United States securities and exchange commission logo
September 8, 2021
Bjarne Bergheim
Chief Executive Officer
Sonendo, Inc.
26061 Merit Circle, Suite 102
Laguna Hills, CA 92653
Re: Sonendo, Inc.
Draft Registration
Statement on Form S-1
Submitted August
11, 2021
CIK No. 0001407973
Dear Mr. Bergheim:
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 filed August 11, 2021
Market, Industry and Other Data, page ii
1. We note your statement
cautioning investors not to place undue reliance on market share
data included in the
prospectus. Such statement may imply an inappropriate disclaimer of
responsibility with
respect to the third-party information; therefore, please either remove
the disclaiming
language or clearly state in this section that you are liable for all
information in the
prospectus.
Bjarne Bergheim
FirstName LastNameBjarne Bergheim
Sonendo, Inc.
Comapany 8,
September NameSonendo,
2021 Inc.
September
Page 2 8, 2021 Page 2
FirstName LastName
Our Company, page 1
2. We refer to your disclosure on page 127 that your currently marketed
products include
Class II devices that are subject to 510(k) clearance. Please revise
to include disclosure of
the Class II classification of the GentleWave System in the Summary.
Please also include
disclosure of your other products that are currently marketed,
including their purpose in
your GentleWave System platform. For example, we note your disclosure
of your
CleanFlow PI, SoundSeal, TDO software and company-branded EDTA.
3. We note your disclosure that conventional methods of RCT depend
primarily on
instruments to manually remove tooth structure, which include the use
of dental drills to
create an access cavity and the use of endodontic files. You also
disclose that your
GentleWaye System is able to clean and disinfect the root canal system
with minimal or
no removal of tooth structure. Please expand your disclosure here and
elsewhere in the
prospectus to explain what you mean by minimal or no removal of
tooth structure. For
example, please clarify whether the GentleWave System requires the use
of instruments
such as dental drills and bars to create access cavities.
4. We refer to your disclosure on pages 2 and elsewhere in the prospectus
that over 30 peer-
reviewed journal publications demonstrate the benefits of the
GentleWave System. Please
revise your disclosure in this section and elsewhere to disclose
whether you funded,
sponsored or if your employees were involved in the peer-reviewed
publications
referenced.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 7
5. You state herein and on page 75 that you have elected to take
advantage of the extended
transition period afforded to emerging growth companies that would
delay the adoption of
certain accounting standards until those standards would otherwise
apply to private
companies. The related checkbox on the cover of the document is also
unchecked.
However, you provide disclosure to the contrary on pages 103 and F-9,
wherein you
indicate you have irrevocably elected to not take advantage of this
benefit. Please clarify
and revise to ensure your disclosures are consistent throughout your
document.
Risk Factors
We face competition from many sources..., page 21
6. We note your disclosure on page 113 that your competitors use various
alternative RCT
technologies, such as sonic, ultrasonic and laser-assisted irrigation
devices. Please clarify
your disclosure here and in the Business section to discuss the type
of technologies your
key competitors utilize in their RCT products. Please also
differentiate your proprietary
mechanism of action of the GentleWave System, which combines fluid
optimization,
broad-spectrum acoustic energy and advanced fluid dynamics, from the
alternative
technologies identified.
Bjarne Bergheim
Sonendo, Inc.
September 8, 2021
Page 3
We depend upon third-party suppliers, including contract manufacturers and
single and sole
suppliers..., page 24
7. We note your disclosure on pages 24 and 124 that certain key
components of your
products are only available from single source suppliers. Please
expand your disclosure to
discuss your sources, the availability of raw materials and the names
of any principal
suppliers. See Item 101(h)(4)(v) of Regulation S-K.
The provisions of our amended and restated certificate of incorporation
requiring exclusive
forum..., page 72
8. We note your disclosure that the forum selection provision in your
amended certificate of
incorporation may have the effect of discouraging lawsuits against you
and your directors
and officers. Please revise this risk factor to disclose that there is
also a risk that your
forum selection provision may result in increased costs for investors
to bring a claim.
Use of Proceeds, page 79
9. Please confirm whether you intend to use the proceeds of the offering
towards the
development of any specific programs or products, and if so, how much
you intend to
allocate and how far the proceeds from the offering will allow you to
proceed with such
programs, as applicable. For example, we refer to your disclosure on
page 109 that you
expect to launch your CleanFlow PI in late 2021.
Management's Discussion and Analysis
Results of Operations, page 92
10. We note the discussion of revenue on page 92 explains the changes
therein for the two
operating and reporting segments. Considering the disclosure on page
F-39 that
your performance measures also include "gross profit and income from
operations",
FirstName LastNameBjarne Bergheim
please revise your analysis under the appropriate headings to explain
the nature of the
Comapany NameSonendo,
changes Inc. measures for the periods presented. Refer to
Section 501.06a
in those foregoing
of the
September 8, Financial
2021 PageReporting
3 Codification.
FirstName LastName
Bjarne Bergheim
FirstName LastNameBjarne Bergheim
Sonendo, Inc.
Comapany 8,
September NameSonendo,
2021 Inc.
September
Page 4 8, 2021 Page 4
FirstName LastName
Critical Accounting Policies and Estimates, page 98
11. We note the critical accounting policies related to stock-based
compensation and common
stock valuations on pages 101-103. Please revise to disclose the
specific methods used to
value your enterprise value and the nature of material assumptions
used. In addition,
disclose in the filing the extent to which any stock-based
compensation has been awarded
during 2021. 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 initial public offering 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.
Business
Market Overview
Limitations of Conventional Methods of Root Canal Therapy, page 114
12. We note your disclosure on page 114 relating to varying concentrations
of sodium
hypoclorite used during irrigation for RCT therapies, which may
contribute to
unpredictable procedure times and outcomes. Please confirm if any
chemicals are used
during irrigation as part of GentleWave System, such as your
company-branded EDTA,
and if so, please expand your disclosure of your product in this
section.
Our Solution
Components of the GentleWave System and Mechanism of Action, page 116
13. Please define EDTA where first used.
Peer-Reviewed Research and Clinical Studies, page 119
14. We note your disclosure of several published studies relating to your
GentleWave
System. Please revise to clarify whether each study was powered for
statistical
significance.
15. We refer to your disclosure on pages 121 and 122 relating to studies
comparing the
penetration depth of treatment fluids, the debridement efficacy and
biofilm removal
efficacy using the GentleWave System with devices commonly used in
conventional
methods. Please revise your disclosure to specify the type of medical
device and
technology used in the conventional method in your studies.
Bjarne Bergheim
FirstName LastNameBjarne Bergheim
Sonendo, Inc.
Comapany 8,
September NameSonendo,
2021 Inc.
September
Page 5 8, 2021 Page 5
FirstName LastName
Intellectual Property, page 126
16. We note that you have U.S. patents, U.S. pending patents, foreign
patents and foreign
pending patent applications that relate to both the GentleWave console
and procedure
instruments and future concepts for your products. Please expand your
disclosure to
specify on an individual or patent family basis the scope and
technology of each patent or
patent application, the type of patent protection, applicable
jurisdictions, and expected
expiration years. Note that it may be useful to include a table
containing this information
to supplement the narrative disclosure.
Financial Statements
9. Term Loan, page F-34
17. We note the disclosure on pages F-7 and F-36 that you are not
forecasting continued
compliance with the debt covenants associated with the term loan over
the next twelve
months, specifically in the first quarter of 2022. Please revise your
document to address
the following:
Quantify the required minimum liquidity amount and your actual
amounts achieved
pursuant to the covenant for the last four quarters.
Quantify the required minimum liquidity amount for the next four
quarters.
Disclose the status of any renegotiations to extend the term loan
and/or obtain a
waiver for an event of default.
Disclose the expected implications on your operations and
financial statements in the
event of a default.
General
18. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain,
copies of those
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
Jane Park at 202-551-7439 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Ross McAloon, Esq.