Update on RUA Vascular

RNS Number : 0730D

RUA Life Sciences PLC

25 June 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 polyurethane (Elast-Eon™), provides the following update on the regulatory application for the large bore vascular grafts in development by RUA Vascular.

All results from both in vivo and in vitro testing have now been gathered and the submission pack for 510k application to the FDA has been prepared. Mechanical testing of the grafts indicate superior performance over the control. Pathology results from the six-month in vivo testing were normal giving the Board confidence that the grafts perform as anticipated. 

The Company has however noted the presence of cellulose, a non-toxic, natural plant-based material, in the analysis of the leachable extracts from the graft samples tested. As the raw materials for the graft only comprise Elast-Eon™ (as sealant) and polyethylene   terephthalate (yarn for graft fabric), the presence of cellulose is currently unexplained other than the samples have been contaminated at some stage in the chain of custody. Submission of the 510k, which was previously anticipated by the end of June 2021, with this unknown factor would in the Board's opinion, risk the application being rejected at the initial filing review stage. As a result, the Company has decided to undertake a secondary test on grafts from another production batch and carry out detailed chemical analysis on the original samples before submission.  The Company continues to anticipate first revenues from the sale of grafts by the end of the current financial year.

Bill Brown, Chairman of RUA Life Sciences, stated : "It is clearly frustrating that the contamination of samples has delayed our filing of the 510k. However, it is better to suffer this short delay now than have a potential rejection due to submitting with unknowns. Critically, the most important test results were all positive and the critical path to commercial launch is not expected to be impacted by this delay in filing."

For further information contact:

RUA Life Sciences

Bill Brown, Chairman     Tel: [phone]                                   

David Richmond, CEO      Tel: [phone]

Shore Capital (Nominated Adviser and Joint Broker) 

Tom Griffiths/David Coaten                                           Tel: [phone]

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

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™, the world's leading long-term implantable polyurethane.

Whether it is licensing Elast-Eon™, 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 designer and manufacturer of medical devices and implantable fabric specialist.
RUA Biomaterials:	Licensor of Elast-Eon™polymers to the medical device industry.
RUA Vascular:	Commercialisation of large bore polymer sealed grafts and soft tissue patches.
RUA Structural Heart:	Development of polymeric leaflet systems for heart valves.

 

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