RUA Life Sciences PLC Update on RUA Vascular (0730D)
25 Junio 2021 - 1:00AM
UK Regulatory
TIDMRUA
RNS Number : 0730D
RUA Life Sciences PLC
25 June 2021
RUA Life Sciences plc
("RUA", the "Company" or the "Group")
Update on RUA Vascular
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 polyurethane
(Elast-Eon(TM)), provides the following update on the regulatory
application for the large bore vascular grafts in development by
RUA Vascular.
All results from both in vivo and in vitro testing have now been
gathered and the submission pack for 510k application to the FDA
has been prepared. Mechanical testing of the grafts indicate
superior performance over the control. Pathology results from the
six-month in vivo testing were normal giving the Board confidence
that the grafts perform as anticipated.
The Company has however noted the presence of cellulose, a
non-toxic, natural plant-based material, in the analysis of the
leachable extracts from the graft samples tested. As the raw
materials for the graft only comprise Elast-Eon(TM) (as sealant)
and polyethylene terephthalate (yarn for graft fabric), the
presence of cellulose is currently unexplained other than the
samples have been contaminated at some stage in the chain of
custody. Submission of the 510k, which was previously anticipated
by the end of June 2021, with this unknown factor would in the
Board's opinion, risk the application being rejected at the initial
filing review stage. As a result, the Company has decided to
undertake a secondary test on grafts from another production batch
and carry out detailed chemical analysis on the original samples
before submission. The Company continues to anticipate first
revenues from the sale of grafts by the end of the current
financial year.
Bill Brown, Chairman of RUA Life Sciences, stated : "It is
clearly frustrating that the contamination of samples has delayed
our filing of the 510k. However, it is better to suffer this short
delay now than have a potential rejection due to submitting with
unknowns. Critically, the most important test results were all
positive and the critical path to commercial launch is not expected
to be impacted by this delay in filing."
For further information contact:
RUA Life Sciences
Bill Brown, Chairman Tel: +44 (0) 77 3071 8296
David Richmond, CEO Tel: +44 (0) 78 9999 6400
Shore Capital (Nominated Adviser and Joint Broker)
Tom Griffiths/David Coaten Tel: +44 (0)20 7408 4080
Cenkos Securities plc (Joint Broker) Tel: +44 (0) 20 7397 8900
Russell Cook/Max Gould (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
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 designer 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 large bore polymer
sealed grafts and soft tissue patches.
RUA Structural Development of polymeric leaflet systems
Heart: for heart valves.
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