Rua Life Sci. Regulatory News (RUA)

20 December 2023

RUA Life Sciences Plc

("RUA Life Sciences", the "Company" or the "Group")

Heart Valve Leaflet Material - Testing Update

RUA Life Sciences (AIM: RUA), the holding company of a group of medical device businesses focused on the exploitation of the world's leading long-term implantable biostable polymer (Elast-Eon?), today provides an update on recent developments of the RUA leaflet composite.

The objective for RUA Structural Heart during 2023 was to evaluate heart valve leaflet material and compare the performance of 100% polymeric valves with the novel composite developed by the Group. The computational modelling of the composite material at the design stage suggested that its mechanical properties would be ideal for heart valve leaflets.

Testing undertaken by RUA has demonstrated:

· Flex fatigue stability over 400m cycles

· Durability as a heart valve leaflet over 200m cycles

· Remarkable tensile strength properties exceeding both base fabric and polymer

· Similar tensile strength in multiple directions

· Highly flexible allowing improved valve efficiency.

· Narrow crimping profile allowing TAVR benefits

· Retention of ElastEon blood contacting properties such as calcification and thrombogenicity.

· Material very stable with no delamination during testing and high tear resistance.

Patent protection for the material has now been sought and coupled with the testing results achieved RUA is now seeking to commercialise the RUA composite material as an alternative to animal tissue used in the manufacture of heart valves. Engagement with the industry has been positive and, as previously announced, a major heart valve company has approached the Company to undertake its own tests and has now entered into a material testing agreement (MTA) in order to do so.

While there can be no certainty that the parties will progress to an agreement, an MTA is the preliminary step to further collaboration.

Bill Brown, Chairman of RUA Life Sciences, stated: "Combining RUA's expertise in implantable textile materials with the clinically proven properties of ElastEon has created a novel material that appears to meet the key properties required of heart valve leaflets and it is pleasing that the business is now transitioning from a R&D phase into early stages of commercialisation."

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 About RUA Life Sciences

The RUA Life Sciences group was created in April 2020 when RUA Life Sciences Plc (formerly known as AorTech International Plc) acquired RUA Medical Devices Limited to create a fully formed medical device business. RUA Life Sciences is the holding company of the Group's four trading businesses, each exploiting the Group's patented polymer technology.

Our vision is to improve the lives of millions of patients by enabling medical devices with Elast-EonTM, the world's leading long-term implantable polyurethane. Whether it is licensing Elast-EonTM, manufacturing a device or component, or developing next generation medical devices, a RUA Life Sciences business is pursuing our vision.

Elast-Eon?'s biostability is comparable to silicone while exhibiting excellent mechanical, blood contacting and flex-fatigue properties. These polymers can be processed using conventional thermoplastic extrusion and moulding techniques. With over 8 million implants and 15 years of successful clinical use, RUA's polymers are proven in long-term life enabling applications.

The Group's four business units are:

100% polymeric valves rely in part on the leaflet design to reduce stress and operate within the performance window of the polymer meaning that polymer would not work in all designs. The composite material retains the blood contacting properties of Elast-Eon but is significantly stronger. This creates the opportunity for RUA Structural Heart to become a supplier of heart valve leaflets to other companies to incorporate in current designs.

Bill Brown, Chairman of the Company, commented: "RUA has a portfolio of four businesses, all of which have made good progress during the period. The mature businesses are growing revenue and generating attractive net margins and the development business segments of Vascular and Structural Heart have made good regulatory and technological progress respectively on relatively low levels of investment."