Correspondence 0001213900-25-008137 from Future Cardia, Inc. (CIK 0001777274)
Future Cardia, Inc. (CIK 0001777274)
Date: Jan. 30, 2025 · CIK: 0001777274 · Accession: 0001213900-25-008137
AI Filing Summary & Sentiment
File numbers found in text: 024-12543
Referenced dates: January 7, 2025
Letter
Division of Corporation Finance Office of Industrial Applications and Re: Future Cardia, Inc. Offering Statement on Form 1-A Filed December 9, 2024 File No. 024-12543
Dear Mr. Stanton,
We hereby submit the responses of Future Cardia, Inc. (the “Company”) to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) set forth in the Staff’s letter, dated January 7, 2025, providing the Staff’s comments with respect to the Company’s offering statement on Form 1-A (the “Offering Statement”). Concurrently with the filing of this response letter, we have filed an amendment to the Offering Statement (the “Offering Statement Amendment”), and the Offering Statement Amendment incorporates our changes as indicated below made in response to the Staff’s comments.
For the convenience of the Staff, each of the Staff’s comments is included and is followed by the corresponding response of the Company. Unless the context indicates otherwise, references in this letter to “we,” “us” and “our” refer to the Company on a consolidated basis.
General
1. We note that your profile page on the StartEngine website reflects that you are providing time-based bonus shares including “Extreme Early Bird,” “Super Early Bird,” and “Early Bird” bonus shares. In addition, the website notes a minimum investment amount of $348 and that the Loyalty Bonus is 5% bonus shares for all previous investors, while your offering circular describes a minimum investment amount of $351 and a Loyalty Bonus of 20% for previous investors or investors who were waitlisted in your prior offering under Regulation CF. Please revise your disclosure to consistently describe all of the bonus shares you are offering, or tell us why your website appears to be inconsistent with the disclosures in your filing. In addition, given that you are offering bonus securities to encourage early investment, it appears the offering of all securities will not be commenced within two calendar days following the qualification date of your filing, and therefore, this is a delayed offering, which is not permitted by Regulation A. See Rule 251(d)(3). Please remove this incentive from your filing, or revise your bonus share structure so that it does not constitute a delayed offering.
Response: We note that the Company’s StartEngine profile page that is currently available to the pubic relates to the Company’s Regulation CF Offering and the bonus shares program available under the Regulation CF offering is not the same as that to be offered under the Company’s Regulation A offering currently under the Commission’s review. A StartEngine profile page for the Company’s Regulation A offering has not yet been published. The Company’s current disclosure in its Offering Statement with respect to its bonus shares program lists the correct bonus share awards that will be available in the Regulation A Offering. The Company has changed its minimum investment requirement to $348 and that is now reflected in the Offering Statement Amendment. The Company’s Offering Statement consistently describes all of the categories of bonus shares that will be available in its Regulation A offering. None of the bonus share categories in the offering are connected to or are categorized as an early investment bonus and, in any case, the offering will commence within two days of the Commission’s qualification of the offering statement. The Company’s offering will not be a delayed offering as that term is used under Regulation A.
Cover Page
2. Please revise your cover page to assign a value to the non-cash consideration for the bonus shares. Please also disclose the maximum offering amount for all of the shares you are seeking to qualify including the aggregate value of the bonus shares and the value of the shares purchased in the offering. Refer to Rule 251(a) of Regulation A, note to paragraph (a) of Rule 251, and General Instruction I to Form 1-A for guidance.
Response: We have made the requested changes in the Offering Statement Amendment.
3. We note your disclosure that “Investors will be required to pay directly to StartEngine Primary a transaction fee equal to 3.5% of the investment amount at the time of the investors’ subscription.” Please revise the minimum investment price of 117 shares of common stock to include the mandatory 3.5% transaction fee to be paid by the investor.
Response: We have made the requested changes in the Offering Statement Amendment.
4. Please revise your cover page to disclose the voting control of your officers and directors after the offering and the impact of this voting control on the ability of investors to influence matters subject to a stockholder vote.
Response: We have made the requested changes in the Offering Statement Amendment.
Summary, page 1
5. Your summary and description of business include several statements noting your beliefs about the accuracy and efficacy of your products, including but not limited to the following:
● your device is “designed to detect signs of heart failure early enough so that nonhospital treatments can be administered and, thus, hospitalizations that typically result from heart failure can be reduced and prevented;”
● your device “will offer a long-term solution to heart failure monitoring that, we believe, features simplicity, improved accuracy, high patient protocol compliance and hospital economics;” and
● “It has been shown that heart failure monitoring with multiple sensors yields improvements in accuracy . . . . We expect that our multiple sensor heart monitoring device will also display such improved 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.
Response: We have made the requested changes in the Offering Statement Amendment.
6. Please expand your disclosure in the summary to briefly discuss the FDA’s regulation of medical devices, 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 the implications if you do not receive approval under the Section 510(k) regulatory pathway. Please also discuss any regulatory approval you received to begin your clinical trials in humans. Please revise your disclosure on page 43 accordingly.
Response: We have made the requested changes in the Offering Statement Amendment. We note that under the 510(K) device approval process, we are not required to conduct clinical trials in humans and ee have indicated that n our offering statement disclosure.
7. Where you reference studies, articles, or other sources throughout the filing, please identify the specific sources you reference. For example only, we note your disclosure on page 2 that “[n]umerous studies that evaluated the decompensation parameter’s ability to reduce heart failure related hospitalizations have indicated that this methodology has failed.” As a related matter, where you refer to studies such as the “Link-HF (study 1, 2, 3),” please disclose the specific data supporting your disclosures.
Response: We have made the requested changes in the Offering Statement Amendment.
Overview, page 1
8. You disclose here and throughout your filing that you have “successfully implanted” your devices in a total of 39 human patients. You also reference various studies throughout your filing, including but not limited to “8 heart failure patient data studies” on page 7, and an animal study on page 8. Please fully describe the clinical studies you have conducted to date. Your disclosure should include information such as the dates of the studies, the number of participants, the length of the trials, the occurrence of any serious adverse events, the reported results or conclusions of the studies and any reported statistical significance of the results. 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.
Response: We have made the requested changes in the Offering Statement Amendment.
Our Historical Performance, page 1
9. Your reference to “independent registered public accounting firm” may imply that your auditors are registered with the PCAOB. Since it does not appear that they are so registered, please revise your disclosures accordingly. Address this comment as it relates to similar references on pages 47 and 50.
Response: We have made the requested changes in the Offering Statement Amendment.
Our Market Opportunity, page 2
10. We note your disclosure referencing a “recent Multi-Sense clinical trial,” and your disclosure on page 38 that your expectation of improved accuracy is based on clinical data provided in Boston Scientific’s Multi-Sense clinical trial. We also note your reference to the CHAMPION trial. Where you discuss the results of studies that were not conducted by you and did not relate to trials of your product, clearly identify the entity who conducted the trial, and disclose that the results of these clinical trials are not related to trials of your product and do not indicate that your product will be successfully commercialized in the future. In addition, revise your disclosure to clarify how these study results are related to your specific product, given that you intend to commercialize a subcutaneously insertable monitor, while in the Multi- Sense trial, patients received an implantable cardioverter defibrillator device and in the CHAMPION trial, patients received a permanent pulmonary artery implant.
Response: We have made the requested changes in the Offering Statement Amendment.
11. We note your disclosure indicating that wearable monitors have not proven beneficial for the long-term chronic management of heart failure. Please provide support for your statements about these wearable monitors.
Response: We have provided the requested support in the Offering Statement Amendment.
Our Product Launch Roadmap, page 7
12. Please revise to disclose the intended timing for each of the steps in your product launch roadmap.
Response: The requested information has been provided in the Offering Statement Amendment.
13. We note your reference to a “resubmission meeting with the FDA,” your disclosure on page 33 that your “target is to submit a 510(k) application to the FDA by the end of 2024,” and your disclosure on page 43 that you “plan to submit [y]our insertable cardiac device for FDA review under a pre-submission filing, or Pre-Sub, in the first quarter of 2021.” Please revise your disclosure to describe the history of your submissions to the FDA, including current status, relevant products, when you first submitted applications to the FDA, and the reasons for the resubmission. In addition, please clearly disclose that there is no guarantee you will obtain the required FDA approval to market your product. Make conforming changes to your description of business.
Response: We note that the use of the word “resubmission” in the Offering Statement was incorrect and we have corrected that reference in the Offering Agreement Amendment to read “pre-submission.” We have also clarified the timing of the FDA pre-submission and 510(K) application process and clearly disclosed that there is no guarantee we will obtain the required FDA 510(K) approval to market our product.
Our Development Highlights, page 7
14. We note your disclosures about the StartX accelerator program, including the combined valuations
Show Raw Text
CORRESP
1
filename1.htm
Future
Cardia, Inc.
910
Woodbridge Court
Safety
Harbor, FL 34695
January
29, 2025
Division
of Corporation Finance
Office
of Industrial Applications and
Services
U.S.
Securities and Exchange Commission
100
F Street, N.E.
Washington,
DC 20549
Attn:
Austin Stanton
Re: Future
Cardia, Inc.
Offering
Statement on Form 1-A
Filed
December 9, 2024
File
No. 024-12543
Dear
Mr. Stanton,
We
hereby submit the responses of Future Cardia, Inc. (the “Company”) to the comments of the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) set forth in the Staff’s letter, dated January
7, 2025, providing the Staff’s comments with respect to the Company’s offering statement on Form 1-A (the “Offering
Statement”). Concurrently with the filing of this response letter, we have filed an amendment to the Offering Statement (the
“Offering Statement Amendment”), and the Offering Statement Amendment incorporates our changes as indicated below
made in response to the Staff’s comments.
For
the convenience of the Staff, each of the Staff’s comments is included and is followed by the corresponding response of the Company.
Unless the context indicates otherwise, references in this letter to “we,” “us” and “our” refer to
the Company on a consolidated basis.
General
1. We
note that your profile page on the StartEngine website reflects that you are providing time-based
bonus shares including “Extreme Early Bird,” “Super Early Bird,” and
“Early Bird” bonus shares. In addition, the website notes a minimum investment
amount of $348 and that the Loyalty Bonus is 5% bonus shares for all previous investors,
while your offering circular describes a minimum investment amount of $351 and a Loyalty
Bonus of 20% for previous investors or investors who were waitlisted in your prior offering
under Regulation CF. Please revise your disclosure to consistently describe all of the bonus
shares you are offering, or tell us why your website appears to be inconsistent with the
disclosures in your filing. In addition, given that you are offering bonus securities to
encourage early investment, it appears the offering of all securities will not be commenced
within two calendar days following the qualification date of your filing, and therefore,
this is a delayed offering, which is not permitted by Regulation A. See Rule 251(d)(3). Please
remove this incentive from your filing, or revise your bonus share structure so that it does
not constitute a delayed offering.
Response:
We note that the Company’s StartEngine profile page that is currently available to the pubic relates to the Company’s Regulation
CF Offering and the bonus shares program available under the Regulation CF offering is not the same as that to be offered under the Company’s
Regulation A offering currently under the Commission’s review. A StartEngine profile page for the Company’s Regulation A
offering has not yet been published. The Company’s current disclosure in its Offering Statement with respect to its bonus shares
program lists the correct bonus share awards that will be available in the Regulation A Offering. The Company has changed its minimum
investment requirement to $348 and that is now reflected in the Offering Statement Amendment. The Company’s Offering Statement
consistently describes all of the categories of bonus shares that will be available in its Regulation A offering. None of the bonus share
categories in the offering are connected to or are categorized as an early investment bonus and, in any case, the offering will commence
within two days of the Commission’s qualification of the offering statement. The Company’s offering will not be a delayed
offering as that term is used under Regulation A.
Cover
Page
2. Please
revise your cover page to assign a value to the non-cash consideration for the bonus shares.
Please also disclose the maximum offering amount for all of the shares you are seeking to
qualify including the aggregate value of the bonus shares and the value of the shares purchased
in the offering. Refer to Rule 251(a) of Regulation A, note to paragraph (a) of Rule 251,
and General Instruction I to Form 1-A for guidance.
Response:
We have made the requested changes in the Offering Statement Amendment.
3. We
note your disclosure that “Investors will be required to pay directly to StartEngine
Primary a transaction fee equal to 3.5% of the investment amount at the time of the investors’
subscription.” Please revise the minimum investment price of 117 shares of common stock
to include the mandatory 3.5% transaction fee to be paid by the investor.
Response:
We have made the requested changes in the Offering Statement Amendment.
4. Please
revise your cover page to disclose the voting control of your officers and directors after
the offering and the impact of this voting control on the ability of investors to influence
matters subject to a stockholder vote.
Response:
We have made the requested changes in the Offering Statement Amendment.
2
Summary,
page 1
5. Your
summary and description of business include several statements noting your beliefs about the accuracy and efficacy of your products,
including but not limited to the following:
● your
device is “designed to detect signs of heart failure early enough so that nonhospital
treatments can be administered and, thus, hospitalizations that typically result from heart
failure can be reduced and prevented;”
● your
device “will offer a long-term solution to heart failure monitoring that, we believe,
features simplicity, improved accuracy, high patient protocol compliance and hospital economics;”
and
● “It
has been shown that heart failure monitoring with multiple sensors yields improvements in
accuracy . . . . We expect that our multiple sensor heart monitoring device will also display
such improved 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.
Response:
We have made the requested changes in the Offering Statement Amendment.
6. Please
expand your disclosure in the summary to briefly discuss the FDA’s regulation of medical
devices, 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 the implications if you
do not receive approval under the Section 510(k) regulatory pathway. Please also discuss
any regulatory approval you received to begin your clinical trials in humans. Please revise
your disclosure on page 43 accordingly.
Response:
We have made the requested changes in the Offering Statement Amendment. We note that under the 510(K) device approval process, we are
not required to conduct clinical trials in humans and ee have indicated that n our offering statement disclosure.
7. Where
you reference studies, articles, or other sources throughout the filing, please identify
the specific sources you reference. For example only, we note your disclosure on page 2 that
“[n]umerous studies that evaluated the decompensation parameter’s ability to reduce
heart failure related hospitalizations have indicated that this methodology has failed.”
As a related matter, where you refer to studies such as the “Link-HF (study 1, 2, 3),”
please disclose the specific data supporting your disclosures.
Response:
We have made the requested changes in the Offering Statement Amendment.
3
Overview,
page 1
8. You
disclose here and throughout your filing that you have “successfully implanted”
your devices in a total of 39 human patients. You also reference various studies throughout
your filing, including but not limited to “8 heart failure patient data studies”
on page 7, and an animal study on page 8. Please fully describe the clinical studies you
have conducted to date. Your disclosure should include information such as the dates of the
studies, the number of participants, the length of the trials, the occurrence of any serious
adverse events, the reported results or conclusions of the studies and any reported statistical
significance of the results. 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.
Response:
We have made the requested changes in the Offering Statement Amendment.
Our
Historical Performance, page 1
9. Your
reference to “independent registered public accounting firm” may imply that your
auditors are registered with the PCAOB. Since it does not appear that they are so registered,
please revise your disclosures accordingly. Address this comment as it relates to similar
references on pages 47 and 50.
Response:
We have made the requested changes in the Offering Statement Amendment.
Our
Market Opportunity, page 2
10. We
note your disclosure referencing a “recent Multi-Sense clinical trial,” and your
disclosure on page 38 that your expectation of improved accuracy is based on clinical data
provided in Boston Scientific’s Multi-Sense clinical trial. We also note your reference to
the CHAMPION trial. Where you discuss the results of studies that were not conducted by you
and did not relate to trials of your product, clearly identify the entity who conducted the
trial, and disclose that the results of these clinical trials are not related to trials of
your product and do not indicate that your product will be successfully commercialized in
the future. In addition, revise your disclosure to clarify how these study results are related
to your specific product, given that you intend to commercialize a subcutaneously insertable
monitor, while in the Multi- Sense trial, patients received an implantable cardioverter defibrillator
device and in the CHAMPION trial, patients received a permanent pulmonary artery implant.
Response:
We have made the requested changes in the Offering Statement Amendment.
11. We
note your disclosure indicating that wearable monitors have not proven beneficial for the
long-term chronic management of heart failure. Please provide support for your statements
about these wearable monitors.
Response:
We have provided the requested support in the Offering Statement Amendment.
4
Our
Product Launch Roadmap, page 7
12. Please
revise to disclose the intended timing for each of the steps in your product launch roadmap.
Response:
The requested information has been provided in the Offering Statement Amendment.
13. We
note your reference to a “resubmission meeting with the FDA,” your disclosure on
page 33 that your “target is to submit a 510(k) application to the FDA by the end of
2024,” and your disclosure on page 43 that you “plan to submit [y]our insertable
cardiac device for FDA review under a pre-submission filing, or Pre-Sub, in the first quarter
of 2021.” Please revise your disclosure to describe the history of your submissions
to the FDA, including current status, relevant products, when you first submitted applications
to the FDA, and the reasons for the resubmission. In addition, please clearly disclose that
there is no guarantee you will obtain the required FDA approval to market your product. Make
conforming changes to your description of business.
Response:
We note that the use of the word “resubmission” in the Offering Statement was incorrect and we have corrected that reference
in the Offering Agreement Amendment to read “pre-submission.” We have also clarified the timing of the FDA pre-submission
and 510(K) application process and clearly disclosed that there is no guarantee we will obtain the required FDA 510(K) approval to market
our product.
Our
Development Highlights, page 7
14. We
note your disclosures about the StartX accelerator program, including the combined valuations