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SEC Comment Letter 0000000000-25-004657 to FirstVitals Inc. (CIK 0002053118)

FirstVitals Inc. (CIK 0002053118)
Date: May 1, 2025 · CIK: 0002053118 · Accession: 0000000000-25-004657

AI Filing Summary & Sentiment

File numbers found in text: 024-12598

Date
May 1, 2025
Author
Not clearly detected
Form
UPLOAD
Company
FirstVitals Inc. (CIK 0002053118)

Letter

May 1, 2025 Ernest Lee Chief Executive Officer FirstVitals, Inc. 2605 Camino Tassajara #2500 Danville, CA 94526 Re:FirstVitals, Inc. Offering Statement on Form 1-A Filed April 4, 2025 File No. 024-12598 Dear Ernest Lee: We have reviewed your 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. Offering Statement on Form 1-A filed April 4, 2025 Cover Page 1.Please revise your cover page to state whether you are utilizing the Form S-1 disclosure format or the Offering Circular disclosure format. Refer to Part II(a)(1) of Form 1-A. Please ensure you include the required disclosure based upon which format you are utilizing. 2.We note your cover page indicates you are offering 6,341,625 shares in this offering. We also note your disclosure that the maximum offering amount is $20,740,000. At that maximum offering amount, you would only be able to sell 2,440,000 at a price per share of $8.50. Please revise the amounts for consistency or advise. 3.Please revise the offering statement to consistently state the price each share will be sold at in the offering. In this regard, we note your disclosure on page 2 that each share will be sold at "Five Dollars ($8.50) per Share." We note your brief description of your company on the cover page. When discussing the company on the cover page, please provide more prominent disclosure that the 4.

May 1, 2025 Page 2 Company has not generated any revenue or commenced revenue generating operations as of the date of the Offering Circular. We note your disclosure in the summary of the offering section on page 6. 5.We note your statements regarding your "first-in-market" AI-driven VCE platform here and on page 6. This term suggest that your product candidate is effective and likely to be approved by the FDA. Please delete these references throughout your offering statement as they are speculative in light of the current regulatory status of your product candidate. To the extent your use of these terms is intended to convey your belief that the product is based on a novel technology or approach and/or is further along in the development process, you may discuss how your technology differs from technology used by competitors and, as applicable, that you are not aware of competing products that are further along in the development process. Statements such as these should be accompanied by cautionary language that the statements are not intended to give any indication that the product candidate has been proven effective or that it will receive regulatory approval. 6.We note your disclosure here and throughout the offering statement that you have a particular focus on companion pets and the equine industry. Please expand your disclosure to discuss the current status of your product development for these applications and any work you have completed to date. Please explain if there are specific aspects of your AI product, or plan for an AI product, that will give you a competitive advantage in these industries. Please disclose if there are any agreements in place to partner with industry participants. If so, please describe the material terms of the agreements and file the agreements as exhibits to the Offering Circular, or, in the alternative, tell us why they are not required to be filed. Refer to Item 17.6 of Form 1-A. 7.Please revise the cover page legend to conform with the legend required by Rule 253(f) of the Securities Act. Specifically, we note that your current legend says "however, the commission has not made an independent determination that this investment involves a degree of risk that may not be suitable for all persons" rather than "however, the Commission has not made an independent determination that the securities offered are exempt from registration." 8.It appears you may be a shell company as defined in Rule 405 under the Securities Act of 1933 because you have no or nominal operations and assets consisting solely of cash and cash equivalents. Please explain whether you currently have more than nominal operations or non-cash assets and provide us with a detailed legal analysis explaining why you are not a shell company. If you conclude you are a shell company, please provide cover page disclosure and add a risk factor that highlights the consequences of your shell company status. Rule 251(d)(3)(i)(F) Disclosure, page 3 9.You state here that Rule 251(d)(3)(i)(F) requires the offering to be in an amount that, at the time the offering statement is qualified, is reasonably expected to be offered and sold within one year from the initial qualification date. Please clarify if this timeframe should be one or two years pursuant to the requirements of Rule 251 or the terms of your offering.

May 1, 2025 Page 3 Summary of the Offering, page 10 10.We note your statement that the Company has not commenced "revenue generating operations" as of the date of the Offering Circular. Please expand your disclosure to explain the current status of your business operations generally and the products or services you intend to offer. Specifically, please disclose whether you have already developed any VCE product or AI software. If you have not yet developed any products or prototypes, please provide prominent disclosure to that effect and include applicable risk factor disclosure. 11.Please remove the inappropriate disclaimer that “[t]his circular is qualified in its entirety by reference to such documents as they may be amended, and all documents related thereto, copies of which will be made available upon request and should be thoroughly reviewed prior to purchasing a share.” 12.Please revise the disclaimer on page 12 to eliminate the inappropriate disclaimer that you “make no express or implied representation or warranty as to the completeness of the information or, in the case of projections, estimates, future plans or forward looking assumptions or statements, as to their attainability or the accuracy and completeness of the assumptions from which they are derived, and it is expected that each prospective investor will pursue his, her or its own independent investigation.” It is not appropriate to directly or indirectly disclaim liability for statements in your offering statement. Investors are entitled to rely on your disclosure. Please revise or specifically state that you take responsibility for these statements in this document. 13.Please note in the summary section that your auditor's report includes an explanatory paragraph regarding substantial doubt about your ability to continue as a going concern. Forward Looking Statements, page 12 14.Please revise or remove your statements that investors should not rely on forward- looking statements. Investors are entitled to rely on your disclosure. Investment Risks There is limited governmental review, page 14 15.Please revise your risk factor on page 14 to remove the statement that “[t]his offering has been qualified by the U.S. Securities and Exchange Commission” or to clarify that no securities may be sold until such time as the offering has been qualified.

May 1, 2025 Page 4 Conflict of Interest Risks The Company is under significant control by one person, Ernest Lee, page 15 16.We note your disclosure that Ernest Lee, Chief Executive Officer, has 94% voting control through his ownership of 6,000,000 shares of common stock. As such, it appears that you are currently a controlled company and, subject to the number of shares sold in the offering, may remain a controlled company. If true, please revise the cover page to prominently disclose that the company is currently, and may continue to be, a controlled company, identify the controlling stockholder and such stockholder's total voting power. General Business Risks The Company's business is indirectly subject to healthcare industry cost containment and healthcare reform measures..., page 19 17.We note your disclosure here that you have several customers. Elsewhere you state that you have not generated any revenue and have not commenced revenue generating operations as of the date of the Offering Circular. Please revise this offering statement to give a description of your customer base or revise clarify that you currently do not have any customers. Dilution, page 25 18.Please reconcile the disclosure of 6,340,625 common shares issued prior to the offering with the 1,000 shares issued as outstanding on the balance sheet and disclosure of 6,341,625 shares issued subsequent to September 30, 2024, disclosed on page 65. 19.We note your disclosure here that 6,051,000 common shares have been issued to two officers prior to this offering. To the extent these shares were acquired in transactions during the past year and there is a material disparity between the public offering price and the effective cash cost to these officers for these shares, please provide a comparison of the public contribution under the proposed public offering and the average effective cash contribution of such persons. Please refer to Item 4 of Part II of Form 1-A. 20.Here or elsewhere in the Offering Circular, please provide a brief discussion of the material terms of the Series A Convertible Promissory Note issued to Dr. Steven Gast in the amount of $250,000. Your disclosure should include a discussion of the conversion terms and note whether this offering will trigger your conversion rights. Additionally, please note if Dr. Gast is a related party or has any affiliation with the Company or management other than as an investor. Finally, please provide risk factor disclosure discussing your indebtedness and the dilution risk to investors upon conversion of the note. Investor Suitability Standards, page 25 21.We note you mention a “Tier 1” offering in this section. Please revise to reflect that this is a Tier 2 offering.

May 1, 2025 Page 5 Plan of Distribution How to Invest Subscription Agreement, page 26 22.We note your disclosure on the cover page that investors will be required to complete a subscription agreement and that "[a]s soon as the Company accepts a subscription, the subscriber's funds will be deposited into the Company's operating account, and then the subscriber will become a shareholder and listed on the Company's share register." We also note your disclosure on page 15 regarding the potential for a delay between the time subscription funds are accepted from Investors and the time when such funds are deposited into the Company’s main operating account and on page 26 that the Company reserves the right to schedule when closings will occur. Please disclose how long you expect it will take to accept or reject a subscription upon receipt of the subscription agreement and how frequently you expect to schedule closings. Additionally, please disclose whether an investor will have the right to request the return of its subscription payment during the period after a subscription has been submitted but before the Company has determined whether to accept the subscription. Description of the Business, page 28 23.Your disclosure in various places in this section is presented in the form of an outline rather than narrative disclosure. Please revise the disclosure to provide a narrative description of your business. Please refer to Item 7(a) of Part II of Form 1-A. 24.Please provide the basis or source for the claims made in the Offering Circular regarding your business or discussing data or statistics about your industry and market in which you intend to operate. As examples only, we note statements such as "$1.5b+ in human endoscopy, untapped veterinary GI market" and "[p]roven demand from hospitals, healthcare providers, and veterinary networks." These statements, and others throughout the offering statement, should be tied to a source. To the extent that any such statement are based on management's beliefs, please revise to state as much. If you revise to state these statements are based on management's beliefs, please provide a basis for these beliefs and also discuss the material assumptions and estimates underlying the amount discussed for each data point or statistic. Management's Discussion and Analysis Of Financial Condition and Results Of Operations Strategic Path Forward and Scaling Plan Overview, page 44 25.We note certain projections beginning on page 44. Please revise the disclosure to provide a reasonable basis to support the projections. Describe the material assumptions underlying the projections and the limitations of the projections. Explain to us how there is a reasonable basis for the projections given you have not reported sales to date, have not received FDA clearance for AI integration, and appear to lack material operating history. Explain the basis for the year-to-year increase in revenue projected from 2025 to 2027. Refer to section (b) of Part II of Form 1-A and Rule 175 under the Securities Act of 1933. Please revise your disclosure that "These projections align with market demand, regulatory timelines, and strategic scaling efforts, ensuring FirstVitals captures a 26.

May 1, 2025 Page 6 significant share of the growing AI-powered GI diagnostics market" to clarify projections do not ensure market share and to appropriately convey the risks and inherent uncertainty. Liquidity and Capital Resources, page 46 27.Revise to disclose the related party payables that funded your business during the period from September 12, 2024 through September 30, 2024 and how you plan to continue to fund your administrative expenses and other cash requirements. Reference Item 303(b)(1)(i) and (ii) of Regulation S-K. Financial Statements of FirstVitals Inc. Note A Description of Business and Summary of Significant Accounting Policies, page 63 28.Revise to clarify if FirstVitals Inc.'s fiscal year end is September 30, 2024. Revenue Recognition, page 64 29.You disclose here that the Company recognizes revenue from HbA1c and Vitamin D tests when the test kits are sold for market price to be us at the medical clinics or at home by individuals. Please discuss these business lines in the Offering Circular or advise. Note E Subsequent Events, page 65 30.We see that subsequent to September 30, 2024, the Company has additionally issued 6,341,625 shares to employees and other service providers. Please tell us how you determined the value of the shares issued to employees and other service providers since there is no market for your stock. Part III - Exhibits, page 66 31.Please refile Exhibits 2.1 and 2.2 in the proper text-searchable format. They appear to have been uploaded as images. For guidance, please refer to Item 301 of Regulation S-T. General We note several references throughout the offering statement to FirstVitals being a leader in the market and using promotional language. Please substantiate your claims or revise them to state these are your beliefs. When you discuss your position in various markets, please clarify what metrics you use to determine your position. The language we are referring to includes, but is not limited to: •"setting new standards;" (pages 2 and 6) •being a "first-mover;" (pages 2,6, and 43) •a "leader in multi-species AI-enhanced endoscopy solutions;" (pages 2 and 6) •"This positions the Company as the leader in both human and veterinary AI- powered GI diagnostics;" (page 42) •"FirstVitals is uniquely positioned to lead the next wave of GI healthcare innovation;" (page 36) and32.

May 1, 2025 Page 7 •"FirstVitals remains at the forefront of AI-driven diagnostics." (page 37) 33.Please revise your disclosure throughout the offering statement

Show Raw Text
May 1, 2025
Ernest Lee
Chief Executive Officer
FirstVitals, Inc.
2605 Camino Tassajara #2500
Danville, CA 94526
Re:FirstVitals, Inc.
Offering Statement on Form 1-A
Filed April 4, 2025
File No. 024-12598
Dear Ernest Lee:
             We have reviewed your 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.
Offering Statement on Form 1-A filed April 4, 2025
Cover Page
1.Please revise your cover page to state whether you are utilizing the Form S-1
disclosure format or the Offering Circular disclosure format. Refer to Part II(a)(1) of
Form 1-A. Please ensure you include the required disclosure based upon which format
you are utilizing.
2.We note your cover page indicates you are offering 6,341,625 shares in this offering.
We also note your disclosure that the maximum offering amount is $20,740,000. At
that maximum offering amount, you would only be able to sell 2,440,000 at a price
per share of $8.50. Please revise the amounts for consistency or advise.
3.Please revise the offering statement to consistently state the price each share will be
sold at in the offering. In this regard, we note your disclosure on page 2 that each
share will be sold at "Five Dollars ($8.50) per Share."
We note your brief description of your company on the cover page. When discussing
the company on the cover page, please provide more prominent disclosure that the 4.

May 1, 2025
Page 2
Company has not generated any revenue or commenced revenue generating
operations as of the date of the Offering Circular. We note your disclosure in the
summary of the offering section on page 6.
5.We note your statements regarding your "first-in-market" AI-driven VCE platform
here and on page 6. This term suggest that your product candidate is effective and
likely to be approved by the FDA. Please delete these references throughout your
offering statement as they are speculative in light of the current regulatory status of
your product candidate. To the extent your use of these terms is intended to convey
your belief that the product is based on a novel technology or approach and/or is
further along in the development process, you may discuss how your technology
differs from technology used by competitors and, as applicable, that you are not aware
of competing products that are further along in the development process. Statements
such as these should be accompanied by cautionary language that the statements are
not intended to give any indication that the product candidate has been proven
effective or that it will receive regulatory approval.
6.We note your disclosure here and throughout the offering statement that you have a
particular focus on companion pets and the equine industry. Please expand your
disclosure to discuss the current status of your product development for these
applications and any work you have completed to date. Please explain if there are
specific aspects of your AI product, or plan for an AI product, that will give you a
competitive advantage in these industries. Please disclose if there are any agreements
in place to partner with industry participants. If so, please describe the material terms
of the agreements and file the agreements as exhibits to the Offering Circular, or, in
the alternative, tell us why they are not required to be filed. Refer to Item 17.6 of
Form 1-A.
7.Please revise the cover page legend to conform with the legend required by Rule
253(f) of the Securities Act. Specifically, we note that your current legend says
"however, the commission has not made an independent determination that this
investment involves a degree of risk that may not be suitable for all persons" rather
than "however, the Commission has not made an independent determination that the
securities offered are exempt from registration."
8.It appears you may be a shell company as defined in Rule 405 under the Securities
Act of 1933 because you have no or nominal operations and assets consisting solely of
cash and cash equivalents. Please explain whether you currently have more than
nominal operations or non-cash assets and provide us with a detailed legal analysis
explaining why you are not a shell company. If you conclude you are a shell
company, please provide cover page disclosure and add a risk factor that highlights
the consequences of your shell company status.
Rule 251(d)(3)(i)(F) Disclosure, page 3
9.You state here that Rule 251(d)(3)(i)(F) requires the offering to be in an amount that,
at the time the offering statement is qualified, is reasonably expected to be offered and
sold within one year from the initial qualification date. Please clarify if this timeframe
should be one or two years pursuant to the requirements of Rule 251 or the terms of
your offering.

May 1, 2025
Page 3
Summary of the Offering, page 10
10.We note your statement that the Company has not commenced "revenue generating
operations" as of the date of the Offering Circular. Please expand your disclosure to
explain the current status of your business operations generally and the products or
services you intend to offer. Specifically, please disclose whether you have already
developed any VCE product or AI software. If you have not yet developed any
products or prototypes, please provide prominent disclosure to that effect and include
applicable risk factor disclosure.
11.Please remove the inappropriate disclaimer that “[t]his circular is qualified in its
entirety by reference to such documents as they may be amended, and all documents
related thereto, copies of which will be made available upon request and should be
thoroughly reviewed prior to purchasing a share.”
12.Please revise the disclaimer on page 12 to eliminate the inappropriate disclaimer that
you “make no express or implied representation or warranty as to the completeness of
the information or, in the case of projections, estimates, future plans or forward
looking assumptions or statements, as to their attainability or the accuracy and
completeness of the assumptions from which they are derived, and it is expected that
each prospective investor will pursue his, her or its own independent investigation.” It
is not appropriate to directly or indirectly disclaim liability for statements in your
offering statement. Investors are entitled to rely on your disclosure. Please revise or
specifically state that you take responsibility for these statements in this document.
13.Please note in the summary section that your auditor's report includes an explanatory
paragraph regarding substantial doubt about your ability to continue as a going
concern.
Forward Looking Statements, page 12
14.Please revise or remove your statements that investors should not rely on forward-
looking statements. Investors are entitled to rely on your disclosure.
Investment Risks
There is limited governmental review, page 14
15.Please revise your risk factor on page 14 to remove the statement that “[t]his offering
has been qualified by the U.S. Securities and Exchange Commission” or to clarify that
no securities may be sold until such time as the offering has been qualified.

May 1, 2025
Page 4
Conflict of Interest Risks
The Company is under significant control by one person, Ernest Lee, page 15
16.We note your disclosure that Ernest Lee, Chief Executive Officer, has 94% voting
control through his ownership of 6,000,000 shares of common stock. As such, it
appears that you are currently a controlled company and, subject to the number of
shares sold in the offering, may remain a controlled company. If true, please revise the
cover page to prominently disclose that the company is currently, and may continue
to be, a controlled company, identify the controlling stockholder and such
stockholder's total voting power.
General Business Risks
The Company's business is indirectly subject to healthcare industry cost containment and
healthcare reform measures..., page 19
17.We note your disclosure here that you have several customers. Elsewhere you state
that you have not generated any revenue and have not commenced revenue generating
operations as of the date of the Offering Circular. Please revise this offering statement
to give a description of your customer base or revise clarify that you currently do not
have any customers.
Dilution, page 25
18.Please reconcile the disclosure of 6,340,625 common shares issued prior to the
offering with the 1,000 shares issued as outstanding on the balance sheet and
disclosure of 6,341,625 shares issued subsequent to September 30, 2024, disclosed on
page 65.
19.We note your disclosure here that 6,051,000 common shares have been issued to two
officers prior to this offering. To the extent these shares were acquired in transactions
during the past year and there is a material disparity between the public offering price
and the effective cash cost to these officers for these shares, please provide a
comparison of the public contribution under the proposed public offering and the
average effective cash contribution of such persons. Please refer to Item 4 of Part II of
Form 1-A.
20.Here or elsewhere in the Offering Circular, please provide a brief discussion of the
material terms of the Series A Convertible Promissory Note issued to Dr. Steven Gast
in the amount of $250,000. Your disclosure should include a discussion of the
conversion terms and note whether this offering will trigger your conversion rights.
Additionally, please note if Dr. Gast is a related party or has any affiliation with the
Company or management other than as an investor. Finally, please provide risk factor
disclosure discussing your indebtedness and the dilution risk to investors upon
conversion of the note.
Investor Suitability Standards, page 25
21.We note you mention a “Tier 1” offering in this section. Please revise to reflect that
this is a Tier 2 offering.

May 1, 2025
Page 5
Plan of Distribution
How to Invest
Subscription Agreement, page 26
22.We note your disclosure on the cover page that investors will be required to complete
a subscription agreement and that "[a]s soon as the Company accepts a subscription,
the subscriber's funds will be deposited into the Company's operating account, and
then the subscriber will become a shareholder and listed on the Company's share
register." We also note your disclosure on page 15 regarding the potential for a delay
between the time subscription funds are accepted from Investors and the time when
such funds are deposited into the Company’s main operating account and on page 26
that the Company reserves the right to schedule when closings will occur. Please
disclose how long you expect it will take to accept or reject a subscription upon
receipt of the subscription agreement and how frequently you expect to schedule
closings. Additionally, please disclose whether an investor will have the right to
request the return of its subscription payment during the period after a subscription
has been submitted but before the Company has determined whether to accept the
subscription.
Description of the Business, page 28
23.Your disclosure in various places in this section is presented in the form of an outline
rather than narrative disclosure. Please revise the disclosure to provide a narrative
description of your business. Please refer to Item 7(a) of Part II of Form 1-A.
24.Please provide the basis or source for the claims made in the Offering Circular
regarding your business or discussing data or statistics about your industry and market
in which you intend to operate. As examples only, we note statements such as "$1.5b+
in human endoscopy, untapped veterinary GI market" and "[p]roven demand from
hospitals, healthcare providers, and veterinary networks." These statements, and
others throughout the offering statement, should be tied to a source. To the extent that
any such statement are based on management's beliefs, please revise to state as much.
If you revise to state these statements are based on management's beliefs, please
provide a basis for these beliefs and also discuss the material assumptions and
estimates underlying the amount discussed for each data point or statistic.
Management's Discussion and Analysis Of Financial Condition and Results Of Operations
Strategic Path Forward and Scaling Plan Overview, page 44
25.We note certain projections beginning on page 44. Please revise the disclosure to
provide a reasonable basis to support the projections. Describe the material
assumptions underlying the projections and the limitations of the projections. Explain
to us how there is a reasonable basis for the projections given you have not reported
sales to date, have not received FDA clearance for AI integration, and appear to
lack material operating history. Explain the basis for the year-to-year increase in
revenue projected from 2025 to 2027. Refer to section (b) of Part II of Form 1-A and
Rule 175 under the Securities Act of 1933.
Please revise your disclosure that "These projections align with market demand,
regulatory timelines, and strategic scaling efforts, ensuring FirstVitals captures a 26.

May 1, 2025
Page 6
significant share of the growing AI-powered GI diagnostics market" to clarify
projections do not ensure market share and to appropriately convey the risks and
inherent uncertainty.
Liquidity and Capital Resources, page 46
27.Revise to disclose the related party payables that funded your business during the
period from September 12, 2024 through September 30, 2024 and how you plan to
continue to fund your administrative expenses and other cash requirements. Reference
Item 303(b)(1)(i) and (ii) of Regulation S-K.
Financial Statements of FirstVitals Inc.
Note A Description of Business and Summary of Significant Accounting Policies, page 63
28.Revise to clarify if FirstVitals Inc.'s fiscal year end is September 30, 2024.
Revenue Recognition, page 64
29.You disclose here that the Company recognizes revenue from HbA1c and Vitamin D
tests when the test kits are sold for market price to be us at the medical clinics or at
home by individuals. Please discuss these business lines in the Offering Circular or
advise.
Note E Subsequent Events, page 65
30.We see that subsequent to September 30, 2024, the Company has additionally issued
6,341,625 shares to employees and other service providers. Please tell us how you
determined the value of the shares issued to employees and other service
providers since there is no market for your stock.
Part III - Exhibits, page 66
31.Please refile Exhibits 2.1 and 2.2 in the proper text-searchable format. They appear to
have been uploaded as images. For guidance, please refer to Item 301 of Regulation
S-T.
General
We note several references throughout the offering statement to FirstVitals being a
leader in the market and using promotional language. Please substantiate your claims
or revise them to state these are your beliefs. When you discuss your position in
various markets, please clarify what metrics you use to determine your position. The
language we are referring to includes, but is not limited to:
•"setting new standards;" (pages 2 and 6)
•being a "first-mover;" (pages 2,6, and 43)
•a "leader in multi-species AI-enhanced endoscopy solutions;" (pages 2 and 6)
•"This positions the Company as the leader in both human and veterinary AI-
powered GI diagnostics;" (page 42)
•"FirstVitals is uniquely positioned to lead the next wave of GI healthcare
innovation;" (page 36) and32.

May 1, 2025
Page 7
•"FirstVitals remains at the forefront of AI-driven diagnostics." (page 37)
33.Please revise your disclosure throughout the offering statement