SecProbe.io

August 31, 2025
Jack Kaye
Chief Executive Officer
Davion Healthcare Plc
The Cube Building, Monahan Road
Cork, T12 H1XY, Ireland
Re:Davion Healthcare Plc
Registration Statement on Form F-1
Filed August 4, 2025
File No. 333-289205
Dear Jack Kaye:
            We have reviewed your registration statement and have the following comments.
            Please respond to this letter by amending your registration 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 registration statement and the information
you provide in response to this letter, we may have additional comments.
Registration Statement on Form F-1
Cover Page
1.Please revise your cover page to disclose that you are registering 25,000,000 ordinary
shares, and clarify whether these ordinary shares are being registered as a secondary
resale transaction. Please also advise whether the ordinary shares being registered are
to be offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act, and identify each potential selling shareholder, as applicable. Your
disclosure should include the number of ordinary shares held by each of the selling
shareholders and the portion of those ordinary shares that may be sold pursuant to this
registration statement, as well as the number of ordinary shares that may be sold in
reliance on Rule 144 of the Securities Act. If no shares are being offered by the
Company or by any selling shareholders, please consider whether the shares should be
registered under the Exchange Act using Form 10 rather than Form F-1.
We note your disclosure on page 3 that the anticipated opening price is $10.00 per 2.

August 31, 2025
Page 2
ordinary share, and on page 61 that "the opening trading price will be determined by
buy and sell orders collected by Nasdaq's designated market maker." Please revise
your cover page to disclose your opening price, and the process by which your
opening price will be determined. Please also disclose your financial advisor and their
role in that process. Please also revise your summary to include corresponding
disclosures. We refer to your disclosure on page 61 that "[i]n order to comply with
NASDAQ Global Market listing requirements, [you have] appointed a FINRA-
registered marketmaker to facilitate the opening of trading and to provide continuous
bid and ask quotations."
3.Please revise your cover page to disclose the duration of the offering.
Prospectus Summary, page 1
4.Please revise your summary to briefly discuss your current pipeline of
products, including BreastCheck, FootFlow, Testic, ThermaDerm and any other
products in development, emphasizing the current state of development and regulatory
approvals of each. In particular, please also note the timing for commercialization and
the markets in which you intend to sell each product. Please also clarify the date that
each product received their regulatory approvals.
5.Please revise your summary to disclose that you are a pre-revenue company that has
not generated any revenue and do not expect to generate revenue until the second half
of 2025 at the earliest. Please also note that during the year ended December 31, 2024,
you incurred an operating loss of €1,320,353.
6.Please revise your summary to note, as you do on page 56, that certain of your
directors and executive officers have agreed to a 90 day lock-up period during which
they will not sell or transfer their ordinary shares. Please also revise to note the
directors and executive officers that have entered into the lock-up agreement, and file
the lock-up agreement as an exhibit to your registration statement.
Our business and prospects depend significantly on our ability to build our product brands...,
page 4
7.Please briefly explain your annual BreastCheck Day.
Risk Factors, page 4
8.Please revise your risk factor disclosure to discuss the risk to investors stemming from
your direct listing. In particular, please consider the risk to investors from increased
price and market volatility, the process for the listing and setting of the opening
trading price of your ordinary shares, the lack of safeguards associated with a
traditional underwritten offering, that the opening trading price of your ordinary
shares may not be related to historical sales prices, uncertainty associated with the fact
that few companies have undertaken direct listings to date, and the challenges the
tracing requirement could pose for potential shareholders in relation to securities
liability claims under Section 11 and Section 12 of the Securities Act for a direct
listing versus a traditional IPO.
We could experience cost increases or disruptions in supply of raw materials or other

August 31, 2025
Page 3
components used in BreastCheck, page 4
9.We note your disclosure that "[yo]ur manufacturer of BreastCheck could incur
significant costs related to procuring raw materials required to manufacture and
assemble BreastCheck," and that "[v]arious raw materials are used in the manufacture
of BreastCheck." Please revise to disclose these raw materials and their source. Please
also revise to identify NeuRX Health Inc as the manufacturer and distributor of
BreastCheck, as you do on page 28.
You may face difficulties in protecting your interests, and your ability to protect your rights
through U.S. courts may be limited..., page 11
10.We note your disclosure that "[c]ertain corporate governance practices in Ireland,
which is [y]our home country, differ significantly from requirements for companies
incorporated in other jurisdictions such as the United States. Currently, [you] do not
plan to rely on home country practice with respect to any corporate governance
matter." However, on page 12, you note that "[b]ecause [you] are a foreign private
issuer under the Exchange Act, [you] are exempt from certain provisions of the
securities rules and regulations in the United States that are applicable to U.S.
domestic issuers." Please reconcile these disclosures, and advise whether you will be
relying on Irish home country practice pursuant to the foreign private issuer
exemptions.
Expenses of Issuance and Distribution, page 14
11.Please explain the source of funds that will be used to pay the estimated $871,900 of
expenses in connection with the registration of your shares given that you have never
generated revenue, have de minimis cash on hand and will not receive any proceeds
from the registration of your shares in a direct listing.
Capitalization, page 15
12.We note the cash and cash equivalents balance presented within Capitalization uses
amounts as of December 31, 2023. Please update for consistency with December 31,
2024 balances.
Corporate History And Structure, page 16
13.We note that Davion Healthcare Plc. (Cyprus) issued 12,258,458 ordinary shares in
2022, along with a further 7,741,542 ordinary shares in 2024 and an additional
5,000,000 ordinary shares in 2024. Please disclose the price at which these ordinary
shares were sold and briefly discuss the nature of each of these transactions, including
whether they were transactions exempt from registration under the Securities Act.
Please also revise your risk factor disclosures, as applicable, to note that recent sales
prices for your ordinary shares may bear little or no relation to the trading price at or
subsequent to the opening of trading of the ordinary shares on Nasdaq.
Management's Discussion And Analysis Of Consolidated Financial Condition And Results
Of Operations
Overview of Business Operations, page 23

August 31, 2025
Page 4
14.We note your disclosure on page 24 that "it can only be assumed that there is a large
and open market of women who would wish to monitor their health in the privacy of
their own home, particularly given that the accuracy level [of BreastCheck] is the
same as a mammogram." Please substantiate your claim that BreastCheck has the
same accuracy level as a mammogram.
Operating Results, page 27
15.Please provide a more detailed discussion of the material factors impacting the
decrease in expenses, and trends management expects in upcoming periods. Please
discuss any material events and uncertainties that would cause reported financial
information not to be necessarily indicative of future operating results or of future
financial condition. As a pre-revenue company focusing on research and development,
please also provide a breakdown of your research and development by product, by
function of costs (e.g. clinical, regulatory application), or by nature of costs (e.g.
payroll, outsourcing consultant). Refer to Item 5.A of Form 20-F.
16.Please revise to explain the decline in your research and development expenses during
the comparative period.
17.We note your disclosure on page 28 that "the Company secured a significant
agreement with NeuRX Health Inc of Rhode Island, USA, [during the year ending
December 31, 2024] for the manufacturing and distribution of BreastCheck," and that
"[t]he agreement will provide a steady revenue stream in the form of payments and
annual royalties based on product manufacturing and distribution volumes." We also
note that an outline agreement was filed with NeuRX Health as Exhibit 10.2 to the
registration statement. Please revise to disclose the material terms of your agreement
with NeuRX Health, including payments and annual royalties due under the
agreement. Please also advise if a final agreement has been entered into with NeuRX,
and if so, file such agreement as an exhibit to your registration statement. Refer to
Item 10.C. of Form 20-F.
Liquidity and Capital Resources, page 28
18.We note your disclosure regarding the Company’s reliance on the personal financial
support of the Chief Executive Officer, who has provided all funding to date. We also
note on page 52 you state that the financial support is provided through Malbrite Ltd.,
a Company owned by Jack Kaye.

•Please reconcile and expand your disclosures to provide information on material
terms of any agreement between the Company and the provider of financial
support.
•We note that Malbrite Ltd. is not listed as an affiliate shareholder on page 52, so it
is not clear how the Company is settling any liabilities from the financial support
it receives. Please include Malbrite Ltd in the listing of affiliate shareholders if
necessary. Refer to Item 404 of Regulation S-K and Item 7.B of Form 20-F.
•As a related matter, tell us your consideration to report the advances from related
parties as operating cash inflow rather than financing cash inflow in your
statement of cash flow at F-5.

August 31, 2025
Page 5
Directors, page 29
19.Please explain why the majority of your board resigned in April 2024.
Directors' Report, page 30
20.Please revise your disclosure to briefly discuss the reason for the inclusion of this
report.
21.Please reconcile your disclosures beginning on page 29 and throughout the section
titled "Directors' Report" with your disclosures in the section titled "Management"
starting on page 46. As an example only, we note that Kevin Riches, Susan M. King,
and Julian F. Sluyters are identified as non-executive directors of the company on
page 46, although the disclosure on page 29 notes that they resigned in April 2024.
We also refer to your disclosure on page 31 that "[i]n January 2025, an Audit
Committee was established comprising of three non-executive directors, Sir Eric
Peacock, Susan King and Julian Sluyters."
22.Please revise to briefly discuss the role of Kurdam Limited as secretary to the
company, and the Bank of Cyprus and the Bank of Ireland as bankers to the company.
Risks Relating to Our Business, page 33
23.Please revise to include all risk factors under the section titled "Risk Factors" starting
on page 4. Please also remove any duplicate risk factor disclosures.
We have a limited operating history, page 34
24.We note your statement that you were formed on November 29, 2022 with no real
activity until the commencement of 2023, though your proto-type “BreastCheck”
product has been held privately for some time. Please clarify what you mean by "no
real activity" in this context and explain the previous private ownership of your
product. Your disclosure should explain who developed your product, how you
acquired it and how long you have owned it.
We could experience cost increases or disruptions in supply of raw materials or other
components used in BreastCheck, page 36
25.Please advise whether you or a third-party manufacturer procure the raw materials
required to manufacture and assemble BreastCheck. We note your disclosure on page
36 that "[you] incur significant costs related to procuring raw materials required to
manufacture and assembling BreastCheck" and "[yo]ur product BreastCheck uses
multiple parts which [you] source from numerous sources." We also refer to your
disclosure on page 4 that "[yo]ur manufacturer of BreastCheck could incur significant
costs related to procuring raw materials required to manufacture and assemble
BreastCheck."
Our future growth is dependent on the demand for, and upon consumers' willingness to adopt
BreastCheck, page 37
26.Please revise to define "new energy BreastCheck" and explain how if differs from
BreastCheck.

August 31, 2025
Page 6
BreastCheck, page 41
27.Please revise to briefly discuss how the technology in each of BreastCheck, FootFlow
and Testic operates to collect temperature data from users. As an example only, we
note your disclosure on page 41 that "BreastCheck averages temperature at three areas
on each breast. By comparing the temperature of corresponding areas of one breast to
the other, and entering the results on [y]our Mobile App, results can be interpreted
immediately." Please also explain how results can be interpreted immediately and
advise on the data output presented by the mobile application, including whether the
application provides a diagnosis for users. Provide corresponding disclosures for each
of your products and/or product candidates, as applicable.
28.We note your disclosure on page 41 that "the technology behind BreastCheck is FDA
registered in the USA, and also registered with the relevant regulatory authorities in
the EU and the UK." We also note your disclosure on page 24 that BreastCheck "was
originally FDA approved for sale but at the time of approval, it was only licensed for
sale through clinicians rather than an over-the-counter product that could be
purchased from pharmacies. BreastCheck will now be available to be sold over the
counter through Pharmacists and over the internet, with an on line or mobile app
results review, providing immediate results." Please advise whether you required a
new FDA approval for the over-the-counter sale of BreastCheck and FootFlow, and if
so, please disclose whether this approval was obtained, the nature of the approval and
the date of the approval. Please also advise whether similar approvals are required to
offer your other products, such as Testic over the counter or from regulatory bodies in
other jurisdictions where you intend to sell your products.
29.We note your reference on page 41 to BreastCheck being "a safe, reliable, low-cost,
and accurate way to routinely monitor for breast abnormalities," and your reference on
page 44 to FootFlow being "a safe, reliable and accurate way to routinely monitor foot
temperatures which can be used as an adjunct to established procedures for the
detection and/or treatment of both PAD and Diabetes, amongst other medical
conditions." Please revise to explain the basis for these claims regarding safety and
efficacy, including the results of any clinical studies and/or trials supporting these
claims.
Business
Overview, page 41
30.We note your disclosure on page 41 that you use "third party Research and
Development (Universities and specialized companies) together w