REG - RUA Life Sciences - Heart Valve Leaflet Material - Testing Update

Rua Life SciencesAnnouncement

20/12/2023 07:00

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RNS Number : 3631X  RUA Life Sciences PLC  20 December 2023

 

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."

 

For further information contact:

 

 

 RUA Life Sciences

 Bill Brown, Chairman                                                    Tel: +44 (0)1294 317073

 Caroline Stretton, Group Managing Director                              Tel: +44 (0)1294 317073

 Cavendish Capital Markets                                               Tel: +44 (0)20 7220 0500
 Limited

 (Nominated Adviser and Broker)

 Giles Balleny/Dan Hodkinson (Corporate Finance)

 Charlie Combe (Broking)

 Michael Johnson (Sales)

 

 

 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-Eon(TM), the world's leading long-term implantable
polyurethane. Whether it is licensing Elast-Eon(TM), 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:

 

 RUA Contract Manufacture:  End-to-end contract developer and manufacturer of medical devices and
                            implantable fabric specialist.

 RUA Biomaterials:          Licensor of Elast-Eon(TM) polymers to the medical device industry.

 RUA Vascular:              Commercialisation of open surgical vascular grafts and patches

 RUA Structural Heart:      Development of polymeric leaflet systems for heart valves.

 

 

 

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."

 

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