SEC Comment Letter 0000000000-25-001386 to Future Cardia, Inc. (CIK 0001777274)
Future Cardia, Inc. (CIK 0001777274)
Date: Feb. 7, 2025 · CIK: 0001777274 · Accession: 0000000000-25-001386
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File numbers found in text: 024-12543
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February 7, 2025
Jaeson Bang
Chief Executive Officer
Future Cardia, Inc.
910 Woodbridge Court
Safety Harbor, FL 34695
Re:Future Cardia, Inc.
Amendment No.1 to Offering Statement on Form 1-A
Filed January 30, 2025
File No. 024-12543
Dear Jaeson Bang:
We have reviewed your amended offering statement and have the following
comments.
Please respond to this letter by amending your offering statement and providing the
requested information. 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 any amendment to your offering statement and the information you
provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our January 7, 2025 letter.
Amendment No. 1 to Offering Statement on Form 1-A Filed January 30, 2025
General
1.Please clearly label Appendix A to note the information contained therein, including
that the studies described in Appendix A were not conducted by you and were not
related to your product.
Cover Page
2.We note your revised disclosure in response to comment 2, that the maximum offering
amount is $18,525,000, including 1,000,000 Bonus Shares valued at $3.00 per share.
Please revise Part I of your filing for consistency with this disclosure in your offering
circular.
February 7, 2025
Page 2
3.We note your revised disclosure in response to comment 4, including your discussion
of the proxy that will be held by your Chief Executive Officer. Please revise to also
disclose, as you do on page 57, the percentage of your common stock held by your
Chief Executive Officer.
Summary
Our Solution, page 3
4.We note your response to prior comment 8. Where you disclose that there is "strong
clinical evidence" on heart sounds as a biomarker, please clarify how you measure the
strength of clinical evidence and the relevant studies supporting this conclusion.
Our Strengths, page 6
5.We note your revisions in response to comment 5, including your reference to
"Improved accuracy," and your disclosure that "studies of hear failure monitoring with
multiple sensors . . . have demonstrated improvements in accuracy." We also note
your disclosure on page 38 that "We expect, although we cannot guarantee, that our
multiple sensor heart monitoring device will also display such improved accuracy."
Please remove statements as to the accuracy of your product, 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 accuracy or efficacy. Please
also revise your disclosure to clarify whether the "studies of heart failure monitoring
with multiple sensors" were conducted for your product or other heart failure
monitoring devices. As a related matter, where you discuss wearable monitors and
related clinical studies on pages 33-34, please refrain from providing disclosure about
your beliefs as to the accuracy or reliability of the clinical data.
FDA Approval Considerations, page 7
6.We note your response to prior comment 6. Please revise to provide greater detail
describing the FDA approval process, including the classification of medical devices
into one of three classes (Class I, Class II and Class III) depending on their level of
risk and an explanation as to why your product is classified as a Class II medical
device. Please revise your disclosure on page 44 accordingly. Consider providing a
cross-reference in your summary to a more detailed discussion of these regulations in
your description of business, if appropriate.
Our Product Launch Roadmap, page 7
7.We note your revised disclosures in response to comment 13. Please briefly describe
the discussions at your guidance meeting with the FDA on May 6, 2024.
Risk Factors
Our insertable cardiac device product . . ., page 18
We note your revised disclosure in response to comment 15, which includes a
discussion of the safeguards you have implemented to minimize the risk of data
breaches or loss, and that your device is designed with a framework that follows FDA
guidance. Please revise your risk factor to discuss the risks related to a potential 8.
February 7, 2025
Page 3
breach or loss, if material, along with your current disclosure describing your efforts
to safeguard against these risks.
Our Development Highlights, page 39
9.We note your response to prior comment 14, including that you removed your
disclosure about the success rates and valuations of companies participating in the
StartX program from your summary. Please make conforming changes throughout
your filing, including on page 40.
Our Heart Monitor Device Clinical Studies, page 41
10.We note your revised disclosure in response to comment 19, including your
description of your heart monitor device clinical studies. Please expand your
discussion of each of the human studies disclosed to discuss the name of the study, the
criteria for selecting patients, and the relevant endpoints. Please also identify any
partners with which you collaborated for these studies, and any related agreements. If
these studies are discussed in more detail elsewhere in your filing, please ensure that
this is clear by noting the name of the study and providing a cross reference to your
more detailed discussion. Where you disclose that results were "consistent," "critical,"
or your device "functioned as intended," please provide additional detail describing
the data that supports these conclusions.
Compensation of Directors and Executive Officers, page 54
11.Please update your disclosure throughout this section to discuss compensation for
your last completed fiscal year, December 31, 2024. See Item 402 of Regulation S-K.
Statements of Cash Flows for the Six Months Ended June 30, 2024, page F-5
12.It appears that you have typographical errors in your determination of net cash
provided in operating activities for both periods presented, including an incorrect net
loss from operations for the six months ended June 30, 2024. In addition, please
clarify why your proceeds from common stock financing activities do not agree to the
activity presented in your statements of stockholders' equity. Finally, it appears that
your stated $32,764,970 cash, end of period for the six months ended June 30, 2023
is incorrect. Please revise as necessary.
Note 2 - Going Concern and Management's Liquidity Plan, page F-9
We note your response to comment 27 and your disclosures on page 51 which indicate
that you will be able to conduct your planned operations using currently available
capital resources for the next six months. As a result, you have determined that there
is substantial doubt about your ability to continue as a going concern. These
disclosures appear inconsistent with your disclosures on page F-9 which indicate that
you have sufficient cash to fund operations for the twelve months subsequent to the
filing date. Please revise your disclosures as necessary. Given your cash balance as of
June 30, 2024 and the significant amounts of cash used in operations each period,
please provide comprehensive disclosures regarding your going concern
considerations pursuant to ASC 205-40-50-1 through 14. In addition, your liquidity
disclosures in MD&A should clearly identify any internal and external sources of 13.
February 7, 2025
Page 4
liquidity including if there are any firm commitments to provide funding or any
material unused sources of liquidity. Refer to Item 9(b) of the Form 1-A.
Note 4 - Notes Payable, page F-9
14.We note your response to comment 25. Please address what consideration you gave as
to whether these convertible notes should also be classified as short-term liabilities on
your audited balance sheet as of December 31, 2023. In this regard, we note that your
notes dated June 2022 and August 2022 appear to have matured in 2024.
Audited Financial Statements
Report on the Audit of the Financial Statements, page F-15
15.We note your response to comment 26. As previously requested, please have your
auditors revise their report to address the following:
•State, if true, that they are required to be independent in accordance with U.S.
federal securities laws and the applicable rules and regulations of the Securities
and Exchange Commission. Refer to AU-Section 700, Part F/S(c)(1)(iii) of the
Form 1-A and Article 2 of Regulation S-X.
•Refer to the years then ended, rather than the year then ended, throughout their
report.
Please contact Nudrat Salik at 202-551-3692 or Jeanne Baker at 202-551-3691 if you
have questions regarding comments on the financial statements and related matters. Please
contact Austin Stanton at 202-551-2197 or Katherine Bagley at 202-551-2545 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Yujia Wei