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RNS Number : 0922W
RUA Life Sciences PLC
16 August 2022
16 August 2022
RUA Life Sciences plc
("RUA", the "Company" or the "Group")
AGM Statement 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 holding its Annual General Meeting ("AGM") at
11.00am today.
At the AGM, the Chairman, Bill Brown, will make the following
statement regarding current trading:
"There are four key parts to the RUA Life Sciences business:
Biomaterials and Contract Manufacturing, being the two mature cash
generative businesses; together with the new product development
divisions of RUA Vascular (vascular grafts) and RUA Structural
Heart (heart valves). All four business units are performing well
and key achievements are summarised below:
Biomaterials
The business responsible for exploiting the Group's Elast-Eon
polymer IP is currently performing ahead of budget with revenues
for the four month period to the end of July amounting to GBP144k,
an increase of 73% on the corresponding period last year. In
addition, the Intellectual Property portfolio has further
developed, with new patents recently being granted in Europe and
China.
Contract Manufacturing
Contract Manufacturing comprises the part of the RUA Medical
Devices subsidiary's activities focussed on third party supply of
medical device components and finished devices. Again, this
business area is exceeding expectations with revenue for the four
month period to end of July being ahead of budget at GBP540k
compared to GBP374k achieved in the same period last year. This
growth has been driven by a combination of both price increases and
an uplift in volumes of devices. Business development activities
have continued despite the pandemic disruption and it is very
pleasing to be able to announce that a new component manufacturing
agreement has just been signed with a global medical device
manufacturer. Once manufacturing is fully set up and volumes build,
we anticipate this contract to becoming a material contributor to
the performance of the Contract Manufacturing business.
Vascular Graft
As previously announced, the regulatory team at RUA have been
actively engaging with the FDA in seeking consensus on the full
scope of the anticipated additional testing required for a small
clinical study. A meeting with the FDA was held earlier this month
and we are pleased to update that the meeting was positive and we
believe we are close to reaching agreement with the FDA on a
clinical trial design that is practical for RUA to pursue.
RUA submitted a detailed trial protocol to the FDA and on review
the FDA have asked for a number of relatively minor changes to be
made with further statistical analysis to support trial design
sample size.
The further information will be provided to the FDA and their
review will be via a faster interactive process rather than a
further pre-submission supplement. We would anticipate being able
to inform shareholders of the full details of the clinical trial
around the end of September.
Heart Valves
The team responsible for developing a new generation heart valve
has made strong progress over the last few months in accelerating
the concept of a composite leaflet material building upon the IP
developed in the graft project.
The new material has the potential to be the ideal valve leaflet
material. Mechanical property test results demonstrate being not
only better than raw polymer by an order of magnitude, but also
much stronger than the current material from which biological
valves are made whilst being around 75% thinner. Coupling these
mechanical properties with the biostability and non-calcific nature
of Elast-Eon creates a very promising opportunity. Good progress
has also been made on manufacturing these composite valves to allow
testing of 'closer to clinical standard' product to commence.
Group Achievements
A vital part of being a medical device manufacturer is to
maintain certification of our Quality Management System ("QMS").
The RUA Medical Device business was previously certified as a
third-party supplier. In early August, the business underwent a
full audit from our Notified Body. The objective was not only to
maintain the ISO 13485 accreditation for RUA Medical but to seek
extension of scope under the newly developed RUA Life Sciences QMS
for the "design, development, manufacture and sale of sealed
vascular prostheses and heart valves". It is a matter of pride to
the business that the audit identified zero findings and a
recommendation has been made to expand the scope. This is an
essential step before we launch into clinical trials later this
fiscal year and eventually start to sell our own devices. The audit
result is the culmination of many months of hard work by
individuals and teams throughout the business - almost every
element of our Quality Management System has been updated in the
last few months. The auditors were highly complimentary of our
processes, procedures, documentation, and the professionalism of
our team.
Overall, the progress made in developing products has been
matched by trading activities and although we are not currently
anticipating the 50% year on year revenue growth to continue for
the rest of the year, it is a good indicator of the building and
development of the business."
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the UK version of the EU Market Abuse Regulation (2014/596) which
is part of UK law by virtue of the European Union (Withdrawal) Act
2018, as amended and supplemented from time to time.
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
Cenkos Securities plc (Nominated Adviser and Broker) Tel: +44 (0)20 7397 8900
Giles Balleny/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
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 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: Commercialisation of open surgical vascular
grafts and patches
RUA Structural Development of polymeric leaflet systems
Heart: for heart valves.
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END
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August 16, 2022 02:00 ET (06:00 GMT)
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