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United States securities and exchange commission logo
June 13, 2020
Vince Burgess
Chief Executive Officer
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad, CA 92008
Re: Acutus Medical,
Inc.
Draft Registration
Statement on Form S-1
Submitted May 15,
2020
CIK No. 0001522860
Dear Mr. Burgess:
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
Overview, page 1
1. Please revise the
Summary to further clarify your existing revenue model and how it is
evolving. In this
regard, we note disclosure on page 90 that your revenue has historically
consisted predominantly
of sales of your disposable products and that you generally
loaned your
first-generation AcQMap console and workstation to customers without
charge. With reference
to page 96, please also clarify in the Summary what types of
products are disposable
and whether any of these product types account for a significant
portion of your
revenue.
2. Please revise the
disclosure on page 2 to indicate the expected timing for US
commercialization of
the AcQBlate force sensing ablation catheters and control unit or
Vince Burgess
FirstName LastNameVince Burgess
Acutus Medical, Inc.
Comapany NameAcutus Medical, Inc.
June 13, 2020
Page 2
June 13, 2020 Page 2
FirstName LastName
disclose that the timing is not presently known.
3. Please revise the second paragraph of the Overview section to explain
briefly the term
"ablation" at first-use.
4. Please revise to disclose when the pilot launch commenced and explain
what a "full
launch" entails in terms of marketing and manufacturing. With
reference to your
disclosure at the bottom of page F-43, please tell us and revise, if
applicable, to clarify
whether the launch fully commenced or remains pending in any respect.
With a view to
disclosure, please tell us whether your installed base and your cost
structure has changed
materially changed since initiating the launch.
5. Please revise your Summary, where appropriate, to quantify the size of
your installed
base.
6. Please tell us your basis for stating on page 1 that you provide
customers with a "complete
solution" for catheter-based treatment and your reference to a
"complete set of tools." In
this regard, we note your disclosures on pages 2 and 129-132 and note
that you presently
sell diagnostic/mapping catheters but you do not presently market any
therapeutic devices,
such as ablation catheters.
Our Market and Industry, page 4
7. We note the market statistics you cite for disposable products used in
ablation procedures.
Please tell us whether your products represent the full spectrum of
disposable products
used in ablation procedures or if they represented only a subset.
Our amended and restated bylaws that will become effective immediately prior to
the completion
of this offering..., page 74
8. We note that your forum selection provision identifies the federal
district courts of the
United States of America as the exclusive forum for certain litigation
arising under the
Securities Act. Please disclose that investors cannot waive compliance
with the federal
securities laws and the rules and regulations thereunder. In that
regard, we note that
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. Please also revise the disclosure on
page 193 to state the
exclusive forum provision would not apply to suits brought to enforce
a duty or liability
created by the Exchange Act or any other claim for which the U.S.
federal courts have
exclusive jurisdiction.
Special Notes Regarding Forward-Looking Statements, page 76
9. We note that you assume no obligation to update or revise
forward-looking statements for
any reason. Please revise your disclosure to clarify that under
certain circumstances,
applicable law may require you to update such statements.
Vince Burgess
FirstName LastNameVince Burgess
Acutus Medical, Inc.
Comapany NameAcutus Medical, Inc.
June 13, 2020
Page 3
June 13, 2020 Page 3
FirstName LastName
Use of Proceeds, page 80
10. Please revise to quantify the amount of proceeds to be allocated to
each purpose cited
in the third paragraph on page 80. Also revise to clarify whether the
amounts you intend
to devote to each purpose will be sufficient to accomplish the
purposes that you intend
to achieve.
Critical Accounting Policies and Estimates, page 105
11. Regarding the Revenue from Contracts with Customers policy, we note
this statement on
page 106: "Generally, for our first-generation AcQMap console and
workstation,
customers purchased disposable products using separate purchase orders
after the
equipment has been installed at no upfront cost with no binding
agreement or requirement
to purchase any disposable products." We also note this disclosure on
page 96:
"Beginning in late 2019, we have begun to install our
second-generation AcQMap console
and workstation with customer accounts under evaluation contracts.
Under these
evaluation contracts, we place our AcQMap console and workstation with
customers at no
upfront cost during the applicable evaluation period and seek to reach
agreement with the
customer for purchase of the console and workstation in the form of a
contractual
commitment to purchase a minimum amount of our disposable products or
a cash
purchase." Please address the following:
Clarify whether the console/workstation and disposable products can
be effectively
utilized without each other;
Explain whether the installation of the console and workstation
would constitute a
separate performance obligation, in addition to the performance
obligation to deliver
disposable products, if there is no binding agreement or
requirement to purchase the
disposable products and/or the console/workstation and disposable
products can be
used without each other; and
Revise your policy herein and in the significant accounting policies
section to
incorporate your policy for how revenue is recognized in
connection with the
installation of your second-generation AcQMap console and
workstation. Clarify
whether the "evaluation contracts" are contracts with customers
within the scope of
ASC 606 and, if so, clearly indicate how you determine that such
"a contractual
commitment" to purchase either disposable products or a cash
purchase is satisfied
and explain how such commitments would or would not result in a
separate
performance obligation.
12. Regarding the Stock-Based Compensation policy beginning on page 106,
please revise to
disclose the extent to which any stock-based compensation has been
awarded during 2020.
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 valuations of your common
stock leading up to
the initial public offering and the estimated offering price for any
grants subsequent to
December 31, 2019. This information will help facilitate our review of
your accounting
Vince Burgess
FirstName LastNameVince Burgess
Acutus Medical, Inc.
Comapany NameAcutus Medical, Inc.
June 13, 2020
June 13, 2020 Page 4
Page 4
FirstName LastName
for equity issuances including stock compensation and any beneficial
conversion features.
Excellent Clinical Outcomes, page 127
13. We note the comparison of the results of your UNCOVER AF post-market
approval trial
to the STAR AF II trial conducted by Abbott Laboratories. Please
disclose whether the
two studies used the same selection criteria for admitting patients to
the respective trials.
Our Comprehensive Portfolio, page 127
14. Please revise the graphic on page 128 to clearly indicate the products
that are still in
development and not currently marketed.
15. Please revise here or elsewhere, as appropriate, to clarify whether
the AcQMap System
can be used with disposable products made by other parties.
16. Please revise to explain in greater detail the development history and
clinical status of the
AcQBlate catheter product line. Without limitation, please discuss
whether Biotronik
and/or you developed this product. Discuss what clinical trial work,
if any, has been
conducted or will need to be conducted in order for you to receive a
CE Mark in the
second-half of 2020. Discuss the two planned US trials and indicate,
if known, the
applicable device classification and whether you will seek 510(k)
clearance or will need to
submit a PMA application. To the extent that development of a
therapeutic ablation
catheter poses development and regulatory challenges that you
previously have not
encountered in the past, please explain.
Ongoing and Future Clinical Trials, page 138
17. For each trial discussed in the section, please revise to discuss, as
applicable, the timing
and duration of the trials and the any endpoints.
Biotronik License Agreement, page 141
18. Please quantify the unit-based royalties paid to Biotronik on sales of
AcQBlate Force
ablation catheters.
Exclusive Patent License Agreement--University of Minnesota, page 144
19. Please quantify the minimum annual royalties payable under the
agreement. We also note
you are obligated to pay a low double-digit percentage of revenue that
you receive from
sublicensees. Please disclose a range of royalties not to exceed 10
percent.
Management, page 160
20. Please tell us whether Mr. Burgess' venture partner position with
OrbiMed limits the time
he can devote to your business. Also, tell us, and revise the risk
factor disclosure on page
70, if applicable, to discuss whether his dual roles could result in
material conflicts of
interest.
Vince Burgess
Acutus Medical, Inc.
June 13, 2020
Page 5
Interim Rhythm Xience Balance Sheet, page F-55
21. Please re-label the prior period column of the interim Rhythm Xience
balance sheet to
December 31, 2018, if true, instead of December 31, 2017.
Exhibits
22. Please file the consulting agreements with Vince Burgess and Elia
Health Sciences, Inc. as
exhibits to the registration statement.
General
23. 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 Jenn Do at (202) 551-3743 or Mary Mast at (202) 551-
3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Chris Edwards at (202) 551-6761 or Joe McCann at (202) 551-6262 with
any other
questions.
FirstName LastNameVince Burgess Sincerely,
Comapany NameAcutus Medical, Inc.
Division of
Corporation Finance
June 13, 2020 Page 5 Office of Life
Sciences
FirstName LastName