RUA Vascular Update

RNS Number : 0652M

RUA Life Sciences PLC

17 September 2021

 

RUA Life Sciences Plc

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

RUA Vascular Update

RUA Life Sciences, 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 announce the following update on testing of the Elast-Eon^TM sealed vascular graft range.

As previously announced, the presence of cellulose, a non-toxic, natural plant-based material,   had been identified during chemical characterisation testing on samples of large bore vascular grafts . A fter undertaking a full analysis of the possible source, a secondary study was commissioned to test grafts manufactured under revised cleanroom protocols, which has now confirmed that no cellulose was present in leachable extracts from the new graft samples tested . Once the full chemical characterisation report has been received from the third-party test house, the Group will proceed to submit the 510k notification.  

RUA can also confirm that a manuscript will be submitted to the European Association of Cardiothoracic Surgeons ("EACTS") to support a presentation on the results of 'in vivo' testing of the RUA grafts at the EACTS' annual meeting in October 2021, and will be submitted for publication in a respected Journal. RUA is very excited by the observations from the 'in vivo' testing and believes this could become a potentially seminal paper on the future direction of surgical graft implantation. RUA looks forward to attending the meeting to gauge both clinical and industry reaction.

Dr Caroline Stretton, Group MD of RUA, said : "I am delighted that the work by the third-party testing house has confirmed our internal work on resolving the cellulose contamination issue and look forward to the final submission of our 510k and receiving feedback on our products from EACTS. We remain on target to launch the world's first non-biogenically sealed grafts by the end of this financial year."

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-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 .

 

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