RUA Life Sciences PLC RUA Vascular Update (0652M)
September 17 2021 - 1:59AM
UK Regulatory
TIDMRUA
RNS Number : 0652M
RUA Life Sciences PLC
17 September 2021
RUA Life Sciences Plc
("RUA Life Sciences", the "Company" or the "Group")
RUA Vascular Update
RUA Life Sciences, 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 the following update on testing of the
Elast-Eon(TM) sealed vascular graft range.
As previously announced, the presence of cellulose, a non-toxic,
natural plant-based material, had been identified during chemical
characterisation testing on samples of large bore vascular grafts .
A fter undertaking a full analysis of the possible source, a
secondary study was commissioned to test grafts manufactured under
revised cleanroom protocols, which has now confirmed that no
cellulose was present in leachable extracts from the new graft
samples tested . Once the full chemical characterisation report has
been received from the third-party test house, the Group will
proceed to submit the 510k notification.
RUA can also confirm that a manuscript will be submitted to the
European Association of Cardiothoracic Surgeons ("EACTS") to
support a presentation on the results of 'in vivo' testing of the
RUA grafts at the EACTS' annual meeting in October 2021, and will
be submitted for publication in a respected Journal. RUA is very
excited by the observations from the 'in vivo' testing and believes
this could become a potentially seminal paper on the future
direction of surgical graft implantation. RUA looks forward to
attending the meeting to gauge both clinical and industry
reaction.
Dr Caroline Stretton, Group MD of RUA, said : "I am delighted
that the work by the third-party testing house has confirmed our
internal work on resolving the cellulose contamination issue and
look forward to the final submission of our 510k and receiving
feedback on our products from EACTS. We remain on target to launch
the world's first non-biogenically sealed grafts by the end of this
financial year."
For further information contact:
RUA Life Sciences Tel: +44 (0)1294 317073
Bill Brown, Chairman
Dr Caroline Stretton, Group MD
Shore Capital (Nominated Adviser and Joint Broker) Tel: +44 (0)20 7408 4080
Tom Griffiths/David Coaten
Cenkos Securities plc (Joint Broker) Tel: +44 (0)20 7397 8900
Max Gould, Giles Balleny (Corporate Finance)
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 ElastEon (TM) , the world's leading
long-term implantable polyurethane.
Whether it is licensing ElastEon (TM) , manufacturing a device
or component, or developing next generation medical devices, a RUA
Life Sciences business is pursuing our vision.
ElastEon(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 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 :
A copy of this announcement will be available shortly at
www.rualifesciences.com/investor-relations/regulatory-news-alerts
.
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