TIDMRUA
RNS Number : 1198R
RUA Life Sciences PLC
03 November 2021
RUA Life Sciences plc
("RUA", the "Company" or the "Group")
Significant Milestone at RUA Vascular
and
Trading Update
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 the submission by RUA
Vascular to the US Food and Drug Administration ("FDA") of its
Premarket Notification (510k) for a range of polymerically sealed
vascular grafts. In addition, it is providing the following update
on each of the Group companies for the six months ended 30
September 2021 (the "Period"):
RUA Vascular - the business commercialising large bore vascular
grafts, cardiac and vascular patches - is delighted to announce the
submission to the FDA of its Premarket Notification (510k) for a
range of polymerically sealed vascular grafts. This follows an
introduction of the RUA graft at the recent annual meeting of the
European Association for Cardio-Thoracic Surgery (EACTS) held in
Barcelona. The unmet need for non-biogenic devices was discussed
broadly at the meeting and interest in implanting the RUA grafts
was expressed by both US and European surgeons confirming to the
Board the Company's plans for launch strategy and distribution
channels. Interest from potential industry partners continues and a
further two non-disclosure agreements have been entered into to
allow incorporating RUA grafts into currently marketed devices. The
Company's R&D team now has a major task of validating
production equipment in advance of the commercial launch of grafts
during the first quarter of 2022.
The delays to patch production equipment have been resolved and
prototype production is now underway. The regulatory pathway for
patches is very similar to grafts and, based on current design
parameters, will utilise much of the data currently submitted to
the FDA for grafts. Th e Company has been advised that it would be
better to run two applications relying on the same data in series
rather than in parallel to avoid compromising either submission. As
such, the patch 510k submission will now follow on from the graft
510k approval. This revised regulatory submission strategy also
allows the Company to focus resource on a feasibility study into
Peripheral Artery Disease and Critical Limb Ischemia devices for
which the Company was successful in competing for Innovate UK grant
finance. This exciting new project, which the Board hopes will add
to the product pipeline, will be undertaken during the first
quarter of 2022.
RUA Biomaterials - the licensor of Elast-Eon(TM) - performed
ahead of the Board's expectations with royalties on shipments of
Elast-Eon(TM) by the Company's manufacturing licensee, Biomerics,
growing in the Period by 22 per cent. (in US$) over the same period
last year. Sales of Elast-Eon(TM)-enabled devices by other
licensees also continue to grow with one licensee reaching its
annual royalty cap (US$200k) for the calendar year 2021 in the
first quarter. As such, revenues from this licensee will not be
recognised during the first half (2020: $100,000) resulting in a
more extreme second half weighting in royalties. All royalty and
license fees are US$ denominated and the strengthening of Sterling
has also impacted reported revenues which for the six months to 30
September 2021 are expected to be GBP156,000 (2020: GBP216,000).
The Company's manufacturing partner, Biomerics, is currently
undertaking an expansion of its Elast-Eon(TM) manufacturing
capacity and further increasing marketing activities relating to
its polymer offering. It is also pleasing to report that RUA's
Intellectual Property portfolio has been enhanced with the granting
of a new European patent titled: "PROCESS FOR THE PREPARATION OF
POLYURETHANE SOLUTIONS BASED ON SILICON-POLYCARBONATE DIOLS."
RUA Medical Devices (" RUA Medical") - order intake from RUA
Medical's major customer for US supply has now returned to
pre-Covid levels whilst Europe remains behind pre-COVID levels.
Revenues for the six months to 30 September 2021 increased by 33
per cent. to GBP552,000 over the same period last year (2020: GBP
416,000).
A recent review of the resources available to RUA Medical and
competing demands for those resources from group wide development
plans has resulted in a slight change to RUA Medical's business
model to ensure that priority is given to long term strategic
opportunities that can add a minimum of 10 per cent. to RUA Medical
revenues together with Group projects.
In line with this revised strategy, RUA Medical has been
involved in a long running development project for a global medical
device company. The time invested in this project has resulted in a
new income stream from manufacturing medical textile components,
which is expected to commence in the second half of this financial
year.
Investment in plant and equipment has continued to support scale
up in graft production, with some GBP280,000 added in the Period.
Furthermore, an additional factory unit adjacent to the Company's
Irvine facility is being acquired, which will increase footprint by
around 40 per cent. The purchase is due to complete on 5 November
2021.
The good work within RUA Medical has recently attracted external
endorsement, with the Company being awarded the Scottish
Engineering's prestigious President's Award for Excellence.
RUA Structural Heart - the business developing tri-leaflet
polymeric heart valves for both surgical and catheter-based
implantation - has continued to progress over the Period. Polymers
and non-biogenic valve options are now being openly discussed at
influential global surgical meetings as being the future and RUA is
being mentioned in those discussions. RUA is now conducting
in-house testing on a family of polymeric valves utilising
Elast-Eon(TM) as the enabling polymer. In addition to the 100%
polymeric leaflet system designed over the last two years, RUA has
now been able to replicate a low stress design in a composite
material comprising textile and Elast-Eon(TM). Initial hydrodynamic
testing looks very promising and has the potential to take valve
durability to a much higher level whilst reducing the risk of
failure.
RUA - the holding company for the Group and group treasury - had
a cash position at the Period end of GBP4,763,000 (31 March 2021:
GBP6,293,000). This cash burn includes the final element of the
consideration payable for the acquisition of RUA Medical in April
2020 together with additional R&D costs and capital investment.
The Company previously announced the intention to further
strengthen the senior management team within RUA. The role of
Clinical and Regulatory Affairs Director has now been filled and
the appointee is due to start on 16 November 2021. Additionally,
the process of recruiting a Chief Financial Officer has also now
concluded with the successful candidate expected to start next
month, with a further announcement to made upon their
commencement.
Bill Brown, Chairman of RUA Life Sciences , stated : " I am very
happy with the developments at RUA. Our two revenue generating
businesses are growing, RUA Vascular has reached a major milestone
in submitting for regulatory clearance to market and with the risk
in biogenic material becoming a serious topic of conversation, our
strategy of exploiting Elast-Eon(TM) in both Vascular and Heart
Valve devices is now very much of the moment."
For further information contact:
RUA Life Sciences
Bill Brown, Chairman Tel: +44 (0)1294 317073
Dr Caroline Stretton, Group MD Tel: +44 (0)1294 317073
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 8
million implants and 15 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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END
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