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RUA Life Sciences PLC Update on RUA Vascular

30/03/2021 7:00am

UK Regulatory (RNS & others)


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RNS Number : 8587T

RUA Life Sciences PLC

30 March 2021

RUA Life Sciences plc

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

Update on 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(TM)), is pleased to update on recent progress at its subsidiary RUA Vascular, which is developing Elast-Eon(TM) sealed vascular grafts and cardiac/vascular patches.

RUA Vascular - Regulatory Testing and Pathway

As previously announced, RUA Vascular is pursuing a 510k regulatory process with the FDA on both its large bore vascular graft and cardiac/vascular patch products. This 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 a different technology that does not raise new questions regarding safety or effectiveness. The RUA Vascular large bore graft was designed with the 510k process in mind and therefore the testing of the graft both in the lab and in the large animal model is to demonstrate this "Substantial Equivalence".

The animal trial started last summer, and the first seven explants have now been made. Initial observations indicate that the grafts have performed to design expectations. The grafts are a bespoke design mimicking equivalent Dacron grafts on the inside and having the Elast-Eon(TM) sealant confined to the outside to reduce bleeding whilst eliminating the use of animal sourced material. The explants show normal anastomotic neo-intima formation (the desired form of tissue in growth or "healing process") on the inside of the graft. Additionally, no adherent tissue was seen on the outside of the graft, pointing towards a less severe host implant response. The Company is very encouraged by these early observations which demonstrate the required graft performance necessary for the 510k submission.

While all the key elements of the project timeline that are within RUA's control are on time and on target, due to COVID-19, we have experienced delays from packaging suppliers which have impacted the timetable for sterilisation and product shelf-life validation testing. Despite this, the Company remains on target to submit the 510k during the second quarter of 2021, which is expected to be towards the end of the quarter, and is continuing to manage all residual risks to avoid any further slippage to project timelines.

As discussed previously, the vascular graft is, by far, the more complicated of the initial two product ranges under development and the IP developed would be used to create the range of cardiac/vascular patches. The regulatory strategy for the patches was initially to include patches within the graft 510k with the option of making a separate 510k submission if it provided additional commercial benefits. After completing a proof-of-concept study on the patch, a substantial development programme is now underway which includes optimised fabric construction to provide greater compliance of the patch, and automated manufacturing equipment to our bespoke design has been ordered. This specialist equipment will allow highly consistent product to be made efficiently thus maximising margins in what is a higher volume, but lower price medical device.

Having had confirmation of how Elast-Eon(TM) sealed fabric performs in a long-term animal implant, we can now see additional opportunities for the Company's patch range. The marketing claims and indications for use that we now wish to pursue for the patches are much broader than previously anticipated. Therefore, given these additional opportunities, the Company has decided to submit a separate 510k application specifically for its patch range. The Company does not anticipate having to undertake any additional animal work and thus expects the filing of this additional 510k submission to be made by the end of this year.

The Company expects to release a trading update for the year ended 31 March 2021 in late April 2021.

Bill Brown, Chairman of RUA Life Sciences, stated: "It is just under a year ago that the Group acquired RUA Medical to bring the development of our graft and patch products in-house. Despite having spent that entire year living through a global pandemic, the progress made since the acquisition has been truly remarkable. The grafts look to have performed as anticipated and we look forward to completing the regulatory submission in late Q2 which will be a significant milestone for RUA. The team has done a great job in achieving demanding targets particularly given Covid and Brexit related problems throughout the supply chain."

For further information contact:

RUA Life Sciences

   Bill Brown, Chairman                                                      Tel: +44 (0) 77 3071 8296 
   David Richmond, CEO                                                     Tel: +44 (0) 78 9999 6400 

Shore Capital (Nominated Adviser and Joint Broker)

   Tom Griffiths/David Coaten                                          Tel: +44 (0)20 7408 4080 
   Cenkos Securities plc  (Joint Broker)                            Tel: +44 (0) 20 7397 8900 

Russell Cook/Max Gould (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 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(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 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-Eon (TM) polymers to the 
  :                  medical device industry. 
 RUA Vascular:      Commercialisation of large bore polymer sealed 
                     grafts and soft tissue patches. 
 RUA Structural     Development of polymeric leaflet systems for 
  Heart :            heart valves. 
 

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