RUA Life Sciences PLC Successful completion of Heart Valve Testing (0823G)
November 23 2020 - 2:00AM
UK Regulatory
TIDMRUA
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(TM)), 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(TM) 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: +44 (0) 77 3071 8296
David Richmond, CEO Tel: +44 (0) 78 99996400
Shore Capital
Tom Griffiths/David Coaten Tel: +44 (0)20 7408 4080
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 (TM)'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-Eon(TM) polymers to the medical
: device industry.
RUA Vascular : Development of large bore polymer sealed grafts
and soft tissue patches.
RUA Structural Development of tri leaflet polymeric heart valves.
Heart :
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