DAVION HEALTHCARE PLC

Davion Healthcare Plc is an Irish Public Limited Company focused on the development and commercialization of non-invasive home tests for the early indication of potential anomalies. Our home tests are non-diagnostic, focusing on early indication of potential 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 second half of 2026. BreastCheck is a non-invasive home test designed to detect temperature anomalies in breast tissue 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. 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 indication of potential anomalies, prevention, and wellness monitoring. Each of the Company’s products — BreastCheck, FootFlow, Testic, and ThermaDerm — are designed and intended to be sold directly to consumers over the counter, without the involvement of a healthcare professional, subject to compliance with applicable regulatory requirements in each jurisdiction. The ability to sell a product over the counter is a product-specific determination and does not apply to all Class I medical devices generally. Our products are designed for home use and are registered with the FDA as Class I medical devices under applicable self-declaration and registration frameworks in relevant jurisdictions. Class I medical devices are generally subject to general regulatory controls and, in many cases, do not require premarket review or clearance by the U.S. Food and Drug Administration (“the FDA”), or equivalent review by applicable foreign regulatory authorities, before marketing. Class I medical devices are generally not subject to premarket review for safety or efficacy, and no regulatory authority has made any determination that they are safe or effective for their intended use. The performance and reliability statements included in this prospectus are based on prototype validation, and applicable regulatory registrations for Class I medical devices, and such testing has not been reviewed or independently validated by the FDA or other regulatory authorities. The Company has not conducted large-scale, randomized clinical trials for the current home-use configuration. Our products are not intended to diagnose cancer or any other medical condition and are intended only to provide an early indication of potential anomalies. Users should seek appropriate clinical evaluation from a qualified healthcare professional for any findings or concerns. 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 film-based technology with artificial intelligence analysis of smartphone images, our products deliver standardized, reliable, and easy-to-understand results. This enables early indication of potential anomalies at home in a safe, non-invasive, and scalable way. 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 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 are designed to meet applicable Class I regulatory requirements 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 prescribed. 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 registered 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 reclassification of a medical device and require the product to meet the applicable technical and regulatory standards for its revised classification before it may be sold in the relevant country or region. Our commercial strategy provides flexibility to manufacture, market, sell and distribute our products either directly, through members of the Davion group, or through third-party manufacturers, licensees and distributors appointed on a regional or territory-specific basis. We may use different commercialization arrangements in different markets depending upon regulatory requirements, available infrastructure, market conditions and the capabilities of potential commercial partners. Our strategic commercialisation model may involve direct manufacturing/distribution and regional third-party manufacturers and distributors. We continually evaluate market conditions and the performance of our licensees where appointed. 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 second half of 2026, 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. During the year ended December 31, 2025, we incurred an operating loss of €1.1 million. --- The address and telephone number of our principal executive offices, The Cube Building, Monahan Road. Cork, T12 H1XY, Ireland. Our telephone number: +353 2238 808 958. Our main website is www.davionhealthcare.com. Our agent for service of process in the United States is the Law Offices of David E Price PC, 3 Bethesda Metro Center, Suite 700, Bethesda, MD 20814.