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.
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,
FirstName LastNameDagi Ben-Noon
Division of
Corporation Finance
Comapany NameInspira Technologies OXY B.H.N. Ltd
Office of Life
Sciences
June 24, 2021 Page 2
cc: David Huberman, Esq.
FirstName LastName