United States securities and exchange commission logo
August 18, 2021
David Clapper
Chief Executive Officer
Minerva Surgical, Inc.
4255 Burton Dr.
Santa Clara, CA 95054
Re: Minerva Surgical,
Inc.
Draft Registration
Statement on Form S-1
Submitted July 23,
2021
CIK No. 0001452965
Dear Mr. Clapper:
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, page 1
1. Please revise the
Prospectus Summary, where appropriate, to briefly describe the material
terms of your
acquisition of BSC's intrauterine health assets, including the products
acquired and the
consideration paid.
2. We note your statement
that there is a significant body of peer-reviewed literature that you
believe validates the
clinical performance of your solutions, as well as similar statements
throughout the
prospectus (e.g. "We have developed a substantial body of clinical data to
support and supplement
our PMAs and other marketing authorizations.").
David Clapper
FirstName LastNameDavid Clapper
Minerva Surgical, Inc.
Comapany
August 18, NameMinerva
2021 Surgical, Inc.
August
Page 2 18, 2021 Page 2
FirstName LastName
However, the prospectus only contains descriptions of clinical trials
that evaluated the
Minerva ES and Genesys systems. Please revise your disclosure in the
prospectus, where
appropriate, to summarize the data that validates the clinical
performance of the Symphion
system and the Resectr device. Alternatively, please clarify your
disclosure here and
elsewhere in the prospectus, including in the Prospectus Summary, to
specify that you are
referring to the Minerva ES and Genesys systems, rather than to all of
your
products. Please also revise your disclosure in this section and in
greater detail in the
Business section to disclose, if applicable, whether (i) you funded or
sponsored the studies
published in peer-reviewed literature and (ii) your employees were
involved in the
publication of these studies.
Our market opportunity, page 2
3. Please revise here and in the market and industry subsection on page
115 to discuss the
limitations on market opportunity referenced elsewhere in the
prospectus, including that
the Minerva ES and Genesys HTA are contraindicated in patients who are
pregnant or
who may want to become pregnant.
Risk Factors
Our amended and restated bylaws designate..., page 65
4. Please also disclose the possible risk of increased costs for
investors to bring a claim
under these provisions.
Market, industry and other data, page 72
5. We note your statements that (i) you have not separately verified
third party data and (ii)
no third party has verified your internal research. These statements
may imply an
inappropriate disclaimer of responsibility with respect to such
information that appears in
your prospectus. Please either delete these statements or specifically
state that you are
liable for the disclosure regarding to the market and industry data
and your internal
company research that appears in the prospectus.
Use of proceeds, page 73
6. Please disclose the amount of proceeds that could be used to pay the
deferred payment
obligation and potential milestone payments.
Capitalization, page 75
7. Tell us if you have entered into any agreements with the convertible
note holders which
would result in conversion of the notes into shares upon the
completion of the offering. If
not, tell us why you believe it is appropriate to include the
voluntary conversion of all
principal and interest on your convertible promissory notes in the pro
forma column on
pages 11 and 75.
David Clapper
FirstName LastNameDavid Clapper
Minerva Surgical, Inc.
Comapany
August 18, NameMinerva
2021 Surgical, Inc.
August
Page 3 18, 2021 Page 3
FirstName LastName
Results of operations
Comparison of the years ended December 31, 2019 and 2020
Other income and expenses, page 92
8. Given the significance of the items included within your other income
and expenses to
your operations, please include a table disaggregating such items to
complement the
period to period change explanations. This comment applies to both
your interim and
annual disclosures.
Convertible notes, page 96
9. Please disclose what would constitute a qualified financing and
non-qualified financing.
Critical accounting policies, significant judgments and use of estimates
Revenue Recognition, page 100
10. Based on your disclosure on pages 12 and F-19, 95% of your revenue is
derived from the
sale of single-use (disposable) products and appears to be attributed
to four products.
Please address the following:
Tell us your consideration of providing disaggregated revenue by
product pursuant to
ASC 606-10-50-5 and 606-10-55-89 through 55-91.
Clarify your reference on pages 1, 82 and elsewhere, as
applicable, to a "broad suite
of products" that you offer. It is unclear if the terminology is
appropriate since you
appear to only sell four products.
Expand your discussion of revenue in results of operations in
Management's
Discussion and Analysis on pages 89 and 91 to discuss the
reasons, quantitatively and
qualitatively, for the changes in revenue for each significant
product.
Common stock valuation and stock-based compensation, page 104
11. 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 IPO 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.
12. You state on page 106 that you applied the market approach for your
valuations
performed in March 2019, March 2020, and May 2020. Please clarify if
any valuations
were done subsequent to May 2020 and the valuation method and nature
of significant
assumptions used. In this regard, we note on page 107 that you granted
options in January,
March, and June 2021. In addition, you state on page 106 that until
March 31, 2021 you
determined the OPM method was the most appropriate method for
allocating your
enterprise value to determine the estimated fair value of your common
stock. Please
clarify what method was used after that date and the nature of
significant assumptions.
David Clapper
FirstName LastNameDavid Clapper
Minerva Surgical, Inc.
Comapany
August 18, NameMinerva
2021 Surgical, Inc.
August
Page 4 18, 2021 Page 4
FirstName LastName
Business
Our success factors, page 112
13. We note your statement that you are on the leading edge of significant
technological advancements in gynecologic surgery. We further note (i)
your disclosure
elsewhere that your products obtained approvals in 2001, 2014, 2015
and 2016 and (ii)
that your prospectus does not currently contain any descriptions of
new technologies
under development. Please revise your disclosure to disclose the basis
for this statement.
Key benefits for patients and healthcare providers, page 118
14. Please remove your statement that the reported hysterectomy rate of
your leading
competitor's product in its clinical trial was 6.3% after 36 months as
this comparison is not
based on a head-to-head study.
Summary of Minerva RCT study, page 129
15. Please revise your "Study Conclusions" subsection to reflect your
disclosure on page 130
which appears to indicate similar rates of pre-menstrual symptoms and
reduction in
dysmenorrhea between the Minerva group and the control group at
one-year post-
procedure.
Efficacy results, page 132
16. We note that the Genesys HTA group appears to have had a lower success
and
amenorrhea rates as compared to the control group. Please clearly
address how these
results satisfied the trial's primary and secondary effectiveness
endpoints when discussing
the results of the trials for Genesys HTA. Please revise your related
disclosure elsewhere
accordingly.
Manufacturing and supply, page 135
17. Your disclosure on page 17 indicates that you depend on a limited
number of single
source suppliers and that you are not certain whether alternative
sources of supply will be
available if and when you need them. Please revise this subsection to
disclose the names
of these suppliers and file any related agreements as an exhibit.
Alternatively, please tell
us why this would not be required. See Item 101(h)(4)(v) and Item
601(b)(10) of
Regulation S-K.
Competition, page 139
18. Please revise this section to reflect your disclosure on page 27
indicating that your
competitors have historically undercut the price of your products.
Intellectual property, page 153
19. We note your disclosure relating to your patent portfolio in the
United States and in
David Clapper
Minerva Surgical, Inc.
August 18, 2021
Page 5
foreign jurisdictions. Please expand your disclosure to identify for
each material patent
and patent application, as applicable, the scope and technology of each
such patent or
patent application, the type of patent protection, expiration date, and
jurisdiction.
20. Please revise in this subsection, or elsewhere within the Business
section, to describe the
material terms of your license agreement with Hermes Innovations.
Certain relationships and related-party transactions
Convertible note financings, page 181
21. Please disclose the amount of interest paid during the periods presented
in this section and
the interest rate. For guidance, please refer to Item 404(a)(5) of
Regulation S-K.
Principal stockholders, page 185
22. In a footnote to the table, please disclose the names of the natural
persons that have
ultimate voting or dispositive control over the company s shares that
are held by CFV,
LLC and Vivo Ventures.
Recent sale of unregistered securities, page II-2
23. For each transaction, please specifically indicate the exemption from
registration claimed
and state the facts relied upon to make the exemption available. For
example, please
disclose how the applicable transactions meet the requirements under
Regulation S.
General
24. 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.
You may contact Ibolya Ignat at 202-551-3636 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tom Kluck at 202-551-3233 or Alan Campbell at 202-551-4224 with any
other
questions.
Sincerely,
FirstName LastNameDavid Clapper
Division of
Corporation Finance
Comapany NameMinerva Surgical, Inc.
Office of Life
Sciences
August 18, 2021 Page 5
cc: Philip Oettinger
FirstName LastName