RUA Life Sciences provided 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; Rem 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. Patient 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.