RUA Life Sciences cheers positive testing of heart valve technology

Medical device company RUA Life Sciences announced “significant” recent success within its RUA Structural Heart business on Monday.

The AIM-traded firm had said in its trading update on 23 October that the most recently manufactured surgical valves “looked very promising” and, as a result, it had chosen to undertake additional pilot testing of the valve earlier than previously expected.

It said on Monday that the testing, which had now been undertaken, was hydrodynamic, or ‘pulsatile flow’ testing, which replicates the flow of blood in the human heart.

ISO standard 5840 for surgically implanted heart valve substitutes sets out minimum parameters or performance requirements for the hydrodynamic tests, the board explained.

It said all valves tested “easily surpassed” the minimum ISO requirements, 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.

RUA said 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 were designed to minimise stress, with the objective of increasing the durability of heart valves, the company said.

That was achieved by combining several elements of its intellectual property portfolio, including heart valve design patents, polymer patents, and newly-developed manufacturing and design intellectual property, which together removed the historic constraints on leaflet manufacture.

RUA said that had allowed additional strength to be built into the leaflets where it was most required, replicating what happens in the natural heart valve.

The proof-of-concept valves were manufactured using regular industrial-type equipment, allowing next-generation valves to be made to a “much higher standard” with improved performance, while still retaining high levels of scalability of manufacture.

It said the next stage of development would include further refinement to the manufacturing process, allowing “even better” hydrodynamic performance.

In addition, the computational modelling would be further enhanced by incorporating the data from recent testing.

Preliminary durability testing would be also conducted on the same generation of valve used in the hydrodynamic tests to generate further data.

“RUA has succeeded in making a heart valve that has demonstrated it would perform in man, straight out of the box,” said chairman Bill Brown.

“The combination of our repeatable manufacturing process, a world class polymer and the low stress design gives us additional confidence that the durability of the leaflet system should at least achieve our own high expectations.”

At 1110 GMT, shares in RUA Life Sciences were up 3.51% at 147.5p.