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CVRx, Inc.
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2021-06-25
CVRx, Inc.
Filing - Correspondence from CVRx, Inc.
CORRESP · 2021-06-25
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CVRx, Inc.
Awaiting Response
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-11 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-10 | SEC Comment Letter | CVRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-10 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-06-22 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-06-04 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-05-27 | SEC Comment Letter | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-05-07 | SEC Comment Letter | CVRx, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2022-11-10 | SEC Comment Letter | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-05-27 | SEC Comment Letter | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-05-07 | SEC Comment Letter | CVRx, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-11 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2022-11-10 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-06-22 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
| 2021-06-04 | Company Response | CVRx, Inc. | DE | N/A | Read Filing View |
2025-12-11 - CORRESP - CVRx, Inc.
CORRESP 1 filename1.htm CVRx, Inc. 9201 West Broadway Avenue Suite 650 Minneapolis, Minnesota 55445 December 11, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: CVRx, Inc. Registration Statement on Form S-3 File No. 333-291309 Ladies and Gentlemen: Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, on behalf of CVRx, Inc., respectfully requests that the effective date of the Registration Statement on Form S-3 referred to above be accelerated so that it will become effective at 4:00 P.M. Eastern Time on December 15, 2025, or as soon as practicable thereafter. If you have any questions or require additional information, please contact Ben A. Stacke, Esq., of Faegre Drinker Biddle & Reath LLP at (612) 766-6836. Thank you for your assistance and cooperation in this matter. Very truly yours, CVRX, INC. By: /s/ Jared Oasheim Jared Oasheim Chief Financial Officer cc: Kevin Hykes, President and Chief Executive Officer, CVRx, Inc. Amy C. Seidel, Esq., Faegre Drinker Biddle & Reath LLP Ben A. Stacke, Esq., Faegre Drinker Biddle & Reath LLP Ilir Mujalovic, Esq., Allen Overy Shearman Sterling US LLP
2022-11-10 - UPLOAD - CVRx, Inc.
United States securities and exchange commission logo
November 10, 2022
Nadim Yared
President and Chief Executive Officer
CVRx, Inc.
9201 West Broadway Avenue, Suite 650
Minneapolis, MN 55445
Re:CVRx, Inc.
Registration Statement on Form S-3
Filed November 4, 2022
File No. 333-268183
Dear Nadim Yared:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Margaret Schwartz at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Amy C. Seidel, Esq.
2022-11-10 - CORRESP - CVRx, Inc.
CORRESP
1
filename1.htm
CVRx, Inc.
9201 West Broadway
Avenue
Suite 650
Minneapolis, Minnesota
55445
November 10, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
CVRx, Inc.
Registration
Statement on Form S-3
File No. 333-268183
Ladies and Gentlemen:
Pursuant to Rule 461 of Regulation C of the General
Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, on behalf of CVRx, Inc., respectfully requests that
the effective date of the Registration Statement on Form S-3 referred to above be accelerated so that it will become effective at 4:00
P.M. Eastern Time on November 15, 2022, or as soon as practicable thereafter.
If you have any questions or require additional
information, please contact Ben A. Stacke, Esq., of Faegre Drinker Biddle & Reath LLP at (612) 766-6836. Thank you for your assistance
and cooperation in this matter.
Very truly yours,
CVRX, INC.
By:
/s/ Jared Oasheim
Jared Oasheim
Chief Financial Officer
cc: Nadim Yared, President and Chief Executive Officer, CVRx, Inc.
Amy C. Seidel, Esq., Faegre Drinker Biddle & Reath LLP
Ben A. Stacke, Esq., Faegre Drinker Biddle & Reath LLP
Ilir Mujalovic, Esq., Shearman & Sterling LLP
2021-06-25 - CORRESP - CVRx, Inc.
CORRESP
1
filename1.htm
CVRx, Inc.
9201 West Broadway Avenue, Suite 650
Minneapolis, MN 55445
June 25, 2021
VIA EDGAR TRANSMISSION
Division of Corporation Finance
Office of Life Sciences
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Ibolya Ignat
Jeanne Baker
Kasey Robinson
Jeffrey Gabor
Re:
CVRx, Inc.
Registration Statement on Form S-1 (Registration No. 333-256800)
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities
Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-1, as amended
(File No. 333-256800) (the “Registration Statement”), of CVRx, Inc. (the “Company”). We respectfully
request that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on Tuesday, June 29, 2021, or as soon as
practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel,
Faegre Drinker Biddle & Reath LLP, by calling Ben A. Stacke at (612) 766-6836.
We understand
that the staff of the Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware of
its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
If you have any questions regarding the foregoing, please contact Ben A. Stacke of Faegre Drinker Biddle & Reath LLP at the number
set forth above.
Thank you for your assistance in this matter.
[The remainder of this page has intentionally
been left blank.]
Very truly yours,
CVRx, Inc.
By:
/s/ Nadim Yared
Name:
Nadim Yared
Title:
President and Chief Executive Officer
cc:
(via email)
Jared Oasheim, Chief Financial Officer, CVRx, Inc.
Amy Seidel, Esq., Faegre Drinker Biddle & Reath LLP
Ben Stacke, Esq., Faegre Drinker Biddle & Reath LLP
[Signature page to CVRx, Inc. Acceleration
Request]
2021-06-25 - CORRESP - CVRx, Inc.
CORRESP
1
filename1.htm
June 25, 2021
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn: Ibolya Ignat,
Jeanne Baker
Kasey Robinson
Jeffrey Gabor
Re:
CVRx, Inc.
Registration Statement on Form S-1 (as amended) (SEC File No. 333-256800)
Ladies and Gentlemen:
In connection with the above-referenced Registration Statement, and
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we hereby join in the request of
CVRx, Inc. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 4:00 p.m.,
New York City time, on June 29, 2021, or as soon thereafter as practicable.
Pursuant to Rule 460 under the Act, please be advised that we
have distributed approximately 425 copies of the Preliminary Prospectus dated June 23, 2021 (the “Preliminary Prospectus”)
through the date hereof, to underwriters, dealers, institutions and others.
In connection with the Preliminary Prospectus distribution for the
above-referenced issue, the prospective underwriters have confirmed that they are complying with the 48-hour requirement in Rule 15c2-8(b) under
the Securities Exchange Act of 1934, as amended.
Very truly yours,
J.P. MORGAN SECURITIES LLC
PIPER SANDLER & CO.
WILLIAM BLAIR & COMPANY, L.L.C.
As Representatives of the several underwriters
[SIGNATURE PAGES FOLLOW]
J.P. MORGAN SECURITIES LLC
By:
/s/ Benjamin Burdett
Name:
Benjamin Burdett
Title:
Managing Director
PIPER SANDLER & CO.
By:
/s/ Neil Riley
Name:
Neil Riley
Title:
Managing Director
WILLIAM BLAIR & COMPANY, L.L.C.
By:
/s/ Steve Maletzky
Name:
Steve Maletzky
Title:
Partner, Head of ECM
As representatives of the several underwriters.
cc: Ilir Mujalovic, Partner, Shearman & Sterling LLP
[Signature Page to UW Acceleration Request]
2021-06-22 - CORRESP - CVRx, Inc.
CORRESP
1
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Faegre
Drinker Biddle & Reath LLP
2200 Wells Fargo Center
90 S. Seventh Street
Minneapolis, Minnesota 55402
+1 612 766 7000 main
+1 612 766 1600 fax
By Secured Electronic Transmission and EDGAR
June 17, 2021
FOIA Confidential Treatment Request
Under 17 C.F.R. §200.83
Ibolya Ignat
Jeanne Baker
Kasey Robinson
Jeffrey Gabor
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re: CVRx, Inc.
Registration Statement on Form S-1
Filed on June 4, 2021
CIK No. 0001235912
Dear Ms. Ignat and Ms. Baker:
On
behalf of CVRx, Inc. (the “Company”), we submit this letter to the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”). The above-referenced Registration Statement on Form S-1
was confidentially submitted to the Commission on April 9, 2021, confidentially resubmitted to the Commission on May 14, 2021,
and subsequently publicly filed with the Commission on June 4, 2021 (as amended, the “Registration Statement”).
Because of the commercially sensitive nature of the information contained herein, this submission is accompanied by the Company’s
request for confidential treatment of selected portions of this letter pursuant to Rule 83 of the Commission’s Rules on
Information and Requests, 17 C.F.R. § 200.83. A redacted letter has been filed on EDGAR, omitting the confidential information contained
in this letter.
For the convenience of the Staff, we are providing
to the Staff copies of this letter by hand delivery
To
assist the Staff in its review, the Company advises the Staff that, although not yet reflected in the Registration Statement, based on
discussions with the Company’s board of directors and reflecting input from the lead underwriters (the “Underwriters”)
for the Company’s initial public offering (“IPO”), if the Company were to commence marketing of the transaction
today, the Company presently anticipates that the estimated price range would be approximately $[***] to $[***] per share for the
Company’s common stock (the “Preliminary IPO Price Range”) with a midpoint of the anticipated range of approximately
$[***] per share (the “Preliminary Assumed IPO Price”). The Company expects to reflect a reverse stock split
in a pre-effective amendment to the Registration Statement that includes the actual price range; however, all dollar amounts and per share
amounts in this letter are pre-stock split, and therefore, consistent with the Registration Statement.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY
CVRx, INC.
June 17, 2021
Page 2
The Company advises the Staff that the final price
range to be included in a pre-effective amendment to the Registration Statement, after giving effect to an appropriate reverse stock split,
will include a price range of no more than $2.00, if the maximum price is $10.00 per share or less, or 20%, if the maximum price is greater
than $10.00 per share, unless otherwise approved by the Staff. The Company’s final post-split price range remains under discussion
between the Company and the Underwriters, and a bona fide price range will be included in an amendment to the Registration Statement
prior to any distribution of the preliminary prospectus in connection with the Company’s roadshow.
Analysis of Stock Option Grants Since December 31,
2019
As there has been no public market for the Company’s
common stock to date, the estimated fair value of its common stock has been determined by the Company’s board of directors as of
the date of each option grant, with input from management, considering the Company’s most recent third-party valuation of its common
stock and the board of directors’ assessment of additional objective and subjective factors that it believed were relevant.
The following table summarizes by grant date the
aggregate number of shares of common stock underlying options granted since December 31, 2019, the per share exercise price of the
options and the estimated fair value of the common stock underlying the options on each grant date:
Grant Date
Aggregate
Number of Common
Shares
Underlying
Stock Options
Granted
Exercise
Price of
Award
per
Share
Fair Value of
Common
Stock per
Share on
Grant Date
Per Share
Estimated
Fair Value
of Awards (Non-
Officer/Officer)
Date of third-party
valuation
October 1, 2020
18,968,000
$ 0.11
$ 0.11
$
0.0432/$ 0.0455
July 1, 2020
October 16, 2020
1,500,000
$ 0.11
$ 0.11
N/A/$ 0.0456
July 1, 2020
January 5, 2021
5,380,000
$ 0.13
$ 0.13
$
0.0518/$ 0.0530
November 30, 2020
February 4, 2021
16,415,000
$ 0.18
$ 0.18
$
0.0715/$ 0.0736
January 28, 2021
The
third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’
Audit and Accounting Practice Aid entitled Valuation of Privately-Held-Company Equity Securities Issued as Compensation and
were prepared using the probability-weighted expected return method (“PWERM”). The PWERM involves a forward-looking
analysis of the potential future outcomes available to the enterprise, the estimation of future value and present value under each outcome,
and the application of a probability factor to each outcome as of the valuation date. The PWERM was determined to be the most appropriate
methodology for valuing the common stock given the broad range of possible future outcomes for the Company. In the PWERM, a discount for
lack of marketability (“DLOM”) is applied to the value indicated for the common stock.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY
CVRx, INC.
June 17, 2021
Page 3
October 2020 Option Grants
The Company obtained an independent third-party
valuation of the Company’s common stock as of July 1, 2020, and based on its consideration of this valuation, the Company’s
board of directors determined that the fair value of the Company’s common stock was $0.11 per share as of October 1, 2020 and
October 16, 2020 (the “October 2020 Valuation”). The independent third-party valuation used the PWERM, pursuant
to which the value of the Company’s equity securities was calculated based on six scenarios: an IPO by November 30, 2021, an
IPO by September 30, 2022, a merger or acquisition (“M&A”) by June 30, 2022, an M&A by December 31,
2023, dissolution, and continuing to stay private. The October 2020 Valuation applied the scenario weightings and discounts for lack
of marketability as shown in the chart below.
Valuation Scenario
Marketable
Value Per
Share
Assigned Weight
Discount for
Lack of
Marketability
Non-
Marketable
Value Per
Share
September 30, 2022 IPO
$
0.29
35.0 %
28.0 %
$
0.21
November 30, 2021 IPO
$
0.24
15.0 %
26.0 %
$
0.18
December 31, 2023 M&A
$
⸺
15.0 %
29.0 %
$
⸺
June 30, 2022 M&A
$
⸺
15.0 %
27.0 %
$
⸺
Dissolution
$
⸺
5.0 %
⸺ %
$
⸺
Stay Private
$
0.06
15.0 %
31.0 %
$
0.04
January 2021 Option Grants
The Company obtained an independent third-party
valuation of the Company’s common stock as of November 30, 2020, and based on its consideration of this valuation, the Company’s
board of directors determined that the fair value of the Company’s common stock was $0.13 per share as of January 5, 2021 (the
“January 2021 Valuation”). The independent third-party valuation used the PWERM, pursuant to which the value of
the Company’s equity securities was calculated based on six scenarios: an IPO by June 30, 2021, an IPO by September 30,
2022, an M&A by September 30, 2022, an M&A by December 31, 2023, dissolution, and continuing to stay private. The January 2021
Valuation applied the scenario weightings and discounts for lack of marketability as shown in the chart below.
Valuation Scenario
Marketable
Value Per
Share
Assigned Weight
Discount for
Lack of
Marketability
Non-
Marketable
Value Per
Share
September 30, 2022 IPO
$
0.32
30.0 %
27.0 %
$
0.23
June 30, 2021 IPO
$
0.38
20.0 %
22.0 %
$
0.29
December 31, 2023 M&A
$
⸺
15.0 %
30.0 %
$
⸺
September 30, 2022 M&A
$
⸺
15.0 %
28.0 %
$
⸺
Dissolution
$
⸺
5.0 %
⸺ %
$
⸺
Stay Private
$
0.04
15.0 %
30.0 %
$
0.03
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY
CVRx, INC.
June 17, 2021
Page 4
February 2021 Option Grants
The Company obtained an independent third-party
valuation of the Company’s common stock as of January 28, 2021, and based on its consideration of this valuation, the Company’s
board of directors determined that the fair value of the Company’s common stock was $0.18 per share as of February 4, 2021
(the “February 2021 Valuation”). The independent third-party valuation used the PWERM, pursuant to which the value
of the Company’s equity securities was calculated based on six scenarios: an IPO by June 30, 2021, an IPO by September 30,
2022, an M&A by September 30, 2022, an M&A by December 31, 2023, dissolution, and continuing to stay private. The February 2021
Valuation applied the scenario weightings and discounts for lack of marketability as shown in the chart below.
Valuation Scenario
Marketable
Value Per
Share
Assigned Weight
Discount for
Lack of
Marketability
Non-
Marketable
Value Per
Share
September 30, 2022 IPO
$
0.35
15.0 %
26.0 %
$
0.26
June 30, 2021 IPO
$
0.46
35.0 %
20.0 %
$
0.37
December 31, 2023 M&A
$
⸺
15.0 %
30.0 %
$
⸺
September 30, 2022 M&A
$
⸺
15.0 %
26.0 %
$
⸺
Dissolution
$
⸺
5.0 %
⸺ %
$
⸺
Stay Private
$
0.09
15.0 %
29.0 %
$
0.07
Analysis of Preliminary IPO Price Range
As noted above, the Preliminary IPO Price Range
is $[***] to $[***] per share, with a Preliminary Assumed IPO Price of approximately $[***] per share. The Company notes that, as is typical
in IPOs, the Preliminary IPO Price Range was not derived using a formal determination of fair value but was determined based upon discussions
between the Company and the Underwriters. Among the factors that were considered in setting this range were:
●
an analysis of the typical valuation ranges seen in recent IPOs for companies in the Company’s industry;
●
the general condition of the securities markets and the recent market prices of, and the demand for, publicly traded common stock of generally comparable companies;
●
an assumption that there would be a receptive public trading market for medical device companies such
as the Company; and
●
an assumption that there would be sufficient demand for the Company’s common stock to support an offering of the size contemplated by the Company.
CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED BY CVRx, INC.
June 17, 2021
Page 5
The Preliminary IPO Price Range of $[***] to $[***]
per share, which does not reflect the reverse stock split the Company expects to effect, is $[***] to $[***] above the Company’s
February 2021 Valuation. This increase in the price per share fair value of the Company’s common stock is primarily the result
of the following key factors:
●
The Company and the third-party valuation specialist utilized quantitative methodologies to determine the historical fair values of the Company’s common stock, which may differ from the more qualitative and subjective methodologies that may be used by some public market investors to determine the price they are willing to pay in an IPO.
●
The anticipated price range for this offering is based only upon a scenario in which the Company completes this offering and is not probability weighted, in contrast to the Company’s prior valuations of common stock, which considered other potential outcomes under the probability weighted expected return method, which would have resulted in a lower value of its common stock than an initial public offering.
●
The Preliminary IPO Price Range necessarily assumes that the IPO has occurred and an active trading market for the common stock will exist following the IPO and therefore it does not include a discount for lack of marketability. In contrast, the historical fair values of the Company’s common stock took into account that the Company’s common stock was then illiquid, may have never become liquid and, even if an IPO was successfully completed, would remain illiquid at least until the expiration of the 180-day lock-up period following the IPO.
●
The significant benefits the Company expects to accrue as a result of becoming publicly traded through the IPO, including (i) a substantial increase in the Company’s cash position after receiving the net proceeds from the IPO, (ii) an anticipated improved ability of the Company to raise equity and debt capital going forward, and at a lower expected cost of capital and with reduced borrowing costs, as a result of being a publicly traded company, and (iii) the expected increased attractiveness of the Company’s equity as a currency to raise capital, compensate employees and other strategic transactions.
●
The Company’s ability to use some proceeds from the IPO to accelerate commercialization of its BAROSTIM NEO product in the U.S., relative to expectations without such proceeds.
In conclusion, the Company respectfully submits
to the Staff that the differences between the estimated grant date fair values and the Preliminary IPO Price Range are reasonable and
appropriate in light of the considerations outlined above.
The Company respectfully requests that certain
of the information contained in this request letter be treated as confidential information and that the Commission provide timely notice
to Jared Oasheim, Chief Financial Officer, CVRx, Inc., 9201 West Broadway Avenue, Suite 650, Minneapolis, MN 55445, telephone
(763) 416-2840, before it permits any disclosure of the underlined and highlighted information contained in this letter.
If you have any questions or comments regarding
the foregoing, or if there is any additional information that we might provide to assist the Staff’s review, please contact the
undersigned at (612) 766-6836.
Respectfully,
FAEGRE DRINKER BIDDLE & REATH LLP
/s/ Ben A. Stacke
Ben A. Stacke
CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED BY CVRx, INC.
June 17, 2021
Page 6
Enclosures
cc: Nadim Yared, CVRx, Inc.
Jared Oasheim, CVRx, Inc.
Amy Seidel, Esq., Faegre Drinker Biddle & Reath
LLP
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY
CVRx, INC.
2021-06-04 - CORRESP - CVRx, Inc.
CORRESP
1
filename1.htm
Faegre Drinker Biddle & Reath LLP
2200 Wells Fargo Center
90 S. Seventh Street
Minneapolis, Minnesota 55402
+1 612 766 7000 main
+1 612 766 1600 fax
By EDGAR
June 4, 2021
Ibolya Ignat
Jeanne Baker
Kasey Robinson
Jeffrey Gabor
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
CVRx, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted May 14, 2021
CIK No. 0001235912
Dear Ms. Ignat and Ms. Baker:
On behalf of CVRx, Inc. (the “Company”),
we are transmitting the following responses of the Company to the comments of the Securities and Exchange Commission’s staff (the
“Staff”) as set forth in the letter of Ibolya Ignat, Jeanne Baker, Kasey Robinson and Jeffrey Gabor, dated May 27,
2021, to Amendment No. 1 to Draft Registration Statement on Form S-1 submitted confidentially to the Securities and Exchange Commission
on May 14, 2021.
The Company is concurrently filing via EDGAR the
Registration Statement on Form S-1 (the “Registration Statement”). The responses herein were provided to this firm
by the Company. In this letter, we have recited the comment from the Staff in italicized, bold type and have followed the comment with
the Company’s response in regular type. All references to page numbers in the Company’s responses refer to page numbers in
the Registration Statement.
June 4, 2021
Page 2
Prospectus Summary
Overview, page 3
1. Please balance the disclosure of your revenue for the three months ended March 31, 2021 and 2020 by presenting other measures
of your performance such as net loss for the same periods.
Company Response: In
response to the Staff’s comment, the Registration Statement has been revised. Please see pages 3 and 77, which now disclose
gross margin and net loss for the three months ended March 31, 2021 and 2020.
Summary consolidated financial data, page 11
2. Please revise to present your pro forma earnings per share for only the most recent fiscal year and the most recent interim
period. Refer to Rule 8-05 and Rule 11-02(c)(2)(i) of Regulation S-X. Please also provide a footnote to show how you compute your pro
forma earnings per share data. In this regard, while we note that you refer to Notes 2 and 9 to your consolidated financial statements
for an explanation of the method used to calculate your forma net loss per share and the weighted-average number of shares used in the
computation of the per share amounts, those notes do not include pro forma information. Please address this comment as it relates to your
Selected Financial Data on page 57.
Company Response: In response
to the Staff’s comment, the Registration Statement has been revised. Please see pages 11 and 58, which now disclose the Company’s
pro forma earnings per share for only the most recent fiscal year and the most recent interim period and include revised footnotes that
cross-reference to a new subsection on pages 67 and 68 entitled “Unaudited pro forma information.” This new subsection explains
how the Company computed its pro forma earnings per share data for the relevant periods.
Principal Stockholders, page 140
3. We note your revised disclosure in response to comment 9. Please revise footnote 5 to disclose the natural persons who have
or share beneficial ownership.
Company Response: In response to the Staff’s
comment, the Registration Statement has been revised. Please see footnote 5 on page 142, which now discloses that Action Potential Venture
Capital Limited is an indirect wholly owned subsidiary of GlaxoSmithKline plc.
June 4, 2021
Page 3
Respectfully,
FAEGRE DRINKER BIDDLE & REATH LLP
/s/ Ben A. Stacke
Ben A. Stacke
Enclosures
cc:
Nadim Yared, CVRx, Inc.
Jared Oasheim, CVRx, Inc.
Amy Seidel, Esq., Faegre Drinker Biddle & Reath LLP
2021-05-27 - UPLOAD - CVRx, Inc.
United States securities and exchange commission logo
May 27, 2021
Nadim Yared
President and Chief Executive Officer
CVRx, Inc.
9201 West Broadway Avenue, Suite 650
Minneapolis, MN 55445
Re:CVRx, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted May 14, 2021
CIK No. 0001235912
Dear Mr. Yared:
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 May 14, 2021
Prospectus Summary
Overview, page 3
1.Please balance the disclosure of your revenue for the three months ended March 31, 2021
and 2020 by presenting other measures of your performance such as net loss for the same
periods.
Summary consolidated financial data, page 11
2.Please revise to present your pro forma earnings per share for only the most recent fiscal
year and the most recent interim period. Refer to Rule 8-05 and Rule 11-02(c)(2)(i) of
Regulation S-X. Please also provide a footnote to show how you compute
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Comapany NameCVRx, Inc.
May 27, 2021 Page 2
FirstName LastName
Nadim Yared
CVRx, Inc.
May 27, 2021
Page 2
your pro forma earnings per share data. In this regard, while we note that you refer
to Notes 2 and 9 to your consolidated financial statements for an explanation of the
method used to calculate your forma net loss per share and the weighted-average number
of shares used in the computation of the per share amounts, those notes do not include pro
forma information. Please address this comment as it relates to your Selected Financial
Data on page 57.
Principal Stockholdesr, page 140
3.We note your revised disclosure in response to comment 9. Please revise footnote 5 to
disclose the natural persons who have or share beneficial ownership.
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.
2021-05-07 - UPLOAD - CVRx, Inc.
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
FirstName LastNameNadim Yared
Comapany NameCVRx, Inc.
May 7, 2021 Page 2
FirstName LastNameNadim Yared
CVRx, Inc.
May 7, 2021
Page 2
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.
FirstName LastNameNadim Yared
Comapany NameCVRx, Inc.
May 7, 2021 Page 3
FirstName LastName
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
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 LastNameNadim Yared
Comapany NameCVRx, Inc.
May 7, 2021 Page 4
FirstName LastName
Nadim Yared
CVRx, Inc.
May 7, 2021
Page 4
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.
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