(Incorporated in Ireland)

Note: This is NOT an IPO. This is a Direct Listing on the NASDAQ. Revere Securities is the financial advisor and the lead market maker for the Direct Listing, according to the prospectus. The opening price of our ordinary shares will not be fixed in advance. It will be established by Nasdaq’s opening auction process, which will be facilitated by the lead market maker. The lead market maker will provide continuous quotations and indicative pricing following the commencement of trading. For purposes of meeting Nasdaq’s initial listing requirements, management has used an expected opening price of $12 per share solely as a valuation reference.

Davion Healthcare Plc is an Irish Public Limited company focused exclusively on the development and commercialization of non-invasive home tests for the early detection of health anomalies, including cancers. Our home tests are non-diagnostic, focusing on early detection of potential health anomalies, for which if identified, further clinical tests outside of the scope of our products would be required.

We currently have four non-invasive home tests completed, namely, BreastCheck, FootFlow, Testic, and ThermaDerm. Our flagship product, BreastCheck, will be the first product to be launched in the first half of 2026. BreastCheck is a non-invasive home test designed to detect temperature anomalies in breast tissue, which may be indicative of cancer or other health conditions. The second product to be launched will be FootFlow, which is a home test for diabetics to monitor blood flow in feet and hands, for which poor circulation as a result of diabetes can lead to fingers and toes being amputated if poor blood circulation goes unchecked. The third product to be launched will be Testic. Testic is a home test for testicular anomalies, including testicular cancer. Testic works in a similar way to BreastCheck, by monitoring testicular temperature. Our fourth home test is ThermaDerm. ThermaDerm monitors skin temperature across various locations on the body to identify potential temperature changes which appear abnormal compared to other similar locations to help identify potential anomalies. None of the company’s home tests are diagnostic. They provide early warning of potential anomalies, for which further clinical investigation would be required in order for a diagnosis to be provided. The Company’s broad suite of non-invasive home testing kits help provide targeted additional health indicators for early detection, prevention, and wellness monitoring.

Our products, including BreastCheck and FootFlow, use thermography to detect small but meaningful changes in skin surface temperature. Liquid crystal film placed on the skin produces color shifts in response to temperature differences, creating a simple thermal map that highlights areas of concern.

BreastCheck applies this approach to identify abnormal breast tissue patterns that may warrant further clinical assessment, while FootFlow monitors circulation in the extremities of diabetic patients to detect risks associated with reduced blood flow, infection, or inflammation. By combining this proven film-based technology with artificial intelligence analysis of smartphone images, our products deliver standardized, reliable, and easy-to-understand results. This enables early detection at home in a safe, non-invasive, and scalable way.

All four tests meet Class I regulatory standards for non-invasive medical devices in the USA (FDA), in Europe (CE) and in the United Kingdom (UKCA). Regulatory approval for Class I products is by self-declaration, confirming that products registered meet the relevant regulatory standards as proscribed. Currently BreastCheck and FootFlow are registered with the FDA in the United States and have been since November 2023, and with regulatory bodies in the UK and the European Union also since November 2023.

All four products, BreastCheck, FootFlow, Testic and ThermaDerm are registerable as Class I Medical devices (which are “over the counter” product, meaning they can be sold in pharmacies, and on line, and are not required to be provided through clinicians), with the FDA in the USA, CE in Europe and UKCA in the United Kingdom. Non-invasive, non-diagnostic medical devices such as our four home tests, are registered under a “self-declaration” process, provided the device specification adheres to regulatory standards for Class I medical devices, supported by medical data sheets. Medical regulators have the ability to “question” the classification category for any medical device, and may on examination require re-classification of any medical device and the requirement for any such product to meet the revised technical product standard re-categorized as necessary in order to be able to be sold in the relevant country/region.

Our commercial strategy is primarily focused on licensing the manufacturing, marketing, sales, and distribution rights for our products to regional or global commercial partners. These licensees are responsible for obtaining necessary regulatory approvals in their territories and for delivering product support, including customer service and warranty administration. We believe this structure enables us to leverage the established infrastructure, expertise, and market reach of third parties, while allowing us to remain a capital-efficient innovator in medical device technology.

Although our strategic model is licensing-driven, we continually evaluate market conditions and the performance of our licensees. If we determine that a licensee has failed to meet its obligations or if commercial, operational, or regulatory conditions change, we may elect to assume responsibility for manufacturing, sales, or distribution of one or more of our products directly. Such a transition may require additional capabilities, resources, and investment and may involve a period of operational realignment as we establish or expand internal commercialization capacity.

Product launches commence with BreastCheck in the USA in the first half of 2026 under a global license agreement with NeuRX Health, Inc. (“NeuRX”), with follow on product launches in Europe and the United Kingdom, the timing of which will be subject to market conditions while the Company will monitor on an ongoing basis. In respect of initial product launches in the USA, FootFlow is anticipated to launch six months after the initial launch of BreastCheck, and like BreastCheck, it will launch in the USA initially and then develop operations into Europe and the United Kingdom. ThermaDerm and Testic launch dates will be reviewed by management as to launch times and all regulatory filings will be established and filed as applicable, prior to the launch of those two products. During our initial year of commercialization, we expect revenues to be derived primarily from BreastCheck and FootFlow. For additional discussion of risks related to our business and products, see the “Risk Factors” section.

Note: Davion Healthcare is a pre-revenue company.

Note: Net loss is in U.S. dollars (converted from euros) for the 12 months that ended June 30, 2025.

Note: Davion Healthcare has no employees. Its management team serves under contract, the prospectus said.

(Note: Davion Healthcare increased the reference price for its NASDAQ Direct Listing to $12.00 – up from $10.00 initially – in an F-1/A filing on Nov. 7, 2025. Background: On Aug. 4, 2025, Davion Healthcare filed plans for its NASDAQ Direct Listing of 25 million shares. No new stock is being issued.)