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SEC Comment Letter 0000000000-25-003854 to Heartflow, Inc. (HTFL)

Heartflow, Inc.
Date: April 10, 2025 · CIK: 0001464521 · Accession: 0000000000-25-003854

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
April 10, 2025
Author
cc: Ryan Coombs, Esq.
Form
UPLOAD
Company
Heartflow, Inc.

Letter

Re: Heartflow, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted March 27, 2025 CIK No. 0001464521 Dear John C.M. Farquhar:

April 10, 2025

John C.M. Farquhar Chief Executive Officer Heartflow, Inc. 331 E. Evelyn Avenue Mountain View, CA 94041

We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in our March 5, 2025 letter.

Amendment No. 1 to Draft Registration Statement on Form S-1 Prospectus Summary Overview, page 1

1. We note your disclosure in response to comment 3, including that your Heartflow FFRct Analysis "calculates blood flow and pinpoints clinically significant CAD, which is CAD with a fractional flow reserve value of .80 or below." Please revise your disclosure to define and explain at first instance the significance of "fractional flow reserve" with respect to coronary artery disease. 2. We note your response to comment 7, including that "all of the approximately 0.4 million patients with acute chest pain with NSTE...will be eligible for [y]our April 10, 2025 Page 2

Heartflow Plaque Analysis." Please revise to briefly explain why you believe that all of these patients will be eligible for your Heartflow Plaque Analysis. The Offering, page 13

3. We note your disclosure that $98.4 million of convertible promissory notes will automatically convert with the initial public offering. We also note that $23 million of outstanding indebtedness under the 2024 Credit Agreement was converted into 2025 Convertible Notes. Please revise your disclosure to include these additional 2025 Convertible Notes. Risk factors If we are unable to design, implement and maintain effective internal control over financial reporting..., page 62

4. We note that you previously included a risk factor detailing identified material weaknesses in your internal control over financial reporting, the material adjustments to your fiscal year 2023 financial statements as a result of these material weaknesses, along with adjustments made to your fiscal years 2019 through 2022 financial statements, and the remediation steps that have been implemented to address the material weaknesses. Please expand your risk factor to discuss the previously identified material weaknesses, the remediation steps implemented for the identified material weaknesses, and the status of your testing of your remediation efforts. We face risks associated with a concentrated customer base, page 62

5. We note your revised disclosure in response to comment 13, including that for the year ended December 31, 2024, your top two largest customers collectively represented approximately 8% of your revenue, and that as you expand the adoption of the Heartflow Platform to new accounts, your customer concentration risk may increase. Please clarify why the addition of new accounts may increase your customer concentration, including whether you expect current customers to open new accounts, and if so, the impact of the same on your growth strategies. Please also explain how you determine an account is "new," given your disclosure that decision-making for accounts is concentrated in a relatively small number of customers. Management's Discussion and Analysis of Financial Condition and Results of Operations Results of operations, page 86

6. Please expand your discussion and analysis of revenue to quantify the impact of the change in utilization and pricing, including the impact of rebates and the change in mix of customer accounts. Also, provide an explanation for the changes in mix of customer accounts. Refer to Item 303(b)(2) of Regulation S-K for guidance. 7. Please expand your discussion and analysis of gross margin to quantify the impact of the increase in revenue versus the automation of manual components of the production teams process. Refer to Item 303(b)(2) of Regulation S-K and Section 501.12 of the Financial Reporting Codification (i.e., Release 33-8350, Section III.B) for guidance. April 10, 2025 Page 3 Liquidity and capital resources Sources of liquidity, page 88

8. We note that you no longer believe that there is substantial doubt about your ability to continue as a going concern as of December 31, 2024 due to the 2025 Convertible Notes offering during the first quarter of fiscal year 2025. We further note that as of December 31, 2024, your working capital has decreased, the degree to which total liabilities exceeds total assets has increased, total stockholders deficit has increased, and you continue to recognize loss from operations and net loss that you expect will continue into the future. As such, please expand your disclosures to provide investors with a balanced outlook about the material factors that have impacted and will continue to impact your liquidity from a short-term and long-term perspective. Also provide a discussion about why the 2025 Convertible Notes issuances provide you with sufficient liquidity to meet all of your obligations within the next 12 months, including the amount of the net proceeds received from the issuances along with how the net proceeds were utilized. Refer to Item 303(b)(1) of Regulation S-K and Section 501.13 of the Financial Reporting Codification (i.e., Release 33-8350, Section IV) for guidance. Business Our Clinical Results and Economic Evidence, page 119

9. We note your response to comment 23, including the revised disclosures on pages 119 through 126. Please revise to disclose whether statistical significance was demonstrated, including supporting p-values, as appropriate, for all of the studies cited, specifically the PRECISE and PLATFORM studies. Please also expand upon the "usual care" pathways noted in the PRECISE trial, and explain how your PRECISE trial demonstrated that "NITs are inaccurate a majority of the time, and often result in either missed CAD diagnoses or unnecessary invasive procedures," as disclosed on page 125. Certain Relationships and Related-Party Transactions, page 162

10. We note your response to comment 26, including your disclosure on page 166 that "[c]ertain of [y]our obligations under the BCLS Letter Agreement will remain in effect after the completion of this offering, including [y]our obligation to obtain the consent of Bain Capital prior to making certain public disclosures about Bain Capital or certain of its affiliates, certain indemnification obligations and certain pro rata lock- up release rights of Bain Capital." Please revise to further discuss these indemnification obligations and pro-rata lock-up release rights. 18. Subsequent Events, page F-39

11. Please expand your disclosure for the 2025 Convertible Notes to disclose the net proceeds and effective interest rate. April 10, 2025 Page 4

Please contact Tracey Houser at 202-551-3736 or Terence O'Brien at 202-551-3355 if you have questions regarding comments on the financial statements and related matters. Please contact Juan Grana at 202-551-6034 or Katherine Bagley at 202-551-2545 with any other questions.

Sincerely,
Division of
Corporation Finance
Office of Industrial
Applications and
Services
cc: Ryan Coombs, Esq.

Show Raw Text
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 10, 2025

John C.M. Farquhar
Chief Executive Officer
Heartflow, Inc.
331 E. Evelyn Avenue
Mountain View, CA 94041

 Re: Heartflow, Inc.
 Amendment No. 1 to Draft Registration Statement on Form S-1
 Submitted March 27, 2025
 CIK No. 0001464521
Dear John C.M. Farquhar:

 We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to
comments in
our March 5, 2025 letter.

Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1

1. We note your disclosure in response to comment 3, including that your
Heartflow
 FFRct Analysis "calculates blood flow and pinpoints clinically
significant CAD,
 which is CAD with a fractional flow reserve value of .80 or below."
Please revise
 your disclosure to define and explain at first instance the significance
of "fractional
 flow reserve" with respect to coronary artery disease.
2. We note your response to comment 7, including that "all of the
approximately 0.4
 million patients with acute chest pain with NSTE...will be eligible for
[y]our
 April 10, 2025
Page 2

 Heartflow Plaque Analysis." Please revise to briefly explain why you
believe that all
 of these patients will be eligible for your Heartflow Plaque Analysis.
The Offering, page 13

3. We note your disclosure that $98.4 million of convertible promissory
notes will
 automatically convert with the initial public offering. We also note
that $23 million of
 outstanding indebtedness under the 2024 Credit Agreement was converted
into 2025
 Convertible Notes. Please revise your disclosure to include these
additional 2025
 Convertible Notes.
Risk factors
If we are unable to design, implement and maintain effective internal control
over financial
reporting..., page 62

4. We note that you previously included a risk factor detailing identified
material
 weaknesses in your internal control over financial reporting, the
material adjustments
 to your fiscal year 2023 financial statements as a result of these
material weaknesses,
 along with adjustments made to your fiscal years 2019 through 2022
financial
 statements, and the remediation steps that have been implemented to
address the
 material weaknesses. Please expand your risk factor to discuss the
previously
 identified material weaknesses, the remediation steps implemented for
the identified
 material weaknesses, and the status of your testing of your remediation
efforts.
We face risks associated with a concentrated customer base, page 62

5. We note your revised disclosure in response to comment 13, including
that for the
 year ended December 31, 2024, your top two largest customers
collectively
 represented approximately 8% of your revenue, and that as you expand the
adoption
 of the Heartflow Platform to new accounts, your customer concentration
risk may
 increase. Please clarify why the addition of new accounts may increase
your customer
 concentration, including whether you expect current customers to open
new accounts,
 and if so, the impact of the same on your growth strategies. Please also
explain how
 you determine an account is "new," given your disclosure that
decision-making for
 accounts is concentrated in a relatively small number of customers.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of operations, page 86

6. Please expand your discussion and analysis of revenue to quantify the
impact of the
 change in utilization and pricing, including the impact of rebates and
the change in
 mix of customer accounts. Also, provide an explanation for the changes
in mix of
 customer accounts. Refer to Item 303(b)(2) of Regulation S-K for
guidance.
7. Please expand your discussion and analysis of gross margin to quantify
the impact of
 the increase in revenue versus the automation of manual components of
the
 production teams process. Refer to Item 303(b)(2) of Regulation S-K
and Section
 501.12 of the Financial Reporting Codification (i.e., Release 33-8350,
Section III.B)
 for guidance.
 April 10, 2025
Page 3
Liquidity and capital resources
Sources of liquidity, page 88

8. We note that you no longer believe that there is substantial doubt about
your ability to
 continue as a going concern as of December 31, 2024 due to the 2025
Convertible
 Notes offering during the first quarter of fiscal year 2025. We further
note that as of
 December 31, 2024, your working capital has decreased, the degree to
which total
 liabilities exceeds total assets has increased, total stockholders
deficit has increased,
 and you continue to recognize loss from operations and net loss that you
expect will
 continue into the future. As such, please expand your disclosures to
provide investors
 with a balanced outlook about the material factors that have impacted
and will
 continue to impact your liquidity from a short-term and long-term
perspective. Also
 provide a discussion about why the 2025 Convertible Notes issuances
provide you
 with sufficient liquidity to meet all of your obligations within the
next 12 months,
 including the amount of the net proceeds received from the issuances
along with how
 the net proceeds were utilized. Refer to Item 303(b)(1) of Regulation
S-K and Section
 501.13 of the Financial Reporting Codification (i.e., Release 33-8350,
Section IV) for
 guidance.
Business
Our Clinical Results and Economic Evidence, page 119

9. We note your response to comment 23, including the revised disclosures
on pages 119
 through 126. Please revise to disclose whether statistical significance
was
 demonstrated, including supporting p-values, as appropriate, for all of
the studies
 cited, specifically the PRECISE and PLATFORM studies. Please also expand
upon
 the "usual care" pathways noted in the PRECISE trial, and explain how
your
 PRECISE trial demonstrated that "NITs are inaccurate a majority of the
time, and
 often result in either missed CAD diagnoses or unnecessary invasive
procedures," as
 disclosed on page 125.
Certain Relationships and Related-Party Transactions, page 162

10. We note your response to comment 26, including your disclosure on page
166 that
 "[c]ertain of [y]our obligations under the BCLS Letter Agreement will
remain in
 effect after the completion of this offering, including [y]our
obligation to obtain the
 consent of Bain Capital prior to making certain public disclosures about
Bain Capital
 or certain of its affiliates, certain indemnification obligations and
certain pro rata lock-
 up release rights of Bain Capital." Please revise to further discuss
these
 indemnification obligations and pro-rata lock-up release rights.
18. Subsequent Events, page F-39

11. Please expand your disclosure for the 2025 Convertible Notes to disclose
the net
 proceeds and effective interest rate.
 April 10, 2025
Page 4

 Please contact Tracey Houser at 202-551-3736 or Terence O'Brien at
202-551-3355 if
you have questions regarding comments on the financial statements and related
matters. Please contact Juan Grana at 202-551-6034 or Katherine Bagley at
202-551-2545
with any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Ryan Coombs, Esq.
</TEXT>
</DOCUMENT>