TIDMRUA
RNS Number : 1448V
RUA Life Sciences PLC
05 August 2020
RUA Life Sciences Plc
("RUA Life Sciences", the "Company" or the "Group")
Significant Milestones achieved by RUA Vascular
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 that its subsidiary, RUA Vascular, the
business which is developing Elast-Eon(TM) sealed vascular grafts
and cardiac/vascular patches, has recently achieved significant
milestones for each of these products on the path to early
commercialisation.
Large Bore Vascular Grafts at "Design Freeze"
The three key design inputs for the RUA Vascular large bore
(18mm to 38mm) vascular graft project were:
1. The elimination of animal by-products;
2. Improving on the permeability and porosity claims of
currently available market leading products; and
3. Improving handling characteristics and surgical feel.
During the development of the Elast-Eon(TM) sealed large bore
vascular graft, a number of different iterations were produced,
each adding to the know-how and intellectual property relating to
the thin film polymer sealing of a vascular graft without the need
for any animal tissue.
Subsequently, a combination of animal pilot studies and bench
testing have demonstrated that the thin film polymer sealed
vascular graft is indistinguishable in handling and needle/suture
acceptance from the currently available commercial collagen and
gelatin sealed grafts. The latest animal pilot study demonstrated
that on release of clamp, allowing blood to flood into the graft at
normal blood pressure, no leaks were recorded and bench testing to
the ISO7198:2017 standard measured the water permeability to be
significantly below the market leading animal by-product coated
grafts. In addition to achieving the three key design objectives
set out above, all other design inputs have been met to the
satisfaction of the technical team and a commercially viable and
validatable product has been developed.
The large bore graft project is now at "design freeze" stage and
the technical team is confident that the graft meets all of the
regulatory requirements. In addition, regulatory testing of the
large bore graft has now commenced with third party test
houses.
These recent achievements have significantly de-risked the
vascular graft project and allows regulatory testing to commence
and confirm the in-house test data before a submission is made for
FDA approval.
This regulatory testing is anticipated to be completed during
the early part of 2021 with commercial launch and associated
revenue generation being anticipated after FDA regulatory approval
is achieved. The Group's regulatory team has already started to
construct the 510k FDA submission pack to facilitate a smooth
regulatory pathway towards approval.
Cardiac and Vascular Patches
Development of the large bore vascular graft was the most
technically challenging of the initial two products in RUA
Vascular's medical device portfolio. The technology developed for
the grafts has now been applied to the coronary and vascular
patches and a manufacturing method designed and developed that can
produce patches of the sizes and characteristics required by the
market. Prototype patches have been manufactured using the new and
novel method and the regulatory pathway will run in parallel with
that for the large bore vascular graft with commercial launch
anticipated around the same time.
Commercial Implications
RUA Medical Devices, the Group's end-to-end contract developer
and manufacturing business, will be the sub-contract manufacturer
of the devices developed for RUA Vascular. Over the last two years,
RUA Medical Devices has made substantial investment in its
infrastructure and clean room capacity in anticipation of the need
to manufacture medical devices both for third party customers and
for RUA Vascular. RUA Medical Devices is currently at no more than
33% of total manufacturing capacity and, as a result, little
additional infrastructure or overhead will be required to
manufacture and commercialise the RUA Vascular products. Initial
costings of both grafts and patches indicate a gross margin
potential of between 70% and 80%.
It is the Group's intention to bring its patches and grafts to
market through a combination of distribution and OEM supply
agreements. It is anticipated that negotiation of these commercial
agreements will be further progressed at the same time as
regulatory testing is being undertaken with the objective of
enabling commercial sales to begin as soon after regulatory
approval has been granted as practicable.
Further updates will be provided on each of the Group's vascular
grafts and cardiac/vascular patches as appropriate.
Bill Brown, Chairman of RUA Life Sciences, commented :
"Achieving design freeze on this important product line is a major
step along the path of creating a profitable medical device company
and moves the RUA Vascular business from being an early stage
development project to a later stage business with near term
revenue and profit potential. "
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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END
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