at (202) 551-3606 or Gary Todd, Senior Accountant, at (202) 551 -3605 if you have questions regarding comments on the financial statements and related matters. Please contact Tom Jones at (202) 551 -3602 or Tim Buchmiller, Senior Attorney, at (202) 551 -3635 with any other quest ions. Sincerely, /s/ Tim Buchmiller for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Michael A. Hedge, Esq. K&L Gates LLP
2017-12-05 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
December 5, 2017
Via
EDGAR and Courier
Amanda
Ravitz
Assistant
Director
United
States Securities and Exchange Commission
Office
of Electronics and Machinery
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1/A
Filed
November 6, 2017
File
No. 333-220372
Dear
Ms. Ravitz:
Hancock
Jaffe Laboratories, Inc., a Delaware corporation (the “Company”), hereby provides the following information
in response to the comments received from the staff (the “Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) in its letter to the Company dated November 17, 2017 (the “Comment
Letter”). The Company’s responses are preceded by a reproduction of the Staff’s comment in italics as
set forth in the Comment Letter.
In
addition, the Company is concurrently filing an amended Registration Statement on Form S-1 (as amended, the “Registration
Statement”). Enclosed are two courtesy copies of the Registration Statement submitted to the Commission on the date
hereof, in a clean and blacklined version showing changes that were made from the Registration Statement on Form S-1/A filed with
the Commission on November 6, 2017.
Dilution,
page 52
1.
Please
show us how historical net book value (deficit) per share as of September 30, 2017 and the pro forma increase from conversion
of preferred stock were determined. In that regard, given the amounts of stockholders’ deficit and intangible assets
reported on your balance sheet as of September 30, 2017, it is not clear how historical deficit per share is not greater than
$(.80).
Company
Response: The Company’s historical net tangible book value (deficit) as of September 30, 2017 was ($4,927,628) which
was the difference of $597,897 total tangible assets and ($5,525,525) total liabilities. The Company’s historical total
tangible assets was the difference of $1,931,225 in historical total assets and $1,333,328 in intangible assets which included
$193,091 in deferred offering costs. Based on 6,133,679 shares of common stock outstanding as of September 30, 2017,
the Company’s historical net tangible book value (deficit) as of September 30, 2017 would be ($0.80) per share
of the Company’s common stock.
Amanda
Ravitz
Page
2 of 2
The
Company’s pro forma net tangible book value (deficit) as of September 30, 2017 was ($4,353,751) which was the difference
of $1,171,774 total tangible assets and ($5,525,525) total liabilities. The Company’s proforma total tangible assets was
the difference of $2,505,102 in proforma total assets less $1,333,328 in intangible assets which included $193,091 in deferred
offering costs. Based on 7,795,290 shares of the Company’s common stock outstanding, the Company's pro
forma net tangible book value (deficit) as of September 30, 2017 was ($0.56) per share of common stock, after
giving effect to (i) the sale of 110,167 additional shares of Series B preferred stock prior to the offering for net proceeds
of $573,877, and (ii) the automatic conversion of all outstanding shares of the Company's preferred stock into an aggregate of
1,661,611 shares of the Company's common stock, which included 75,178 shares of common stock in payment of accrued dividends as
of November 30, 2017, which will occur immediately prior to the closing of the offering pursuant to which the Registration Statement
relates.
Description
of Capital Stock, page 105
2. Please
provide the disclosure required by Regulation S-K Item 201(b)(1).
Company
Response: The Company acknowledges the Staff’s comment and has revised its disclosure on page 104 of the Registration
Statement.
Recent
Sales of Unregistered Securities, page II-2
3. Please
provide the Regulation S-K Item 701 disclosure for the convertible promissory notes and
warrants disclosed on page 56.
Company
Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page II-3 of the
Registration Statement.
Should
you have any questions or require any additional information, please contact Hancock Jaffe Laboratories, Inc., attention Bill
Abbott, by phone at (949) 387-9279, or by e-mail at billabbott@hjlinc.com.
Sincerely,
/s/
Benedict Broennimann, M.D.
Benedict
Broennimann, M.D.
Co-Chief
Executive Officer
Hancock
Jaffe Laboratories, Inc.
Cc:
Tim
Buchmiller, U.S. Securities and Exchange Commission
Tom
Jones, U.S. Securities and Exchange Commission
Gary
Todd, U.S. Securities and Exchange Commission
Jeanne
Bennett, U.S. Securities and Exchange Commission
Bill
Abbott, Hancock Jaffe Laboratories, Inc.
Michael
Hedge, K&L Gates LLP
2017-11-17 - UPLOAD - enVVeno Medical Corp
Mail Stop 3030 November 1 7, 2017 Via E -mail Benedict Broennimann, M.D. Co-Chief Executive Officer Hancock Jaffe Laboratories, Inc. 70 Doppler Irvine, California 92618 Re: Hancock Jaffe Laboratories, Inc. Amendment No. 1 to Registration Statement on Form S -1 Filed November 6, 2017 File No. 333 -220372 Dear Dr. Broennimann : We have reviewed your amended registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our October 4, 2017 letter . Dilution, page 52 1. Please show us how historical net book value (deficit) per share as of September 30, 2017 and the pro forma increase from conversion of preferred stock were determined. In that regard, given the amounts of stockholders’ deficit and intangible assets reported on your balance sheet as of September 30, 2017, it is not clear how historical deficit per sha re is not greater than $(.80). Description of Capital Stock, page 105 2. Please provide the disclosure required by Regulation S -K Item 201(b)(1). Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. November 1 7, 2017 Page 2 Recent Sales of Unregistered Securities, page II-2 3. Please provide the Regulation S -K Item 701 disclosure for the convertible promissory notes and warrants disclosed on page 56. You may contact J eanne Bennett at (202) 551-3606 or Gary Todd, Senior Accountant, at (202) 551 -3605 if you have questions regarding comments on the financial statements and related matters. Please contact Tom Jones at (202) 551 -3602 or Tim Buchmiller, Senior Attorney, at (202) 551 -3635 with any other questions. Sincerely, /s/ Tim Buchmiller for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Michael A. Hedge, Esq. K&L Gates LLP
2017-11-03 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
November
6, 2017
Via
EDGAR and Courier
Amanda
Ravitz
Assistant
Director
United
States Securities and Exchange Commission
Office
of Electronics and Machinery
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hancock
Jaffe Laboratories, Inc.
Registration
Statement on Form S-1
Filed
September 7, 2017
Registration
Statement on Form S-1/A
Filed
November 6, 2017
File
No. 333-220372
Dear
Ms. Ravitz:
Hancock
Jaffe Laboratories, Inc., a Delaware corporation (the “Company”), hereby provides the following information
in response to the comments received from the staff (the “Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) in its letter to the Company dated October 4, 2017 (the “Comment
Letter”). The Company’s responses are preceded by a reproduction of the Staff’s comment in italics as
set forth in the Comment Letter.
In
addition, the Company is concurrently filing an amended Registration Statement on Form S-1 (as amended, the “Registration
Statement”). Enclosed are two courtesy copies of the Registration Statement submitted to the Commission on the date
hereof, in a clean and blacklined version showing changes that were made from the Registration Statement on Form S-1 filed with
the Commission on September 7, 2017.
We
utilize a third-party, single-source supplier for some components…, page 11
1.
Please
expand the appropriate section to disclose, if applicable, the material terms of your agreement with the single source supplier,
such as the duration of the agreement and the termination provisions of the agreement.
Company Response: The Company
acknowledges the Staff’s comment and has revised the disclosure on page 13 of the Registration Statement accordingly.
Use
of Proceeds, page 45
2.
We
note your response to prior comment 17. If any material amounts of other funds are necessary to accomplish the specified purposes,
please state the amounts and sources of other such funds. See Item 504 of Regulation S-K and Instruction 3 to that Item. In
this regard, also address any capital needs necessary to achieve the disclosed regulatory clearances.
Amanda
Ravitz
Page 2 of 3
Company
Response: The Company acknowledges the Staff’s comment and has revised its disclosure on page 48 of the Registration
Statement. In addition, at this time, the Company believes that proceeds derived from the offering will be sufficient to accomplish
the specified purposes for which the proceeds are to be obtained. As such, the Company does not expect to require additional funding
sources that would trigger the applicable disclosure requirements under Instruction 3 to Item 504 of Regulation S-K.
Capitalization,
page 47
3.
Please
revise so that cash and cash equivalents are not included in the mathematical sum of total capitalization.
Company Response: The Company
acknowledges the Staff’s comment and has revised the disclosure on page 50 of the Registration Statement to include
cash and cash equivalents in the mathematical sum of total capitalization.
4.
Under
the caption “Senior Convertible Notes” on page 96 you disclose that the convertible notes are convertible at the
option of the holder upon completion of the offering. Accordingly, tell us and revise to clarify why it is appropriate to
assume that the notes fully convert upon consummation of your offering.
Company
Response: The Company acknowledges the Staff’s comments and has revised the disclosure on page 56 of the Registration
Statement to remove any assumption that the Company’s senior convertible notes will convert upon consummation of the offering.
Certain
Relationships and Related Transactions, page 94
5.
We
note your response to prior comment 25. Please tell us how you determined that HJLA is not a related person.
Company
Response: The Company’s only relationship to Hancock Jaffe Laboratory Aesthetics, Inc. (“HJLA”)
is with respect to the Company’s 28.5% ownership investment in HJLA. Pursuant to Instruction 1 of Item 404(a) of Regulation
S-K, HJLA is not a director or executive officer of the Company, a security holder of the Company, or an immediate family member
of any such security holder of the Company. As a result, HJLA is not a related party to the Company.
Undertakings
6.
We
note your response to prior comment 33. Please include the undertakings required by Item 512(a)(6) of Regulation S-K as they
are required for primary offerings.
Company Response: The Company
acknowledges the Staff’s comment and has revised the disclosure beginning on page II-3 of the Registration
Statement to include the undertaking set forth in Item 512(a)(6) of Regulation S-K.
Amanda Ravitz
Page 3 of 3
Exhibits
7.
Please
file as exhibits the amended and restated certificate of incorporation and the loan agreement mentioned on pages F-7 and F-14,
respectively.
Company Response: The Company
acknowledges the Staff’s comment and has filed the Company’s Amended and Restated Certificate of Incorporation and
the Loan Agreement referenced on pages F-7 and F-14, respectively, as Exhibits 3.1 and 10.27 and 10.28, respectively.
8. We
note your response to prior comment 36. However, it appears that you have not re-filed
several agreements, such as exhibits 10.10, 10.11 and 10.12 as exhibits to this filing.
We note that the agreements were filed as exhibits to your draft registration statement
and were presented as a graphic or image file. Please re-file your exhibits as appropriate.
Company
Response: The Company acknowledges the Staff’s comment and has filed the exhibits as indicated above with the Registration
Statement.
Should
you have any questions or require any additional information, please contact Hancock Jaffe Laboratories, Inc., attention Bill
Abbott, by phone at (949) 387-9279, or by e-mail at billabbott@hjlinc.com.
Sincerely,
HANCOCK JAFFE LABORATORIES, INC.
By:
/s/
Benedict Broennimann, M.D.
Benedict Broennimann, M.D.
Co-Chief Executive Officer
Cc:
Tim
Buchmiller, U.S. Securities and Exchange Commission
Tom
Jones, U.S. Securities and Exchange Commission
Gary
Todd, U.S. Securities and Exchange Commission
Jeanne
Bennett, U.S. Securities and Exchange Commission
Bill
Abbott, Hancock Jaffe Laboratories, Inc.
Michael
Hedge, K&L Gates LLP
2017-10-04 - UPLOAD - enVVeno Medical Corp
Mail Stop 3030 October 4, 2017 Via E -mail Benedict Broennimann, M.D. Co-Chief Executive Officer Hancock Jaffe Laboratories, Inc. 70 Doppler Irvine, California 92618 Re: Hancock Jaffe Laboratories, Inc. Registration Statement on Form S -1 Filed September 7, 2017 File No. 333 -220372 Dear Dr. Broennimann : We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your regis tration statement and the information you provide in response to these comments, we may have additional comments. We utilize a third -party, single -source supplier for some components …, page 11 1. Please expand the appropriate section to disclose, if applicable, the material terms of your agreement with the single source supplier, such as the duration of the agreement and the termination provisions of the agreement. Use of Proceeds, page 45 2. We note your response to prior comment 17. If any material amounts of other funds are necessary to accomplish the specified purposes, please state the amounts and sources of other such funds. See Item 504 of Regulation S -K and Instruction 3 to that Item. In this regard, also address any capital needs necessary to achieve the disclosed regulatory clearances. Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. October 4, 2017 Page 2 Capitalization, page 47 3. Please revise so that cash and cash equivalents are not included in the mathematical sum of total capitalization. 4. Unde r the caption “Senior Convertible Notes” on page 96 you disclose that the convertible notes are convertible at the option of the holder upon completion of the offering. Accordingly, tell us and revise to clarify why it is appropriate to assume that the no tes fully convert upon consummation of your offering. Certain Relationships and Related Transactions, page 94 5. We note your response to prior comment 25. Please tell us how you determined that HJLA is not a related person. Undertakings 6. We note your response to prior comment 33. Please include the undertakings required by Item 512(a)(6) of Regulation S -K as they are required for primary offerings. Exhibits 7. Please file as exhibits the amended and restated certificate of incorporation and the loan agreement mentioned on pages F -7 and F -14, respectively . 8. We note your response to prior comment 36. However, it appears that you have not re - filed several agreements, such as exhibits 10.10, 10.11 and 10.12 as exhibits to this filing. We note that the agreements were filed as exhibits to your draft registratio n statement and were presented as a graphic or image file. Please re -file your exhibits as appropriate . We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, co mments, 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. Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. October 4, 2017 Page 3 You may contact Jeanne Bennett at (202) -551-3606 or Gary Todd, Senior Accountant, at (202) 551 -3605 if you have questions regarding comments on the financial statements and related matters. Please contact Tom Jones at (202) 551 -3602 or Tim Buchmiller, Senior Attorney, at (202) 551 -3635 with any other questions. Sincerely, /s/ Tim Buchmiller for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Michael A. Hedge, Esq. K&L Gates LLP
2017-09-06 - CORRESP - enVVeno Medical Corp
CORRESP
1
filename1.htm
September
7, 2017
Via
EDGAR and Courier
Amanda
Ravitz
Assistant
Director
United
States Securities and Exchange Commission
Office
of Electronics and Machinery
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hancock
Jaffe Laboratories, Inc.
Draft
Registration Statement on Form S-1
Submitted
February 13, 2017
CIK
No. 0001661053
Dear
Ms. Ravitz:
Hancock
Jaffe Laboratories, Inc., a Delaware corporation (the “Company”), hereby provides the following information
in response to the comments received from the staff (the “Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) in its letter to the Company dated March 10, 2017 (the “Comment
Letter”). The Company’s responses are preceded by a reproduction of the Staff’s comment in italics as
set forth in the Comment Letter. In addition, the Company is concurrently filing an amended Registration Statement on Form S-1
(as amended, the “Registration Statement”).
General
1.
Please
indicate whether you will be a non-accelerated filer or a smaller reporting company.
Company
Response: The Company expects to be a smaller reporting company and has checked the appropriate box indicating as such
on the front cover page of the Registration Statement.
Prospectus
Cover Page
2.
In
your next amendment, please revise to name the lead underwriters or advise. Please note that we may defer further review of
the filing until the lead underwriters are named.
Company
Response: The Registration Statement reflects the inclusion of the Company’s underwriter, Network 1 Financial Securities,
Inc.
Amanda Ravitz
Page 2 of 10
3.
Please
revise your prospectus summary disclosure on pages 1-10 to avoid repetition of the detail that you include later in your document.
For example, we note that much of the disclosure in the summary appears on pages 64-74 in your document. Please also relocate
from your prospectus summary unnecessary detail that overwhelms the most important aspects of the offering and your business
and is more appropriate for a subsequent section of your prospectus.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised the prospectus summary disclosure
in the Registration Statement to avoid repetition and unnecessary details.
4.
Please
revise throughout your prospectus to indicate the basis for each of your product claims. If your claims are not based on clinical
studies, please revise to make that clear. If your claims are based on clinical studies, please tell us about any relationships
you had with those studies, including whether you commissioned such studies.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised the Registration Statement to
remove or disclose the basis for each of the Company’s product claims.
5.
With
a view toward balanced disclosure as to what your medical devices have shown in clinical studies, please tell us whether the
studies have revealed any material disadvantages. Also, if your studies have not generated statistically significant long-term
results, please balance your disclosure to make clear the significance of the absence of such results.
Company
Response: The Company respectfully notes the Staff’s comment and has revised its disclosures to indicate that human
trials have not been performed.
6.
Please
revise to explain your technology by avoiding the use of technical terms that may not be familiar to investors or explain
their use in context. For example, please explain such terms as proprietary estate of processes, cumulative patency and native
arteriovenous fistulae.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has added simplified explanations to the
Registration Statement with the aim of making disclosures more understandable. The Company has further removed references
to the term “propriety estate of processes” in the narrative.
Products
Under Development, page 2
7.
Please
clearly explain each step you must take to reach commercialization of your products to address the billion dollar markets
mentioned on pages 4-10. Also, disclose any material hurdles before you are able to address these markets. If such information
is appropriate for your prospectus summary, carefully consider the information that is the most significant, and briefly highlight
that information in the summary and include more detailed disclosure elsewhere in your document.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has included a commercialization section
to explain the steps anticipated to reach commercialization in the Registration Statement.
Amanda Ravitz
Page 3 of 10
Bioprosthetic
Coronary Artery Bypass Graft – CoreoGrafttm, page 3
8.
Please
clarify if the market for your CoreoGraft product is intended for the population of the patients in the study (patients without
sufficient available autologous grafts or patients with incomplete cardiac revascularization) or the larger CABG market referenced
in the third paragraph on page 7. If you intend to compete for the entire CABG market, please add in an appropriate location
in your prospectus how you intend to compete against the established market which uses grafts from the patient. Include appropriate
risk factor disclosure.
Company
Response: The Company respectfully acknowledges the Staff’s comment and its disclosure now reflects that its initial
target market would be “those patients without available autologous conduits.” The Company has further revised
disclosures in the “Industry Overview” section to reflect size of market numbers in response to the Staff’s
questions.
Intellectual
Property, page 8
9.
In
an appropriate location in your prospectus, please explain how the documentation process described in the second paragraph
of this section provides a competitive advantage and clarify why that process could not be infringed.
Company
Response: The Company respectfully acknowledges the Staff’s comment and its disclosure now reflects that,
although the patent has expired on the radiation process, the experience and know-how is documented well within the Company’s
quality program in the tissue preparation.
HJL
Venous Valve, The VenoValve, page 10
10.
It
appears from your disclosure that there is presently no reimbursement code for your intended product. In an appropriate location
in your prospectus, please indicate what steps you would have to complete in order to obtain such code and reimbursement rates
at the range per valve disclosed in this section. Include risk factor disclosure as appropriate.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised this disclosure to indicate
that it plans to obtain consultants to assist with the reimbursement code efforts once the first in human trial starts.
Implications
of Being an Emerging Growth Company, page 11
11.
Please
supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that
you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities
Act, whether or not they retain copies of the communications.
Company
Response: The Company has not furnished any written communications to potential investors in reliance on Section 5(d)
of the Securities Act of 1933, as amended. If and when the Company does provide such information to potential investors, the
Company will supplementally provide the Staff with copies of all such written communications.
Amanda Ravitz
Page 4 of 10
12.
Please
reconcile your disclosure on page 11 that you have “elected to avail [y]ourselves of this extended transition period”
with your disclosure on page 63 that you have elected not to avail yourself of the extended transition period.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised the Registration Statement to
reconcile the inconsistent statements. The Company will elect to avail itself of the extended transition period.
The
Offering, page 13
13.
Please
tell us why you have not included the (i) options to purchase 2,592,000 shares of common stock and (ii) the warrants issued
to Legend Securities, Inc. for 1,005,700 shares of Series A preferred stock, that are disclosed on page 92, in the first set
of bullet points on this page or revise your disclosure as appropriate. Please also tell us why you assume in the second set
of bullet points that the conversion of your preferred stock will be into an aggregate of 935,700 shares of common stock when
you assume in other locations of your prospectus, such as on page 88, that 1,005,700 shares of common stock would be issued
upon such conversion.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised the Registration Statement to
include the options and warrants referenced above, as well as clarify the number of shares the Company’s preferred stock
will convert into.
Legislative
or regulatory healthcare reform measures…, page 33
14.
We
note your reference to a 2.3% medical device tax. If true, please update your disclosure that this tax was suspended until
the end of 2017 and is uncertain to take effect after that.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised the Registration Statement to
reflect the discussion of the 2.3% medical device tax to indicate that it has been suspended until 2017 and its reinstatement
is uncertain.
Even
if we are able to commercialize any product candidates…, page 34
15.
Please
revise your disclosure so that it is clear why your references to “drug companies,” “pharmacoeconomic studies”
and “newly approved drugs” apply to your current or intended business.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosures in the Registration
Statement to more closely relate to the Company’s business.
Amanda Ravitz
Page 5 of 10
Industry
and Market Data, page 48
16.
Please
revise to include the information missing from this section.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised this section in the Registration
Statement to include missing information.
Use
of Proceeds, page 49
17.
Please
expand the disclosure in this section to discuss the amount of proceeds from this offering that you intend to devote to the
development of the products mentioned in the three bullet points on page 2. If any of those products may take priority over
the other products please make that clarification as well.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised this section in the Registration
Statement and is unable to state with certainty the amount of proceeds the Company intends to devote to each of the Company’s
product candidates.
Capitalization,
page 51
18.
Please
revise to classify the Series A preferred stock in the mezzanine, consistent with the presentation in your financial statements.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised this section in the Registration
Statement accordingly.
Results
of Operations, page 56
19.
Please
expand to explain the reasons for the gross loss on revenues from LeMaitre and clarify whether you expect to continue to realize
losses under the arrangement.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has expanded the disclosure in this section
of the Registration Statement to explain the reason for the Company’s losses under its arrangement with LeMaitre Vascular,
Inc. (“LMAT”), and its go forward expectations.
Overview,
page 64
20.
Based
on your disclosure on page 54 that the agreement with Cryolife, Inc. was terminated, please update your disclosure here regarding
that agreement and clarify how your currently derive your “ongoing revenue stream.”
Company
Response: The Company respectfully acknowledges the Staff’s comment and has expanded the disclosure in this section
in the Registration Statement to clarify that the Company derives its ongoing revenue stream from the sub-contract manufacture
of product for LMAT and royalties earned on LMAT sales, pursuant to the agreement with LMAT.
Amanda Ravitz
Page 6 of 10
Bioprosthetic
Coronary Artery Bypass Graft Device Need, page 66
21.
We
note your disclosure that “a significant cost of CABG procedures is associated with graft harvest and the extended recovery
and complications related to the harvest procedure.” We also note your disclosure that your device that substitutes
for graft harvest would be priced at between $6,000 and $7,000 per unit. To the extent known, please disclose how your product
cost compares to the current cost of patient graft harvest.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised its disclosure to explain that
less morbidity, shorter hospital stays, shorter surgery and fewer assistants because of this product use will
result in cost savings.
Bioprosthetic
Coronary Artery Bypass Graft — CoreoGrafttm, page 69
22.
Please
disclose the intended end-points of the human clinical trials that you plan to begin in 2017.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised its disclosure to indicate that
the endpoint of the trials will be based on patient survival and graft survival after one year and the clinical trial will
begin in 2018.
Management,
page 75
23.
Please
revise to ensure that you have disclosed the principal occupations and employment of Dr. Glickman and Messrs. Anderson, Doyle
and Alferenko during the past five years. Also, revise to include the information missing from the fourth paragraph on page
77.
Company
Response: The Company respectfully acknowledges the Staff’s comment and has revised its disclosure to indicate the
principal occupations and employment of its directors. The Company respectfully notes that Mr. Alferenko is no longer a member
of the Company’s board of directors and is no longer referenced in this section.
24.
Please
disclose the principal business of Biodyne Holding SA and whether Mr. Zhivilo may have any conflicts of interest with your
company as a result of his affiliation with Biodyne.
Company
Response: The Company has revised the Registration Statement to disclose that Biodyne Holding, S.A.’s (“Biodyne”),
principal line of business is to invest in medical device technology companies. While the Company does not believe that Mr.
Zhivilo currently has any conflict of interest with the Company as a result of his affiliation with Biodyne, the Company cannot
predict, ascertain or comment on any future conflict of interests that may arise out of Mr. Zhivilo’s association with
both the Company and Biodyne. Accordingly, the Company has not revised the Registration Statement to disclose any current
or future conflict of interest.
Amanda Ravitz
Page 7 of 10
Hancock
Jaffe Laboratories Aesthetics, Inc., page 89
25.
Please
2017-03-13 - UPLOAD - enVVeno Medical Corp
Mail Stop 3030 March 10, 2017 Via E -mail Benedict Broennimann, M.D. Chief Executive Officer Hancock Jaffe Laboratories, Inc. 70 Doppler Irvine, California 92618 Re: Hancock Jaffe Laboratories, Inc. Draft Registration Statement on Form S -1 Submitted February 13, 2017 CIK No. 0001661053 Dear Dr. Broennimann: We have reviewed your draft registration statement 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 and either submitting an amended draft registration statement or publicly filing your registration stateme nt on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and you r amended draft registration statement or filed registration statement, we may have additional comments. General 1. Please indicate whether you will be a non -accelerated filer or a smaller reporting company. Prospectus Cover Page 2. In your next amendment, please revise to name the lead underwriters or advise. Please note that we may defer further review of the filing until the lead underwriters are named. Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. March 10, 2017 Page 2 Prospectus Summary, page 1 3. Please revise your prospectus summary disclosure on pages 1 -10 to avoid repetition of the detail that you include later in your document. For example, we note that much of the disclosure in the summary appears on pages 64 -74 in your document. Please also relocate from your prospectus summary unnecessa ry detail that overwhelms the most important aspects of the offering and your business and is more appropriate for a subsequent section of your prospectus. 4. Please revise throughout your prospectus to indicate the basis for each of your product claims. If your claims are not based on clinical studies, please revise to make that clear. If your claims are based on clinical studies, please tell us about any relationships you had with those studies, including whether you commissioned such studies. 5. With a view toward balanced disclosure as to what your medical device s have shown in clinical studies, please tell us whether the studies have revealed any material disadvantages. Also, if your studies have not generated statistically significant long -term results, please balance your disclosure to make clear the significance of the absence of such results. 6. Please revise to explain your technology by avoiding the use of technical terms that may not be familiar to investors or explain their use in context. For example, please explain such terms as proprietary estate of processes, cumulative patency and native arteriovenous fistulae. Products Under Development, page 2 7. Please clearly explain each step you must take to reach commercialization of your products to address the billion dollar markets mentioned on pages 4 -10. Also, disclose any material hurdles before you are able to address these markets. If such information is appropriate for your prospectus summary, carefully consider the information that is the most significant, and briefly highlight that information in the summary and include more detailed disclosure elsewhere in your document. Bioprosthetic Coronary Artery Bypass Graft – CoreoGrafttm, page 3 8. Please clarify if the market for your CoreoGraft product is intended for the population of the patients in the study (patients without sufficient available autologous grafts or patients with incomplete cardiac revascularization) or the larger CABG market referenced in the third paragraph on page 7. If y ou intend to compete for the entire CABG market, please add in an appropriate location in your prospectus how you intend to compete against the established market which uses grafts from the patient. Include appropriate risk factor disclosure. Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. March 10, 2017 Page 3 Intellect ual Property, page 8 9. In an appropriate location in your prospectus, please explain how the documentation process described in the second paragraph of this section provides a competitive advantage and clarify why that process could not be infringed. HJL Venous Valve, The VenoValve, page 10 10. It appears from your disclosure that there is presently no reimbursement code for your intended product. In an appropriate location in your prospectus, please indicate what steps you would have to complete in order to obtain such code and reimbursement rates at the range per valve disclosed in this section. Include risk factor disclosure as appropriate. Implications of Being an Emerging Growth Company, page 11 11. Please supplementally provide us with copies of all wr itten communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the commun ications. 12. Please reconcile your disclosure on page 11 that you have “elected to avail [y]ourselves of this extended transition period” with your disclosure on page 63 that you have elected not to avail yourself of the extended transition period. The Offering, page 13 13. Please tell us why you have not included the (i) options to purchase 2,592,000 shares of common stock and (ii) the warrants issued to Legend Securities, Inc. for 1,005,700 shares of Series A preferred stock, that are disclosed on page 92 , in the first set of bullet points on this page or revise your disclosure as appropriate. Please also tell us why you assume in the second set of bullet points that the conversion of your preferred stock will be into an aggregate of 935,700 shares of com mon stock when you assume in other locations of your prospectus, such as on page 88, that 1,005,700 shares of common stock would be issued upon such conversion. Legislative or regulatory healthcare reform measures…, page 33 14. We note your reference to a 2.3% medical device tax. If true, please update your disclosure that this tax was suspended until the end of 2017 and is uncertain to take effect after that. Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. March 10, 2017 Page 4 Even if we are able to commercialize any product candidates…, page 34 15. Please revise your disclosure so that it is clear why your references to “drug companies,” “pharmacoeconomic studies” and “newly approved drugs” apply to your current or intended business. Industry and Market Data, page 48 16. Please revise to include the information missing from this section. Use of Proceeds, page 49 17. Please expand the disclosure in this section to discuss the amount of proceeds from this offering that you intend to devote to the development of the products mentioned in the three bullet points on page 2. If any of those products may take priority over the other products please make that clarification as well. Capitalization, page 51 18. Please revise to classify the Series A preferred stock in the mezzanine, consistent with the presentation in your financial statements. Results of Operations, page 56 19. Please expand to explain the reasons for the gross loss on revenues from LeMaitre and clarify whether you expect to continue to realize losses under the arrangement. Overview, page 64 20. Based on your disclosure on page 54 that the agreement with Cryolife, Inc. was terminated, please update your disclosure here regarding that agreem ent and clarify how your currently derive your “ongoing revenue stream.” Bioprosthetic Coronary Artery Bypass Graft Device Need, page 66 21. We note your disclosure that “a significant cost of CABG procedures is associated with graft harvest and the extende d recovery and complications related to the harvest procedure.” We also note your disclosure that your device that substitutes for graft harvest would be priced at between $6,000 and $7,000 per unit. To the extent known, please disclose how your product cost compares to the current cost of patient graft harvest. Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. March 10, 2017 Page 5 Bioprosthetic Coronary Artery Bypass Graft -- CoreoGrafttm, page 69 22. Please disclose the intended end -points of the human clinical trials that you plan to begin in 2017. Management, page 75 23. Please revise to ensure that you have disclosed the principal occupations and employment of Dr. Glickman and Messrs. Anderson, Doyle and Alferenko during the past five years. Also, revise to include the information missing from the fourth paragraph on pa ge 77. 24. Please disclose the principal business of Biodyne Holding SA and whether Mr. Zhivilo may have any conflicts of interest with your company as a result of his affiliation with Biodyne. Hancock Jaffe Laboratories Aesthetics, Inc., page 89 25. Please disclose the basis on which HJLA is a related person and the nature and current business activities of HJLA. Refer to Regulation S -K Item 404(a)(1) and (6). 26. Please reconcile your disclosure that you have an option to purchase shares of HJLA until January 15, 2017 with your disclosure on page 54 which appears to indicate that your option was extended until April 1, 2021. Please also clarify if this extension continues to allow you to purchase all 484,358 shares underlying the option and your current in tention with respect to exercising such option to the extent it is still available. Common Stock, page 91 27. Please reconcile your disclosure here that any director may be removed without cause by a majority vote with your disclosure on page 95 that indic ates that directors may only be removed for cause by two -thirds vote. Please also reconcile your disclosure that shareholders may act by written consent with your disclosure on page 95 that shareholders may not act by written consent. Where you can fin d more information, 101 28. Please tell us why you refer in the second paragraph of this section to the website of another company. Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. March 10, 2017 Page 6 Financial Statements, page F -1 Condensed Statements of Cash Flows, page F -5 29. Tell us why proceeds from advances from distributor are presented in operating activities in the statements of cash flows for the nine -month interim periods versus in financing activities in the statement of cash flows for the twelve -months ended December 31, 2015. Financial Statements for December 31, 2015 Note 5. Intangible Assets, page F -13 30. Tell us how you obtained the 30% interest in the related party and explain how the acquisition of the interest was accounted for, including the basis in GAAP fo r your accounting determination. Please also clarify the financial statement disclosure. Note 9. Temporary Equity and Stockholders’ Deficiency, page F -16 31. We note the reference to the independent third -party valuation to determine the estimated fair market value of the employee warrant. Please tell us the nature and extent of your reliance on the third party for that purpose. Also, please describe to us your consideration of Question 141.02 of the Compliance and Disclosure Interpretations on Securit ies Act Sections. 32. Please tell us the estimated initial public offering price range. To the extent that there is a significant difference between the estimated grant -date fair value of your common stock during the past twelve months and the estimated IPO price, please discuss for us each significant factor contributing to the difference. Undertakings 33. Please provide the undertakings required by Item 512(a)(6) of Regulation S -K. Exhibits 34. Please tell us why you have not provided disclosure regarding your relationship with the members of your medical advisory board in an appropriate location in your prospectus. In this regard, we note that you have filed as exhibits your medical advisory bo ard agreements with several doctors as exhibits 10.13 through 10.17. 35. We note that you indicate that confidential treatment has been requested as to portions of an exhibit. However, it does not appear that you indicated the specific exhibit that is the subject of the request. Please advise or revise. Dr. Benedict Broennimann Hancock Jaffe Laboratories, Inc. March 10, 2017 Page 7 36. Please note that the text of your exhibits should not be presented as a graphic or image file. See the last sentence of Regulation S -T Item 304(e). Please re -file your exhibits accordingly. You may c ontact Jeanne Bennett at 202 -551-3606 or Gary Todd, Senior Accountant, at (202) 551 -3605 if you have questions regarding comments on the financial statements and related matters. Please contact Tom Jones at (202) 551 -3602 or Tim Buchmiller, Senior Attorne y, at (202) 551 -3635 with any other questions. Sincerely, /s/ Tim Buchmiller for Amanda Ravitz Assistant Director Office of Electronics and Machinery