RUA Life Sciences PLC Further Progress at RUA Vascular (5686B)
October 09 2020 - 2:00AM
UK Regulatory
TIDMRUA
RNS Number : 5686B
RUA Life Sciences PLC
09 October 2020
RUA Life Sciences plc
("RUA", the "Company" or the "Group")
Further Progress at 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 polymer
(Elast-Eon (TM) ), is pleased to announce that its subsidiary RUA
Vascular, which is developing Elast-Eon (TM) sealed vascular grafts
and cardiac/vascular patches, has made further progress on both the
regulatory and commercial pathways towards product launch.
RUA Vascular - Product Development and Commercialisation
As previously announced on 5 August 2020, RUA Vascular recently
reached the important milestone of achieving design freeze on its
vascular graft products. This allowed grafts to enter the
regulatory testing phase in advance of 510k submission to the FDA.
The 510k process, or "Pre-Market Notification", is a much simpler
regulatory path than the more stringent "Pre-Market Approval"
process and is available to medical devices that can claim
"Substantial Equivalence" to legally marketed equivalent devices
that are for the same intended use and have the same technology or
different technology that does not raise new questions regarding
safety or effectiveness. The RUA Vascular graft was designed with
the 510k process in mind and the testing of the recently "frozen"
design is to demonstrate this "Substantial Equivalence". RUA
anticipates the 510k data package to be submitted early Q2 of
2021.
An important part of this testing phase includes a long-term
animal trial of both RUA's graft and the market leading graft as a
control (the "Substantial Equivalent"). The RUA grafts have now
been implanted without incident and the animals have recovered
well. The graft has performed perfectly during surgical implant.
Initial feedback given by the surgeons and confirmed by videos of
the procedures was that the graft was simple to suture with no
difference to the control graft. No or little bleeding from the
anastomosis (or suture line) was observed with a suggestion that
the elastomeric coating on the graft has assisted suture sealing.
Importantly, the graft body maintained zero porosity throughout the
procedure with no "blush" to the fabric which was observed in the
control grafts. In short, RUA's graft has performed as well as, if
not better than, the market leading Substantial Equivalent.
Good progress has also been made on commercialising the product
development work successfully undertaken by the Company's R&D
team. The route to market is anticipated to be through a
combination of Original Equipment Manufacturer (OEM) agreements and
distribution agreements. RUA has been engaged with the medical
device industry for some time with regards to potential OEM
agreements. These discussions are developing at pace and have now
progressed to sharing volume data and requests for quotations.
Bill Brown, Chairman of RUA Life Sciences , stated : "I was
present and observed the implantation of our final grafts and was
very impressed with their performance as surgical devices. The team
has succeeded in our design objectives of eliminating animal
by-products and creating a zero porosity graft without having to
compromise on the implantability of the product. These recent
developments, both technically and commercially, are key
achievements on the path to the anticipated market launch of our
grafts during 2021."
Release of trading update
The Company proposes to release a trading update for the six
months ended 30 September 2020 in the week commencing 19 October
2020.
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
Heart : valves.
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