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Vivos Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-02-13
Vivos Therapeutics, Inc.
Summary
Generating summary...
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Vivos Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-01-23
Vivos Therapeutics, Inc.
Summary
Generating summary...
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Company responded
2025-01-29
Vivos Therapeutics, Inc.
Summary
Generating summary...
Vivos Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-08-02
Vivos Therapeutics, Inc.
Summary
Generating summary...
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Company responded
2024-08-05
Vivos Therapeutics, Inc.
Summary
Generating summary...
Vivos Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-04-12
Vivos Therapeutics, Inc.
Summary
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Company responded
2024-04-24
Vivos Therapeutics, Inc.
Summary
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Vivos Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-11-30
Vivos Therapeutics, Inc.
Summary
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Company responded
2023-11-30
Vivos Therapeutics, Inc.
Summary
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Vivos Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-02-03
Vivos Therapeutics, Inc.
Summary
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Company responded
2023-02-06
Vivos Therapeutics, Inc.
Summary
Generating summary...
Vivos Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-02-14
Vivos Therapeutics, Inc.
Summary
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Company responded
2022-02-14
Vivos Therapeutics, Inc.
Summary
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Vivos Therapeutics, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2021-05-04
Vivos Therapeutics, Inc.
Summary
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Company responded
2021-05-04
Vivos Therapeutics, Inc.
Summary
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Company responded
2021-05-04
Vivos Therapeutics, Inc.
Summary
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Company responded
2021-05-18
Vivos Therapeutics, Inc.
Summary
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Vivos Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-04-20
Vivos Therapeutics, Inc.
Summary
Generating summary...
Vivos Therapeutics, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2020-10-16
Vivos Therapeutics, Inc.
Summary
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Company responded
2020-10-26
Vivos Therapeutics, Inc.
Summary
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Company responded
2020-11-25
Vivos Therapeutics, Inc.
Summary
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Company responded
2020-12-09
Vivos Therapeutics, Inc.
Summary
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Company responded
2020-12-09
Vivos Therapeutics, Inc.
Summary
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Vivos Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-11-24
Vivos Therapeutics, Inc.
Summary
Generating summary...
Vivos Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2020-09-25
Vivos Therapeutics, Inc.
Summary
Generating summary...
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Company responded
2020-10-09
Vivos Therapeutics, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-08 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-02-13 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | 333-284834 | Read Filing View |
| 2025-01-29 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-01-23 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | 333-284399 | Read Filing View |
| 2024-08-05 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-08-02 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | 333-281090 | Read Filing View |
| 2024-04-24 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-04-12 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | 333-278564 | Read Filing View |
| 2023-11-30 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-11-30 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-02-03 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-02-14 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-02-14 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-18 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-04 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-04 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-04 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-04-20 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-09 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-09 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-25 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-24 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-26 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-16 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-09 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-25 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-02-13 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | 333-284834 | Read Filing View |
| 2025-01-23 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | 333-284399 | Read Filing View |
| 2024-08-02 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | 333-281090 | Read Filing View |
| 2024-04-12 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | 333-278564 | Read Filing View |
| 2023-11-30 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-02-03 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-02-14 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-04 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-04-20 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-24 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-16 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-25 | SEC Comment Letter | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-08 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-01-29 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-08-05 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-04-24 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-11-30 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-02-14 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-18 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-04 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-04 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-09 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-09 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-25 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-26 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-09 | Company Response | Vivos Therapeutics, Inc. | DE | N/A | Read Filing View |
2025-09-08 - CORRESP - Vivos Therapeutics, Inc.
CORRESP 1 filename1.htm Vivos Therapeutics, Inc. 7921 Southpark Plaza, Suite 210 Littleton, Colorado 80120 September 8, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Vivos Therapeutics Inc. Registration Statement on Form S-3 Filed February 11, 2025 File No. 333-284834 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, Vivos Therapeutics, Inc. hereby requests acceleration of effectiveness of the above referenced Registration Statement so that it will become effective at 4:30 p.m. ET on Wednesday, September 10, 2025, or as soon as thereafter practicable. Very truly yours, /s/ R. Kirk Huntsman R. Kirk Huntsman Chief Executive Officer cc: Ellenoff Grossman & Schole LLP
2025-02-13 - UPLOAD - Vivos Therapeutics, Inc. File: 333-284834
February 13, 2025
Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
7921 Southpark Plaza, Suite 210
Littleton, CO 80120
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-3
Filed February 11, 2025
File No. 333-284834
Dear Kirk Huntsman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Juan Grana at 202-551-6034 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Lawrence A. Rosenbloom, Esq.
2025-01-29 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
VIVOS
THERAPEUTICS, INC.
7921
Southpark Plaza, Suite 210
Littleton,
Colorado 80120
January
29, 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:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1, as amended
File
No. 333-284399
Attention:
Conlon Danberg
Dear
Mr. Danberg:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Vivos Therapeutics, 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, January 30, 2025, or as soon as
practicable thereafter.
Very
truly yours,
/s/
Bradford Amman
Bradford
Amman
Chief
Financial Officer
cc:
Ellenoff Grossman & Schole LLP
2025-01-23 - UPLOAD - Vivos Therapeutics, Inc. File: 333-284399
January 23, 2025
R. Kirk Huntsman
Chairman of the Board and Chief Executive Officer
Vivos Therapeutics, Inc.
7921 Southpark Plaza, Suite 210
Littleton, Colorado 80120
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-1
Filed January 22, 2025
File No. 333-284399
Dear R. Kirk Huntsman:
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:Lawrence A. Rosenbloom, Esq.
2024-08-05 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
Vivos
therapeautics, Inc.
7921
Southpark Plaza, Suite 210
Littleton,
Colorado 80120
August
5, 2024
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Margaret Sawicki
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-3
File
No. 333-281090
Filed
July 30, 2024
Dear
Ms. Sawicki:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Vivos Therapeutics, Inc. (the “Company”) hereby requests
acceleration of effectiveness of the above referenced Registration Statement so that it will become effective at 4:30 p.m. on Wednesday,
August 7, 2024 (the “Effective Time”). The Company hereby grants to Lawrence A. Rosenbloom, Esq. of Ellenoff Grossman
& Schole LLP the authority to communicate to the staff of the U.S. Securities and Exchange Commission one or more requests for any
potential deferral of the Effective Time.
Very
truly yours,
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chief
Executive Officer
2024-08-02 - UPLOAD - Vivos Therapeutics, Inc. File: 333-281090
August 2, 2024
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
7921 Southpark Plaza, Suite 210
Littleton, Colorado 80120
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-3
Filed July 30, 2024
File No. 333-281090
Dear R. Kirk Huntsman:
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 Sawicki at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Lawrence Rosenbloom, Esq.
2024-04-24 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
Vivos
therapeautics, Inc.
7921
Southpark Plaza, Suite 210
Littleton,
Colorado 80120
April
24, 2024
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Jane Park
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1
File
No. 333-278564
Filed
April 9, 2024, as amended
Dear
Mr. Richie:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Vivos Therapeutics, Inc. (the “Company”) hereby requests
acceleration of effectiveness of the above referenced Registration Statement, as amended, so that it will become effective at 4:30 p.m.
on Friday, April 26, 2024 (the “Effective Time”). The Company hereby grants to Lawrence A. Rosenbloom, Esq. of Ellenoff
Grossman & Schole LLP the authority to communicate to the staff of the U.S. Securities and Exchange Commission one or more requests
for any potential deferral of the Effective Time.
Very
truly yours,
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chief
Executive Officer
2024-04-12 - UPLOAD - Vivos Therapeutics, Inc. File: 333-278564
United States securities and exchange commission logo
April 12, 2024
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
7921 Southpark Plaza, Suite 210
Littleton, Colorado 80120
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-1
Filed April 9, 2024
File No. 333-278564
Dear R. Kirk Huntsman:
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: Lawrence Rosenbloom, Esq.
2023-11-30 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
Vivos
therapeautics, Inc.
7921
Southpark Plaza, Suite 210
Littleton,
Colorado 80120
November
30, 2023
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Ben Richie
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1
File
No. 333-275726
Filed
November 22, 2023
Dear
Mr. Richie:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Vivos Therapeutics, Inc. (the “Company”) hereby requests
acceleration of effectiveness of the above referenced Registration Statement so that it will become effective at 4:00 p.m. Eastern
Time on Friday, December 1, 2023 (the “Effective Time”). The Company hereby grants to Lawrence A. Rosenbloom,
Esq. of Ellenoff Grossman & Schole LLP the authority to communicate to the staff of the U.S. Securities and Exchange Commission one
or more requests for any potential deferral of the Effective Time.
Very
truly yours,
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chief
Executive Officer
2023-11-30 - UPLOAD - Vivos Therapeutics, Inc.
United States securities and exchange commission logo
November 30, 2023
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
7921 Southpark Plaza, Suite 210
Littleton, CO 80120
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-1
Filed November 22, 2023
File No. 333-275726
Dear R. Kirk Huntsman:
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 Benjamin Richie at 202-551-7857 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Lawrence A. Rosenbloom, Esq.
2023-02-06 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
Vivos
therapeautics, Inc.
7921
Southpark Plaza, Suite 210
Littleton,
Colorado 80120
February
6, 2023
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Margaret Schwartz
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1
File
No. 333-269453
Filed
January 30, 2023
Dear
Ms. Schwartz:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Vivos Therapeutics, Inc. (the “Company”) hereby
requests acceleration of effectiveness of the above referenced Registration Statement so that it will become effective at 4:30 p.m.
on Wednesday, February 8, 2023 (the “Effective Time”). The Company hereby grants to Lawrence A. Rosenbloom, Esq.
of Ellenoff Grossman & Schole LLP the authority to communicate to the staff of the U.S. Securities and Exchange Commission one
or more requests for any potential deferral of the Effective Time.
Very
truly yours,
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chief
Executive Officer
2023-02-03 - UPLOAD - Vivos Therapeutics, Inc.
United States securities and exchange commission logo
February 3, 2023
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
7921 Southpark Plaza, Suite 210
Littleton, Colorado 80120
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-269453
Filed January 30, 2023
Dear R. Kirk Huntsman:
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 Industrial Applications and
Services
cc: Lawrence A. Rosenblooml, Esq.
2022-02-14 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
Vivos
Therapeutics, Inc.
9137
S. Ridgeline Boulevard, Suite 135
Highlands
Ranch, Colorado 80129
February
14, 2022
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Vivos Therapeutics Inc.
Registration Statement
on Form S-3
Filed February 7, 2022
File No. 333-262554
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as
amended, Vivos Therapeutics, Inc. hereby requests acceleration of effectiveness of the above referenced Registration Statement so that
it will become effective at 4:30 p.m. ET on Monday, February 14, 2022, or as soon as thereafter practicable.
Very truly yours,
/s/
R. Kirk Huntsman
R. Kirk Huntsman
Chief
Executive Officer
cc:
Ellenoff Grossman & Schole LLP
2022-02-14 - UPLOAD - Vivos Therapeutics, Inc.
United States securities and exchange commission logo
February 14, 2022
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
9137 S. Ridgeline Boulevard, Suite 135
Highlands Ranch, CO 80129
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-3
Filed February 7, 2022
File No. 333-262554
Dear Mr. Huntsman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lawrence A. Rosenbloom, Esq.
2021-05-18 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
Vivos
Therapeutics, Inc.
9137
South Ridgeline Boulevard, Suite 135
Highlands
Ranch, Colorado 80129
May
18, 2021
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Alan Campbell
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1
(File
No. 333-255553)
Dear
Mr. Campbell:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Vivos Therapeutics, Inc. (the “Company”) hereby requests
acceleration of effectiveness of the above referenced Registration Statement so that it will become effective at 5:00 p.m. on Wednesday,
May 19, 2021 (the “Effective Time”). The Company hereby grants to Lawrence A. Rosenbloom, Esq. the authority to communicate
to the staff of the U.S. Securities and Exchange Commission one or more requests for any potential deferral of the Effective Time.
Very
truly yours,
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chief
Executive Officer
2021-05-04 - UPLOAD - Vivos Therapeutics, Inc.
United States securities and exchange commission logo
May 4, 2021
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
9137 Ridgeline Boulevard, Suite 135
Highlands Ranch, Colorado 80129
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-1
Filed April 27, 2021
File No. 333-255553
Dear Mr. Huntsman:
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
2021-05-04 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
May
4, 2021
VIA
EDGAR
Mr.
Alan Campbell
Securities
and Exchange Commission
Division of Corporation Finance
100
F Street NE
Washington,
DC 20549
Re: Vivos
Therapeutics, Inc.
Registration Statement on Form S-1 (File No. 333-255736)
Dear
Mr. Campbell:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), we hereby join in the
request of Vivos Therapeutics, Inc. (the “Registrant”), for the acceleration of the effective date of the Registrant’s
Registration Statement on Form S-1 (File No. 333-255736) (as amended, the “Registration Statement”), relating to the
public offering of shares of the common stock of the Registrant, so that the Registration Statement may be declared effective
on May 5, 2021 at 5:30 P.M. Eastern Time, or as soon thereafter as practicable. The undersigned, as the representative of the
underwriters, confirms that we are aware of our obligations under the Securities Act.
Pursuant
to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably
anticipated to be invited 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 confirms that it has complied with and will continue to comply with, and it has been informed or will be informed
by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange
Act of 1934, as amended, in connection with the above-referenced issue.
Very
truly yours,
Roth
Capital Partners, LLC
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
cc:
Lawrence A. Rosenbloom (Ellenoff
Grossman & Schole LLP)
Christopher
J. Barry (Dorsey & Whitney LLP)
2021-05-04 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
Vivos
Therapeutics, Inc.
9137
South Ridgeline Boulevard, Suite 135
Highlands
Ranch, Colorado 80129
May
4, 2021
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Alan Campbell
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1
(File
No. 333-255736)
Dear
Mr. Campbell:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Vivos Therapeutics, Inc. (the “Company”) hereby requests
acceleration of effectiveness of the above referenced Registration Statement so that it will become effective at 5:30 p.m. on
Wednesday, May 5, 2021 (the “Effective Time”). The Company hereby grants to each of Lawrence A. Rosenbloom,
Esq. and Matthew Bernstein, Esq. the authority to communicate to the staff of the U.S. Securities and Exchange Commission one
or more requests for any potential deferral of the Effective Time.
Very
truly yours,
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chief
Executive Officer
2021-04-20 - UPLOAD - Vivos Therapeutics, Inc.
United States securities and exchange commission logo
April 20, 2021
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
9137 Ridgeline Boulevard, Suite 135
Highlands Ranch, CO 80129
Re:Vivos Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted April 13, 2021
CIK No. 0001716166
Dear Mr. Huntsman:
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 Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lawrence A. Rosenbloom, Esq.
2020-12-09 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
Vivos
Therapeutics, Inc.
9137
Ridgeline Boulevard, Suite 135
Highlands
Ranch, Colorado 80129
December
9, 2020
VIA
EDGAR
U.S.
SECURITIES AND EXCHANGE COMMISSION
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Alan Campbell
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1
(File
No. 333-249412)
Dear
Mr. Campbell:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Vivos Therapeutics, Inc. (the “Company”) hereby requests
acceleration of effectiveness of the above referenced Registration Statement so that it will become effective at 5:00 p.m. on
Thursday, December 10, 2020 (the “Effective Time”). The Company hereby grants to each of Lawrence A. Rosenbloom,
Esq. and Matthew Bernstein, Esq. the authority to communicate to the staff of the U.S. Securities and Exchange Commission one
or more requests for any potential deferral of the Effective Time.
Very
truly yours,
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chief
Executive Officer
2020-12-09 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
December
9, 2020
VIA
EDGAR
Mr.
Alan Campbell
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street NE
Washington,
DC 20549
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1 (File No. 333-249412)
Dear
Mr. Campbell:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), we hereby join in the
request of Vivos Therapeutics, Inc. (the “Registrant”), for the acceleration of the effective date of the Registrant’s
Registration Statement on Form S-1 (File No. 333-249412) (as amended, the “Registration Statement”), relating to the
public offering of shares of the common stock of the Registrant, so that the Registration Statement may be declared effective
on December 10, 2020 at 5:00 P.M. Eastern Time, or as soon thereafter as practicable. The undersigned, as the representative of
the underwriters, confirms that we are aware of our obligations under the Securities Act.
Pursuant
to Rule 460 under the Securities Act, we wish to advise you that we have distributed approximately 1,200 copies of the preliminary
prospectuses dated November 25, 2020, through the date hereof.
We,
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 the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended.
Very
truly yours,
Roth
Capital Partners, LLC
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
cc:
Lawrence
A. Rosenbloom (Ellenoff Grossman & Schole LLP)
Christopher
J. Barry (Dorsey & Whitney LLP)
2020-11-25 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
1345
Avenue of the Americas, 11th floor
New
York, New York 10105
Telephone:
(212) 370-1300
Facsimile:
(212) 370-7889
www.egsllp.com
VIA
EDGAR
November
25, 2020
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
D.C. 20549
Attn:
Alan Campbell
Re:
Vivos
Therapeutics, Inc.
Amendment
No. 2 to Registration Statement on Form S-1
Filed
November 19, 2020
File
No. 333-249412
Dear
Mr. Campbell:
On
behalf of our client, Vivos Therapeutics, Inc. (the “Company”), we hereby transmit our response to the comment
letter received by the Company from the staff (the “Staff”) of the U.S. Securities and Exchange Commission
(the “Commission”), on November 24, 2020, regarding Amendment No. 2 to the Company’s Registration Statement
on Form S-1 (File No. 333-249412) submitted to the Commission on November 19, 2020. Disclosure changes discussed below have been
made in the Company’s Amendment No. 3 to the Registration Statement (“Amendment No. 3”), which is being
filed with the Commission contemporaneously with the submission of this letter.
For
the Staff’s convenience, we have repeated below the Staff’s comments in bold, and have followed each comment with
the Company’s response.
Amendment
No. 2 to Registration Statement on Form S-1
Prospectus
Summary
Overview,
page 2
1.
We
note your new disclosure on page 2 indicating that the Vivos System led to lower mean AHI scores by up to 69.6% in patients
with varying degrees of OSA as well as the five studies cited in your table and your statement that you are not aware of any
additional published studies that evaluate the impact of the Vivos System on AHI scores in patients with OSA.
We
further note your statement on page 1 indicating that there are 17 peer-reviewed studies that examined the impact of your
“technologies and protocols” on the AHI scores of patients with varying degrees of OSA, that patient AHI scores
were reduced from a low of 38% to a high of 98.6% and that you are not aware of any additional published studies evaluating
the impact of the Vivos System on AHI scores in patients with OSA.
Please
revise your disclosure to reconcile your presentation of these studies including whether “published studies” and
“peer-reviewed studies” are terms for the same type of study and, if not, the difference between a “published
study” and a “peer-reviewed” study.
Mr.
Alan Campbell
November
25, 2020
Page
2 of 3
In
response to the Staff’s comment, the Company has revised its disclosure to refer to the same 17 “published, peer-reviewed
studies” when discussing reductions of AHI scores. Please see pages 1 and 66 of Amendment No. 3 and the removal of related
disclosure on page 2. The Staff is advised that there is no difference between a “published study” and a “peer-reviewed”
study in this case, as all referenced studies are both published and peer-reviewed, and the disclosure now reflects this.
Executive
Compensation
October
2020 Derivative Demand and Settlement, page 107
2.
We
note your statement that the Demanding Stockholders asked your board of directors to review and investigate certain actions
taken by your board of directors and senior management, including actions related to the IPO, the rejection of a transaction
proposal, management of corporate assets and matters related to stock sales. We further note your statement at the beginning
of the following paragraph which refers to “assertions” made by the Demanding Stockholders. Please revise your
disclosure to clarify what those “assertions” were.
In
response to the Staff’s comment, the Company has revised its disclosure to describe the assertions in the Demanding Stockholders’
demand. Please see page 102 of Amendment No. 3.
Please
also file the Settlement and Release Agreement as an exhibit to your registration statement or explain to us why it is not required
to be filed.
As
discussed with the Staff, the Company respectfully submits that the Settlement and Release Agreement need not be filed as an exhibit
in that: (i) the material terms of the Settlement and Release Agreement are fully disclosed in the Registration Statement, and
such terms impose no obligations on the Company that are material to Company or its business on a going forward basis, (ii) the
Settlement and Release Agreement is not a contract with directors of the Company named in the Registration Statement as contemplated
by Item 601(b)(10)(ii)(A) of Regulation S-K and (iii) the Settlement and Release Agreement is not a contract upon which the Company’s
business is substantially dependent as contemplated by Item 601(b)(10)(ii)(B) of Regulation S-K.
Finally,
we note that your cross-references elsewhere in the document state that this disclosure appears in the Business section. Please
correct those cross-references or move this disclosure to Business.
In response to the
Staff’s comment, the Company has elected to move this disclosure and associated disclosures to the “Management”
section beginning at page 101 of Amendment No. 3.
*
* *
Mr.
Alan Campbell
November
25, 2020
Page
3 of 3
We
thank the Staff for its review of the foregoing. If you have further comments, please feel free to contact me at lrosenbloom@egsllp.com
or by telephone at (212) 370-1300.
Sincerely,
/s/
Lawrence A. Rosenbloom
Lawrence
A. Rosenbloom
2020-11-24 - UPLOAD - Vivos Therapeutics, Inc.
United States securities and exchange commission logo
November 24, 2020
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
9137 Ridgeline Boulevard, Suite 135
Highlands Ranch, Colorado 80129
Re:Vivos Therapeutics, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed November 19, 2020
File No. 333-249412
Dear Mr. Huntsman:
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.
Amendment No. 2 to Registration Statement on Form S-1
Prospectus Summary
Overview, page 2
1.We note your new disclosure on page 2 indicating that the Vivos System led to lower
mean AHI scores by up to 69.6% in patients with varying degrees of OSA as well as the
five studies cited in your table and your statement that you are not aware of any additional
published studies that evaluate the impact of the Vivos System on AHI scores in patients
with OSA.
We further note your statement on page 1 indicating that there are 17 peer-reviewed
studies that examined the impact of your "technologies and protocols" on the AHI scores
of patients with varying degrees of OSA, that patient AHI scores were reduced from a low
FirstName LastNameR. Kirk Huntsman
Comapany NameVivos Therapeutics, Inc.
November 24, 2020 Page 2
FirstName LastName
R. Kirk Huntsman
Vivos Therapeutics, Inc.
November 24, 2020
Page 2
of 38% to a high of 98.6% and that you are not aware of any additional published studies
evaluating the impact of the Vivos System on AHI scores in patients with OSA.
Please revise your disclosure to reconcile your presentation of these studies including
whether "published studies" and "peer-reviewed studies" are terms for the same type of
study and, if not, the difference between a "published study" and a "peer-reviewed" study.
Executive Compensation
October 2020 Derivative Demand and Settlement, page 107
2.We note your statement that the Demanding Stockholders asked your board of directors to
review and investigate certain actions taken by your board of directors and senior
management, including actions related to the IPO, the rejection of a transaction proposal,
management of corporate assets and matters related to stock sales. We further note your
statement at the beginning of the following paragraph which refers to "assertions" made
by the Demanding Stockholders. Please revise your disclosure to clarify what those
"assertions" were.
Please also file the Settlement and Release Agreement as an exhibit to your registration
statement or explain to us why it is not required to be filed.
Finally, we note that your cross-references elsewhere in the document state that this
disclosure appears in the Business section. Please correct those cross-references or move
this disclosure to Business.
You may contact Michael Fay at 202-551-3812 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lawrence A. Rosenbloom, Esq.
2020-10-26 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
1345
AVENUE OF THE AMERICAS, 11TH FLOOR
NEW
YORK, NEW YORK 10105
TELEPHONE:
(212) 370-1300
FACSIMILE:
(212) 370-7889
www.egsllp.com
VIA
EDGAR
October
26, 2020
U.S.
Securities & Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
D.C. 20549
Attn:
Alan Campbell
Re:
Vivos
Therapeutics, Inc.
Registration
Statement on Form S-1
Filed
October 9, 2020
File
No. 333-249412
Dear
Mr. Campbell:
On
behalf of our client, Vivos Therapeutics, Inc. (the “Company”), we hereby transmit the Company’s response
to the comment letter received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission
(the “Commission”), dated October 16, 2020, regarding the Company’s Registration Statement on Form S-1
filed on October 9, 2020 (the “Registration Statement”). For the Staff’s convenience, we have repeated
below the Staff’s comments in bold, and have followed each comment with the Company’s response.
Responses
to the Staff’s comments as well as other updates to the Registration Statement have been incorporated into an Amendment
No. 1 to Registration Statement (“Amendment No. 1”), which is being filed with the Commission concurrently
with the submission of this response letter.
Registration
Statement on Form S-1 filed October 9, 2020
Overview,
page 2
1.
We note your revised disclosure in response to prior comment 1. Your revised disclosure references published studies but only includes disclosure regarding one study that involved your founder. Please tell us how you determined to highlight only one of these published studies and how you ensured that your disclosure is a balanced presentation of the results of all published studies, including any studies that may have shown different results. As requested by the prior comment, please also revise to clarify whether the Vivos System was actually used in any studies that you disclose.
In
response to the Staff’s comment, the Company has added disclosure on pages 1 and 66 of Amendment No. 1 to
reflect the results of the 17 published studies of which the Company is aware relating to the technology incorporated in
the Vivos System (noting that these studies included the Company’s founder as an author). The Staff is advised that
these are the only studies of which the Company is aware that studied the Company’s technology with respect to AHI scores,
and the Company has updated its disclosure to reflect this. The new disclosure also includes the range of AHI score
reduction across all such studies, as well as the mean reduction in AHI score across all such studies. The Company believes
the disclosure as revised is therefore balanced and supports the accompanying statements in Amendment No. 1.
U.S.
Securities and Exchange Commission
Attn:
Alan Campbell
October
26, 2020
Page
2 of 2
2.
We note your response to prior comment 2 and your updated disclosure regarding potential off-label use of the DNA appliance. Please update your disclosure here and in the Business section to briefly discuss the potential consequences of off-label use of the DNA appliance. Please also consider whether the risk factor beginning at the bottom of page 34 should be updated to discuss potential off-label use of the DNA appliance.
In
response to the Staff’s comment, the Company has added disclosure on pages 3 and 68 of Amendment No. 1 as well as a cross
reference to the referenced risk factor to address the potential consequences to the Company off-label use of the DNA device.
The Company has also added clarifying disclosure to the referenced risk factor to address the Staff’s comment.
Our
Market Opportunity, page 3
3.
We note your response to prior comment 3. Please update your “Market Opportunity” sections here and in Business to clarify, if true, that a majority of patients diagnosed with SDB or OSA are initially referred to pulmonologists, who do not currently prescribe the Vivos System, as opposed to dentists.
The
Company has added disclosure to pages 3 and 69 of Amendment No. 1 to address the Staff’s comment and the means in which
the Company is going about seeking to capture its addressable market.
Our
Competitive Strengths, page 6
4.
We note your response to prior comment 4. Your response indicates that OSA has been linked to other complications which may be fatal. However, your response does not appear to support the statement that a treatment for OSA or SDB is potentially life-saving in and of itself. Please revise your disclosure as appropriate. You may state, if true, that you believe that the Vivos System can improve quality of life and may reduce the risk of SDB/OSA patients with such complications.
The
Company has revised its disclosures on pages 4, 8 and 75 of Amendment No. 1 in response to the Staff’s comment.
Capitalization,
page 50
5.
On a pro forma as adjusted basis you are presenting no authorized, issued or outstanding Series A Convertible Redeemable Preferred Stock. Please revise the pro forma as adjusted bullet point preceding the table to describe the circumstances supporting this presentation as directly attributable to the transaction and factually supportable.
The
Company has revised its narrative bullet point disclosure in the Capitalization table to reflect that full redemption of the Series
A Preferred Stock as described in “Use of Proceeds.”
We
thank the Staff for its review of the foregoing and the Registration Statement. If you have further comments, please feel free
to contact the undersigned at lrosenbloom@egsllp.com or by telephone at (212) 370-1300.
Sincerely,
/s/
Lawrence A. Rosenbloom
Lawrence
A. Rosenbloom, Esq.
2020-10-16 - UPLOAD - Vivos Therapeutics, Inc.
United States securities and exchange commission logo
October 16, 2020
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
9137 Ridgeline Boulevard, Suite 135
Highlands Ranch, Colorado 80129
Re:Vivos Therapeutics, Inc.
Registration Statement on Form S-1
Filed October 9, 2020
File No. 333-249412
Dear Mr. Huntsman:
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 registration statement and the information
you provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1 filed October 9, 2020
Overview, page 2
1.We note your revised disclosure in response to prior comment 1. Your revised disclosure
references published studies but only includes disclosure regarding one study that
involved your founder. Please tell us how you determined to highlight only one of these
published studies and how you ensured that your disclosure is a balanced presentation of
the results of all published studies, including any studies that may have shown different
results. As requested by the prior comment, please also revise to clarify whether the
Vivos System was actually used in any studies that you disclose.
2.We note your response to prior comment 2 and your updated disclosure regarding
potential off-label use of the DNA appliance. Please update your disclosure here and in
the Business section to briefly discuss the potential consequences of off-label use of the
DNA appliance. Please also consider whether the risk factor beginning at the bottom of
FirstName LastNameR. Kirk Huntsman
Comapany NameVivos Therapeutics, Inc.
October 16, 2020 Page 2
FirstName LastName
R. Kirk Huntsman
Vivos Therapeutics, Inc.
October 16, 2020
Page 2
page 34 should be updated to discuss potential off-label use of the DNA appliance.
Our Market Opportunity, page 3
3.We note your response to prior comment 3. Please update your "Market Opportunity"
sections here and in Business to clarify, if true, that a majority of patients diagnosed with
SDB or OSA are initially referred to pulmonologists, who do not currently prescribe the
Vivos System, as opposed to dentists.
Our Competitive Strengths, page 6
4.We note your response to prior comment 4. Your response indicates that OSA has been
linked to other complications which may be fatal. However, your response does not
appear to support the statement that a treatment for OSA or SDB is potentially life-saving
in and of itself. Please revise your disclosure as appropriate. You may state, if true, that
you believe that the Vivos System can improve quality of life and may reduce the risk of
SDB/OSA patients with such complications.
Capitalization, page 50
5.On a pro forma as adjusted basis you are presenting no authorized, issued or outstanding
Series A Convertible Redeemable Preferred Stock. Please revise the pro forma as adjusted
bullet point preceding the table to describe the circumstances supporting this presentation
as directly attributable to the transaction and factually supportable.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Michael Fay at 202-551-3812 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lawrence A. Rosenbloom, Esq.
2020-10-09 - CORRESP - Vivos Therapeutics, Inc.
CORRESP
1
filename1.htm
1345
AVENUE OF THE AMERICAS, 11TH FLOOR
NEW
YORK, NEW YORK 10105
TELEPHONE:
(212) 370-1300
FACSIMILE:
(212) 370-7889
www.egsllp.com
VIA
EDGAR
October
9, 2020
U.S.
Securities & Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
D.C. 20549
Attn:
Alan Campbell
Re:
Vivos
Therapeutics, Inc.
Draft
Registration Statement on Form S-1
Submitted
August 31, 2020
CIK
0001716166
Dear
Mr. Campbell:
On
behalf of our client, Vivos Therapeutics, Inc. (the “Company”), we hereby transmit the Company’s response
to the comment letter received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission
(the “Commission”), dated September 25, 2020, regarding the Company’s Draft Registration Statement on
Form S-1 filed on August 31, 2020 (the “Registration Statement”). For the Staff’s convenience, we have
repeated below the Staff’s comments in bold, and have followed each comment with the Company’s response.
Responses
to the Staff’s comments as well as other updates to the Registration Statement have been incorporated into revised Registration
Statement, which is being filed “live” with the with the Commission concurrently with the submission of this response
letter.
Draft
Registration Statement on Form S-1 submitted August 31, 2020
Overview,
page 2
1.
We
note your disclosure that published studies have shown that the patented and proprietary technologies and protocols incorporated
into the Vivos System alter the size, shape and position of the tissues that comprise the human airway, leading to lower mean
AHI scores by up to 65.9% in patients with mild-to-moderate OSA. In an appropriate location in your prospectus, please revise
your disclosure to indicate the studies where this effect was observed and clarify whether the Vivos System was actually used
in those studies.
The
Company acknowledges the Staff’s comment and advises the Staff that the Vivos System was used in the study cited. The Company
has revised the Registration Statement in accordance with the Staff’s comment on pages 2, 67 and 72.
U.S.
Securities and Exchange Commission
Attn:
Alan Campbell
October 9, 2020
Page 2 of 4
2.
We
note your disclosure that your DNA appliance is currently registered with the FDA for palatal expansion, that the DNA appliance
also currently has a pending 510(k) application to include additional indications of use for the treatment of mild-to-moderate
OSA, snoring, and SDB in adults, and that your dentists regularly prescribe the DNA appliance to treat conditions associated
with OSA. Please update your disclosure to clarify if the OSA uses or prescriptions would be considered off-label at this
time.
The
Company acknowledges the Staff’s comment and advises the Staff that all dentists prescribing the DNA appliance are instructed
by the Company of the fact that the DNA appliance is a Class I FDA registered oral appliance and are instructed by the Company
on its approved indications of use. Dentists are then free to diagnose, treat and prescribe the appropriate oral appliance therapy
as they see fit (including uses which might be “off label”), based on their patient’s individual diagnosis,
as a licensed clinician within his or her scope of practice. The Company has revised its disclosure on pages 3 and 68 of the Registration
Statement to clarify this.
Our
Market Opportunity, page 3
3.
Your
disclosure on page 21 indicates that a majority of patients being treated today for SDB or OSA are initially referred to pulmonologists,
who may not currently use your system. Please update your estimates of market size here and on page 69 to address that pulmonologists
do not currently recommend your system.
The
Company acknowledges the Staff’s comment and advises the Staff that the Company does not believe its addressable market
is dependent on pulmonologists recommending its devices. While a pulmonologist or other licensed medical professional must provide
a diagnosis of SDB or OSA in order for a dentist to then prescribe the Company’s devices, the Company’s business model
is driven by its focus on the dentists, not the other medical professionals that a patient might encounter in connection with
the patient’s treatment. As such, the Company respectfully submits that no modification is estimate of market size is necessary.
Our
Competitive Strengths, page 6
4.
We
note your disclosure here and in other locations in your prospectus that your system can be a “potentially life-saving
treatment.” Please provide us with support for this disclosure or revise as appropriate.
The
Company acknowledges the Staff’s comment and advises the Staff that according to multiple sources (including the Mayo Clinic),
obstructive sleep apnea causes breathing to repeatedly stop and start during sleep. This can trigger a series of complications,
including cardiovascular problems (hypertension and heart disease), which can be fatal. As such, given the serious, potentially
life-threatening, adverse medical effects of SDB and OSA, the Company believes is it appropriate to say that its treatment is
“potentially life-saving”.
Emerging
Growth Company under the JOBS Act, page 13
5.
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.
The
Staff is advised that no such written communications have been utilized by the Company.
U.S.
Securities and Exchange Commission
Attn:
Alan Campbell
October 9, 2020
Page 3 of 4
Liquidity
and Capital Resources, page 56
6.
We
note that you have entered into a loan under the Paycheck Protection Program, pursuant to which the company borrowed $1,265,067.
Please revise your risk factor section to disclose any associated risks with the loan, including, but not limited to the risk
that all or parts of the loan may not be forgiven. In addition, please disclose the following: (i) the material terms of the
loan; (ii) how you intend to use the loan proceeds; and (iii) whether you expect the loan to be forgiven.
The
Company acknowledges the Staff’s comment and advises the Staff that a new risk factor has been added to the Registration
Statement on page 36. The Company has also revised the Registration Statement disclosure in the liquidity section on page 57 to
include the material terms of the loan, use of proceeds and the basis for the Company’s anticipation that a significant
portion of the loan will be forgiven.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies Involving Management Estimates
and Assumptions Stock-Based Compensation, page 63
7.
Please
revise your filing to explain in more detail the methodologies and underlying assumptions that your board of directors utilized
in determining the fair value of your common stock underlying your equity instruments granted during the periods presented.
Additionally, progressively bridge to the current estimated IPO price the fair value per share determinations used for any
option grant since June 30, 2020. We will delay our assessment of your response pending inclusion of the estimated IPO price
in the filing. Please discuss with the staff how to submit your response.
The
Company acknowledges the Staff’s comment and advises the Staff that stock options are granted at fair value at the time
of grant. Since November 2018, all stock options have been granted with an exercise price of $2.50 per share on a pre-reverse
split basis ($7.50 on post-split basis). Exercise price of such stock options has been consistent with the price offered to private
investors in the Company’s private placements during this period, which the Company’s board of directors or
its compensation committee deemed to be the fair value of the underlying common stock. The Company has added disclosure on page
63 of the Registration Statement to clarify this. With respect to the assumptions regarding the accounting for share-based payments,
the Company believes these are addressed in the Registration Statement.
Current
Treatments for OSA and their Limitations, page 69
8.
We
note your disclosure that CPAP “was generally” the “gold standard” of care for treatment of Obstructive
Sleep Apnea by the medical community, and your disclosure on page 69 that CPAP therapy is the mainstay of therapy for adults
with OSA. If you believe CPAP is no longer the “gold standard” for treatment, please revise to clarify the basis
of your belief. We also note your statement that 29 to 83 percent of patients are nonadherent to CPAP therapy, although 60%
or more find they are intolerant, refuse treatment or fail to continue their CPAP treatment. Please update your disclosure
to clarify whether the 60% figure is a subset of the initial 29 to 83 percent range or is taken from a different study.
The
Company acknowledges the Staff’s comment and has revised the Registration Statement to remove any references to “gold
standard” or “mainstay” and changed those references to “first-line standard of care”, which the
Company believes to be the case. The Company has further removed the reference to “60% or more find they are intolerant”
to further clarify the referenced disclosure.
U.S.
Securities and Exchange Commission
Attn:
Alan Campbell
October 9, 2020
Page 4 of 4
Our
Solution for OSA – the Vivos System, page 70
9.
We
note your statement that you believe that the Vivos system is the first truly effective solution for mild-to-moderate OSA,
snoring and SDB. Please explain to us why your solution is “truly effective” as compared to CPAP, MADs and surgical
options.
The
Company acknowledges the Staff’s comment and has revised the Registration Statement to change “the first truly effective”
to “an effective.”
Choice
of Forum, page 115
10.
We
note that your forum selection provision identifies a state court located within the State of Delaware (or, if the Court of
Chancery does not have jurisdiction, the federal district court for the District of Delaware) as the exclusive forum for certain
litigation, including any “derivative action.” Please disclose whether this provision applies to actions arising
under the Exchange Act. If so, please also state that there is uncertainty as to whether a court would enforce such provision.
If this provision does not apply to actions arising under the Exchange Act, please also ensure that the exclusive forum provision
in the governing documents states this clearly, or tell us how you will inform investors in future filings that the provision
does not apply to any actions arising under the Exchange Act.
The
Company has revised the Registration Statement in accordance with the Staff’s comment on pages 44 and 115 to include disclosure
regarding the uncertainty referenced by the Staff. The Company has further filed as an exhibit to the Registration Statement
a recently adopted amended and restated bylaws for the Company that addresses this issue.
We
thank the Staff for its review of the foregoing and the Registration Statement. If you have further comments, please feel free
to contact the undersigned at lrosenbloom@egsllp.com or by telephone at (212) 370-1300.
Sincerely,
/s/
Lawrence A. Rosenbloom
Lawrence
A. Rosenbloom, Esq
2020-09-25 - UPLOAD - Vivos Therapeutics, Inc.
United States securities and exchange commission logo
September 25, 2020
R. Kirk Huntsman
Chief Executive Officer
Vivos Therapeutics, Inc.
9137 Ridgeline Boulevard, Suite 135
Highlands Ranch, Colorado 80129
Re:Vivos Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted August 31, 2020
CIK 0001716166
Dear Mr. Huntsman:
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 statement 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 your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 submitted August 31, 2020
Overview, page 2
1.We note your disclosure that published studies have shown that the patented and
proprietary technologies and protocols incorporated into the Vivos System alter the size,
shape and position of the tissues that comprise the human airway, leading to lower mean
AHI scores by up to 65.9% in patients with mild-to-moderate OSA. In an appropriate
location in your prospectus, please revise your disclosure to indicate the studies where this
effect was observed and clarify whether the Vivos System was actually used in those
studies.
2.We note your disclosure that your DNA appliance is currently registered with the FDA for
palatal expansion, that the DNA appliance also currently has a pending 510(k) application
FirstName LastNameR. Kirk Huntsman
Comapany NameVivos Therapeutics, Inc.
September 25, 2020 Page 2
FirstName LastNameR. Kirk Huntsman
Vivos Therapeutics, Inc.
September 25, 2020
Page 2
to include additional indications of use for the treatment of mild-to-moderate OSA,
snoring, and SDB in adults, and that your dentists regularly prescribe the DNA appliance
to treat conditions associated with OSA. Please update your disclosure to clarify if the
OSA uses or prescriptions would be considered off-label at this time.
Our Market Opportunity, page 3
3.Your disclosure on page 21 indicates that a majority of patients being treated today for
SDB or OSA are initially referred to pulmonologists, who may not currently use your
system. Please update your estimates of market size here and on page 69 to address that
pulmonologists do not currently recommend your system.
Our Competitive Strengths, page 6
4.We note your disclosure here and in other locations in your prospectus that your system
can be a "potentially life-saving treatment." Please provide us with support for this
disclosure or revise as appropriate.
Emerging Growth Company under the JOBS Act, page 13
5.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.
Liquidity and Capital Resources, page 56
6.We note that you have entered into a loan under the Paycheck Protection Program,
pursuant to which the company borrowed $1,265,067. Please revise your risk factor
section to disclose any associated risks with the loan, including, but not limited to the risk
that all or parts of the loan may not be forgiven. In addition, please disclose the following:
(i) the material terms of the loan; (ii) how you intend to use the loan proceeds; and (iii)
whether you expect the loan to be forgiven.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies Involving Management Estimates and Assumptions
Stock-Based Compensation , page 63
7.Please revise your filing to explain in more detail the methodologies and underlying
assumptions that your board of directors utilized in determining the fair value of your
common stock underlying your equity instruments granted during the periods presented.
Additionally, progressively bridge to the current estimated IPO price the fair value per
share determinations used for any option grant since June 30, 2020. We will delay our
assessment of your response pending inclusion of the estimated IPO price in the
filing. Please discuss with the staff how to submit your response.
FirstName LastNameR. Kirk Huntsman
Comapany NameVivos Therapeutics, Inc.
September 25, 2020 Page 3
FirstName LastName
R. Kirk Huntsman
Vivos Therapeutics, Inc.
September 25, 2020
Page 3
Current Treatments for OSA and their Limitations, page 69
8.We note your disclosure that CPAP "was generally" the "gold standard" of care for
treatment of Obstructive Sleep Apnea by the medical community, and your disclosure on
page 69 that CPAP therapy is the mainstay of therapy for adults with OSA. If you believe
CPAP is no longer the "gold standard" for treatment, please revise to clarify the basis of
your belief. We also note your statement that 29 to 83 percent of patients are nonadherent
to CPAP therapy, although 60% or more find they are intolerant, refuse treatment or fail to
continue their CPAP treatment. Please update your disclosure to clarify whether the 60%
figure is a subset of the initial 29 to 83 percent range or is taken from a different study.
Our Solution for OSA – the Vivos System, page 70
9.We note your statement that you believe that the Vivos system is the first truly effective
solution for mild-to-moderate OSA, snoring and SDB. Please explain to us why your
solution is "truly effective" as compared to CPAP, MADs and surgical options.
Choice of Forum, page 115
10.We note that your forum selection provision identifies a state court located within the
State of Delaware (or, if the Court of Chancery does not have jurisdiction, the federal
district court for the District of Delaware) as the exclusive forum for certain litigation,
including any "derivative action." Please disclose whether this provision applies to actions
arising under the Exchange Act. If so, please also state that there is uncertainty as to
whether a court would enforce such provision. If this provision does not apply to actions
arising under the Exchange Act, please also ensure that the exclusive forum provision in
the governing documents states this clearly, or tell us how you will inform investors in
future filings that the provision does not apply to any actions arising under the Exchange
Act.
You may contact Michael Fay at 202-551-3812 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lawrence A. Rosenbloom, Esq.