RUA Life Sciences PLC RUA Vascular Update on 510k (3539V)
13 December 2021 - 6:00PM
UK Regulatory
TIDMRUA
RNS Number : 3539V
RUA Life Sciences PLC
13 December 2021
RUA Life Sciences Plc
("RUA Life Sciences", the "Company" or the "Group")
RUA Vascular Update on 510k
On 3 November 2021, 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)), announced 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.
After initial document review, the Company's regulatory team
held an initial meeting with the FDA to discuss certain novel
aspects of the RUA grafts and, as a result, mutually agreed to
convert the 510k submission to a pre submission process, allowing
the Company and the FDA to agree the additional data required to
facilitate the 510k approval. The regulatory pathway has been
extended and, as a result, RUA no longer anticipates first
commercial sales of grafts to be achieved during the first quarter
of 2022.
A further update on the agreed process with the FDA and the
likely new timelines for approval of the 510k will be made in due
course.
For further information contact:
RUA Life Sciences Tel: +44 (0)1294 317073
Bill Brown, Chairman
Dr Caroline Stretton, Group MD
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 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.
Heart :
A copy of this announcement will be available shortly at
www.rualifesciences.com/investor-relations/regulatory-news-alerts
.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
UPDFIFSAFSLLLIL
(END) Dow Jones Newswires
December 13, 2021 02:00 ET (07:00 GMT)
Aortech (LSE:AOR)
Historical Stock Chart
From Apr 2024 to May 2024
Aortech (LSE:AOR)
Historical Stock Chart
From May 2023 to May 2024