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SEC Comment Letter 0000000000-23-008113 to Envoy Medical, Inc. (COCH, COCHW) (CIK 0001840877) (COCH)

Envoy Medical, Inc. (COCH, COCHW) (CIK 0001840877)
Date: July 28, 2023 · CIK: 0001840877 · Accession: 0000000000-23-008113

AI Filing Summary & Sentiment

File numbers found in text: 333-271920

Date
July 28, 2023
Author
Not clearly detected
Form
UPLOAD
Company
Envoy Medical, Inc. (COCH, COCHW) (CIK 0001840877)

Letter

United States securities and exchange commission logo July 28, 2023 Dr. Whitney Haring-Smith Chief Executive Officer Anzu Special Acquisition Corp I 12610 Race Track Road, Suite 250 Tampa, FL 33626 Re:Anzu Special Acquisition Corp I Amendment No. 1 to Registration Statement on Form S-4 Filed June 30, 2023 File No. 333-271920 Dear Dr. Whitney Haring-Smith: We have reviewed your amended 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 amending your registration statement and providing the requested information. 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 any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our June 13, 2023 letter. Amendment No. 1 to Registration Statement on Form S-4 Filed June 30, 2023 Q. Will Anzu enter into any financing arrangements in connection with the Business Combination?, page xiv 1.We note your amended disclosure in response to comment 2. Please briefly describe the "ertain customary adjustments in the event of certain events affecting the price of the New Envoy Class A Common Stock." Interests of the Sponsor and Anzu's Directors and Officers in the Business Combination, page 11 2.We note your response to previous comment 25, but we are not persuaded by your response. Please provide your analysis of how purchases under your forward purchase agreement will comply, and how the extension support agreements described at the

FirstName LastNameDr. Whitney Haring-Smith Comapany NameAnzu Special Acquisition Corp I July 28, 2023 Page 2 FirstName LastNameDr. Whitney Haring-Smith Anzu Special Acquisition Corp I July 28, 2023 Page 2 bottom of page 11 comply, with Rule 14e-5. Specifically, please provide additional detail explaining how the agreement satisfies the requirement in the exemption in 14e-5(b)(7)(ii) that the agreement is "unconditional and binding on both parties," given your disclosure that "[p]ursuant to the terms of the Forward Purchase Agreement, Seller intends, but is not obligated, to purchase . . . shares of Anzu Class A Common Stock" (emphasis added). Alternatively, please provide the disclosure required by Tender Offer Compliance and Disclosure Interpretation 166.01 (March 22, 2022), and ensure that the required conditions are met. Risk Factors Certain of our directors, director nominees . . ., page 36 3.We note your amended disclosure in response to comment 13. Please amend your disclosure to briefly describe the duties or obligations of the relevant directors with respect to the entities discussed, including fiduciary duties or contractual obligations. The Proposed Charter will provide that the Court of Chancery . . ., page 80 4.Please revise this risk factor, and your discussion of the warrant agreement exclusive forum provision on page 251, to disclose the risks that the exclusive forum provision may both limit a warrant holder's ability to bring a claim and potentially increase costs for investors to bring a claim. Unaudited Pro Forma Condensed Combined Financial Statements, page 129 5.We note your response to comment 19. Please expand your disclosure to discuss the impact to the financial statements on a pro forma basis should the working capital loan be converted into warrants. 6.We note your response to comment 20, please clarify the reason that the $10 million convertible promissory note with the shareholder is not presented as a liability on the pro forma balance sheets, given the note will be funded prior to the merger and the maturity date is December 31, 2025. Representations, Warranties, and Covenants, page 144 7.We note your amended disclosure in response to comment 22, including "material representations and warranties: . . . litigation and actions pending or threated against . . . Envoy or any settlements related thereto." Given your risk factor disclosure that Envoy is currently a party to litigation, please clarify the representation or warranty related to litigation and the potential impact, if any, of the disclosed litigation on the merger agreement. 8.We note your amended disclosure on page 144 that the representations and warranties included a representation by Anzu that there would be at least $43,913,470 in the trust account. Please amend your filing, including your risk factors and background of the

FirstName LastNameDr. Whitney Haring-Smith Comapany NameAnzu Special Acquisition Corp I July 28, 2023 Page 3 FirstName LastName Dr. Whitney Haring-Smith Anzu Special Acquisition Corp I July 28, 2023 Page 3 business combination, to disclose this minimum cash condition. In your background discussion, please disclose how the parties arrived at this minimum cash condition, including any negotiations and relative positions of each party to the merger. Background of the Business Combination, page 159 9.We note your revisions in response to previous comment number 28 and reissue the comment. Please revise your disclosure throughout this section to include detailed descriptions of negotiations relating to material terms of the business combination and related transactions, including, but not limited to, the key terms of the PIPE Transaction; the Sponsor Support Agreement, including the Sponsor agreeing to forfeit certain securities; the proposed Envoy Conversions and the cancellation of outstanding Envoy options for nominal consideration; the determination to enter into the Forward Purchase Agreement and the key terms of the agreement, including the Shortfall Warrants; the determination to enter into the Envoy Bridge note and the key terms of the note, including the purpose of the note and any conflicts of interest considered; the initial valuation for Envoy of $150.0 million and any related negotiations; the agreements with Key Shareholders; and the Exchange Offer. In your revised disclosure, please explain the reasons for such agreements and terms, each party's position on such issues, and how you reached agreement on the final terms and agreements. For example, where you disclose statements such as "[p]rincipal terms were discussed, including what terms would be acceptable to shareholders for Envoy and Anzu," describe the terms, negotiations, each party's position on these issues, and ultimately how the parties came to a final agreement. This is one example only, and changes should be made to your discussion throughout this section. 10.We note your disclosure in response to comment 33 that Anzu engaged MCRA to conduct diligence with respect to the Acclaim implant device and its potential for insurance reimbursement. Please disclose whether the Anzu board received a due diligence report from MCRA, and if so, please provide the information required by Item 4(b) of Form S-4 and Item 1015(b) of Regulation M-A, or tell us why you do not believe you are required to do so. Side Letters with Legacy Forward Purchasers, page 159 11.We note your amended disclosure in response to comment 27, including that "[n]otwithstanding the termination of the Legacy Forward Purchase Agreements described above, the side letter agreements between Anzu and the Legacy Forward Purchasers remain in full force and effect as of the date of this proxy statement/prospectus." Please clarify the purpose of the side letter agreements, including why these agreements remain in full force and effect notwithstanding the termination of the Legacy Forward Purchase Agreements. Please also file the side letter agreements as exhibits to your registration statement or tell us why you believe you are not required to do so.

FirstName LastNameDr. Whitney Haring-Smith Comapany NameAnzu Special Acquisition Corp I July 28, 2023 Page 4 FirstName LastName Dr. Whitney Haring-Smith Anzu Special Acquisition Corp I July 28, 2023 Page 4 The Anzu Board's Reasons for the Business Combination, page 167 12.We note your response to previous comment 34 and reissue in part. Please amend your disclosure to describe the Board's reasoning in deciding to forego obtaining a fairness opinion and describe the relevant expertise of the board members. Also, please identify the management and financial, legal, tax and accounting advisors consulted by management to the extent any differ from those discussed in the Background of the Business Combination section. 13.We note the your revisions in response to previous comment 35, including that the Anzu Board considered, among other factors, the revenues, earnings and market capitalizations of the incumbent competitors currently selling partially-implanted medical devices, and the capture of market share by analogous medical device companies. Please revise to describe the Board's methodology for identifying comparable companies and describe the analyses performed to arrive at the valuation of Envoy. Additionally, please remove the reference to other public listing transactions and their valuation methods or explain how the valuations of these other companies are relevant to Envoy's valuation. Finally, please clarify why the opportunity for holders of Anzu Class A Common Stock to exchange their shares for Series A Preferred Stock provided additional comfort that the valuation of Envoy was reasonable. 14.We note your disclosure referencing "[t]hird party diligence providers" and industry- relevant consultants, including that these entities provided diligence regarding the potential timing for FDA approval and reimbursement. Please revise to identify these providers. Management's Discussion and Analysis of Financial Condition and Results of Operations of Anzu Liquidity and Capital Resources, page 180 15.We note your response to comment 37, including your amended disclosure that "following industry developments, one of the two underwriters from our initial public offering unconditionally resigned and $4,462,500 of the $14,875,000 deferred underwriter discount was forgiven. In February 2023, the remaining underwriter resigned from its role in the Business Combination and thereby waived its entitlement to $10,412,500 in deferred underwriting fees solely with respect to the Business Combination." Please identify the relevant underwriters in your disclosure and provide a detailed discussion of the reasons underlying the resignation of both of these underwriters, including the "industry developments" that caused one of the two underwriters to resign, and the reasons underlying the resignation of the second underwriter. In your discussion, and where appropriate throughout your registration statement, please address the following:

•We understand that the underwriters in your SPAC IPO intend to waive the deferred underwriting commissions that would otherwise be due to them upon the closing of

FirstName LastNameDr. Whitney Haring-Smith Comapany NameAnzu Special Acquisition Corp I July 28, 2023 Page 5 FirstName LastNameDr. Whitney Haring-Smith Anzu Special Acquisition Corp I July 28, 2023 Page 5 the business combination. Please disclose how this waiver was obtained, why the waiver was agreed to, and clarify the SPAC’s current relationship with the underwriters.

•Please describe what relationship existed between the underwriters and Anzu after the close of the IPO, including any financial or merger-related advisory services conducted by the underwriters. For example, clarify whether the underwriters had any role in the identification or evaluation of business combination targets.

•Tell us whether the underwriters were involved in the preparation of any disclosure that is included in the Form S-4 registration statement, including any analysis underlying disclosure in the registration statement. If so, clarify their involvement, whether they have retracted any work product associated with the transaction, and the risk of such withdrawal and reliance on their expertise. Further, please clarify that whether the underwriters claim no role in the SPAC’s business combination transaction and whether the underwriters have affirmatively disclaimed any responsibility for any of the disclosure in this registration statement.

•Please tell us whether you are aware of any disagreements with the underwriters regarding the disclosure in your registration statement. Further, please add risk factor disclosure that clarifies that the underwriters were to be compensated, in part, on a deferred basis for its underwriting services in connection with the SPAC IPO and such services have already been rendered, yet the underwriters are waiving such fees. Clarify the unusual nature of such a fee waiver and the impact of it on the evaluation of the business combination.

•Disclose whether the underwriters provided you with any reasons for the fee waiver. If there was no dialogue and you did not seek out the reasons why the underwriters were waiving deferred fees, despite already completing their services, please indicate so in your registration statement. Further, revise the risk factor disclosure to explicitly clarify that the underwriters have performed all their obligations to obtain the fee and therefore is gratuitously waiving the right to be compensated. Acclaim's Market Opportunity, page 188 16.We note your revisions throughout this section in response to previous comment 38 and reissue in part. Please provide a citation to the referenced articles and, at each source's first instance, include language summarizing the material conclusions of such literature. With regard to citations, footnotes may be useful. 17.We note your response to comment 39, and your amended disclosure in response to the comment that "although the process of obtaining FDA approval is uncertain, and we may not obtain approval on that timeline or at all; and "FDA approval is not guaranteed and

FirstName LastNameDr. Whitney Haring-Smith Comapany NameAnzu Special Acquisition Corp I July 28, 2023 Page 6 FirstName LastName Dr. Whitney Haring-Smith Anzu Special Acquisition Corp I July 28, 2023 Page 6 each step of the process may take longer than we have planned." Please amend your disclosure, here and throughout the description of Envoy's business and market opportunity, to provide a detailed discussion of the challenges you face in corporate growth, distribution capabilities and partnerships, and product development, if regulatory approvals are delayed or not received. This disclosure should balance your prominent discussions of your device's competitive strengths. Market Competition, page 189 18.We note your disclosure here that Cochlear Ltd. is the leading cochlear implant device manufacturer with approximately 60% of global market share, and your disclosure that "[w]hile there is some overlap between hearing aid and cochlear implant use, candidates for cochlear implants are no longer appropriate hearing aid candidates. As a result, we believe the competition between hearing aid and cochlear implant manufacturers for the same clinical patient population is minimal." Given your disclosure that Cochlear Ltd. is a cochlear implant device manufacturer, please clarify the relevance of your above statement about hearing aids. In addition, please describe your competitive position with respect to the other of the "three major cochlear implant manufacturers." General 19.Where appropriate throughout your filing, including but not limited to your risk factors, please disclose certain interests of the Envoy directors and officers, to include, but not limited to, a reference to the GAT Convertible Note, including that this note will convert into 74.8 million shares of Envoy common stock immediately prior to

Show Raw Text
United States securities and exchange commission logo
July 28, 2023
Dr. Whitney Haring-Smith
Chief Executive Officer
Anzu Special Acquisition Corp I
12610 Race Track Road, Suite 250
Tampa, FL 33626
Re:Anzu Special Acquisition Corp I
Amendment No. 1 to Registration Statement on Form S-4
Filed June 30, 2023
File No. 333-271920
Dear Dr. Whitney Haring-Smith:
            We have reviewed your amended 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 amending your registration statement and providing the
requested information.  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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.  Unless we note
otherwise, our references to prior comments are to comments in our June 13, 2023 letter.
Amendment No. 1 to Registration Statement on Form S-4 Filed June 30, 2023
Q. Will Anzu enter into any financing arrangements in connection with the Business
Combination?, page xiv
1.We note your amended disclosure in response to comment 2.  Please briefly describe the
"ertain customary adjustments in the event of certain events affecting the price of the New
Envoy Class A Common Stock."
Interests of the Sponsor and Anzu's Directors and Officers in the Business Combination, page 11
2.We note your response to previous comment 25, but we are not persuaded by your
response.  Please provide your analysis of how purchases under your forward purchase
agreement will comply, and how the extension support agreements described at the

 FirstName LastNameDr. Whitney Haring-Smith
 Comapany NameAnzu Special Acquisition Corp I
 July 28, 2023 Page 2
 FirstName LastNameDr. Whitney Haring-Smith
Anzu Special Acquisition Corp I
July 28, 2023
Page 2
bottom of page 11 comply, with Rule 14e-5.  Specifically, please provide additional detail
explaining how the agreement satisfies the requirement in the exemption in 14e-5(b)(7)(ii)
that the agreement is "unconditional and binding on both parties," given your disclosure
that "[p]ursuant to the terms of the Forward Purchase Agreement, Seller intends, but is not
obligated, to purchase . . . shares of Anzu Class A Common Stock" (emphasis added).
Alternatively, please provide the disclosure required by Tender Offer Compliance and
Disclosure Interpretation 166.01 (March 22, 2022), and ensure that the required conditions
are met.
Risk Factors
Certain of our directors, director nominees . . ., page 36
3.We note your amended disclosure in response to comment 13.  Please amend your
disclosure to briefly describe the duties or obligations of the relevant directors with
respect to the entities discussed, including fiduciary duties or contractual obligations.
The Proposed Charter will provide that the Court of Chancery . . ., page 80
4.Please revise this risk factor, and your discussion of the warrant agreement exclusive
forum provision on page 251, to disclose the risks that the exclusive forum provision
may both limit a warrant holder's ability to bring a claim and potentially increase costs for
investors to bring a claim.
Unaudited Pro Forma Condensed Combined Financial Statements, page 129
5.We note your response to comment 19.  Please expand your disclosure to discuss the
impact to the financial statements on a pro forma basis should the working capital loan be
converted into warrants.
6.We note your response to comment 20, please clarify the reason that the $10 million
convertible promissory note with the shareholder is not presented as a liability on the pro
forma balance sheets, given the note will be funded prior to the merger and the maturity
date is December 31, 2025.
Representations, Warranties, and Covenants, page 144
7.We note your amended disclosure in response to comment 22, including "material
representations and warranties: . . . litigation and actions pending or threated against . . .
Envoy or any settlements related thereto."  Given your risk factor disclosure that Envoy is
currently a party to litigation, please clarify the representation or warranty related to
litigation and the potential impact, if any, of the disclosed litigation on the merger
agreement.
8.We note your amended disclosure on page 144 that the representations and warranties
included a representation by Anzu that there would be at least $43,913,470 in the
trust account.  Please amend your filing, including your risk factors and background of the

 FirstName LastNameDr. Whitney Haring-Smith
 Comapany NameAnzu Special Acquisition Corp I
 July 28, 2023 Page 3
 FirstName LastName
Dr. Whitney Haring-Smith
Anzu Special Acquisition Corp I
July 28, 2023
Page 3
business combination, to disclose this minimum cash condition.  In your background
discussion, please disclose how the parties arrived at this minimum cash condition,
including any negotiations and relative positions of each party to the merger.
Background of the Business Combination, page 159
9.We note your revisions in response to previous comment number 28 and reissue the
comment.  Please revise your disclosure throughout this section to include detailed
descriptions of negotiations relating to material terms of the business combination and
related transactions, including, but not limited to, the key terms of the PIPE Transaction;
the Sponsor Support Agreement, including the Sponsor agreeing to forfeit certain
securities; the proposed Envoy Conversions and the cancellation of outstanding Envoy
options for nominal consideration; the determination to enter into the Forward Purchase
Agreement and the key terms of the agreement, including the Shortfall Warrants; the
determination to enter into the Envoy Bridge note and the key terms of the note, including
the purpose of the note and any conflicts of interest considered; the initial valuation for
Envoy of $150.0 million and any related negotiations; the agreements with Key
Shareholders; and the Exchange Offer.  In your revised disclosure, please explain the
reasons for such agreements and terms, each party's position on such issues, and how you
reached agreement on the final terms and agreements.  For example, where you disclose
statements such as "[p]rincipal terms were discussed, including what terms would be
acceptable to shareholders for Envoy and Anzu," describe the terms, negotiations, each
party's position on these issues, and ultimately how the parties came to a final agreement.
This is one example only, and changes should be made to your discussion throughout this
section.
10.We note your disclosure in response to comment 33 that Anzu engaged MCRA to conduct
diligence with respect to the Acclaim implant device and its potential for insurance
reimbursement.  Please disclose whether the Anzu board received a due diligence report
from MCRA, and if so, please provide the information required by Item 4(b) of Form S-4
and Item 1015(b) of Regulation M-A, or tell us why you do not believe you are required
to do so.
Side Letters with Legacy Forward Purchasers, page 159
11.We note your amended disclosure in response to comment 27, including that
"[n]otwithstanding the termination of the Legacy Forward Purchase Agreements described
above, the side letter agreements between Anzu and the Legacy Forward Purchasers
remain in full force and effect as of the date of this proxy statement/prospectus."  Please
clarify the purpose of the side letter agreements, including why these agreements remain
in full force and effect notwithstanding the termination of the Legacy Forward Purchase
Agreements.  Please also file the side letter agreements as exhibits to your registration
statement or tell us why you believe you are not required to do so.

 FirstName LastNameDr. Whitney Haring-Smith
 Comapany NameAnzu Special Acquisition Corp I
 July 28, 2023 Page 4
 FirstName LastName
Dr. Whitney Haring-Smith
Anzu Special Acquisition Corp I
July 28, 2023
Page 4
The Anzu Board's Reasons for the Business Combination, page 167
12.We note your response to previous comment 34 and reissue in part.  Please amend your
disclosure to describe the Board's reasoning in deciding to forego obtaining a fairness
opinion and describe the relevant expertise of the board members.  Also, please identify
the management and financial, legal, tax and accounting advisors consulted by
management to the extent any differ from those discussed in the Background of the
Business Combination section.
13.We note the your revisions in response to previous comment 35, including that the Anzu
Board considered, among other factors, the revenues, earnings and market capitalizations
of the incumbent competitors currently selling partially-implanted medical devices, and
the capture of market share by analogous medical device companies.  Please revise to
describe the Board's methodology for identifying comparable companies and describe the
analyses performed to arrive at the valuation of Envoy.  Additionally, please remove the
reference to other public listing transactions and their valuation methods or explain how
the valuations of these other companies are relevant to Envoy's valuation.  Finally, please
clarify why the opportunity for holders of Anzu Class A Common Stock to exchange their
shares for Series A Preferred Stock provided additional comfort that the valuation of
Envoy was reasonable.
14.We note your disclosure referencing "[t]hird party diligence providers" and industry-
relevant consultants, including that these entities provided diligence regarding the
potential timing for FDA approval and reimbursement.  Please revise to identify these
providers.
Management's Discussion and Analysis of Financial Condition and Results of Operations of
Anzu
Liquidity and Capital Resources, page 180
15.We note your response to comment 37, including your amended disclosure that "following
industry developments, one of the two underwriters from our initial public offering
unconditionally resigned and $4,462,500 of the $14,875,000 deferred underwriter discount
was forgiven.  In February 2023, the remaining underwriter resigned from its role in the
Business Combination and thereby waived its entitlement to $10,412,500 in deferred
underwriting fees solely with respect to the Business Combination."  Please identify the
relevant underwriters in your disclosure and provide a detailed discussion of the reasons
underlying the resignation of both of these underwriters, including the "industry
developments" that caused one of the two underwriters to resign, and the reasons
underlying the resignation of the second underwriter.  In your discussion, and where
appropriate throughout your registration statement, please address the following:

•We understand that the underwriters in your SPAC IPO intend to waive the deferred
underwriting commissions that would otherwise be due to them upon the closing of

 FirstName LastNameDr. Whitney Haring-Smith
 Comapany NameAnzu Special Acquisition Corp I
 July 28, 2023 Page 5
 FirstName LastNameDr. Whitney Haring-Smith
Anzu Special Acquisition Corp I
July 28, 2023
Page 5
the business combination.  Please disclose how this waiver was obtained, why the
waiver was agreed to, and clarify the SPAC’s current relationship with the
underwriters.

•Please describe what relationship existed between the underwriters and Anzu after the
close of the IPO, including any financial or merger-related advisory services
conducted by the underwriters.  For example, clarify whether the underwriters had
any role in the identification or evaluation of business combination targets.

•Tell us whether the underwriters were involved in the preparation of any disclosure
that is included in the Form S-4 registration statement, including any analysis
underlying disclosure in the registration statement.  If so, clarify their involvement,
whether they have retracted any work product associated with the transaction, and the
risk of such withdrawal and reliance on their expertise.  Further, please clarify that
whether the underwriters claim no role in the SPAC’s business combination
transaction and whether the underwriters have affirmatively disclaimed any
responsibility for any of the disclosure in this registration statement.

•Please tell us whether you are aware of any disagreements with the
underwriters regarding the disclosure in your registration statement.  Further, please
add risk factor disclosure that clarifies that the underwriters were to be compensated,
in part, on a deferred basis for its underwriting services in connection with the SPAC
IPO and such services have already been rendered, yet the underwriters are waiving
such fees.  Clarify the unusual nature of such a fee waiver and the impact of it on the
evaluation of the business combination.

•Disclose whether the underwriters provided you with any reasons for the fee waiver.
If there was no dialogue and you did not seek out the reasons why the
underwriters were waiving deferred fees, despite already completing their services,
please indicate so in your registration statement.  Further, revise the risk factor
disclosure to explicitly clarify that the underwriters have performed all their
obligations to obtain the fee and therefore is gratuitously waiving the right to be
compensated.
Acclaim's Market Opportunity, page 188
16.We note your revisions throughout this section in response to previous comment 38 and
reissue in part.  Please provide a citation to the referenced articles and, at each source's
first instance, include language summarizing the material conclusions of such literature.
With regard to citations, footnotes may be useful.
17.We note your response to comment 39, and your amended disclosure in response to the
comment that "although the process of obtaining FDA approval is uncertain, and we may
not obtain approval on that timeline or at all; and "FDA approval is not guaranteed and

 FirstName LastNameDr. Whitney Haring-Smith
 Comapany NameAnzu Special Acquisition Corp I
 July 28, 2023 Page 6
 FirstName LastName
Dr. Whitney Haring-Smith
Anzu Special Acquisition Corp I
July 28, 2023
Page 6
each step of the process may take longer than we have planned."  Please amend your
disclosure, here and throughout the description of Envoy's business and market
opportunity, to provide a detailed discussion of the challenges you face in corporate
growth, distribution capabilities and partnerships, and product development, if regulatory
approvals are delayed or not received.  This disclosure should balance your prominent
discussions of your device's competitive strengths.
Market Competition, page 189
18.We note your disclosure here that Cochlear Ltd. is the leading cochlear implant device
manufacturer with approximately 60% of global market share, and your disclosure that
"[w]hile there is some overlap between hearing aid and cochlear implant use, candidates
for cochlear implants are no longer appropriate hearing aid candidates.  As a result, we
believe the competition between hearing aid and cochlear implant manufacturers for the
same clinical patient population is minimal."  Given your disclosure that Cochlear Ltd. is
a cochlear implant device manufacturer, please clarify the relevance of your above
statement about hearing aids.  In addition, please describe your competitive position with
respect to the other of the "three major cochlear implant manufacturers."
General
19.Where appropriate throughout your filing, including but not limited to your risk factors,
please disclose certain interests of the Envoy directors and officers, to include, but not
limited to, a reference to the GAT Convertible Note, including that this note will convert
into 74.8 million shares of Envoy common stock immediately prior to