Successful completion of Heart Valve Testing

RNS Number : 0823G

RUA Life Sciences PLC

23 November 2020

 

RUA Life Sciences plc

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

Successful completion of Heart Valve Testing

RUA Life Sciences plc  (AIM: RUA.L), 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™), is pleased to announce significant recent success within its RUA Structural Heart business.

In the 'Trading Update' issued on 23 October 2020, the Company stated that   the most recently manufactured surgical valves looked very promising and, as a result, it had elected to undertake additional pilot testing of the valve earlier than it had previously anticipated.

The testing, which has now been undertaken, was hydrodynamic or pulsatile flow testing, which replicates the flow of blood in the human heart. ISO Standard-5840 (surgically implanted heart valve substitutes) sets out minimum parameters or performance requirements for these hydrodynamic tests. The results of the tests carried out are summarised below:

· All valves tested easily surpassed the minimum ISO requirements thus indicating that they would work in the human heart;

· The valves tested, which were chosen at random from a single production run, demonstrated remarkable consistency in performance; and

· The sealing of the valve during diastole (when the valve is closed) was outstanding with any flow monitored within the measurement error of the testing equipment.

The RUA surgical valve and Elast-Eon™ leaflet system have been designed to minimise stress with the objective of increasing the durability of heart valves. This was achieved by combining several elements of RUA's growing intellectual property portfolio, including heart valve design patents, polymer patents and newly developed manufacturing and design IP, which together have removed the historic constraints on leaflet manufacture. This has allowed additional strength to be built into the leaflets where it is most required, replicating what happens in the natural heart valve.

These proof of concept valves were manufactured using regular industrial type equipment so allowing next generation valves to be made to a much higher standard with improved performance whilst still retaining high levels of scalability of manufacture.  

The next stage of development will include further refinement to the manufacturing process thereby allowing even better hydrodynamic performance. In addition, the computational modelling will be further enhanced by incorporating the data from recent testing. Preliminary durability testing will be also conducted on the same generation of valve used in the hydrodynamic tests to generate further data.

Bill Brown, Chairman of RUA Life Sciences ,   stated : "RUA has succeeded in making a heart valve that has demonstrated it would perform in man, straight out of the box. The combination of our repeatable manufacturing process, a world class polymer (Elast-Eon^TM) and the low stress design gives us additional confidence that the durability of the leaflet system should at least achieve our own high expectations."

For further information contact:

RUA Life Sciences

Bill Brown, Chairman                                  Tel: [phone]                                    

David Richmond, CEO                                   Tel: [phone]    

Shore Capital  

Tom Griffiths/David Coaten                        Tel: [phone]

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 improving and 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 7 million implants and over 14 years of successful clinical use, RUA's polymers are proven in long-term life enabling applications.

The Group's four business units are:  

RUA Medical :	End-to-end contract developer and manufacturer of medical devices and implantable fabric specialist.
RUA Biomaterials :	Licensor of Elast-EonTM polymers to the medical device industry.
RUA Vascular :	Development of large bore polymer sealed grafts and soft tissue patches.
RUA Structural Heart :	Development of tri leaflet polymeric heart valves.

 

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