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SEC Comment Letter 0000000000-23-010771 to Capstone Dental Pubco, Inc. (CIK 0001989397)

Capstone Dental Pubco, Inc. (CIK 0001989397)
Date: Sept. 29, 2023 · CIK: 0001989397 · Accession: 0000000000-23-010771

AI Filing Summary & Sentiment

File numbers found in text: 333-274297

Date
September 29, 2023
Author
Not clearly detected
Form
UPLOAD
Company
Capstone Dental Pubco, Inc. (CIK 0001989397)

Letter

United States securities and exchange commission logo September 29, 2023 Melker Nilsson Chief Executive Officer Capstone Dental Pubco, Inc. 154 Middlesex Turnpike Burlington, MA 01803 Re:Capstone Dental Pubco, Inc. Registration Statement on Form S-4 Filed September 1, 2023 File No. 333-274297 Dear Melker Nilsson: We have reviewed your 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. Registration Statement on Form S-4 Cover Page 1.You disclose that New Parent will submit an application for Nasdaq listing and that the authorization for the listing on the Nasdaq Capital Market of the shares of New Parent common stock to be issued to Check-Cap shareholders in the Business Combination is a condition to the consummation of the Business Combination. Please update this disclosure, as appropriate, and disclose whether you will file the initial listing application prior to mailing the materials to shareholders.

FirstName LastNameMelker Nilsson Comapany NameCapstone Dental Pubco, Inc. September 29, 2023 Page 2 FirstName LastName Melker Nilsson Capstone Dental Pubco, Inc. September 29, 2023 Page 2 2.We note disclosure that New Parent may qualify as a “controlled company” and is subject to reduced public company disclosure standards. Please revise your "controlled company" disclosures to indicate that Accelmed will be your controlling shareholder and will own a majority of your outstanding common stock following the completion of the Business Combination. 3.Revise to describe the exchange ratio to provide additional context for shareholders instead of referring to the definition in the Business Combination Agreement. Q: What happens if the Business Combination is not consummated?, page 3 4.Please revise to clarify whether Check-Cap will remain a public reporting company and Check-Cap shareholders will continue to hold equity in Check-Cap if the Business Combination is not consummated. Q: What are the conditions to the consummation of the Business Combination?, page 3 5.Please revise to clarify whether the U.S. Merger and Israeli Merger are conditioned upon each other. Questions and Answers Q: Do any of the directors or executive officers of Keystone or Check-Cap have any interests in the Business Combination that may be differe, page 4 6.Revise to expand your disclosure to highlight the material conflicts of interests. Summary, page 8 7.We note your statement that Keystone develops and offers "effective and high-quality" technologies for dental practitioners. You also state elsewhere that certain technology can "accurately scan," "significantly reduce procedural complexity," and "implant data with high levels of accuracy." Please revise these and all similar statements in your registration statement to eliminate conclusions or predictions that your device in development is effective, implicitly or impliedly, as determinations of safety and efficacy are solely within the authority of the FDA and comparable regulatory bodies. We do not object to the presentation of objective data resulting from your trials without conclusions related to efficacy. 8.We note that you state that C-Scan is the first and only "patient-friendly preparation-free" test designed to detect polyps. Please further explain what you mean by both "patient- friendly" and "preparation-free." Please revise or also provide support for your statement that the test is the first and only of its kind, as you also disclose that Check-Cap expects to continue to generate losses for at least the next several years as it continues its investment in research and development and clinical trials in order to complete the development of C- Scan and to attain regulatory approvals.

FirstName LastNameMelker Nilsson Comapany NameCapstone Dental Pubco, Inc. September 29, 2023 Page 3 FirstName LastName Melker Nilsson Capstone Dental Pubco, Inc. September 29, 2023 Page 3 Risk Factors, page 24 9.We note your disclosure on page 248 that Keystone may be exposed to inflation risk in the United States and in some of the areas in which the company has international operations. Please describe this risk in the Risk Factors section. Background of the Business Combination, page 107 10.Please revise this section to provide additional details regarding the negotiations that led to the finalization of the key terms of the proposed business combination between the companies. For example, it is not clear how the parties determined the amount of consideration, relative valuations of the companies, or which parties was negotiating on a certain side of a material term or provision. Also expand your discussion of the initial term sheet and the ancillary agreements to identify the material terms negotiated and how they evolved. For example, where you disclose statements such as "GT, GGS and SL exchanged multiple drafts of the ancillary agreements," describe the terms, negotiations, each party's position on these issues, and ultimately how the parties came to a final agreement. 11.We note that on March 13, 2023, Mr. Ovadia and the management team delivered to the Board three proposed courses of action for the Company. We further note that following this meeting, and the announcement that Check-Cap did not meet their efficacy goal, the company adopted Plan A, to conduct additional clinical data analysis and amend the pivotal study protocol. Please revise to describe Check-Cap's rationale behind the adoption of Plan A and the Board's initial response to these proposals. 12.We note the disclosure that on April 6, 2023, Check-Cap’s Board held a meeting in which it considered three primary strategic options for Check-Cap: (i) continued investment in the development of C-Scan; (ii) liquidation and distribution of Check-Cap’s cash to its shareholders; and (iii) a reverse triangular merger transaction, which the company adopted. Please revise to include additional details to explain why a reverse triangular merger was deemed to provide higher value compared to other alternatives. 13.We note that between June 12 and June 15, 2023 Check-Cap exchanged drafts of non- binding term sheets with four companies, including Keystone. Please specify the industries in which these companies operated, summarize the material discussions held between May 30 and June 1, 2023, and state why each of the companies, other than Keystone, were not as strong of a candidate to participate in a strategic merger with Check-Cap. Please provide the same information for the third party inquiry considered in July 2023. 14.Revise to clarify whether Check-Cap received any non-binding offers from the four candidates after receipt of the draft term sheets. 15.Please clarify the FDA's position taken in the written feedback regarding Check-Cap's proposed alternative approaches as part of the Sprint process.

FirstName LastNameMelker Nilsson Comapany NameCapstone Dental Pubco, Inc. September 29, 2023 Page 4 FirstName LastName Melker Nilsson Capstone Dental Pubco, Inc. September 29, 2023 Page 4 16.You disclosed that in late July, 2023, in response to the receipt of an unsolicited inquiry from a third party, Check-Cap requested that Keystone release Check-Cap from the exclusivity provisions in the term sheet between the parties, to enable Check-Cap to respond to this inquiry, and Keystone subsequently permitted Check-Cap to do so. You further disclose that notwithstanding these interactions, the Check-Cap Board determined that the best course of action for Check-Cap’s shareholders was to proceed with the contemplated transaction with Keystone. Revise to disclose whether Check-Cap received any non-binding offers from this third party and discuss the reasons why the Check- Cap Board determined that the best course of action for Check-Cap’s shareholders was to proceed with the contemplated transaction with Keystone. 17.Based on press reports, Symetryx Corporation provided a non-binding offer, which was subsequently increased, to purchase Check-Cap. Please revise to disclose the reasons why the Check-Cap board did not accept the Symetryx Corporation offer and proceeded with the Keystone transaction. Check-Cap's Reasons for Approving the Business Combination, page 114 18.We note that at the August 15, 2023 board meeting, where the Check-Cap Shareholder Transaction Matters were unanimously approved, one director was absent. Please disclose whether this director voted, abstained, and or held a personal interest in the outcome of vote. Opinion of Check-Cap's Financial Advisors Discounted Cash Flow Analysis, page 127 19.We note your statements that "Keystone’s future financial results may materially differ from those expressed in the projections" and "[n]one of Check-Cap, Keystone, Ladenburg or any other person assumes responsibility if future results are materially different from those projected." It is not appropriate to directly or indirectly disclaim liability for statements in your registration statement. Accordingly, please delete these statements, and those similar, or revise to specifically state that you take liability for these statements. 20.Revise to disclose with greater specifically the "potential market for the Keystone portfolio," "competitive landscape" and "data from various databases" that the Check-Cap board of directors considered in formulating the financial projections. Please provide additional details and explain how the "revenue forecasts were modeled based on NORAM and the rest of world (RoW) sales." 21.We note the statement that "The projections included below are not being included herein to influence Check-Cap’s shareholders’ decision on whether to vote in favor of any proposal." However, we note that you have used and included the projections in this registration statement. Please revise to remove any implication that shareholders may not consider or rely on the disclosures.

FirstName LastNameMelker Nilsson Comapany NameCapstone Dental Pubco, Inc. September 29, 2023 Page 5 FirstName LastName Melker Nilsson Capstone Dental Pubco, Inc. September 29, 2023 Page 5 Opinion of Check-Cap's Financial Advisors Discounted Cash Flow Analysis, page 127 22.We see that you have provided projections of estimated annual revenues, cost of sales, research & development, other expenses, EBITDA and Unlevered cash flow for the years ended December 31, 2023 through 2033 and operating profit, income taxes, depreciation, capital expenditures and available cash flow through 2024. Please revise your disclosure to provide more specific assumptions to enhance an investors understanding of the basis for your projections. Please also specifically discuss your ability, and the related limitations with projections as far as 10 years out. We refer you to the Commissions guidance regarding projections provided in Item 10(b)(3) of Regulation S-K. 23.We also see that you present EBITDA and Unlevered Cash Flow. The presentation of projections that include a non-GAAP financial measures should include a clear definition or explanation of the measure, a description of the GAAP financial measure to which it is most closely related, and an explanation why the non- GAAP financial measure was used instead of a GAAP measure. Please revise. Regulatory Approvals, page 137 24.We note that, in order to make a distribution, Check-Cap must request approval for the distribution from a applicable Israeli District Court and that the court "may approve the distribution if it is convinced that there is no reasonable concern that the payment of a dividend will prevent Check-Cap from satisfying its existing and foreseeable obligations as they become due." We further note disclosure on page 275 noting that Check- Cap expects that it will continue to generate losses from its research and development and clinical trials, regulatory activities, manufacturing infrastructure and commercialization efforts of C-Scan, which will result in a negative cash flow from operating activity. You further disclose that Check-Cap anticipates that it will need to raise substantial additional financing in the future to fund its operations. Please disclose any existing and foreseeable obligations that Check-Cap may be required to pay or, if there are none, please so state. Material U.S. Federal Income Tax Consequences of the Business Combination for Holders of Keystone Securities, page 138 25.We note your statement that this section is a "discussion of certain U.S. federal income tax consequences" and that the section is "necessarily general..." Please revise your disclosure here to clarify that this section addresses the material U.S. federal income tax considerations as opposed to “certain” material U.S. federal income tax considerations. Additionally, please delete the disclaimer on page 143 that the summary of material tax considerations is necessarily general as such statement implies that investors are not entitled to rely on the disclosure in your registration statement.

FirstName LastNameMelker Nilsson Comapany NameCapstone Dental Pubco, Inc. September 29, 2023 Page 6 FirstName LastName Melker Nilsson Capstone Dental Pubco, Inc. September 29, 2023 Page 6 Representations and Warranties, page 159 26.Your disclosure in this section states that the Business Combination Agreement contains "customary" representations and warranties, and you describe general topics of representations and warranties. Please tailor your disclosure to your particular facts and circumstances by describing the specific, material representations and warranties included in your Business Combination Agreement. Unaudited Pro Forma Combined Financial Information Selected Unaudited Pro Forma Condensed Combined Balance Sheet Data, page 179 27.Pro forma total assets as presented in this table does not appear to agree with the amount presented on page 182. Please reconcile. Keystone's Products, page 191 28.Please revise your disclosure, here and throughout your discussions the companies' products, to balance your prominent discussions of the companies' competitive strengths with a discussion of the challenges they both face in corporate growth, international partnerships, growing competition, product development, and regulatory approvals. 29.Please further explain how manufacturing and research and development facilities provide more control over Keystone's supply chain and allow them to be nimble and quickly bring innovative products to market. 30.You state that "Osteon’s core technology can digitally perform an oral scan ... in a single, simple treatment." Please describe the treatment or remove the qualifier, "simple." 31.We note your statement that there are approximately 4 billion individuals missing one or more teeth, globally, and that Keystone's existing annual market opportunity is approximately $9 billion. We also note that sum of the market values in the table referenced on the same page, and your market disclosure on page 194, both appear to indicate a global market value of $11.3 billion. Please provide additional disclosure to reconcile these figures. We further note that Keystone's products are "commercially available in the United States and select international markets" and that "Keystone generated revenues of $60.6 million and a net loss of $28.3 million for the year ended December 31, 2022." Please provide additional disclosure to support the claim that Keystone's existing annual market opportunit

Show Raw Text
United States securities and exchange commission logo
September 29, 2023
Melker Nilsson
Chief Executive Officer
Capstone Dental Pubco, Inc.
154 Middlesex Turnpike
Burlington, MA 01803
Re:Capstone Dental Pubco, Inc.
Registration Statement on Form S-4
Filed September 1, 2023
File No. 333-274297
Dear Melker Nilsson:
            We have reviewed your 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.
Registration Statement on Form S-4
Cover Page
1.You disclose that New Parent will submit an application for Nasdaq listing and that the
authorization for the listing on the Nasdaq Capital Market of the shares of New Parent
common stock to be issued to Check-Cap shareholders in the Business Combination is a
condition to the consummation of the Business Combination. Please update this
disclosure, as appropriate, and disclose whether you will file the initial listing
application prior to mailing the materials to shareholders.

 FirstName LastNameMelker Nilsson
 Comapany NameCapstone Dental Pubco, Inc.
 September 29, 2023 Page 2
 FirstName LastName
Melker Nilsson
Capstone Dental Pubco, Inc.
September 29, 2023
Page 2
2.We note disclosure that New Parent may qualify as a “controlled company” and is subject
to reduced public company disclosure standards. Please revise your "controlled company"
disclosures to indicate that Accelmed will be your controlling shareholder and will own a
majority of your outstanding common stock following the completion of the Business
Combination.
3.Revise to describe the exchange ratio to provide additional context for shareholders
instead of referring to the definition in the Business Combination Agreement.
Q: What happens if the Business Combination is not consummated?, page 3
4.Please revise to clarify whether Check-Cap will remain a public reporting company and
Check-Cap shareholders will continue to hold equity in Check-Cap if the Business
Combination is not consummated.
Q: What are the conditions to the consummation of the Business Combination?, page 3
5.Please revise to clarify whether the U.S. Merger and Israeli Merger are conditioned upon
each other.
Questions and Answers
Q: Do any of the directors or executive officers of Keystone or Check-Cap have any interests in
the Business Combination that may be differe, page 4
6.Revise to expand your disclosure to highlight the material conflicts of interests.
Summary, page 8
7.We note your statement that Keystone develops and offers "effective and high-quality"
technologies for dental practitioners. You also state elsewhere that certain technology can
"accurately scan," "significantly reduce procedural complexity," and "implant data with
high levels of accuracy." Please revise these and all similar statements in your registration
statement to eliminate conclusions or predictions that your device in development is
effective, implicitly or impliedly, as determinations of safety and efficacy are solely
within the authority of the FDA and comparable regulatory bodies. We do not object to
the presentation of objective data resulting from your trials without conclusions related to
efficacy.
8.We note that you state that C-Scan is the first and only "patient-friendly preparation-free"
test designed to detect polyps. Please further explain what you mean by both "patient-
friendly" and "preparation-free." Please revise or also provide support for your statement
that the test is the first and only of its kind, as you also disclose that Check-Cap expects to
continue to generate losses for at least the next several years as it continues its investment
in research and development and clinical trials in order to complete the development of C-
Scan and to attain regulatory approvals.

 FirstName LastNameMelker Nilsson
 Comapany NameCapstone Dental Pubco, Inc.
 September 29, 2023 Page 3
 FirstName LastName
Melker Nilsson
Capstone Dental Pubco, Inc.
September 29, 2023
Page 3
Risk Factors, page 24
9.We note your disclosure on page 248 that Keystone may be exposed to inflation risk in the
United States and in some of the areas in which the company has international operations.
Please describe this risk in the Risk Factors section.
Background of the Business Combination, page 107
10.Please revise this section to provide additional details regarding the negotiations that led
to the finalization of the key terms of the proposed business combination between the
companies. For example, it is not clear how the parties determined the amount of
consideration, relative valuations of the companies, or which parties was negotiating on a
certain side of a material term or provision. Also expand your discussion of the initial
term sheet and the ancillary agreements to identify the material terms negotiated and how
they evolved.  For example, where you disclose statements such as "GT, GGS and SL
exchanged multiple drafts of the ancillary agreements," describe the terms, negotiations,
each party's position on these issues, and ultimately how the parties came to a final
agreement.
11.We note that on March 13, 2023, Mr. Ovadia and the management team delivered to the
Board three proposed courses of action for the Company. We further note that following
this meeting, and the announcement that Check-Cap did not meet their efficacy goal, the
company adopted Plan A, to conduct additional clinical data analysis and amend the
pivotal study protocol.  Please revise to describe Check-Cap's rationale behind the
adoption of Plan A and the Board's initial response to these proposals.
12.We note the disclosure that on April 6, 2023, Check-Cap’s Board held a meeting in which
it considered three primary strategic options for Check-Cap: (i) continued investment in
the development of C-Scan; (ii) liquidation and distribution of Check-Cap’s cash to its
shareholders; and (iii) a reverse triangular merger transaction, which the company
adopted. Please revise to include additional details to explain why a reverse triangular
merger was deemed to provide higher value compared to other alternatives.
13.We note that between June 12 and June 15, 2023 Check-Cap exchanged drafts of non-
binding term sheets with four companies, including Keystone. Please specify the
industries in which these companies operated, summarize the material discussions held
between May 30 and June 1, 2023, and state why each of the companies, other than
Keystone, were not as strong of a candidate to participate in a strategic merger with
Check-Cap. Please provide the same information for the third party inquiry considered in
July 2023.
14.Revise to clarify whether Check-Cap received any non-binding offers from the four
candidates after receipt of the draft term sheets.
15.Please clarify the FDA's position taken in the written feedback regarding Check-Cap's
proposed alternative approaches as part of the Sprint process.

 FirstName LastNameMelker Nilsson
 Comapany NameCapstone Dental Pubco, Inc.
 September 29, 2023 Page 4
 FirstName LastName
Melker Nilsson
Capstone Dental Pubco, Inc.
September 29, 2023
Page 4
16.You disclosed that in late July, 2023, in response to the receipt of an unsolicited inquiry
from a third party, Check-Cap requested that Keystone release Check-Cap from the
exclusivity provisions in the term sheet between the parties, to enable Check-Cap to
respond to this inquiry, and Keystone subsequently permitted Check-Cap to do so. You
further disclose that notwithstanding these interactions, the Check-Cap Board determined
that the best course of action for Check-Cap’s shareholders was to proceed with the
contemplated transaction with Keystone. Revise to disclose whether Check-Cap received
any non-binding offers from this third party and discuss the reasons why the Check-
Cap Board determined that the best course of action for Check-Cap’s shareholders was to
proceed with the contemplated transaction with Keystone.
17.Based on press reports, Symetryx Corporation provided a non-binding offer, which was
subsequently increased, to purchase Check-Cap.  Please revise to disclose the reasons why
the Check-Cap board did not accept the Symetryx Corporation offer and proceeded with
the Keystone transaction.
Check-Cap's Reasons for Approving the Business Combination, page 114
18.We note that at the August 15, 2023 board meeting, where the Check-Cap Shareholder
Transaction Matters were unanimously approved, one director was absent. Please disclose
whether this director voted, abstained, and or held a personal interest in the outcome of
vote.
Opinion of Check-Cap's Financial Advisors
Discounted Cash Flow Analysis, page 127
19.We note your statements that "Keystone’s future financial results may materially differ
from those expressed in the projections" and "[n]one of Check-Cap, Keystone, Ladenburg
or any other person assumes responsibility if future results are materially different from
those projected." It is not appropriate to directly or indirectly disclaim liability for
statements in your registration statement. Accordingly, please delete these statements, and
those similar, or revise to specifically state that you take liability for these statements.
20.Revise to disclose with greater specifically the "potential market for the Keystone
portfolio," "competitive landscape" and "data from various databases" that the Check-Cap
board of directors considered in formulating the financial projections. Please provide
additional details and explain how the "revenue forecasts were modeled based on
NORAM and the rest of world (RoW) sales."
21.We note the statement that "The projections included below are not being included herein
to influence Check-Cap’s shareholders’ decision on whether to vote in favor of any
proposal." However, we note that you have used and included the projections in this
registration statement. Please revise to remove any implication that shareholders may not
consider or rely on the disclosures.

 FirstName LastNameMelker Nilsson
 Comapany NameCapstone Dental Pubco, Inc.
 September 29, 2023 Page 5
 FirstName LastName
Melker Nilsson
Capstone Dental Pubco, Inc.
September 29, 2023
Page 5
Opinion of Check-Cap's Financial Advisors
Discounted Cash Flow Analysis, page 127
22.We see that you have provided projections of estimated annual revenues, cost of sales,
research & development, other expenses, EBITDA and Unlevered cash flow for the years
ended December 31, 2023 through 2033 and operating profit, income taxes, depreciation,
capital expenditures and available cash flow through 2024. Please revise your disclosure
to provide more specific assumptions to enhance an investors understanding of the basis
for your projections. Please also specifically discuss your ability, and the related
limitations with projections as far as 10 years out. We refer you to the Commissions
guidance regarding projections provided in Item 10(b)(3) of Regulation S-K.
23.We also see that you present EBITDA and Unlevered Cash Flow. The presentation
of projections that include a non-GAAP financial measures should include a clear
definition or explanation of the measure, a description of the GAAP financial measure to
which it is most closely related, and an explanation why the non- GAAP financial measure
was used instead of a GAAP measure. Please revise.
Regulatory Approvals, page 137
24.We note that, in order to make a distribution, Check-Cap must request approval for the
distribution from a applicable Israeli District Court and that the court "may approve the
distribution if it is convinced that there is no reasonable concern that the payment of a
dividend will prevent Check-Cap from satisfying its existing and foreseeable obligations
as they become due." We further note disclosure on page 275 noting that Check-
Cap expects that it will continue to generate losses from its research and development and
clinical trials, regulatory activities, manufacturing infrastructure and commercialization
efforts of C-Scan, which will result in a negative cash flow from operating activity. You
further disclose that Check-Cap anticipates that it will need to raise substantial additional
financing in the future to fund its operations. Please disclose any existing and foreseeable
obligations that Check-Cap may be required to pay or, if there are none, please so state.
Material U.S. Federal Income Tax Consequences of the Business Combination for Holders of
Keystone Securities, page 138
25.We note your statement that this section is a "discussion of certain U.S. federal income tax
consequences" and that the section is "necessarily general..."  Please revise your
disclosure here to clarify that this section addresses the material U.S. federal income tax
considerations as opposed to “certain” material U.S. federal income tax considerations.
Additionally, please delete the disclaimer on page 143 that the summary of material tax
considerations is necessarily general as such statement implies that investors are not
entitled to rely on the disclosure in your registration statement.

 FirstName LastNameMelker Nilsson
 Comapany NameCapstone Dental Pubco, Inc.
 September 29, 2023 Page 6
 FirstName LastName
Melker Nilsson
Capstone Dental Pubco, Inc.
September 29, 2023
Page 6
Representations and Warranties, page 159
26.Your disclosure in this section states that the Business Combination Agreement contains
"customary" representations and warranties, and you describe general topics of
representations and warranties. Please tailor your disclosure to your particular facts and
circumstances by describing the specific, material representations and warranties included
in your Business Combination Agreement.
Unaudited Pro Forma Combined Financial Information
Selected Unaudited Pro Forma Condensed Combined Balance Sheet Data, page 179
27.Pro forma total assets as presented in this table does not appear to agree with the amount
presented on page 182. Please reconcile.
Keystone's Products, page 191
28.Please revise your disclosure, here and throughout your discussions the companies'
products, to balance your prominent discussions of the companies' competitive strengths
with a discussion of the challenges they both face in corporate growth, international
partnerships, growing competition, product development, and regulatory approvals.
29.Please further explain how manufacturing and research and development facilities
provide more control over Keystone's supply chain and allow them to be nimble and
quickly bring innovative products to market.
30.You state that "Osteon’s core technology can digitally perform an oral scan ... in a single,
simple treatment." Please describe the treatment or remove the qualifier, "simple."
31.We note your statement that there are approximately 4 billion individuals missing one or
more teeth, globally, and that Keystone's existing annual market opportunity is
approximately $9 billion. We also note that sum of the market values in the table
referenced on the same page, and your market disclosure on page 194, both appear to
indicate a global market value of $11.3 billion. Please provide additional disclosure to
reconcile these figures. We further note that Keystone's products are "commercially
available in the United States and select international markets" and that "Keystone
generated revenues of $60.6 million and a net loss of $28.3 million for the year ended
December 31, 2022." Please provide additional disclosure to support the claim that
Keystone's existing annual market opportunit