F-1/A: Davion Healthcare Prepares Nasdaq Direct Listing

Sentiment:

Direct Listing Registration Statement Amendment 26 September 2025 4:07 PM

Davion Healthcare Plc, a pre-revenue medical device company, is preparing for a direct listing on the Nasdaq Global Market, registering 25 million ordinary shares for resale by existing shareholders.

Delay expectedThe Cyprus company's listing plans were postponed in April 2024, leading to a reduction in the board of directors.

Capital raiseThe company may pursue a registered offering or other capital raise following the effectiveness of this registration statement and commencement of trading on Nasdaq.Advances from the CEO's company, Malbrite Ltd, are repayable only upon completion of a future capital raise.

Worse than expectedThe company is pre-revenue and has incurred significant operating losses of €1,320,353 in 2024 and €5,308,332 in 2023.The company is heavily reliant on financial support from its CEO to meet its obligations, indicating a lack of independent financial sustainability currently.A material weakness in internal controls over financial reporting was identified for multiple years, leading to restatements, which suggests deficiencies in financial reporting processes.

Summary

Davion Healthcare Plc is an Irish Public Limited Company focused on developing and commercializing non-invasive home tests for early detection of health anomalies, including cancers.
The company has four completed non-invasive home tests: BreastCheck, FootFlow, Testic, and ThermaDerm, all registered as Class I medical devices with the FDA, CE, and UKCA.
BreastCheck, the flagship product, is scheduled for launch in the USA in the first half of 2026, followed by FootFlow six months later, with other products to be reviewed.
Davion Healthcare has entered into a global manufacturing and distribution agreement with NeuRX Health Inc., effective October 8, 2025, for BreastCheck.
This agreement includes a $120 million license fee, with $1 million cash by December 1, 2025, $19 million in 12 monthly installments starting January 1, 2026, and $100 million in annual $10 million tranches (cash or NeuRX shares) from January 1, 2026, to January 1, 2035.
The agreement also stipulates minimum annual royalties of $10 million per year and a $5.00 royalty per Product unit manufactured.
The company is currently pre-revenue, having incurred operating losses of €1,320,353 in 2024 and €5,308,332 in 2023.
Davion Healthcare is dependent on ongoing financial support from its CEO, Jack Kaye, through his private company Malbrite Ltd, to cover operating expenses.
The company is registering 25,000,000 ordinary shares for a direct listing on the Nasdaq Global Market under the ticker symbol DAVI, with an anticipated opening price of $10.00 per share, implying a total market capitalization of $250 million.
No new securities are being offered by the company in this direct listing, and it will not receive any proceeds from the sale of shares by Registered Shareholders.
A material weakness in internal controls over financial reporting was identified for the years ended December 31, 2024, 2023, and 2022, leading to a restatement of financial statements.

Sentiment

Score: 5

Explanation: While the company is pre-revenue and has significant historical losses and internal control issues, the securing of a substantial global licensing and distribution agreement with NeuRX Health Inc. (totaling $120M in license fees and $10M minimum annual royalties) provides a clear and significant path to future revenue and financial stability. The regulatory approvals for its product portfolio and the upcoming Nasdaq direct listing are also strong positive indicators, despite the inherent risks of a direct listing and pre-revenue status.

Positives

Secured a global manufacturing and distribution agreement with NeuRX Health Inc. for BreastCheck, including a $120 million license fee and $10 million minimum annual royalties.
All four non-invasive home tests (BreastCheck, FootFlow, Testic, ThermaDerm) have achieved Class I regulatory registration with the FDA (USA), CE (Europe), and UKCA (United Kingdom).
Possesses proprietary intellectual property, patents, and technology for its home testing systems, with no other known competitors utilizing like-technologies.
Management believes the company has sufficient financial resources for at least the next 12 months, supported by the CEO's ongoing financial backing and future contractual inflows.
The company has a clear product launch roadmap, starting with BreastCheck in H1 2026 in the USA, followed by FootFlow six months later.

Negatives

The company is pre-revenue and does not expect to generate revenue until the first half of 2026 at the earliest.
Incurred significant operating losses of €1,320,353 in 2024 and €5,308,332 in 2023.
Highly dependent on the personal financial support of the Chief Executive Officer, Jack Kaye, through Malbrite Ltd, to meet working capital requirements and cover expenses.
Identified a material weakness in internal controls over financial reporting for 2024, 2023, and 2022, which led to a restatement of financial statements.
The direct listing process carries additional risks, including no underwriters for price stabilization, potential for high volatility, and no contractual lock-up agreements for most existing shareholders (except for directors and affiliates for 90 days).
The company has a limited operating history with no commercial sales, providing limited basis for investors to evaluate its ability to successfully market and sell products.
Products are non-diagnostic and may be misunderstood by consumers or healthcare professionals, potentially leading to misuse, reputational damage, or liability claims.

Risks

Potential for cost increases or disruptions in the supply of raw materials (liquid crystal, thermochromic inks/films) for BreastCheck, impacting manufacturing costs and royalty margins.
Reliance on a third-party licensee (NeuRX Health Inc.) for manufacturing and distribution exposes the company to risks of non-performance, production delays, quality issues, or regulatory non-compliance by the licensee.
Regulatory authorities may reclassify products from Class I to higher categories, leading to increased costs, delays, or inability to commercialize.
Misunderstanding or misuse of non-diagnostic products by consumers or healthcare professionals could result in adverse outcomes, reputational damage, and liability claims.
Limited operating history with no commercial sales makes it difficult for investors to evaluate future commercial success.
Commercial success depends on market acceptance, which can be affected by consumer confidence, healthcare provider recommendations, pricing, competition, and regulatory scrutiny.
Significant dependence on the continued service of executive officers, with no key person insurance, poses a risk if they leave or join competitors.
Demand for products is influenced by macroeconomic, political, and social conditions, as well as product pricing and health awareness.
Exposure to product liability claims if health-related products do not perform as expected, with potentially inadequate insurance coverage.
Failure to manage growth effectively as the licensing model and product portfolio expand could adversely affect business and financial results.
Risks associated with protecting and storing sensitive consumer medical records, including potential for data breaches, liability, and reputational harm.
Dependence on third-party mobile platforms (Apple iOS, Google Android) for product functionality, exposing the company to risks from platform policy changes or application defects.
Reliance on back-end server infrastructure and AI algorithms for test result analysis, with risks of system failures, cybersecurity incidents, or evolving AI regulatory environments.
Uncertainty in recovering the full value of the intellectual property portfolio, as fair value estimates involve significant judgment and are sensitive to market conditions and commercialization success.
Potential for patent or trademark infringement claims from competitors, leading to costly litigation, product redesigns, or unfavorable licensing terms.
Inability to prevent unauthorized use of intellectual property, eroding competitive position and harming revenues.
Risks associated with future strategic alliances or acquisitions, including loss of proprietary information, non-performance by partners, integration difficulties, or dilution.
Adverse macroeconomic or geopolitical events (e.g., inflation, energy prices, conflicts) could reduce consumer confidence and demand.
Additional risks from direct listing (no underwriters, price volatility, no fixed price, limited lock-ups) compared to a traditional IPO.
Potential for dilution and adverse share price effects from future public offerings or capital raises.
Lack of current plans to pay cash dividends means investors may only receive returns through share price appreciation.
U.S. persons owning 10% or more of shares may face adverse U.S. federal income tax consequences (CFC rules).
U.S. Holders may suffer adverse consequences if the company is treated as a passive foreign investment company (PFIC).
Difficulties for investors in enforcing rights as an Irish company due to differences in corporate law and directors/officers residing outside the U.S.
Increased costs associated with becoming a public company, particularly after ceasing to qualify as an emerging growth company.

Future Outlook

The company expects to generate its first revenues in the first half of 2026, primarily from BreastCheck and FootFlow, following their commercial launches in the USA. Management believes that with current capitalization, ongoing CEO financial support, and future contractual inflows from the NeuRX Health Inc. licensing agreement, it has sufficient financial resources for at least the next 12 months. The company may pursue a registered offering or other capital raise after the Nasdaq listing to support business growth.

Management Comments

"Our strength as a Company at this early stage is twofold, that we possess our own intellectual property, patents and technology; and that to date, there are no other known competitors attempting to utilize like-technologies."
"The Company believes as of the date of this registration statement, that with its current capitalization, our Chief Executive Officers ongoing financial support, and future contractual inflows, the Company believes that it has sufficient financial resources to meet its obligations for at least the next 12 months."
"While the estimated fair value of the asset significantly exceeds its carrying value, this difference is not recognized in the statement of financial position, consistent with the Company’s cost accounting policy. The Company believes this asset will contribute materially to revenue and operating income from the first half of 2026 onwards, upon commercial launch of related products."

Industry Context

Davion Healthcare operates in the growing non-invasive home health testing market, leveraging thermography and AI for early detection of health anomalies, including cancers. This aligns with broader industry trends towards preventative care, personalized medicine, and accessible at-home diagnostics. The focus on Class I medical devices allows for over-the-counter sales, potentially expanding market reach beyond traditional clinical settings. The global incidence of breast cancer, for example, highlights a significant unmet need for early detection tools, which Davion aims to address with BreastCheck.

Comparison to Industry Standards

The filing does not provide specific comparable companies, projects, or results for direct comparison.
Davion Healthcare's approach of combining liquid crystal film thermography with AI analysis of smartphone images for non-invasive, non-diagnostic early detection is presented as a unique technology with no other known competitors utilizing like-technologies.
The market opportunity for BreastCheck is described as global, citing statistics such as 2.3 million women diagnosed with breast cancer globally in 2020 and 297,790 new cases of invasive breast cancer estimated in U.S. women in 2023, indicating a large potential market for early detection adjuncts.

Management Changes

Role	Previous Person	New Person	Effective Date	Reason
Director (Cyprus entity)	George Barry Jackson		2024-04-27	Resigned due to postponement of Cyprus company's listing plans and reduction of board size.
Director (Cyprus entity)	Jonathan Robin Chadwick		2024-04-27	Resigned due to postponement of Cyprus company's listing plans and reduction of board size.
Director (Cyprus entity)	Julian Fernand Sluyters		2024-04-27	Resigned due to postponement of Cyprus company's listing plans and reduction of board size.
Director (Cyprus entity)	Mark Bernard Battles		2024-04-27	Resigned due to postponement of Cyprus company's listing plans and reduction of board size.
Director (Cyprus entity)	Vasim Ul-Haq		2024-04-27	Resigned due to postponement of Cyprus company's listing plans and reduction of board size.
Director (Cyprus entity)	Kevin Malcolm Riches		2024-04-29	Resigned due to postponement of Cyprus company's listing plans and reduction of board size.
Director (Cyprus entity)	Susan Matteson King		2024-04-29	Resigned due to postponement of Cyprus company's listing plans and reduction of board size.
Director (Cyprus entity)	William Eric Peacock		2024-04-29	Resigned due to postponement of Cyprus company's listing plans and reduction of board size.
Chief Executive Officer (Irish entity)		Jack Kaye	2024-09-25	Appointment to the newly re-domiciled Irish entity.
Chief Commercial Officer (Irish entity)		David Over	2024-09-25	Appointment to the newly re-domiciled Irish entity.
Non-Executive Chairman (Irish entity)		Sir Eric Peacock	2025-01-06	Rejoined the board in a non-executive capacity after company re-domiciled to Ireland.
Non-Executive Director (Irish entity)		Kevin Riches	2025-01-06	Rejoined the board in a non-executive capacity after company re-domiciled to Ireland.
Non-Executive Director (Irish entity)		Susan M King	2025-01-06	Rejoined the board in a non-executive capacity after company re-domiciled to Ireland.
Non-Executive Director (Irish entity)		Julian F Sluyters	2025-01-06	Rejoined the board in a non-executive capacity after company re-domiciled to Ireland.

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Board Composition	Board reduced from 10 to 2 executive directors in April 2024 following postponement of Cyprus listing plans. Subsequently, four non-executive directors rejoined in January 2025, establishing a six-member board with a majority of independent directors upon SEC effectiveness.	2024-04-27	Initial reduction streamlined the board during a period of uncertainty; subsequent re-establishment with independent directors enhances governance for public listing.
Committee Establishment	Establishment of an audit committee, a compensation committee, and a nominating and corporate governance committee upon the effectiveness of the F-1 registration statement.	Upon F-1 effectiveness	Enhances corporate oversight, financial reporting integrity, executive compensation practices, and board composition, aligning with Nasdaq listing requirements and best practices for public companies.
Director Indemnification	The company intends to procure Directors and Officers liability insurance prior to the commencement of trading on Nasdaq.	Prior to Nasdaq listing	Provides protection for directors and officers against certain liabilities, which is standard for public companies and helps attract and retain qualified board members.
Executive Compensation	Executive directors Jack Kaye and David Over voluntarily waived their salaries from January 1, 2025, until the company's ordinary shares are listed on Nasdaq, with no accrual of unpaid salary for this period.	2025-01-01	Demonstrates management's commitment to the company's success and conserves cash during the pre-listing phase, but also highlights the company's current cash constraints.
Executive Equity Incentive Plan	Adopted an Executive Officers Share Option Plan in January 2025 for Jack Kaye (3,000,000 options) and David Over (1,500,000 options), vesting in tranches from April 2027 to April 2029, subject to continued employment and 5% annual EPS growth.	2025-01-02	Aligns executive incentives with long-term shareholder value creation and company performance, particularly EPS growth.

Legal Proceedings

Currently not a party to any legal or administrative proceedings and not aware of any pending or threatened material legal or administrative proceedings.

Related Party Transactions

Malbrite Ltd, a private company wholly owned and controlled by CEO Jack Kaye, has provided ongoing financial support to the company since its inception, covering operating expenses. These advances are non-interest-bearing, unsecured, and repayable only upon completion of a future capital raise.
In 2023, the company acquired intellectual property rights valued at €65 million from Davion Healthcare Ltd (a UK company) in exchange for 12,258,458 shares. This was a related party transaction as Jack Kaye was a director and shareholder of both the seller and buyer, but he declared his interest and abstained from voting.
On June 30, 2024, advances from Jack Kaye (through Malbrite Ltd) totaling €4.6 million and €1.0 million in fees due to David Paul Alexander Over were converted into 598,246 ordinary shares.
For the years ended December 31, 2024 and 2023, the company incurred NIL and €1,100,000, respectively, in management fees by Malbrite Limited and Kurdam Inc., companies controlled by Jack Kaye.
For the years ended December 31, 2024 and 2023, the company incurred €400,000 and €600,000, respectively, in director fees by David Paul Alexander Over. The balance payable was paid in full with share issuances.
For the year ended December 31, 2023, the company paid approximately €287,000 for marketing services to Tulk House International Limited, a company controlled by David Paul Alexander Over.
For the years ended December 31, 2024 and 2023, the company incurred NIL and €77,415, respectively, in management fees by Rallinson Limited, a company controlled by Jack Kaye.
For the years ended December 31, 2024 and 2023, the company incurred NIL and €1,707,178, respectively, in research and development costs by Rallinson Limited.
For the years ended December 31, 2024 and 2023, the company incurred NIL and €556,279, respectively, in research and development costs by Malbrite Limited.
As of December 31, 2024, €30,804 was owed to Jack Kaye, classified in Trade and other payables.

Stakeholder Impact

**Shareholders**: Existing shareholders will have their shares registered for direct listing on Nasdaq, providing liquidity. However, the direct listing model carries risks of price volatility due to no underwriter support and no fixed opening price. Future capital raises could dilute existing shareholders. Directors and affiliates are subject to a 90-day lock-up.
**Employees**: Currently, the company has no full-time or part-time employees. Executive officers have waived salaries until listing, indicating a lean operational structure and reliance on future revenue/capital for compensation.
**Customers**: The launch of non-invasive home tests like BreastCheck and FootFlow aims to provide accessible early detection tools, potentially improving health outcomes. The reliance on a dedicated Test Portal for results and data recording ensures standardized user experience and regulatory compliance.
**Suppliers**: The company's licensed manufacturer (NeuRX Health Inc.) is dependent on its suppliers for raw materials, and any disruptions could impact product availability and royalty revenues.
**Creditors**: The company's ability to meet obligations is currently supported by the CEO's advances, which are unsecured and repayable upon a future capital raise. The NeuRX Health Inc. agreement provides a significant future revenue stream to improve financial health.

Next Steps

BreastCheck to be launched in the USA in the first half of 2026.
FootFlow to be launched in the USA six months after BreastCheck.
Management to review launch dates for ThermaDerm and Testic.
Company to monitor market conditions for follow-on product launches in Europe and the United Kingdom.
Company to procure Directors and Officers liability insurance prior to Nasdaq listing.
Company intends to remediate identified material weaknesses in internal controls by hiring additional resources and modifying controls.
Company may pursue a registered offering or other capital raise following the Nasdaq listing.

Key Dates

Date	Description
2022-11-29	Davion Healthcare Plc (Cyprus) incorporated in the Republic of Cyprus with initial issue of 12,258,458 Ordinary Shares.
2023-02-06	Sale and Purchase Agreement dated for acquisition of intellectual property rights from Davion Healthcare (UK) Ltd by Davion Healthcare Plc (Cyprus) for €65 million in exchange for 12,258,458 shares.
2023-12-31	End of fiscal year, operating loss of €5,308,332 reported.
2023-11	BreastCheck and FootFlow registered with FDA in the United States and with regulatory bodies in the UK and European Union.
2024-01-01	Jack Kaye and David Over service agreements commence.
2024-02-01	Jonathan Robin Chadwick, Julian Fernand Sluyters, Kevin Malcolm Riches, Mark Bernard Battles, Susan Matteson King, and Vasim Ul-Haq appointed as directors to the Cyprus entity.
2024-04	Postponement of Cyprus company's listing plans and reduction of board from 10 to 2 executive directors; George Barry Jackson, Jonathan Robin Chadwick, Julian Fernand Sluyters, Mark Bernard Battles, Vasim Ul-Haq resigned on April 27, 2024. Kevin Malcolm Riches, Susan Matteson King, William Eric Peacock resigned on April 29, 2024.
2024-06	Issuance of 5,000,000 ordinary shares related to conversion of debt to equity and payment in equity for services.
2024-06-30	Advances by Jack Kaye (through Malbrite Ltd) and fees due to David Paul Alexander Over converted into 598,246 shares.
2024-09	Davion Healthcare Plc incorporated in Ireland.
2024-09-25	Jack Kaye appointed Chief Executive Officer and David Over appointed Chief Commercial Officer of the Irish registered company Davion Healthcare Plc.
2024-12	Restructuring occurred with shareholders of Cyprus entity exchanging shares for same number of shares in Davion Healthcare Plc (Ireland), making Cyprus a wholly owned subsidiary.
2024-12-31	End of fiscal year, operating loss of €1,320,353 reported.
2025-01-01	Commencement Date for Jack Kaye and David Over service agreements.
2025-01-02	Executive Officers Share Option Plan adopted for Jack Kaye and David Over.
2025-01-06	Sir Eric Peacock, Kevin Riches, Susan M King, and Julian Sluyters rejoined the board in non-executive capacities for the Irish entity.
2025-03-03	Executive Waiver of Salary under Service Contracts signed by Jack Kaye and David Over.
2025-03-07	Letter of financial support from Malbrite Ltd provided to auditor.
2025-08-01	Consolidated Financial statements approved by the board of directors and authorized for issue.
2025-08-29	BreastCheck EU Declaration of Conformity signed.
2025-09-01	Date for beneficial ownership calculation for Registered Shareholders.
2025-09-17	Directors Lock-In Agreement signed by all directors.
2025-09-26	F-1/A Registration Statement filed with the SEC; Audit report date; Section 302 and 906 Certifications signed.
2025-10-08	Effective Date of Global Manufacturing and Distribution Agreement with NeuRX Health Inc.
2025-12-01	First cash payment of $1,000,000 due from NeuRX Health Inc.
2026-01-01	Operational Date for NeuRX Health Inc. agreement; Commencement of 12 equal monthly installments of $19,000,000 from NeuRX; First annual issuance of $10,000,000 (cash or shares) from NeuRX.
2026-H1	Expected launch of BreastCheck in the USA.
2027-04-01	First vesting date (33.3%) for Executive Officers Share Option Plan, subject to EPS growth.
2028-04-01	Second vesting date (33.3%) for Executive Officers Share Option Plan, subject to EPS growth.
2029-04-01	Third vesting date (33.4%) for Executive Officers Share Option Plan, subject to EPS growth.
2034-03-31	Expiration of 10-year term for Executive Officers Share Option Plan.
2035-01-01	Final annual issuance of $10,000,000 (cash or shares) from NeuRX Health Inc.

Recommendation

hold

Davion Healthcare Plc is a pre-revenue company with a promising product pipeline and a significant global licensing agreement with NeuRX Health Inc. that provides a clear path to substantial future revenue. The regulatory approvals for its key products and the upcoming Nasdaq direct listing are positive catalysts. However, the company's current financial position, marked by significant operating losses and heavy reliance on CEO funding, along with identified material weaknesses in internal controls and the inherent volatility risks of a direct listing, warrant caution. An investor should 'hold' to monitor the successful commercialization of BreastCheck, the realization of license fees and royalties, and the remediation of internal control deficiencies before considering further investment. The long-term potential is considerable if execution is strong, but the near-term risks are also high.

Keywords

Davion Healthcare, Nasdaq Direct Listing, Non-invasive home tests, BreastCheck, FootFlow, Testic, ThermaDerm, Medical devices, Early detection, Cancer screening, Thermography, AI analysis, NeuRX Health Inc., Licensing agreement, Pre-revenue company, SEC F-1/A, Ireland company, Healthcare technology, Diagnostic products

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