RUA Vascular Update on 510k

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: [phone] 

Bill Brown, Chairman                                                           

Dr Caroline Stretton, Group MD                                           

Shore Capital (Nominated Adviser and Joint Broker)              Tel: [phone] 

Tom Griffiths/David Coaten                                           

Cenkos Securities plc (Joint Broker)                                            Tel: [phone]

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-EonTM 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 .

 

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