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Inspira Technologies OXY B.H.N. Ltd
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Inspira Technologies OXY B.H.N. Ltd
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Inspira Technologies OXY B.H.N. Ltd
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Inspira Technologies OXY B.H.N. Ltd
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1 company response(s)
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Inspira Technologies OXY B.H.N. Ltd
Response Received
8 company response(s)
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Company responded
2021-03-22
Inspira Technologies OXY B.H.N. Ltd
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2021-03-29
Inspira Technologies OXY B.H.N. Ltd
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2021-03-29
Inspira Technologies OXY B.H.N. Ltd
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2021-03-31
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2021-04-02
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2021-06-28
Inspira Technologies OXY B.H.N. Ltd
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2021-07-09
Inspira Technologies OXY B.H.N. Ltd
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2021-07-09
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Inspira Technologies OXY B.H.N. Ltd
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2021-06-24
Inspira Technologies OXY B.H.N. Ltd
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2021-03-30
Inspira Technologies OXY B.H.N. Ltd
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Inspira Technologies OXY B.H.N. Ltd
Response Received
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2021-03-24
Inspira Technologies OXY B.H.N. Ltd
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2021-03-29
Inspira Technologies OXY B.H.N. Ltd
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Inspira Technologies OXY B.H.N. Ltd
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2021-03-03
Inspira Technologies OXY B.H.N. Ltd
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2021-03-05
Inspira Technologies OXY B.H.N. Ltd
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2021-01-28
Inspira Technologies OXY B.H.N. Ltd
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-30 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2025-12-29 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | 333-292364 | Read Filing View |
| 2025-01-22 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2025-01-21 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | 333-284308 | Read Filing View |
| 2024-05-22 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2024-05-17 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | 333-279276 | Read Filing View |
| 2022-08-17 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2022-08-16 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-07-09 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-07-09 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-06-28 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-06-24 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-04-02 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-31 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-30 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-29 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-29 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-29 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-24 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-22 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-17 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-05 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-03 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-01-28 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-29 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | 333-292364 | Read Filing View |
| 2025-01-21 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | 333-284308 | Read Filing View |
| 2024-05-17 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | 333-279276 | Read Filing View |
| 2022-08-16 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-06-24 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-30 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-24 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-17 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-03 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-01-28 | SEC Comment Letter | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-30 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2025-01-22 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2024-05-22 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2022-08-17 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-07-09 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-07-09 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-06-28 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-04-02 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-31 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-29 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-29 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-29 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-22 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
| 2021-03-05 | Company Response | Inspira Technologies OXY B.H.N. Ltd | Israel | N/A | Read Filing View |
2025-12-30 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP 1 filename1.htm Inspira Technologies OXY B.H.N. Ltd. 2 Ha-Tidhar St. Ra'anana 4366504, Israel December 30, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: Inspira Technologies OXY B.H.N. Ltd. (CIK: 0001837493) Registration Statement No. 333-292364 on Form F-1 (the "Registration Statement") Ladies and Gentlemen: Inspira Technologies OXY B.H.N. Ltd. (the " Registrant ") hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended, so that it may become effective on January 2, 2026, at 9:00 a.m., Eastern Time, or as soon thereafter as is practicable. The Registrant respectfully requests that it be notified of such effectiveness by a telephone call to Ron Ben-Bassat, Esq. of Sullivan & Worcester LLP at (212) 660-5003 and that such effectiveness also be confirmed in writing. Very truly yours, Inspira Technologies OXY B.H.N. Ltd. By: /s/ Yafit Tehila Name: Yafit Tehila Title: Chief Financial Officer
2025-12-29 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd File: 333-292364
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> December 29, 2025 Dagi Ben-Noon Chief Executive Officer Inspira Technologies OXY B.H.N. Ltd 2 Ha-Tidhar Street Ra anana, 4366504 Israel Re: Inspira Technologies OXY B.H.N. Ltd Registration Statement on Form F-1 Filed December 22, 2025 File No. 333-292364 Dear Dagi Ben-Noon: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Robert Augustin at 202-551-8483 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Oded Har-Even </TEXT> </DOCUMENT>
2025-01-22 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
filename1.htm
Inspira Technologies OXY
B.H.N. Ltd.
2 Ha-Tidhar St.
Ra’anana, 4366504, Israel
January 22, 2025
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: Inspira Technologies OXY B.H.N. Ltd. (CIK: 0001837493)
Registration Statement on Form F-3 (File No. 333-
284308) (the “Registration Statement”)
Request for Acceleration of Effective Date
Dear Sir or Madam:
Pursuant to Rule 461
under the Securities Act of 1933, as amended (the “Securities Act”), Inspira Technologies OXY B.H.N. Ltd. (the “Registrant”)
hereby requests that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective
on January 23, 2025 at 4:00 p.m., Eastern Time, or as soon as practicable thereafter.
The Registrant understands
that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed
public offering of the securities specified in the Registration Statement.
The Registrant respectfully
requests that it be notified of such effectiveness by a telephone call to Ron Ben-Bassat, Esq. of Sullivan & Worcester LLP at (212)
660-5003 and that such effectiveness also be confirmed in writing.
Very truly yours,
Inspira
Technologies OXY B.H.N. LTD.
By:
/s/ Dagi Ben-Noon
Dagi Ben-Noon
Chief Executive Officer
2025-01-21 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd File: 333-284308
January 21, 2025
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.
Ra’anana, 4366504, Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Registration Statement on Form F-3
Filed January 16, 2025
File No. 333-284308
Dear Dagi Ben-Noon:
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:Ron Ben-Bassat, Esq.
2024-05-22 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
filename1.htm
Inspira Technologies OXY B.H.N. Ltd.
2 Ha-Tidhar St.
Ra’anana 4366504, Israel
May 22, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Inspira Technologies OXY B.H.N. Ltd. (CIK: 0001837493)
Registration Statement No. 333-279276 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Inspira Technologies OXY B.H.N.
Ltd. (the “Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective
on May 23, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant understands
that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange
Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement.
Very truly yours,
Inspira Technologies OXY B.H.N. Ltd.
By:
/s/
Yafit Tehila
Name:
Yafit Tehila
Title:
Chief Financial Officer
2024-05-17 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd File: 333-279276
United States securities and exchange commission logo
May 17, 2024
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.
Ra’anana, 4366504 Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Registration Statement on Form F-1
Filed May 9, 2024
File No. 333-279276
Dear Dagi Ben-Noon:
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: Ron Ben-Bassat
2022-08-17 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
filename1.htm
Inspira Technologies OXY B.H.N. Ltd.
2 Ha-Tidhar St.
Ra’anana 4366504, Israel
August 17, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Inspira Technologies OXY B.H.N. Ltd. (CIK: 0001837493)
Registration Statement No. 333-266748 on Form F-3 (the “Registration Statement”)
Ladies and Gentlemen:
Inspira Technologies OXY B.H.N.
Ltd. (the “Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective
on August 18, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant understands
that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange
Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement.
Very truly yours,
Inspira Technologies OXY B.H.N. Ltd.
By:
/s/ Dagi Ben-Noon
Name:
Dagi Ben-Noon
Title:
Chief Executive Officer
2022-08-16 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd
United States securities and exchange commission logo
August 16, 2022
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.
Ra’anana, 4366504 Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Registration Statement on Form F-3
Filed August 10, 2022
File No. 333-266748
Dear Mr. Ben-Noon:
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: Ron Ben-Bassat, Esq.
2021-07-09 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
filename1.htm
AEGIS CAPITAL CORP.
July 9, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Re:
Inspira Technologies Oxy B.H.N. Ltd.
Registration Statement on Form F-1
File No. 333-253920
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and
Regulations under the Securities Act of 1933, as amended (the “Securities Act”), Aegis Capital Corp., as representative of
the several underwriters, hereby joins Inspira Technologies Oxy B.H.N. Ltd. in requesting that the Securities and Exchange Commission
take appropriate action to accelerate the effective date of the above-referenced registration statement on Form F-1, as amended, so as
to become effective on Tuesday, July 13, 2021, at 4 PM Eastern Time, or as soon thereafter as practicable.
Pursuant to Rule 460 under the Securities Act,
please be advised that we will distribute as many electronic copies of the proposed form of preliminary prospectus as it appears to be
reasonable to secure adequate distribution.
Very truly yours,
Aegis Capital Corp.
/s/ Robert J. Eide
Robert J. Eide
Chief Executive Officer
810 Seventh Avenue, 18th floor, New
York, New York 10019 (212) 813-1010/Fax (212) 813-1047
Member FINRA, SIPC
2021-07-09 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
filename1.htm
Inspira Technologies Oxy B.H.N. Ltd.
2 Ha-Tidhar St.
Ra’anana, 4366504 Israel
July 9, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Inspira Technologies Oxy B.H.N. Ltd. (CIK: 0001837493)
Registration Statement No. 333-253920 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Inspira Technologies Oxy B.H.N.
Ltd. (the “Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective
on July 13, 2021 at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable. By separate letter, the underwriters of the issuance
of the securities being registered have joined in this request for acceleration.
The Registrant understands
that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation
of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed public offering
of the securities specified in the Registration Statement.
Very truly yours,
Inspira Technologies Oxy B.H.N. Ltd.
By:
/s/ Dagi Ben-Noon
Dagi Ben-Noon, Chief Executive Officer
2021-06-28 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
filename1.htm
INSPIRA
TECHNOLOGIES OXY B.H.N. LTD.
2
Ha-Tidhar Street
Ra’anana
436650 Israel
June
28, 2021
Via
EDGAR
Ibolya
Ignat
Kevin
Vaughn
Securities
and Exchange Commission (the “Commission”)
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
DC 20549
Re: Inspira
Technologies OXY B.H.N. Ltd.
Amendment
No. 5 to Registration Statement on Form F-1
Filed
June 8, 2021
File
No. 333-253920
Dear
Sirs:
The
purpose of this letter is to respond to your letter of June 24, 2021, regarding the abovementioned registration statement. For your convenience,
your original comments appear in bold text, followed by our response. On June 28, 2021, we filed amendment No. 6 to the registration
statement on Form F-1. Page references in our responses are to the amended Form F-1.
Amendment
No. 5 Registration Statement on Form F-1
Cover
Page
1. We
note that you have set a price range for the units of $5.00 to $8.00 per unit. Please revise
to provide a price range that does not exceed $2.00. Refer to Item 501(b)(3) of Regulation
S-K and Regulation S-K C&DI 134.04. Please also clearly disclose the exercise price of
the warrants to be included in the units.
Response:
In response to the Staff’s comments, we have revised our disclosure to provide a price range that does not exceed $2.00.
2. Please
revise your description of the compensation to be paid to Aegis Capital Corp. to include
a discussion of the representative's warrant discussed on page 119, or advise.
Response:
In response to the Staff’s comments, we have revised our description of the compensation to be paid to Aegis Capital Corp. to include
a discussion of the representative's warrant.
Our
Company, page 1
3. We
note your revised disclosure indicating that you "completed and tested" the first
prototype of your ART500 in March 2020. Please revise your disclosure to discuss how the
ART500 was tested, including whether the ART500 has been tested with any human subjects.
Also, clarify whether you plan to conduct human testing prior to commercialization.
Response:
In response to the Staff’s comments, we have revised our disclosure to describe how the ART500 was tested, to clarify that the
ART500 is yet to be tested with any human subjects, and to clarify that we do not currently expect to conduct human testing prior to
commercialization. Any future testing on humans will be subject to the request of the appropriate regulators, including the
FDA.
Our
Strategy, page 2
4. We
note your statements here and in Business that you will collect data to demonstrate theART500's
efficacy and reduced cost of treatment. Efficacy is a determination solely within the purview
of the FDA and foreign regulators. Please revise to remove any implication that the ART500
system will be found to be efficacious or to provide additional context so that it is clear
that this claim does not connote a current or future regulatory finding of efficacy.
Response:
In response to the Staff’s comments, we have revised our disclosure to remove any implication that the ART500 system will be found
to be efficacious within the purview of the FDA and foreign regulators.
Business
Redefining
Artificial Respiration, page 64
5. We
note your statements that patients can experience immediate relief in 1 minute by using your
system and that your system will enable patients to be treated while awake, mobile and breathing
spontaneously. Please revise your disclosure here to clarify, if true, that the ART500 has
yet to be tested in humans and, as such, these claims of a potential advantage in humans
are unproven and speculative.
Response:
In response to the Staff’s comments, we have revised our disclosure to clarify that the ART500 has yet to be tested in humans and,
as such, these claims of a potential advantage in humans are unproven and speculative.
Exhibits
6. Please
have counsel revise the Exhibit 5.2 opinion to opine as to the Underwriter Warrants.
Response:
In response to the Staff’s comments, we had our counsel revise the Exhibit 5.2 opinion to opine as to the Underwriter Warrants.
*
* *
2
If
you have any questions or require additional information, please call our attorney Ron Ben-Bassat at (332) 650-5003, of Sullivan &
Worcester LLP.
Sincerely,
INSPIRA
TECHNOLOGIES OXY B.H.N. LTD.
By:
/s/
Mr. Dagi Ben-Noon
Chief
Executive Officer
cc:
David
Huberman
Alan
Campbell
Ibolya
Ignat
Joe
McCann
Kevin
Vaughn
3
2021-06-24 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd
United States securities and exchange commission logo
June 24, 2021
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.,
Ra’anana, 436650
Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Amendment No. 5 to Registration Statement on Form F-1
Filed June 8, 2021
File No. 333-253920
Dear Mr. Ben-Noon:
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. 5 to Registration Statement on Form F-1
Cover Page
1.We note that you have set a price range for the units of $5.00 to $8.00 per unit. Please
revise to provide a price range that does not exceed $2.00. Refer to Item 501(b)(3) of
Regulation S-K and Regulation S-K C&DI 134.04. Please also clearly disclose the
exercise price of the warrants to be included in the units.
2.Please revise your description of the compensation to be paid to Aegis Capital Corp. to
include a discussion of the representative's warrant discussed on page 119, or advise.
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
June 24, 2021 Page 2
FirstName LastName
Dagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
June 24, 2021
Page 2
Prospectus Summary
Our Company, page 1
3.We note your revised disclosure indicating that you "completed and tested" the first
prototype of your ART500 in March 2020. Please revise your disclosure to discuss how
the ART500 was tested, including whether the ART500 has been tested with any human
subjects. Also, clarify whether you plan to conduct human testing prior to
commercialization.
Our Strategy, page 2
4.We note your statements here and in Business that you will collect data to demonstrate the
ART500's efficacy and reduced cost of treatment. Efficacy is a determination solely
within the purview of the FDA and foreign regulators. Please revise to remove any
implication that the ART500 system will be found to be efficacious or to provide
additional context so that it is clear that this claim does not connote a current or future
regulatory finding of efficacy.
Business
Redefining Artificial Respiration, page 64
5.We note your statements that patients can experience immediate relief in 1 minute by
using your system and that your system will enable patients to be treated while awake,
mobile and breathing spontaneously. Please revise your disclosure here to clarify, if true,
that the ART500 has yet to be tested in humans and, as such, these claims of a potential
advantage in humans are unproven and speculative.
Exhibits
6.Please have counsel revise the Exhibit 5.2 opinion to opine as to the Underwriter
Warrants.
You may contact Ibolya Ignat at 202-551-3636 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2021-04-02 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
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Inspira
Technologies Oxy B.H.N. Ltd.
2 Ha-Tidhar St.,
Ra’anana, 4366504 Israel
April 2, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Inspira Technologies Oxy B.H.N. Ltd. (CIK 0001837493)
Registration Statement No. 333-253920 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Inspira Technologies Oxy B.H.N.
Ltd. (the “Registrant”) hereby respectfully withdraws its request submitted on March 29, 2021, for acceleration of
the effectiveness of the above-referenced Registration Statement pursuant to 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 hereby formally withdraws its
request for acceleration of the effective date.
Very truly yours,
Inspira Technologies Oxy B.H.N. Ltd.
By:
/s/ Dagi Ben-Noon
Dagi Ben-Noon
Chief Executive Officer
2021-03-31 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
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INSPIRA
TECHNOLOGIES OXY B.H.N. LTD.
2 Ha-Tidhar Street
Ra’anana 436650 Israel
March 31, 2021
Via EDGAR
Alan Campbell
Joe McCann
Securities and Exchange Commission (the “Commission”)
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
Inspira Technologies OXY B.H.N. Ltd.
Amendment No. 3 to Registration Statement on Form
F-1
Filed March 29, 2021
File No. 333-253920
Dear Sirs:
The purpose of this letter is to respond to your letter of March 30,
2021, regarding the abovementioned registration statement. For your convenience, your original comments appear in bold text, followed
by our response. On March 31, 2021, we filed amendment No. 4 to the registration statement on Form F-1.
Amendment No. 3 to Registration Statement on Form F-1
Exhibits
1. We note that the Exhibit 5.1 legal opinion opines to the ordinary
shares being registered, including the ordinary shares underlying the Underwriter Warrants, but does not opine as to the Underwriter Warrants
themselves. Please revise the opinion to opine that the Underwriter Warrants will be binding obligations of the company in accordance
with Section II.B.1 of Staff Legal Bulletin No. 19.
RESPONSE: Our U.S. counsel has provided a 5.2 opinion that opines
as to the binding obligations of the Underwriter Warrants.
* * *
If you have any questions or require additional information, please
call our attorney David Huberman at (332) 208-9012, of Sullivan & Worcester LLP.
Sincerely,
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
By:
/s/ Mr. Dagi Ben-Noon
Chief Executive Officer
cc:
David Huberman
Alan Campbell
Ibolya Ignat
Joe McCann
Kevin Vaughn
2021-03-30 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd
United States securities and exchange commission logo
March 30, 2021
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.,
Ra’anana, 436650
Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Amendment No. 3 to Registration Statement on Form F-1
Filed March 29, 2021
File No. 333-253920
Dear Mr. Ben-Noon:
We have reviewed your registration statement 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 letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Amendment No. 3 to Registration Statement on Form F-1
Exhibits
1.We note that the Exhibit 5.1 legal opinion opines to the ordinary shares being registered,
including the ordinary shares underlying the Underwriter Warrants, but does not opine as
to the Underwriter Warrants themselves. Please revise the opinion to opine that the
Underwriter Warrants will be binding obligations of the company in accordance with
Section II.B.1.f of Staff Legal Bulletin No. 19.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
March 30, 2021 Page 2
FirstName LastName
Dagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
March 30, 2021
Page 2
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Ibolya Ignat at 202-551-3636 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2021-03-29 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
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INSPIRA
TECHNOLOGIES OXY B.H.N. LTD.
2 Ha-Tidhar Street
Ra’anana 436650 Israel
March 29, 2021
Via EDGAR
Alan Campbell
Joe McCann
Securities and Exchange Commission (the “Commission”)
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re: Inspira Technologies OXY B.H.N. Ltd.
Amendment No. 2 to Registration Statement
on Form F-1
Filed March 22, 2021
File No. 333-253920
Dear Sirs:
The purpose of this letter is to respond to your letter of March
24, 2021, regarding the abovementioned registration statement. For your convenience, your original comments appear in bold text,
followed by our response. On March 29, 2021, we filed amendment No. 3 to the registration statement on Form F-1. Page references
in our responses are to the amended Form F-1.
Amendment No. 2 to Registration Statement on Form
F-1
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and
Estimates
Stock-Based Compensation, page 60
1. Please address the following regarding your response
dated March 22, 2021 to prior comment number seven:
● Your response does not provide the fair values
assigned for the shares underlying your options granted on February 21, 2021 and March 16, 2021. Please revise this section
of your MD&A to detail the options granted during 2020 and 2021, including number of shares, exercise price, and
estimated fair value per share at grant date used to value the options.
RESPONSE: We have added a description of the Company’s
grants of share-based compensation in 2020 and 2021 to the MD&A under share-based compensation section on page 61.
2021 grants are based on an estimated fair value per share of
the current assumed public offering price, as we believe those grants were issued closer to the date of the proposed public offering.
We are still in the process of completing our valuation on the share-based compensation that was issued in 2021.
●You disclose on page F-43 that you signed
certain agreements would require you to issue 2,950,000 shares upon an initial public offering within certain agreed upon
dates. Please tell us the agreed upon dates before which the offering must take place under these agreements. To the extent
any portion of those shares is likely to be triggered by your current proposed offering, revise this section of your MD&A
to disclose that fact and quantify the expected charge to be recorded.
RESPONSE: The reference to 2,950,000 ordinary shares
stated in our financial statements refers to 236,000 ordinary shares following our reverse stock split. We have added a description
of these agreements to the MD&A section under shared-based compensation on page 61.
● You disclose in your Capitalization and
Dilution tables that you expect the issuance of the following: (i) 5,518,956 Ordinary Shares issued as bonus shares in
November 2020 for no consideration to our shareholders; (ii) 1,987,617 Ordinary Shares, issued pursuant to the Termination
Agreement upon the conversion of a convertible note in the amount of A$3,535,750 (approximately $2,374,004); (iii) 236,000
Ordinary Shares issued to a promoter as part of the Termination Agreement; (iv) 1,379,848 Ordinary Shares to be issued upon
the conversion of the SAFEs; (v) 725,861 Ordinary Shares to be issued upon the conversion of certain convertible
loan agreements; and (vi) 414,441 Ordinary Shares to be issued to financial advisors upon the consummation of this offering.
For each of these issuances that will result in an additional incremental expense upon its issuance, revise this section to
quantify the amount to be expensed and the nature of the charge.
RESPONSE: We have responded to each item separately below:
(i) with respect to the 5,518,956 Ordinary Shares issued
as bonus shares in November 2020 for no consideration to our shareholders, this issuance does not result in an additional
expense upon issuance but an internal equity classification.
(ii) with respect to
the 1,987,617 Ordinary Shares, issued pursuant to the Termination Agreement upon the conversion of a convertible note in the amount
of A$3,535,750 (approximately $2,374,004). this issuance does not result in an additional expense upon issuance but only a conversion
of a liability to equity.
(iii) with respect
to the 236,000 Ordinary Shares issued to a promoter as part of the Termination Agreement, this resulted in an additional expense
of $815,000.
(iv) with respect to
the 1,379,848 Ordinary Shares to be issued upon the conversion of the SAFEs, the conversion of the SAFEs does not result in additional
expenses but only a conversion of a convertible note to equity.
(v) with respect to
the 725,861 Ordinary Shares to be issued upon the conversion of certain convertible loan agreements, the conversion of the convertible
loan agreements results in an additional expense of $200,000 related to a promoters’ fees in cash.
(vi) with respect
to the 414,441 Ordinary Shares to be issued to financial advisors upon the consummation of this offering, the issuance of these
ordinary shares will result in an additional expense of $1,480,000 in promoter fees.
We have added these disclosures to the MD&A on page 61.
Set forth below is information in response to a comment on the
expected costs of treatment with our ART system that we received during our telephone conversation with the Staff on March 25,
2021, relating to slide “Health Economics Model – Driving Factors” of our Free Writing Prospectus filed with
the Commission on March 22, 2021.
We have revised our disclosure on page 69 of the amended Form F-1
to remove references to the expected costs of treatment with our ART system. Similarly, we have revised slide “Health Economics
Model – Driving Factors” of our amended Free Writing Prospectus filed with the Commission on March 29, 2021, to remove references
to the expected costs of treatment with our ART system. Considering our company’s stage of development and the fact that we do not
have an approved product yet, we believe that it is best to refrain from providing the exact numbers for the costs of treatment with our
ART system. However, we believe that such costs will be significantly lower than the costs of mechanical ventilation treatment due to
several reasons. Firstly, there is no need for weaning because treatment with our ART system does not require induced coma and intubation.
Secondly, absence of weaning reduces the number of days spent in an intensive care unit. Finally, our ART system is also designed for
treatment of patients in general medical unit settings, therefore, the costs are further expected to be reduced because the daily bed
costs in a general medical unit setting significantly lower the costs of staying in an intensive unit care.
* * *
If you have any questions or require additional information,
please call our attorney David Huberman at (332) 208-9012, of Sullivan & Worcester LLP.
Sincerely,
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
By:
/s/ Mr. Dagi Ben-Noon
Chief Executive Officer
cc:
David Huberman
Alan Campbell
Ibolya Ignat
Joe McCann
Kevin Vaughn
2021-03-29 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
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Inspira
Technologies Oxy B.H.N. Ltd.
2 Ha-Tidhar St.,
Ra’anana, 4366504 Israel
March 29, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Inspira Technologies Oxy B.H.N. Ltd. (CIK 0001837493)
Registration Statement No. 333-253920 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Inspira Technologies Oxy B.H.N.
Ltd. (the “Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective
on March 31, 2021 at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant understands that
the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed
public offering of the securities specified in the Registration Statement.
Very truly yours,
Inspira Technologies Oxy B.H.N. Ltd.
By:
/s/ Dagi Ben-Noon
Dagi Ben-Noon
Chief Executive Officer
2021-03-29 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
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March 29, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Inspira Technologies Oxy B.H.N. Ltd.
Registration Statement on Form F-1
File No. 333- 253920
Ladies and Gentlemen:
Pursuant to Rule 461 of the General
Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities
Act”), The Benchmark Company, LLC, as representative of the underwriters of the offering, hereby joins the request of Inspira Technologies
Oxy B.H.N. Ltd that the effective date of the above-referenced Registration Statement on Form F-1 be declared effective at 5:00 p.m. (Washington,
D.C. time) on March 31, 2021, or as soon as practicable thereafter.
In connection with this acceleration
request and 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 securities, as many copies, as well as “e-red”
copies of the 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.
Sincerely,
The Benchmark Company, LLC
By:
/s/ Michael
S. Jacobs
Name:
Title:
Michael
S. Jacobs
MD/Head
of Equity Capital Markets
2021-03-24 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd
United States securities and exchange commission logo
March 24, 2021
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.,
Ra’anana, 436650
Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Amendment No. 2 to Registration Statement on Form F-1
Filed March 22, 2021
File No. 333-253920
Dear Mr. Ben-Noon:
We have reviewed your registration statement 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 letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Amendment No. 2 to Registration Statement on Form F-1
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Estimates
Stock-Based Compensation, page 60
1.Please address the following regarding your response dated March 22, 2021 to prior
comment number seven:
•Your response does not provide the fair values assigned for the shares underlying
your options granted on February 21, 2021 and March 16, 2021. Please revise this
section of your MD&A to detail the options granted during 2020 and 2021, including
number of shares, exercise price, and estimated fair value value per share at grant
date used to value the options.
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
March 24, 2021 Page 2
FirstName LastName
Dagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
March 24, 2021
Page 2
•You disclose on page F-43 that you signed certain agreements would require you to
issue 2,950,000 shares upon an initial public offering within certain agreed upon
dates. Please tell us the agreed upon dates before which the offering must take place
under these agreements. To the extent any portion of those shares is likely to be
triggered by your current proposed offering, revise this section of your MD&A to
disclose that fact and quantify the expected charge to be recorded.
•You disclose in your Capitalization and Dilution tables that you expect the issuance
of the following: (i) 5,518,956 Ordinary Shares issued as bonus shares in November
2020 for no consideration to our shareholders; (ii) 1,987,617 Ordinary Shares, issued
pursuant to the Termination Agreement upon the conversion of a convertible note in
the amount of A$3,535,750 (approximately $2,374,004); (iii) 236,000 Ordinary
Shares issued to a promoter as part of the Termination Agreement; (iv) 1,379,848
Ordinary Shares to be issued upon the conversion of the SAFEs; (v) 725,861
Ordinary Shares to be issued upon the conversion of certain convertible loan
agreements; and (vi) 414,441 Ordinary Shares to be issued to financial advisors upon
the consummation of this offering. For each of these issuances that will result in an
additional incremental expense upon its issuance, revise this section to quantify the
amount to be expensed and the nature of the charge.
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 Ibolya Ignat at 202-551-3636 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2021-03-22 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
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INSPIRA
TECHNOLOGIES OXY B.H.N. LTD.
2 Ha-Tidhar Street
Ra’anana 436650 Israel
March 22, 2021
Via EDGAR
Alan Campbell
Joe McCann
Securities and Exchange Commission (the “Commission”)
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re: Inspira Technologies OXY B.H.N. Ltd.
Registration Statement on Form F-1
Filed March 5, 2021
File No. 333-253920
Dear Sirs:
The purpose of this letter is to respond to your letter of March
16, 2021, regarding the abovementioned registration statement. For your convenience, your original comments appear in bold text,
followed by our response. On March 22, 2021, we filed amendment No. 2 to the registration statement on Form F-1. Page references
in our responses are to the amended Form F-1.
Registration Statement on Form F-1
Beneficial Ownership of Principal Shareholders and Management,
page 103
1. Please revise the second paragraph, the table and footnotes
to clarify whether IML’s preoffering holdings include the 24,845,209 ordinary shares referenced on page 105. Also, please
confirm that (i) the table identifies all individual shareholders who will beneficially own 5% or more following IML’s distribution
of shares and (ii) the post-offering percentages reflect the effects of the distribution. Also revise to clarify whether the table
reflects the 3 million option shares referenced in footnote 2 and explain whether the option grant will be made prior to the offering.
Response: We have revised the second paragraph, the table
and the fourth footnote on page 101 to clarify that IML’s preoffering holdings in the beneficial ownership table include
2,223,617 Ordinary Shares and options to purchase 496,905 Ordinary shares that are exercisable within 60 days, at an exercise price
equal to the offering price per share, issued to IML in connection with the Termination Agreement. We confirm that no individual
shareholder will beneficially own 5% or more following the IML’s distribution of shares. Additionally, we have revised our
disclosure in the seventh footnote on page 101 to clarify that we granted Professor Benad Goldwasser options to purchase 240,000
Ordinary Shares at an exercise price of NIS 0.13 (approximately $0.04) per share in February 2021. The options vest on a quarterly
basis for three years and are not exercisable within 60 days after March 18, 2021.
Set forth below is information in response to comment number
7 contained in your letter to our company dated January 27, 2021 relating to our Draft Registration Statement on Form F-1 submitted
to the Commission on December 29, 2020. For the convenience of the Staff, we have recited the prior comment from the Staff in bold
type and have followed the comment with our response.
Management’s Discussion and Analysis of Financial
Condition and Results of Operations
Critical Accounting Policies and Estimates
Share-based compensation, page 60
7. Once you have an estimated offering price or range, please
explain to us how you determined the fair value of the common stock underlying your equity issuances, and the reasons for any differences
between the recent valuations of your common stock leading up to the initial public offering and the estimated offering price.
This information will help facilitate our review of your accounting for equity issuances including stock compensation and beneficial
conversion features. Please discuss with the staff how to submit your response.
Our discussion of our accounting for share-based
compensation is primarily contained within the sections of the Registration Statement entitled “Management’s Discussion
and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Estimates— Share-Based
Compensation” and appears on page 60 of the Registration Statement.
To assist the Staff in our evaluation
of stock compensation disclosures and certain other matters, we advise the Staff that we currently estimate a price range of $5.50
to $6.50 per share (the “Price Range”) for the initial public offering (the “IPO”) of our Ordinary Shares,
resulting in a midpoint of the Price Range of $6.00 per share.
This estimated Price Range is based
on a number of factors, including our history and future prospects and those of our industry in general, our financial and operating
information in recent periods, the market prices of securities of companies engaged in activities similar to ours, existing conditions
in the public capital markets and preliminary discussions with the underwriters regarding potential valuations of our company.
The actual price range to be included in a subsequent amendment to the above-referenced Registration Statement (which will comply
with the Staff’s interpretation regarding the parameters of a bona fide price range) has not yet been determined and remains
subject to adjustment based on factors outside of our control. However, we believe that the foregoing estimated price range will
not be subject to significant change. In addition, we will continue to update our disclosure for significant equity-related transactions,
if any, through the effective date of the Registration Statement.
Determination of the Fair Value
of Ordinary Shares Prior to the IPO
The table below is a list of the grants
of options to purchase our Ordinary Shares since the date of our incorporation in February 2018. In November 2020, we issued bonus
shares to all of our shareholders on a basis of 68.097927 bonus shares for each Ordinary Share outstanding (equivalent to a 69.097927-for-1
stock split) and made the customary adjustments to our outstanding options. Additionally, on March 18, 2021, our shareholders approved,
at an extraordinary general shareholders meeting, a one-for-12.5 consolidation (hereinafter refer to as a reverse stock split)
of our Ordinary Shares pursuant to which holders of our Ordinary Shares received one Ordinary Share for every 12.5 Ordinary
Shares held. Unless the context expressly dictates otherwise, all references to share and per share amounts referred to herein
reflect the reverse stock split and reflect issuance of bonus shares.
Grant date
Number of shares
underlying stock
options granted
Exercise price
per share (*)
Estimated
Fair Value
per Share at
Grant Date
April 21, 2020
1,407,514
NIS 0.13 – NIS 0.33
$ 2.00
December 20, 2020
110,557
NIS 0.13
$ 3.50
February 21, 2021(**)
104,000
NIS 0.13
-
March 16, 2021 (**)
240,000
NIS 0.13
-
The exercise prices
of our options granted to date have not reflected fair market value of our Ordinary Shares.
(*) On November 30, 2020, we requested the Israeli Tax Authority
to reduce the exercise price of all Ordinary Shares underlying our outstanding options to NIS 0.125 (approximately $0.04) per
share.
(**) The value per share of the option grant was not evaluated
by a third party.
2
There has been no public market for
our equity instruments to date. In order to measure our expenses in regards to the equity-based compensation has been determined
by our board of directors (the “Board”) as of the grant date, considering the most recently independent third-party
valuation of our Ordinary Shares and the Board’s assessment of additional objective and subjective factors that it believed
were relevant and which may have changed between the effective date of the most recent valuation and the date of the grant of our
Ordinary Shares.
Our valuation of our Ordinary Shares
as of April 21, 2020, which was performed by us with the assistant of independent third-party valuation specialist indicated
that the fair value of the Ordinary Shares on that date was $2 per share. In order to analyze fair value of our operation, we applied
a Discounted Cash Flow approach followed by Black-Scholes analysis based on estimated cost of capital of 21.5%.
Our most recent valuation of our Ordinary
Shares as of December 20, 2020, performed by us with the assistance of an independent third-party valuation specialist, indicated
that the fair value of the Ordinary Shares on that date was $3.5 per share. We arrived at the valuation using a back-solve method
(risk-neutral valuation model based on a Monte-Carlo simulation model, which is designed to model the company’s equity value
over time). The valuation also took into account funds raised pursuant to simple agreements for future equity (the “December
SAFEs”) in December 2020. The December SAFE financing was negotiated at arm’s length. The SAFEs have a conversion price
equal to the lower of: (i) our valuation cap of $35,000,000, or (ii) a discount of 30% from the per share price of the Ordinary
Shares in the event of an initial public offering, merger, acquisition or other liquidity event. If subscription amounts under
SAFEs are converted to Ordinary Shares in connection with an initial public offering, we will issue the SAFE investors warrants
to purchase the Ordinary Shares with an exercise price equal to the public offering price in such offering with 50% warrant coverage
with a three-year warrant.
In accordance with the terms and conditions
of the December SAFE, all the claims on our equity are path dependent. We chose to model these path dependencies using a risk-neutral
Monte-Carlo simulation model (the “Monte-Carlo model”). The Monte-Carlo model produces large quantities of possible
future paths for the fair value of our equity which are drawn from a defined distribution.
For each path, the occurrence of the defined events is mapped,
and the fair value of each claim is calculated in accordance with our terms and conditions and the drawn value of our equity. The
present value of each claim is then obtained as the mean future value, discounted at the risk-free rate. Once the fair value
of each claim has been obtained as a function of the fair value of our assets, applied a back-solve method, so that the modelled
fair value of the purchased instruments of the December SAFE transaction equals their observed purchase price.
During January to February 2021, we entered into certain equity
agreements and raised approximately $6 million from different investors who showed a high level of interest in our company and
our technology. These funds were raised through the SAFEs and convertible loan agreements (the “CLAs”). The SAFEs have
a conversion rate equal to the lower of (i) our valuation cap of $70,000,000, or (ii) a discount of 30% from the per share price
of the Ordinary Shares in the event of an initial public offering, merger, acquisition or other liquidity event. If subscription
amounts under SAFEs are converted to Ordinary Shares in connection with an initial public offering, we will issue the SAFE investors
warrants to purchase the Ordinary Shares with an exercise price equal to the public offering price in such offering with 50% warrant
coverage with a three-year warrant.
Comparison of Most Recent Valuation
and the Price Range
The Price Range was not derived using
a formal determination of fair value but was determined based on discussions between us and the underwriters. The price that investors
are willing to pay in the IPO, for which the Price Range is intended to serve as an estimate, may take into account other factors
that have not been expressly considered in the Company’s prior valuations but are significant to investors in their own subjective
and qualitative assessment of the Company, and thus may not be objectively determinable or quantifiable under the above-described
valuation models.
3
Among the factors that were considered
in setting the Price Range were the following major milestones since the last independent valuation which was completed in mid-December
2020:
1. We completed our preclinical study program and successfully achieved defined main targets, which allowed us to progress with
finalizing our bill of materials in order to start safety trials;
2. We have expanded our portfolio of patents to include an Intent to Use provisional patent filed during the abovementioned time
period;
3. In February 2021, we appointed Professor Benad Goldwasser, who has extensive medical and corporate experience, as our chairman
of the Board; and
4. We started collaboration with Chaim Sheba Medical Center at Tel HaShomer in
Ramat Gan, Israel, which is one of the top 10 hospitals in the world, to test our innovative blood oxygenation technology.
Moreover, a successful completion of
the IPO would strengthen our balance sheet, provide access to public equity, provide enhanced operational flexibility and strengthen
our ability to expedite all her strategic transactions including pre-commercialization of our product to support sales following
regulatory approvals.
In addition, the Price Range assumes
that the IPO has occurred and that a public market for our Ordinary Shares has been created, and, therefore, excludes any factor
for lack of liquidity of our Ordinary Shares.
In light of the above, we respectfully
submit that the difference between the per share fair values used as the basis for determining share-based compensation and the
Preliminary Price Range are reasonable and appropriate for the reasons described herein and in the Registration Statement.
* * *
If you have any questions or require additional information,
please call our attorney David Huberman at (332) 208-9012, of Sullivan & Worcester LLP.
Sincerely,
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
By:
/s/ Mr. Dagi Ben-Noon
Chief Executive Officer
cc:
David Huberman
Alan Campbell
Ibolya Ignat
Joe McCann
Kevin Vaughn
4
2021-03-17 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd
United States securities and exchange commission logo
March 16, 2021
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.,
Ra’anana, 436650
Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Registration Statement on Form F-1
Filed March 5, 2021
File No. 333-253920
Dear Mr. Ben-Noon:
We have reviewed your registration statement 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 letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Registration Statement on Form F-1
Beneficial Ownership of Principal Shareholders and Management, page 103
1.Please revise the second paragraph, the table and footnotes to clarify whether IML’s pre-
offering holdings include the 24,845,209 ordinary shares referenced on page 105. Also,
please confirm that (i) the table identifies all individual shareholders who will beneficially
own 5% or more following IML’s distribution of shares and (ii) the post-offering
percentages reflect the effects of the distribution. Also revise to clarify whether the table
reflects the 3 million option shares referenced in footnote 2 and explain whether the
option grant will be made prior to the offering.
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
March 16, 2021 Page 2
FirstName LastName
Dagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
March 16, 2021
Page 2
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 Ibolya Ignat at 202-551-3636 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2021-03-05 - CORRESP - Inspira Technologies OXY B.H.N. Ltd
CORRESP
1
filename1.htm
INSPIRA
TECHNOLOGIES OXY B.H.N. LTD.
2 Ha-Tidhar Street
Ra’anana 436650 Israel
March 5, 2021
Via EDGAR
Alan Campbell
Joe McCann
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re: Inspira Technologies OXY B.H.N. Ltd.
Amendment No. 1 to Draft Registration
Statement on Form F-1
Submitted February 17, 2021
CIK No. 0001837493
Dear Sirs:
The purpose of this letter is to respond to your letter of
March 3, 2021, regarding the abovementioned amended draft registration statement. For your convenience, your original comments
appear in bold text, followed by our response. On March 5, 2021, we publicly filed a registration statement on Form F-1. Page
references in our responses are to the Form F-1.
Amendment No. 1 to Draft Registration Statement on Form
F-1
Prospectus Summary
Our Company, page 1
1. We note your response to prior comment 1 and updated
disclosure and re-issue in part. Please revise the disclosure in the 4th paragraph on page 1 of your document regarding mortality
rates for patients on MV and the increase in mortality rates due to COVID-19 to be consistent with your revised disclosure on
pages 66 and 73.
Response: We have revised our disclosure on page 1
to be consistent with our disclosure on pages 66 and 73.
Currently Available Respiratory Support Solutions and
Their Limitations, page 68
2. We note your response to prior comment 9 and re-issue
in part. Please revise Table 2 to clearly disclose the products or systems that are being used in the left-most and center columns
of the comparison chart.
Response: We have revised Table 2 on page 68 to clarify
that Table 2 demonstrates competitive advantages of our ART system in comparison to mechanical ventilation (left-most column of
Table 2) and extracorporeal membrane oxygenation (center column of Table 2).
Management
Compensation, page 85
3. Please update your executive compensation information
in this section to include compensation for the year ended December 31, 2020. Refer to Item 6.B. of Form 20-F (incorporated into
Item 4 of Form F-1).
Response: We have revised our disclosure on page 85
to update our executive compensation information to include compensation for the year ended December 31, 2020.
Alan Campbell, Joe McCann
Division of Corporation Finance, Office of Healthcare &
Insurance
Securities and Exchange Commission
March 5, 2021
Page 2
Financial Statements of Inspira Technologies OXY B.H.N.
Ltd., page F-1
4. Please provide your updated financial statements in your
next amendment, or tell us how you determined that you comply with the updating requirements of Item 8 of Form 20-F.
Response: We have included in the Registration Statement
its audited financial statements as of December 31, 2019 and for the fiscal year ended December 31, 2019, and unaudited
condensed interim financial statements as of June 30, 2020, and for each of the six-month periods ended June 30, 2020 and 2019.
Item 8.A.4 of Form 20-F states that in the case of a company’s
initial public offering, the registration statement on Form F-1 must contain audited financial statements as of a date not older
than 12 months from the date of the offering unless a representation is made pursuant to Instruction 2 to Item 8.A.4.
We are making the representation pursuant to Instruction 2
to Item 8.A.4, as amended and in effect as of the date hereof, which provides that a company may instead comply with the 15-month
requirement “if the company is able to represent that it is not required to comply with the 12-month requirement in any
other jurisdiction outside the United States and that complying with the 12-month requirement is impracticable or involves undue
hardship.”
The representation letter has been filed as Exhibit 99.1 to
the Form F-1.
* * *
If you have any questions or require additional information,
please call our attorney David Huberman at (332) 208-9012, of Sullivan & Worcester LLP.
Sincerely,
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
By:
/s/ Mr. Dagi Ben-Noon
Chief Executive Officer
cc: David Huberman
Alan Campbell
Ibolya Ignat
Joe McCann
Kevin Vaughn
2021-03-03 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd
United States securities and exchange commission logo
March 3, 2021
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.,
Ra’anana, 436650
Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted February 17, 2021
CIK No. 0001837493
Dear Mr. Ben-Noon:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form F-1
Prospectus Summary
Our Company, page 1
1.We note your response to prior comment 1 and updated disclosure and re-issue in part.
Please revise the disclosure in the 4th paragraph on page 1 of your document regarding
mortality rates for patients on MV and the increase in mortality rates due to COVID-19 to
be consistent with your revised disclosure on pages 66 and 73.
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
March 3, 2021 Page 2
FirstName LastName
Dagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
March 3, 2021
Page 2
Currently Available Respiratory Support Solutions and Their Limitations, page 68
2.We note your response to prior comment 9 and re-issue in part. Please revise Table 2 to
clearly disclose the products or systems that are being used in the left-most and center
columns of the comparison chart.
Management
Compensation, page 85
3.Please update your executive compensation information in this section to include
compensation for the year ended December 31, 2020. Refer to Item 6.B. of Form 20-F
(incorporated into Item 4 of Form F-1).
Financial Statements of Inspira Technologies OXY B.H.N. Ltd., page F-1
4.Please provide your updated financial statements in your next amendment, or tell us how
you determined that you comply with the updating requirements of Item 8 of Form 20-F.
You may contact Ibolya Ignat at 202-551-3636 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2021-01-28 - UPLOAD - Inspira Technologies OXY B.H.N. Ltd
United States securities and exchange commission logo
January 27, 2021
Dagi Ben-Noon
Chief Executive Officer
Inspira Technologies OXY B.H.N. Ltd
2 Ha-Tidhar St.,
Ra’anana, 436650
Israel
Re:Inspira Technologies OXY B.H.N. Ltd
Draft Registration Statement on Form F-1
Submitted December 29, 2020
CIK No. 0001837493
Dear Mr. Ben-Noon:
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 F-1
Prospectus Summary
Our Company, page 1
1.We note your statement here, on page 66 and on page 73 that the mortality rate for
patients on MV was approximately 50% and that as a result of the COVID-19 pandemic,
the mortality rate for patients on MV is estimated to have increased to 70%. Please revise
your disclosure to provide the bases for these claims.
2.We note your statement on page 1 that your AXT system has the potential to reduce
patients' length of stay in ICU, rehabilitation period in the hospital and re-admission rate.
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
January 27, 2021 Page 2
FirstName LastNameDagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
January 27, 2021
Page 2
We further note your disclosures on page 2 highlighting ease of use and affordability.
Please balance these claims by explaining that your product candidate remains in
development, has not been tested in humans, and is not cleared or approved by FDA or
similar foreign regulatory bodies. To the extent that claims are supported by pre-clinical
data or some other basis, please clarify.
3.Please revise the final paragraph on page 1 to clarify whether/when you developed a
prototype of the AXT system. Given your disclosure concerning the development and
design work that remains to be completed, please tell us whether the graphic on page 71
depicts a prototype and whether that product was used in the pre-clinical studies cited on
pages 73-74.
Implications of Being an Emerging Growth Company, page 4
4.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.
Use of Proceeds, page 49
5.Please revise your disclosure to include the meaning of the phrase "product integration."
Please also revise to include (i) whether the net proceeds of the offering will be sufficient
to fund the purposes listed in this section and (ii) if a material amount of other funds is
necessary, the amount necessary and sources of such other funds.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Estimates
Share-based compensation , page 60
6.Please revise your disclosure to provide an analysis of the uncertainties associated with
the methods, assumptions and estimates underlying your accounting policy for share-
based compensation to provide greater insight into the quality and variability of
information regarding your financial condition and operating performance. In doing so,
please
•Clarify how the volatility rate used in your option pricing model was established. If
the 50% rate disclosed on page F-44 was based on similar companies’ stock
volatility, please tell us the companies that formed the basis for it, and explain what
makes such companies similar and comparable. Tell us about any limitations or
uncertainties over that comparability. Refer to paragraph 47(a) of IFRS 2, and
expand your disclosures within Note 2 of your financial statements as well, as
applicable.
•Clarify what you mean by the statement that the share price is determined according
to the last known closing price of your Ordinary Shares at the grant date. Clarify
your disclosure that states that your shares started trading on a stock exchange in
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
January 27, 2021 Page 3
FirstName LastNameDagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
January 27, 2021
Page 3
February 2011 given that you disclosed elsewhere in the document that you were
incorporated in Israel in 2018.
7.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances, and the
reasons for any differences between the recent valuations of your common stock leading
up to the initial public offering and the estimated offering price. This information will help
facilitate our review of your accounting for equity issuances including stock compensation
and beneficial conversion features. Please discuss with the staff how to submit your
response.
Business
Industry Overview, page 68
8.We note your statement that it is believed that millions of additional American adults
suffer from COPD but have not been diagnosed and are not being treated. Please revise
your disclosure to clarify the source for this statement as well as other similar statements,
including, without limitation, the following ones:
•More than half of patients are placed on mechanical ventilators within the first 24
hours of their admission to the ICU.
•Recent data states that 18-69 hours of complete diaphragmatic inactivity associated
with MV decreases cross-sectional areas of diaphragmatic fibers by more than 50%
and that MV may affect the regulation of the respiratory center.
•Total hospital stay costs for each patient admitted to ICU may reach approximately
$148,000.
Currently Available Respiratory Support Solutions and Their Limitations, page 68
9.We note your statements in Table 1 and Table 2 regarding the advantages of AXT
compared to mechanical ventilation. Given the current state of development of the AXT
system, please explain to us why it is appropriate for you to state that the AXT system has
competitive advantages over FDA-approved treatments. Please also revise your
disclosure to (i) clarify, if true, that any potential benefits of the AXT system as compared
to MV have yet to be observed in human trials and (ii) discuss any detriments related to
the AXT system. Please also revise Table 2 to clarify which products or treatments are
being compared to the AXT system.
Market Opportunity, page 73
10.Please provide us with the sources for your claims in the second paragraph on page 73
including:
•the prevalence of COPD is estimated to range between 7% and 19%;
•3 million people are estimated to be suffering from acute respiratory distress
syndrome annually;
•the U.S. Health Organization statement that the growing number of people suffering
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
January 27, 2021 Page 4
FirstName LastNameDagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
January 27, 2021
Page 4
from respiratory problems could trigger an "economic tsunami"; and
•the hospital admission and cost numbers discussed in the paragraph.
Pre-Clinical Data and Results, page 75
11.Please revise your description of Table 3 to clarify whether each row represents an
individual pig or refers to the results of a pre-clinical study.
Production and Manufacturing, page 76
12.Your disclosure on page 15 indicates that you are reliant on a limited number of suppliers,
including sole and single-source suppliers. Please revise your disclosure in this section to
discuss your manufacturing process in more detail, including any reliance on sole and
single-source suppliers and the availability of alternative sources of supply.
Research and Development and Governmental Grants, page 76
13.Your disclosure on page 38 and in the notes to your financial statements appears to
indicate that the total amount of the grants received are "linked to the U.S. dollar and
bearing interesting at an annual rate of LIBOR applicable to U.S. dollar deposits." Please
revise your disclosure in this section, and elsewhere in the document as appropriate, to
clarify whether the total amount of the grant that must be repaid through royalties will
increase until repayments begin. Please also file the grant agreement as an exhibit to your
registration statement or explain to us why it is not required to be filed.
Management
Executive Compensation, page 85
14.We note that you present executive compensation on an aggregate basis. However, your
disclosure on page 35 indicates that the Israeli Companies Law requires you to disclose
the annual compensation of your senior officers on an individual basis. Accordingly,
please present the executive compensation of your directors and senior officers on an
individual basis, or advise. Refer to Part I, Item 6.B. of Form 20-F (incorporated by
reference into Form F-1).
Related Party Transactions
Shareholders Loans, page 105
15.We note your discussions of the IPO deed among you, InSense Medical Pty Ltd. ("IML"),
the Founders and Newburyport Partners Pty Ltd. We note that at the time of this
agreement, based on disclosure elsewhere in the prospectus, you were named Insense
Medical Ltd. We further note that IML is listed as one of your 5% shareholders on page
104. Please revise your disclosure to clarify the nature of the relationship between you and
IML including whether (i) the references to IML on pages 105-106 are actually a
reference to you or to a subsidiary and (ii) both you and IML have the same shareholders.
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
January 27, 2021 Page 5
FirstName LastNameDagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
January 27, 2021
Page 5
16.Please revise to explain briefly why you did not conduct the initial public offering on the
Australian Securities Exchange.
Description of Share Capital, page 107
17.We note your statement that you issued 27,795,209 ordinary shares to "Inspira
Technologies Limited". Please revise your disclosure to indicate whether this is a
reference to the shares issued to IML and Newburyport discussed on page 106 or if your
disclosure on page 107 refers to a separate issuance of shares.
Audited Financial Statements for the Years Ended December 31, 2019
Statements of Comprehensive Loss, page F-6
18.You indicate that the number of shares in your statements of comprehensive loss have
been restated based on rights issuance according to subsequent event note. Please
include disclosure in Notes 9.B on page F-24 and 3.B on page F-42 in quantified detail
regarding the transaction you are adjusting for, to include your calculations of the
weighted average number of outstanding shares used in your loss per share calculation.
Please tell us why the basic EPS and diluted EPS is the same on the face of your
unaudited condensed interim statements of comprehensive income on page F-36, in light
of the fact that you have options outstanding at June 30, 2020, and revise your
presentation as appropriate. If the options are not included in the calculation of
diluted earnings per share because they are antidilutive, the amount and nature of the
instruments excluded should be disclosed in Note 3.B on page F-42 in accordance with
paragraph 70(c) of IAS 33. Please assure that this note presents information for the six
months periods ended on June 30, 2020 and 2019. Please ask your independent auditor to
revise its report on page F-3 to reference the retroactive adjustment to the number of
shares disclosed in your audited financial statements.
Notes to Financial Statements
Note 2 - Significant Accounting Policies
Share Based Compensation, page F-16
19.We note your disclosure explaining that where equity instruments are granted to persons
other than employees, the statement of comprehensive loss is charged with the fair value
of goods and services received. We also note your disclosure in the notes to the unaudited
condensed interim financial statements on page F-44 that states that "Since the service
providers are not employees, the fair value at the grant date was not determined in
accordance with services provided but rather in accordance with the options’ fair value."
Please revise to address the following:
•Reconcile the apparent inconsistencies between these disclosures.
•Explain to us how your accounting policy for recording instruments granted to non-
employees complies with IFRS 2. Specifically clarify the extent to which you were
able to reliably estimate the fair value of the goods or services received in your
FirstName LastNameDagi Ben-Noon
Comapany NameInspira Technologies OXY B.H.N. Ltd
January 27, 2021 Page 6
FirstName LastName
Dagi Ben-Noon
Inspira Technologies OXY B.H.N. Ltd
January 27, 2021
Page 6
response as well as in your revised disclosure.
•Please identify the method of settlement, e.g. cash or equity in your accounting policy
disclosure for all of your significant share based awards. Revise your disclosures on
page F-16 to clarify as applicable.
Note 3 - Critical accounting estimates and judgments, page F-20
20.Please revise to specify the convertible loan issuances you refer to in this note. Please
explain, with reference to authoritative literature, how you accounted for your convertible
loan issuances, including subsequent modifications, referencing the accounting principle
that was used and how it was applied. Revise your critical accounting estimates section in
the MD&A to provide an analysis of the uncertainties associated with the methods,
assumptions and estimates underlying your accounting policy for convertible loan
issuances to provide greater insight into the quality and variability of information
regarding your financial condition and operating performance, or direct us to existing
disclosures.
Unaudited Condensed Interim Financial Statements
Notes to the Unaudited Condensed Interim Financial Statements
Note 17 - Subsequent Events, page F-31
21.We note that on December 20, 2020 you entered into a simple agreement for future equity
(SAFE) and raised $2.6 million from this equity financing. Please explain, with reference
to authoritative literature, how you accounted for the elements of this transaction.
General
22.Please revise your prospectus to identify the underwriter(s) of the offering.
You may contact Ibolya Ignat at (202) 551-3636 or Kevin Vaughn at (202) 551-3494 if
you have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at (202) 551-4224 or Joe McCann at (202) 551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.