SEC Comment Letter 0000000000-22-012700 to Neuraxis, INC (NRXS) (CIK 0001933567) (NRXS)
Neuraxis, INC (NRXS) (CIK 0001933567)
Date: Nov. 22, 2022 · CIK: 0001933567 · Accession: 0000000000-22-012700
AI Filing Summary & Sentiment
Letter
United States securities and exchange commission logo November 22, 2022 Mr. Brian Carrico Chief Executive Officer Neuraxis, Inc. 11550 N. Meridian Street, Suite 325 Carmel, IN 46032 Re:Neuraxis, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted November 9, 2022 CIK No. 0001933567 Dear Mr. Brian Carrico: 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 S-1, submitted November 9, 2022 Prospectus Summary Our Opportunity, page 3 1.We note your response to prior comment 8 and your statement on page 3 that "studies have demonstrated long-term benefits in functional disability, psychological co- morbidities, and pain." Please clarify here the studies to which you refer and provide support for these statements. Our Solutions, page 4 2.We note your response to prior comment 9. You state in your response letter that the American Academy of Pediatrics provided a signed letter “supporting” your technology
FirstName LastNameMr. Brian Carrico Comapany NameNeuraxis, Inc. November 22, 2022 Page 2 FirstName LastName Mr. Brian Carrico Neuraxis, Inc. November 22, 2022 Page 2 and recommending payers to cover the technology. Please clarify in your disclosure, if true, that such support is in the form of a recommendation as to the use of your IB-Stim device or otherwise advise. Use of Proceeds, page 39 3.We note your response to prior comment 16 and your revised disclosure that references “510(k) De Novo FDA review for functional abdominal pain and IBS in children and of the regulatory milestones for [your] technology in respect of other indications” set forth in your pipeline chart. Please revise to disclose how far the offering proceeds would allow you to proceed with regulatory development for each of the referenced indications. Additionally, your reference to the functional abdominal pain and IBS in children indication appears to refer to the indication for which you launched the IB-Stim device. Please revise to clarify or advise. Please also revise to provide the interest rate and maturity of the debt to be repaid. Refer to Instruction 4 to Item 504 of Regulation S-K. Business Our Pipeline, page 53 4.We note your response to prior comment 11 and references on pages 1 and 53 to clinicaltrials.gov identifiers. Please revise your disclosure in the Business section to describe the trials, including the number of patients, endpoints and where the trials are being conducted etc. Business, page 57 5.We note your response to prior comment 19. Please enlarge the text in the graphics on page 57 and ensure that the graphics are legible. General 6.Please 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.
FirstName LastNameMr. Brian Carrico Comapany NameNeuraxis, Inc. November 22, 2022 Page 3 FirstName LastName Mr. Brian Carrico Neuraxis, Inc. November 22, 2022 Page 3 You may contact Gary Newberry at 202-551-3761 or Lynn Dicker at 202-551-3616 if you have questions regarding comments on the financial statements and related matters. Please contact Cindy Polynice at 202-551-8707 or Christine Westbrook at 202-551-5019 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Tom Twedt
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United States securities and exchange commission logo
November 22, 2022
Mr. Brian Carrico
Chief Executive Officer
Neuraxis, Inc.
11550 N. Meridian Street, Suite 325
Carmel, IN 46032
Re:Neuraxis, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted November 9, 2022
CIK No. 0001933567
Dear Mr. Brian Carrico:
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 S-1, submitted November 9, 2022
Prospectus Summary
Our Opportunity, page 3
1.We note your response to prior comment 8 and your statement on page 3 that "studies
have demonstrated long-term benefits in functional disability, psychological co-
morbidities, and pain." Please clarify here the studies to which you refer and provide
support for these statements.
Our Solutions, page 4
2.We note your response to prior comment 9. You state in your response letter that the
American Academy of Pediatrics provided a signed letter “supporting” your technology
FirstName LastNameMr. Brian Carrico
Comapany NameNeuraxis, Inc.
November 22, 2022 Page 2
FirstName LastName
Mr. Brian Carrico
Neuraxis, Inc.
November 22, 2022
Page 2
and recommending payers to cover the technology. Please clarify in your disclosure, if
true, that such support is in the form of a recommendation as to the use of your IB-Stim
device or otherwise advise.
Use of Proceeds, page 39
3.We note your response to prior comment 16 and your revised disclosure that references
“510(k) De Novo FDA review for functional abdominal pain and IBS in children and of
the regulatory milestones for [your] technology in respect of other indications” set forth in
your pipeline chart. Please revise to disclose how far the offering proceeds would allow
you to proceed with regulatory development for each of the referenced indications.
Additionally, your reference to the functional abdominal pain and IBS in children
indication appears to refer to the indication for which you launched the IB-Stim device.
Please revise to clarify or advise. Please also revise to provide the interest rate and
maturity of the debt to be repaid. Refer to Instruction 4 to Item 504 of Regulation S-K.
Business
Our Pipeline, page 53
4.We note your response to prior comment 11 and references on pages 1 and 53 to
clinicaltrials.gov identifiers. Please revise your disclosure in the Business section to
describe the trials, including the number of patients, endpoints and where the trials are
being conducted etc.
Business, page 57
5.We note your response to prior comment 19. Please enlarge the text in the graphics on
page 57 and ensure that the graphics are legible.
General
6.Please 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.
FirstName LastNameMr. Brian Carrico
Comapany NameNeuraxis, Inc.
November 22, 2022 Page 3
FirstName LastName
Mr. Brian Carrico
Neuraxis, Inc.
November 22, 2022
Page 3
You may contact Gary Newberry at 202-551-3761 or Lynn Dicker at 202-551-3616 if
you have questions regarding comments on the financial statements and related matters. Please
contact Cindy Polynice at 202-551-8707 or Christine Westbrook at 202-551-5019 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Tom Twedt