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SEC Comment Letter 0000000000-24-002707 to Adagio Medical Holdings, Inc. (ADGM) (CIK 0002006986) (ADGM)

Adagio Medical Holdings, Inc. (ADGM) (CIK 0002006986)
Date: March 12, 2024 · CIK: 0002006986 · Accession: 0000000000-24-002707

AI Filing Summary & Sentiment

Date
March 12, 2024
Author
Not clearly detected
Form
UPLOAD
Company
Adagio Medical Holdings, Inc. (ADGM) (CIK 0002006986)

Letter

United States securities and exchange commission logo March 12, 2024 Adam Stone Chief Executive Officer Aja Holdco, Inc. 51 Astor Place, 10th Floor New York, New York 10003 Re:Aja Holdco, Inc. Draft Registration Statement on Form S-4 Submitted February 14, 2024 CIK No. 0002006986 Dear Adam Stone: We have reviewed your draft registration statement and have the following comments. 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 a comment applies 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 this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Draft Registration Statement on Form S-4 Notice of Extraordinary General Meeting, page i 1.We note that the Dear Shareholders letter contains long sections of what appears to be entire clauses copied and pasted from legal agreements. Please revise to summarize the transactions and agreements described in the letter in plain English. Similarly, revise the entire section on pages 104 through 118. Market and Industry Data, page iii 2.Your statements that (i) "you are cautioned not to give undue weight to these estimates," (ii) "the accuracy and completeness of such information is not guaranteed," and (iii) "Adagio has not independently verified any third-party information" may imply an inappropriate disclaimer of responsibility with respect to the third party information and internal research. Please revise to clarify that, notwithstanding the foregoing, you believe that this information is reliable.

FirstName LastNameAdam Stone Comapany NameAja Holdco, Inc. March 12, 2024 Page 2 FirstName LastNameAdam Stone Aja Holdco, Inc. March 12, 2024 Page 2 3.Please revise here and in the business section to explain what you mean by your disclosure on page iv relating to "the novelty of the markets for Adagio's products" or remove this disclosure. Questions and Answers for Shareholders of Arya Q. What proposals are shareholders of ARYA being asked to vote upon, page xiv 4.We note that The Adjournment Proposal permits adjournment "if the holders of the Public Shares have elected to redeem such number of shares such that the New Adagio Common Stock would not be approved for listing on a U.S. stock exchange." Here or elsewhere in the Prospectus, please briefly describe the specific listing rules that could be implicated by redemptions and to provide additional detail regarding the level of redemptions that could cause the New Adagio Common Stock to fail to qualify for listing on a U.S. stock exchange. Include risk factor disclosure to describe material risks to public shareholders seeking to exercise their redemption rights. Summary Adagio Business Summary, page 1 5.Please balance your disclosure regarding Adagio in the Summary section to include equally prominent disclosure of the limitations you face in implementing your business strategy, including, but not limited to, the fact that Adagio has incurred net losses in each quarterly and annual period since inception and that it has not yet generated any meaningful revenue. 6.We note your statement that the preliminary data from your clinical trials is "suggestive of outcomes favorable to the current standard of care." Please expand on this statement to briefly describe the current standard of care and the way or ways in which the preliminary data from your clinical trials suggests more favorable outcomes compared to the current standard. 7.Please disclose that Adagio's audit report includes a paragraph related to substantial doubt about the ability of Adagio to continue as a going concern. 8.We note your statement here that "[s]ome of Adagio’s products have obtained regulatory approvals in the EU for commercialization" and on page 31 that "Adagio only has one product, iCLAS ULTC catheter and system, which is authorized for commercialization only in the European Union." If true, please revise your Summary section to state that you only have one product that has obtained regulatory approval or otherwise clarify this description. The ARYA Board's Reasons for the Business Combination, page 5 9.We note your statement here and on page 133 regarding "the support for the implied valuation of Adagio indicated by the commitments obtained from the PIPE Investors." Please clarify what you mean by "the implied valuation indicated by such commitments."

FirstName LastNameAdam Stone Comapany NameAja Holdco, Inc. March 12, 2024 Page 3 FirstName LastNameAdam Stone Aja Holdco, Inc. March 12, 2024 Page 3 Sponsor Letter Agreement, page 9 10.We note your disclosure that pursuant to the Sponsor Letter Agreement "each of the Insiders and ARYA agreed to terminate certain existing agreements or arrangements." Please clarify what existing agreements or arrangements will be terminated. Organizational Structure, page 10 11.We note that you included your organizational structures before and after the merger. Please revise the post business combination structure to show what percentages of the combined company will be owned by the current officers, directors and shareholders of both ARYA and Adagio, as well as PIPE investors. Risk Factors Risks Related to Adagio's Business Adagio is dependent on limited third-party suppliers and manufacturers, page 40 12.We note your disclosure that "Adagio relies on third-party suppliers to provide it with certain components of its products, some of which are single-source suppliers." Please identify specific third-party suppliers and briefly describe any contracts with such third- party suppliers, upon which Adagio's business is substantially dependent. Unfavorable U.S. or global economic conditions as a result of the COVID-19 pandemic, page 46 13.We note your reference to the potential impact on Adagio's "proteomics product platform." Please revise here and in the Business section to describe this product platform or advise. Subscription Agreements, page 119 14.We note that in several sections of your prospectus you refer to the “commitments by certain investors to subscribe for and purchase Class A Ordinary Shares in the open market and not to redeem such shares prior to the Closing Date.” Please disclose here and in other appropriate sections of the filing how you will determine the number of shares, also referred to as the “New Adagio Common Stock,” to be issued pursuant to the subscription agreements. Background of the Business Combination, page 123 15.We note your disclosure that on January 25, 2023, representatives of ARYA provided representatives of Adagio with a draft, non-binding term sheet with respect to the potential business combination, which provided for a $75 million pre-transaction equity value of Adagio. Please expand on this disclosure to explain how the parties arrived at the $75 million pre-transaction equity valuation, including the methodology employed in reaching the valuation. Please provide corresponding disclosure for the other valuations noted in the background section or explain what led to the changes in valuation during the course

FirstName LastNameAdam Stone Comapany NameAja Holdco, Inc. March 12, 2024 Page 4 FirstName LastNameAdam Stone Aja Holdco, Inc. March 12, 2024 Page 4 of the negotiations. In this regard, we note that between October 18, 2023 and November 28, 2023 it appears the equity value was reduced to $24 million. Finally, please expand on your discussion of the drafts of the business combination agreement to note the equity valuation included in such drafts or that the terms were consistent with the non-binding term sheet. 16.We note your disclosure that during the November 28, 2023 meeting, "ARYA’s management and representatives of the Sponsor provided the ARYA directors with an update on Adagio’s business, including updates to Adagio’s financial projections and refinements to Adagio’s go-to-market strategy." Please expand on this disclosure to describe Adagio's original financial projections and go-to-market strategy as well as the changes to such items. 17.We note your discussion relating to three potential business combination targets and seven potential business combination targets on page 122. You identify only Adagio and Amucus as potential acquisition targets in this section. Please identify each potential target and describe any letters of intent or confidentially agreements entered into with these target companies. 18.We note your discussion of the PIPE financing in this section. Please revise your disclosure to discuss whether there were any valuations or other material information about the SPAC, the target, or the de-SPAC transaction provided to potential PIPE investors that have not been disclosed publicly. Opinion of ARYA's Financial Advisor, page 136 19.We note your disclosure that in arriving at its opinion, Scalar reviewed certain internal estimates, and other data relating to the business and financial prospects of Adagio that were provided to Scalar by the management of ARYA. We also note your statement that "Scalar also was advised by ARYA’s senior management, and Scalar assumed, that the financial projections and other prospective information, including, but not limited to, projections for the timely receipt of governmental, regulatory and other third-party approvals, represented a reasonable basis upon which to evaluate the future business and financial prospects of Adagio." Please clarify if Scalar received and reviewed financial projections in connection with arriving at its opinion. If so, please disclose such projections and qualitatively and quantitatively describe all material assumptions underlying such projections. Opinion of ARYA's Financial Advisor Selected Precedent Financings and M&A Transactions Analysis, page 141 20.We note your statement that "Scalar selected these financings and M&A transactions based on information obtained by searching SEC filings, public company disclosures, press releases, equity research reports, industry and popular press reports, databases and other sources." Please revise to clarify the specific selection criteria used to create the list

FirstName LastNameAdam Stone Comapany NameAja Holdco, Inc. March 12, 2024 Page 5 FirstName LastName Adam Stone Aja Holdco, Inc. March 12, 2024 Page 5 of precedent financing and M&A transactions. Additionally, please note whether there were any financing or M&A transactions that met the selection criteria but were excluded from the list of precedent transactions. Unaudited Pro Forma Condensed Combined Financial Information, page 166 21.Please expand your disclosures here or within Note 1 to provide a clear description of all material components of Business Combination Agreement in addition to the Subscription Agreements and any other material agreements as required by Article 11-02(a)(2) of Regulation S-X. In this regard, also particularly provide discussions about the conversion of both entity’s equity outstanding prior to the closing. Note 2. Basis of Pro Forma Presentation, page 172 22.We note your conclusion that ARYA will be the accounting acquirer and Adagio will be the accounting acquiree resulting in the use of the accounting method of accounting in accordance with ASC 805. We further note that this conclusion is based, in part, on your assessment that Adagio is considered a Variable Interest Entity (VIE) upon consummation of the business combination due to the amount of “expected cash on hand resulting in the equity at risk being considered insufficient for Adagio to finance its activities without additional subordinated financial support.” Please provide us with your detailed analysis of Adagio’s anticipated facts and circumstances at the closing of the business combination with specific reference to the authoritative literature that supports your position. Refer to ASC 810-10-25-37 and ASC 810-10-15-14 for guidance. In this regard, we note that prior to the closing of the business combination, Adagio’s October 2022 convertible notes, warrants, and convertible preferred stock all convert into Adagio’s common stock. Lastly, please include in your response an accounting acquirer analysis under ASC 805-10-55-11 through ASC 805-10-55-15. 23.Please revise your tabular presentation of the pro forma shares of New Adagio Common Stock outstanding to exclude all dilutive securities and present the dilutive securities to be outstanding with the closing in a separate table or footnote disclosure by type and by holder. Also address the need to disclose the New Adagio options issued to Adagio option holders within Note 6. In this regard, we note the Sponsor Earn-Out Shares will be subject to a vesting criteria and Adagio’s options will be converted into New Adagio options. Also, separately present the shares to be acquired by the Perceptive PIPE Investor from the other PIPE Investors, as it would appear that the Perceptive PIPE Investor has an existing relationship with Adagio prior to the Business Combination. Refer to your disclosures on page 262, which notes CVF LLC, the Preceptive PIPE Investor, is a holder of more than 5% of Adagio’s capital stock.

FirstName LastNameAdam Stone Comapany NameAja Holdco, Inc. March 12, 2024 Page 6 FirstName LastName Adam Stone Aja Holdco, Inc. March 12, 2024 Page 6 Business of Adagio and Certain Information about Adagio, page 202 24.Please revise this section to disclose the following: •In regard to Adagio's product approved in the EU, please disclose if you are seeking EU approval for your other products and if not, why not. •In regard to Adagio's aspiration to receive FDA approval in the USA, clearly disclose which of your three products you are seeking the FDA approval for. •Clarify in what "select European markets" Adagio has commercially launched its iCLAS Cryoablation System, as referenced on page 231. •Clarify where Adagio's 97 full-time employees are located, as referenced on page 230. •Clarify the basis for your belief that "Adagio’s future success is largely dependent on its ability to successfully develop and commercialize in the United States its pipeline products," as stated on page 32, because it appears that even though Adagio's product launched in the EU in 2020, the company only achieved combined sales of less than $0.5 million in the fiscal years 2021 and 2022. Market Opportunity, page 202 25.Please provide the source or basis for the valuations, growth rates and estimates included in this section or note these statements are the belief of management. With respect to the CAGRs listed on page 203, please discuss any material assumptions underlying these projections. Current Ablation Catheter Technology Landscape, page 210 26.Please expand on your disclosure to explain the CIRCA-DOSE randomized clinical trial, including who conducted the trial and when it was performed. Key Benefits of ULTC, page 213 27.We note your statement that "[w]hile still at an early stage, we believe our ULTC results could potentially demonstrate a more durable clinical outcome." Please clarify what you mean by a more durable clinical outcome. Additionally, we note that the data presented in the chart on page 213 is not based on head-to-head clinical trials. You may not present a comparison of your product candidate to other products or third party product candidates unless you have conducted head-to-head trials. You may present objective result of clinical trials, but such results should not be compared to alternative products unless head- to-head studies were conducted. Accordingly, please remove these comparisons from the prospectus. Clinical Data, page 217 28.Please revise this section to include a brief description of the October 2021

Show Raw Text
United States securities and exchange commission logo
March 12, 2024
Adam Stone
Chief Executive Officer
Aja Holdco, Inc.
51 Astor Place, 10th Floor
New York, New York 10003
Re:Aja Holdco, Inc.
Draft Registration Statement on Form S-4
Submitted February 14, 2024
CIK No. 0002006986
Dear Adam Stone:
            We have reviewed your draft registration statement and have the following comments.
            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 a comment applies 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 this letter and your amended
draft registration statement or filed registration statement, we may have additional comments.
Draft Registration Statement on Form S-4
Notice of Extraordinary General Meeting, page i
1.We note that the Dear Shareholders letter contains long sections of what appears to be
entire clauses copied and pasted from legal agreements. Please revise to summarize the
transactions and agreements described in the letter in plain English. Similarly, revise the
entire section on pages 104 through 118.
Market and Industry Data, page iii
2.Your statements that (i) "you are cautioned not to give undue weight to these estimates,"
(ii) "the accuracy and completeness of such information is not guaranteed," and (iii)
"Adagio has not independently verified any third-party information" may imply an
inappropriate disclaimer of responsibility with respect to the third party information and
internal research. Please revise to clarify that, notwithstanding the foregoing, you believe
that this information is reliable.

 FirstName LastNameAdam Stone
 Comapany NameAja Holdco, Inc.
 March 12, 2024 Page 2
 FirstName LastNameAdam Stone
Aja Holdco, Inc.
March 12, 2024
Page 2
3.Please revise here and in the business section to explain what you mean by your disclosure
on page iv relating to "the novelty of the markets for Adagio's products" or remove this
disclosure.
Questions and Answers for Shareholders of Arya
Q. What proposals are shareholders of ARYA being asked to vote upon, page xiv
4.We note that The Adjournment Proposal permits adjournment "if the holders of the Public
Shares have elected to redeem such number of shares such that the New Adagio Common
Stock would not be approved for listing on a U.S. stock exchange." Here or elsewhere in
the Prospectus, please briefly describe the specific listing rules that could be implicated
by redemptions and to provide additional detail regarding the level of redemptions that
could cause the New Adagio Common Stock to fail to qualify for listing on a U.S. stock
exchange. Include risk factor disclosure to describe material risks to public shareholders
seeking to exercise their redemption rights.
Summary
Adagio Business Summary, page 1
5.Please balance your disclosure regarding Adagio in the Summary section to include
equally prominent disclosure of the limitations you face in implementing your business
strategy, including, but not limited to, the fact that Adagio has incurred net losses in each
quarterly and annual period since inception and that it has not yet generated any
meaningful revenue.
6.We note your statement that the preliminary data from your clinical trials is "suggestive of
outcomes favorable to the current standard of care." Please expand on this statement to
briefly describe the current standard of care and the way or ways in which the preliminary
data from your clinical trials suggests more favorable outcomes compared to the current
standard.
7.Please disclose that Adagio's audit report includes a paragraph related to substantial doubt
about the ability of Adagio to continue as a going concern.
8.We note your statement here that "[s]ome of Adagio’s products have obtained regulatory
approvals in the EU for commercialization" and on page 31 that "Adagio only has one
product, iCLAS ULTC catheter and system, which is authorized for commercialization
only in the European Union." If true, please revise your Summary section to state that you
only have one product that has obtained regulatory approval or otherwise clarify this
description.
The ARYA Board's Reasons for the Business Combination, page 5
9.We note your statement here and on page 133 regarding "the support for the implied
valuation of Adagio indicated by the commitments obtained from the PIPE Investors."
Please clarify what you mean by "the implied valuation indicated by such commitments."

 FirstName LastNameAdam Stone
 Comapany NameAja Holdco, Inc.
 March 12, 2024 Page 3
 FirstName LastNameAdam Stone
Aja Holdco, Inc.
March 12, 2024
Page 3
Sponsor Letter Agreement, page 9
10.We note your disclosure that pursuant to the Sponsor Letter Agreement "each of the
Insiders and ARYA agreed to terminate certain existing agreements or arrangements."
Please clarify what existing agreements or arrangements will be terminated.
Organizational Structure, page 10
11.We note that you included your organizational structures before and after the merger.
Please revise the post business combination structure to show what percentages of the
combined company will be owned by the current officers, directors and shareholders of
both ARYA and Adagio, as well as PIPE investors.
Risk Factors
Risks Related to Adagio's Business
Adagio is dependent on limited third-party suppliers and manufacturers, page 40
12.We note your disclosure that "Adagio relies on third-party suppliers to provide it with
certain components of its products, some of which are single-source suppliers." Please
identify specific third-party suppliers and briefly describe any contracts with such third-
party suppliers, upon which Adagio's business is substantially dependent.
Unfavorable U.S. or global economic conditions as a result of the COVID-19 pandemic, page 46
13.We note your reference to the potential impact on Adagio's "proteomics product
platform." Please revise here and in the Business section to describe this product platform
or advise.
Subscription Agreements, page 119
14.We note that in several sections of your prospectus you refer to the “commitments by
certain investors to subscribe for and purchase Class A Ordinary Shares in the open
market and not to redeem such shares prior to the Closing Date.” Please disclose here and
in other appropriate sections of the filing how you will determine the number of shares,
also referred to as the “New Adagio Common Stock,” to be issued pursuant to the
subscription agreements.
Background of the Business Combination, page 123
15.We note your disclosure that on January 25, 2023, representatives of ARYA provided
representatives of Adagio with a draft, non-binding term sheet with respect to the potential
business combination, which provided for a $75 million pre-transaction equity value of
Adagio. Please expand on this disclosure to explain how the parties arrived at the $75
million pre-transaction equity valuation, including the methodology employed in reaching
the valuation. Please provide corresponding disclosure for the other valuations noted in
the background section or explain what led to the changes in valuation during the course

 FirstName LastNameAdam Stone
 Comapany NameAja Holdco, Inc.
 March 12, 2024 Page 4
 FirstName LastNameAdam Stone
Aja Holdco, Inc.
March 12, 2024
Page 4
of the negotiations. In this regard, we note that between October 18, 2023 and November
28, 2023 it appears the equity value was reduced to $24 million. Finally, please expand on
your discussion of the drafts of the business combination agreement to note the equity
valuation included in such drafts or that the terms were consistent with the non-binding
term sheet.
16.We note your disclosure that during the November 28, 2023 meeting, "ARYA’s
management and representatives of the Sponsor provided the ARYA directors with an
update on Adagio’s business, including updates to Adagio’s financial projections and
refinements to Adagio’s go-to-market strategy." Please expand on this disclosure to
describe Adagio's original financial projections and go-to-market strategy as well as the
changes to such items.
17.We note your discussion relating to three potential business combination targets and seven
potential business combination targets on page 122. You identify only Adagio and
Amucus as potential acquisition targets in this section. Please identify each potential target
and describe any letters of intent or confidentially agreements entered into with
these target companies.
18.We note your discussion of the PIPE financing in this section. Please revise your
disclosure to discuss whether there were any valuations or other material information
about the SPAC, the target, or the de-SPAC transaction provided to potential PIPE
investors that have not been disclosed publicly.
Opinion of ARYA's Financial Advisor, page 136
19.We note your disclosure that in arriving at its opinion, Scalar reviewed certain internal
estimates, and other data relating to the business and financial prospects of Adagio that
were provided to Scalar by the management of ARYA. We also note your statement that
"Scalar also was advised by ARYA’s senior management, and Scalar assumed, that the
financial projections and other prospective information, including, but not limited to,
projections for the timely receipt of governmental, regulatory and other third-party
approvals, represented a reasonable basis upon which to evaluate the future business and
financial prospects of Adagio." Please clarify if Scalar received and reviewed financial
projections in connection with arriving at its opinion. If so, please disclose such
projections and qualitatively and quantitatively describe all material assumptions
underlying such projections.
Opinion of ARYA's Financial Advisor
Selected Precedent Financings and M&A Transactions Analysis, page 141
20.We note your statement that "Scalar selected these financings and M&A transactions
based on information obtained by searching SEC filings, public company disclosures,
press releases, equity research reports, industry and popular press reports, databases and
other sources." Please revise to clarify the specific selection criteria used to create the list

 FirstName LastNameAdam Stone
 Comapany NameAja Holdco, Inc.
 March 12, 2024 Page 5
 FirstName LastName
Adam Stone
Aja Holdco, Inc.
March 12, 2024
Page 5
of precedent financing and M&A transactions. Additionally, please note whether there
were any financing or M&A transactions that met the selection criteria but were excluded
from the list of precedent transactions.
Unaudited Pro Forma Condensed Combined Financial Information, page 166
21.Please expand your disclosures here or within Note 1 to provide a clear description of all
material components of Business Combination Agreement in addition to the Subscription
Agreements and any other material agreements as required by Article 11-02(a)(2) of
Regulation S-X. In this regard, also particularly provide discussions about the conversion
of both entity’s equity outstanding prior to the closing.
Note 2. Basis of Pro Forma Presentation, page 172
22.We note your conclusion that ARYA will be the accounting acquirer and Adagio will be
the accounting acquiree resulting in the use of the accounting method of accounting in
accordance with ASC 805. We further note that this conclusion is based, in part, on your
assessment that Adagio is considered a Variable Interest Entity (VIE) upon consummation
of the business combination due to the amount of “expected cash on hand resulting in the
equity at risk being considered insufficient for Adagio to finance its activities without
additional subordinated financial support.” Please provide us with your detailed analysis
of Adagio’s anticipated facts and circumstances at the closing of the business combination
with specific reference to the authoritative literature that supports your position. Refer to
ASC 810-10-25-37 and ASC 810-10-15-14 for guidance. In this regard, we note that prior
to the closing of the business combination, Adagio’s October 2022 convertible notes,
warrants, and convertible preferred stock all convert into Adagio’s common stock. Lastly,
please include in your response an accounting acquirer analysis under ASC 805-10-55-11
through ASC 805-10-55-15.
23.Please revise your tabular presentation of the pro forma shares of New Adagio Common
Stock outstanding to exclude all dilutive securities and present the dilutive securities to be
outstanding with the closing in a separate table or footnote disclosure by type and by
holder. Also address the need to disclose the New Adagio options issued to Adagio option
holders within Note 6. In this regard, we note the Sponsor Earn-Out Shares will be subject
to a vesting criteria and Adagio’s options will be converted into New Adagio options.
Also, separately present the shares to be acquired by the Perceptive PIPE Investor from
the other PIPE Investors, as it would appear that the Perceptive PIPE Investor has an
existing relationship with Adagio prior to the Business Combination. Refer to your
disclosures on page 262, which notes CVF LLC, the Preceptive PIPE Investor, is a holder
of more than 5% of Adagio’s capital stock.

 FirstName LastNameAdam Stone
 Comapany NameAja Holdco, Inc.
 March 12, 2024 Page 6
 FirstName LastName
Adam Stone
Aja Holdco, Inc.
March 12, 2024
Page 6
Business of Adagio and Certain Information about Adagio, page 202
24.Please revise this section to disclose the following:
•In regard to Adagio's product approved in the EU, please disclose if you are seeking
EU approval for your other products and if not, why not.
•In regard to Adagio's aspiration to receive FDA approval in the USA, clearly disclose
which of your three products you are seeking the FDA approval for.
•Clarify in what "select European markets" Adagio has commercially launched its
iCLAS Cryoablation System, as referenced on page 231.
•Clarify where Adagio's 97 full-time employees are located, as referenced on page
230.
•Clarify the basis for your belief that "Adagio’s future success is largely dependent on
its ability to successfully develop and commercialize in the United States its pipeline
products," as stated on page 32, because it appears that even though Adagio's product
launched in the EU in 2020, the company only achieved combined sales of less than
$0.5 million in the fiscal years 2021 and 2022.
Market Opportunity, page 202
25.Please provide the source or basis for the valuations, growth rates and estimates included
in this section or note these statements are the belief of management. With respect to the
CAGRs listed on page 203, please discuss any material assumptions underlying these
projections.
Current Ablation Catheter Technology Landscape, page 210
26.Please expand on your disclosure to explain the CIRCA-DOSE randomized clinical trial,
including who conducted the trial and when it was performed.
Key Benefits of ULTC, page 213
27.We note your statement that "[w]hile still at an early stage, we believe our ULTC results
could potentially demonstrate a more durable clinical outcome." Please clarify what you
mean by a more durable clinical outcome. Additionally, we note that the data presented in
the chart on page 213 is not based on head-to-head clinical trials. You may not present a
comparison of your product candidate to other products or third party product candidates
unless you have conducted head-to-head trials. You may present objective result of
clinical trials, but such results should not be compared to alternative products unless head-
to-head studies were conducted. Accordingly, please remove these comparisons from the
prospectus.
Clinical Data, page 217
28.Please revise this section to include a brief description of the October 2021