RUA Life Sciences PLC Update on RUA Vascular (8587T)
March 30 2021 - 1:00AM
UK Regulatory
TIDMRUA
RNS Number : 8587T
RUA Life Sciences PLC
30 March 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 polymer
(Elast-Eon(TM)), is pleased to update on recent progress at its
subsidiary RUA Vascular, which is developing Elast-Eon(TM) sealed
vascular grafts and cardiac/vascular patches.
RUA Vascular - Regulatory Testing and Pathway
As previously announced, RUA Vascular is pursuing a 510k
regulatory process with the FDA on both its large bore vascular
graft and cardiac/vascular patch products. This 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 a different technology that
does not raise new questions regarding safety or effectiveness. The
RUA Vascular large bore graft was designed with the 510k process in
mind and therefore the testing of the graft both in the lab and in
the large animal model is to demonstrate this "Substantial
Equivalence".
The animal trial started last summer, and the first seven
explants have now been made. Initial observations indicate that the
grafts have performed to design expectations. The grafts are a
bespoke design mimicking equivalent Dacron grafts on the inside and
having the Elast-Eon(TM) sealant confined to the outside to reduce
bleeding whilst eliminating the use of animal sourced material. The
explants show normal anastomotic neo-intima formation (the desired
form of tissue in growth or "healing process") on the inside of the
graft. Additionally, no adherent tissue was seen on the outside of
the graft, pointing towards a less severe host implant response.
The Company is very encouraged by these early observations which
demonstrate the required graft performance necessary for the 510k
submission.
While all the key elements of the project timeline that are
within RUA's control are on time and on target, due to COVID-19, we
have experienced delays from packaging suppliers which have
impacted the timetable for sterilisation and product shelf-life
validation testing. Despite this, the Company remains on target to
submit the 510k during the second quarter of 2021, which is
expected to be towards the end of the quarter, and is continuing to
manage all residual risks to avoid any further slippage to project
timelines.
As discussed previously, the vascular graft is, by far, the more
complicated of the initial two product ranges under development and
the IP developed would be used to create the range of
cardiac/vascular patches. The regulatory strategy for the patches
was initially to include patches within the graft 510k with the
option of making a separate 510k submission if it provided
additional commercial benefits. After completing a proof-of-concept
study on the patch, a substantial development programme is now
underway which includes optimised fabric construction to provide
greater compliance of the patch, and automated manufacturing
equipment to our bespoke design has been ordered. This specialist
equipment will allow highly consistent product to be made
efficiently thus maximising margins in what is a higher volume, but
lower price medical device.
Having had confirmation of how Elast-Eon(TM) sealed fabric
performs in a long-term animal implant, we can now see additional
opportunities for the Company's patch range. The marketing claims
and indications for use that we now wish to pursue for the patches
are much broader than previously anticipated. Therefore, given
these additional opportunities, the Company has decided to submit a
separate 510k application specifically for its patch range. The
Company does not anticipate having to undertake any additional
animal work and thus expects the filing of this additional 510k
submission to be made by the end of this year.
The Company expects to release a trading update for the year
ended 31 March 2021 in late April 2021.
Bill Brown, Chairman of RUA Life Sciences, stated: "It is just
under a year ago that the Group acquired RUA Medical to bring the
development of our graft and patch products in-house. Despite
having spent that entire year living through a global pandemic, the
progress made since the acquisition has been truly remarkable. The
grafts look to have performed as anticipated and we look forward to
completing the regulatory submission in late Q2 which will be a
significant milestone for RUA. The team has done a great job in
achieving demanding targets particularly given Covid and Brexit
related problems throughout the supply chain."
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 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: Commercialisation of large bore polymer sealed
grafts and soft tissue patches.
RUA Structural Development of polymeric leaflet systems for
Heart : heart valves.
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