RNS Number : 0785K
RUA Life Sciences PLC
31 August 2021
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
As previously announced, voting on all resolutions will be
conducted by poll based on valid proxy forms received. The results
of the poll will be published on the Company's website,
www.rualifesciences.com . At the AGM, the Chairman will make the
following statement regarding current trading:
"Good progress is being made across all areas of the Group's
business and development plans despite the disruption to supply
chains due to Brexit - related customs issues and staff shortages
at suppliers as a result of Covid.
As previously reported, cellulose contamination was identified
in the chemical characterisation testing carried out on samples of
the large bore vascular grafts. We are confident that the source of
the contamination has been identified and is attributed to cleaning
material used on cleanroom production equipment, which manufactured
the initial batch of grafts on which the chemical characterisation
work was undertaken. Root cause studies have replicate d the
transfer of cellulose from cleanroom wipes onto production
equipment , and a new cleaning regime has since been implemented.
As such, the original chemical characterisations have been shown to
be unrelated to actual production and, therefore, the results were
discounted due to the contamination issue. R esults from a second
study will form the basis of the biological evaluation report for
the 510( k ) submission. This new study is now well underway and
the final report is expected in a matter of weeks. In conjunction
with the third-party chemical characterisation testing, internal
studies have been undertaken and it is reassuring that there is no
further indication of any cellulose particulate in the
extractables, confirming the Company's belief that the
contamination was limited to the early production batch.
The 510( k ) submission package for large bore grafts is now in
close to final form and is under review by the Board , and John Ely
in particular , to identify any areas of potential questioning that
the FDA might have and to ensure that they are fully addressed in
the submission. We remain on track for approval to coincide with
the availability of clinical product for commercial launch during
the first quarter of 2022. Initial production batches for
commercial launch will be validated on the smaller scale
development equipment which , depending on product mix , has a
manufacturing capacity of over 2,000 units a year. Scale up
production equipment has been designed and is now well into the
build process at our supplier. This new equipment is highly
automated and will allow production capacity to be increased
six-fold using the same production footprint as the development
equipment. The plan remains to have the scale up equipment fully
validated during the second quarter of 2022 thus allowing us to
meet growing demand for the grafts.
The Group is actively engaged with distribution partners who are
excited to handle the commercial launch of the grafts in the US .
Draft contracts have been exchanged which will be finalised in the
near term. Interest continues for OEM use of the grafts and those
opportunities are being advanced in parallel with our plans for
sales into hospitals via distribution partners.
It is anticipated that upon ramp up of production of grafts, the
capacity of the manufacturing unit based in Irvine will be
exhausted. As a result, the Company has recently signed contracts
to purchase the neighboring industrial unit in Irvine, which will
double the built area available and provide further development
opportunities for future expansion. Current plans for the new unit
include moving non - production related facilities from the
existing unit, allowing the textiles department to expand; building
a dedicated Research and Development lab to accommodate new
projects and all heart valve related work ; and building new clean
room suit e s. Vacant possession is anticipated during October 2021
and initial fit out works will commence by the end of the year.
Recruitment of Senior Executives
The Company previously announced the intention to further
strengthen the senior management team within RUA Life Sciences. We
are pleased to announce that the key role of Clinical and
Regulatory Affairs Director has now been filled with a highly
talented and experienced candidate who is expected to join during
November 2021 , after completing his notice with his current
employer. The new appointee has important experience in achieving
regulatory approvals for a number of cardiovascular devices as well
as organizing clinical studies and, as such, has strong contacts
with many Key Opinion Leading (KOL) surgeons.
The other role is that of Chief Financial Officer and the
recruitment process is now underway with Norman Broadbent having
been engaged to undertake the search.
Order intake from the major customer of RUA Medical for US
supply has now returned to pre-Covid levels whilst Europe still has
a little way to go. Indications from the customer are that it is
anticipating high single digit volume growth over the coming year
and opportunities are now being considered regarding expanding the
range of products supplied by RUA Medical. A long running
development project for a global medical device company is also
progressing well and the Company is confident of securing a
manufacturing contract for medical textile components shortly. This
contract can be fulfilled from the current facilities on equipment
already installed and validated. Additionally, the RUA Medical Team
have been approached by another cardiovascular business looking to
have an Elast- Eon (TM) enabled device designed and manufactured.
This contract builds upon the expertise developed within RUA
Medical in both textile engineering and the application of our
Elast- Eon (TM) polymer. The Board is encouraged by these recent
developments as it fits the strategy of RUA Medical, not only being
the engine room of in-house projects and manufacture, but of also
being a growing profit centre.
Research and Development
Further progress has been made on the manufacture of heart valve
prototypes utilising both the 100% Elast- Eon (TM) leaflet system
and the textile reinforced leaflet. The testing equipment for both
hydrodynamic and durability studies is due for installation and
commissioning towards the end of September 2021, and we are looking
forward to comparing the performance of the two technology
Patch development continues to make progress with the base
fabric now designed and manufactured, however we are currently
delayed in having a product ready for design freeze due to
unforeseen supply issues for a pump used in the computer-controlled
coating equipment. The team is working closely with the supplier to
avoid further delay which would have a knock-on effect to starting
the necessary ISO testing on the patch.
With the large bore graft development work now into production
validation , other group R&D projects are now being considered
and planned. A major opportunity relates to utilising the non -
thrombogenic properties of Elast- Eon (TM) to create a range of
small bore grafts to improve the outcomes of patients suffering
from Peripheral Artery Disease (PAD) and Critical Limb Ischaemia
(CLI). In the UK alone, 176 leg, foot and toe amputations are
carried out every week , with diabetes being a major contributory
factor to the lack of blood flow as the root cause of these
amputations. Current small bore graft products have relatively poor
long-term graft patency compared to large bore grafts and,
therefore, improving the long - term performance of grafts would
play a major role in improving patient quality of life and reduce
the burden on the health service. With this in mind, RUA has
recently submitted a grant application through the UK Government
Innovation Funding Service for part funding of a feasibility study
on such a device.
At the conclusion of the AGM, David will retire from the Board
and the Company. David has had a career spanning 44 years in
textiles initially with his family lace firm and latterly having
founded RUA Medical to become an innovator in medical textiles.
David should rightly be proud of what he has achieved in those 44
years but similarly should look forward to enjoying his retirement
and catching up on the outdoor activities he so much enjoys but has
had to sacrifice as he built RUA Medical. I would like to take this
opportunity to personally, and on behalf of the Company and our
shareholders , t hank David for his outstanding contribution to the
G roup and wish him a long and happy retirement."
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 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.
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 7
million implants and 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 valves.
A copy of this announcement will be available shortly at
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(END) Dow Jones Newswires
August 31, 2021 02:00 ET (06:00 GMT)
Rua Life Sciences (LSE:RUA)
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