Further Progress at RUA Vascular

RNS Number : 5686B

RUA Life Sciences PLC

09 October 2020

 

RUA Life Sciences plc

("RUA", the "Company" or the "Group")

Further Progress at RUA Vascular

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 ™ ), is pleased to announce that its subsidiary RUA Vascular, which is developing Elast-Eon ™ sealed vascular grafts and cardiac/vascular patches, has made further progress on both the regulatory and commercial pathways towards product launch.

RUA Vascular - Product Development and Commercialisation

As previously announced on 5 August 2020, RUA Vascular recently reached the important milestone of achieving design freeze on its vascular graft products. This allowed grafts to enter the regulatory testing phase in advance of 510k submission to the FDA. The 510k process, or "Pre-Market Notification", is a much simpler regulatory path than the more stringent "Pre-Market Approval" process and is available to medical devices that can claim "Substantial Equivalence" to legally marketed equivalent devices that are for the same intended use and have the same technology or different technology that does not raise new questions regarding safety or effectiveness. The RUA Vascular graft was designed with the 510k process in mind and the testing of the recently "frozen" design is to demonstrate this "Substantial Equivalence". RUA anticipates the 510k data package to be submitted early Q2 of 2021.

An important part of this testing phase includes a long-term animal trial of both RUA's graft and the market leading graft as a control (the "Substantial Equivalent"). The RUA grafts have now been implanted without incident and the animals have recovered well. The graft has performed perfectly during surgical implant. Initial feedback given by the surgeons and confirmed by videos of the procedures was that the graft was simple to suture with no difference to the control graft.  No or little bleeding from the anastomosis (or suture line) was observed with a suggestion that the elastomeric coating on the graft has assisted suture sealing. Importantly, the graft body maintained zero porosity throughout the procedure with no "blush" to the fabric which was observed in the control grafts. In short, RUA's graft has performed as well as, if not better than, the market leading Substantial Equivalent.

Good progress has also been made on commercialising the product development work successfully undertaken by the Company's R&D team. The route to market is anticipated to be through a combination of Original Equipment Manufacturer (OEM) agreements and distribution agreements. RUA has been engaged with the medical device industry for some time with regards to potential OEM agreements. These discussions are developing at pace and have now progressed to sharing volume data and requests for quotations.

Bill Brown, Chairman of RUA Life Sciences , stated : "I was present and observed the implantation of our final grafts and was very impressed with their performance as surgical devices. The team has succeeded in our design objectives of eliminating animal by-products and creating a zero porosity graft without having to compromise on the implantability of the product.  These recent developments, both technically and commercially, are key achievements on the path to the anticipated market launch of our grafts during 2021."

Release of trading update

The Company proposes to release a trading update for the six months ended 30 September 2020 in the week commencing 19 October 2020.

For further information contact:

RUA Life Sciences

Bill Brown, Chairman                                  Tel: [phone]                                   

David Richmond, CEO    Tel: [phone]   

Shore Capital 

Tom Griffiths/David Coaten                        Tel: [phone]

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 improving and 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™'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 over 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.

 

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