View:
United States securities and exchange commission logo
May 7, 2021
Nadim Yared
President and Chief Executive Officer
CVRx, Inc.
9201 West Broadway Avenue, Suite 650
Minneapolis, MN 55445
Re: CVRx, Inc.
Draft Registration
Statement on Form S-1
Submitted April 9,
2021
CIK No. 0001235912
Dear Mr. Yared:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. Please revise your
Overview to disclose your obligation to perform post-market
surveillance.
2. We note your disclosure
that you commissioned a third-party cost-impact analysis. With
respect to the
statements in your prospectus that are based on this third-party research,
please revise to
clarify whether such statements are statements of the third party or
statements of the
registrant. If your disclosure attributes a statement to the third party,
please revise your
filing to identify such third party and file a consent from such third
Nadim Yared
FirstName
CVRx, Inc.LastNameNadim Yared
Comapany
May 7, 2021NameCVRx, Inc.
May 7,
Page 2 2021 Page 2
FirstName LastName
party. Please see Securities Act Rule 436 and Question 233.02 of the
Securities Act Rules
Compliance and Disclosure Interpretations. Please also identify the
peer-reviewed
manuscript.
Our market and industry, page 4
3. Please disclose any material assumptions and limitations associated
with your estimate of
the initial annual market opportunity.
Summary Risk Factors, page 6
4. Please add a bullet highlighting the risks related to the
concentration of ownership of your
common stock, as discussed on page 46. Please include in this bullet
and in the
corresponding risk factor beginning on page 46 a discussion of the
number of your
executive officers and directors who are affiliated with your
principal stockholders.
Risk Factors
Our ability to use our net operating losses and tax credits to offset future
taxable income and
taxes may be..., page 34
5. Please quantify your net operating loss carryforwards and tax credit
carryforwards.
Business, page 72
6. We note your disclosure that you plan to explore BAROSTIM NEO s
potential to expand
the indications for use to other cardiovascular diseases, including
different forms of HF,
hypertension, and arrhythmias. Please state whether your product will
require
modification to treat these other indications and whether you will
need FDA approval for
any other these potential applications.
Intellectual Property, page 95
7. Please revise your intellectual property disclosure to clearly
describe on an individual
basis the type of patent protection granted for each technology
(composition of matter,
use, or process), the expiration of each patent held, and the
jurisdiction, including any
foreign jurisdiction, of each pending or issued patent. In this
regard, it may be useful to
provide this disclosure in tabular form to support the narrative
already included.
Manufacturing and Supply, page 95
8. We note your disclosure here and in the risk factor on page 17 that
you source certain
components for your BAROSTIM NEO from a single supplier. Please
provide expanded
disclosure identifying such single source suppliers and describing the
material terms of
your agreements with such suppliers, and file such agreements as
exhibits pursuant to
Item 601(b)(10) of Regulation S-K. Alternatively, please provide an
analysis as to why
you are not substantially dependent upon such agreements.
Nadim Yared
CVRx, Inc.
May 7, 2021
Page 3
Principal Stockholders, page 127
9. Please revise the footnotes to your table to disclose the natural
persons who have or share
beneficial ownership of the securities held by each of the entities
listed in your table.
Description of Capital Stock
Choice of Forum, page 134
10. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware as the exclusive forum for certain litigation, including
any derivative
action. Please disclose whether this provision applies to actions
arising under the
Securities Act or Exchange Act. In that regard, we note that Section
27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to
enforce any duty or
liability created by the Exchange Act or the rules and regulations
thereunder, and Section
22 of the Securities Act creates concurrent jurisdiction for federal
and state courts over all
suits brought to enforce any duty or liability created by the
Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act
claims, please also revise
your prospectus to state that there is uncertainty as to whether a
court would enforce such
provision and that investors cannot waive compliance with the federal
securities laws and
the rules and regulations thereunder. If this provision does not apply
to actions arising
under the Securities Act or Exchange Act, please also ensure that the
exclusive forum
provision in the governing documents states this clearly, or tell us
how you will inform
investors in future filings that the provision does not apply to any
actions arising under the
Securities Act or Exchange Act.
Please also provide clear risk factor disclosure regarding the risks
or other impacts of the
provision on investors. Such risks may include, but are not limited
to, increased costs to
bring a claim and the potential discouraging of claims or limitation
of investors ability to
bring claims in judicial forums that they find favorable.
General
11. Please supplementally provide us with copies of all written
communications, as defined in
FirstName LastNameNadim Yared
Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
Comapany NameCVRx,
present to potentialInc.
investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain
May 7, 2021 Page 3 copies of the communications.
FirstName LastName
Nadim Yared
FirstName
CVRx, Inc.LastNameNadim Yared
Comapany
May 7, 2021NameCVRx, Inc.
May 7,
Page 4 2021 Page 4
FirstName LastName
You may contact Ibolya Ignat at 202-551-3636 or Jeanne Baker at
202-551-3691 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Kasey Robinson at 202-551-5880 or Jeffrey Gabor at 202-551-2544 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Ben A. Stacke, Esq.