REG - RUA Life Sciences - RUA Vascular Update on 510k

Rua Life SciencesAnnouncement

13/12/2021 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20211213:nRSM3539Va&default-theme=true

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™), 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™'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 Heart:  Development of tri leaflet polymeric heart valves.

 

 

A copy of this announcement will be available shortly
at www.rualifesciences.com/investor-relations/regulatory-news-alerts
(http://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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDFIFSAFSLLLIL