Significant Milestones achieved by RUA Vascular

RNS Number : 1448V

RUA Life Sciences PLC

05 August 2020

 

RUA Life Sciences Plc

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

Significant Milestones achieved by RUA Vascular

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 that its subsidiary, RUA Vascular, the business which is developing Elast-Eon^TM sealed vascular grafts and cardiac/vascular patches, has recently achieved significant milestones for each of these products on the path to early commercialisation.

Large Bore Vascular Grafts at "Design Freeze"

The three key design inputs for the RUA Vascular large bore (18mm to 38mm) vascular graft project were:

1.  The elimination of animal by-products;  

2.  Improving on the permeability and porosity claims of currently available market leading products; and

3.  Improving handling characteristics and surgical feel.

During the development of the Elast-Eon™ sealed large bore vascular graft, a number of different iterations were produced, each adding to the know-how and intellectual property relating to the thin film polymer sealing of a vascular graft without the need for any animal tissue.

Subsequently, a combination of animal pilot studies and bench testing have demonstrated that the thin film polymer sealed vascular graft is indistinguishable in handling and needle/suture acceptance from the currently available commercial collagen and gelatin sealed grafts. The latest animal pilot study demonstrated that on release of clamp, allowing blood to flood into the graft at normal blood pressure, no leaks were recorded and bench testing to the ISO7198:2017 standard measured the water permeability to be significantly below the market leading animal by-product coated grafts. In addition to achieving the three key design objectives set out above, all other design inputs have been met to the satisfaction of the technical team and a commercially viable and validatable product has been developed.

The large bore graft project is now at "design freeze" stage and the technical team is confident that the graft meets all of the regulatory requirements. In addition, regulatory testing of the large bore graft has now commenced with third party test houses.

These recent achievements have significantly de-risked the vascular graft project and allows regulatory testing to commence and confirm the in-house test data before a submission is made for FDA approval.

This regulatory testing is anticipated to be completed during the early part of 2021 with commercial launch and associated revenue generation being anticipated after FDA regulatory approval is achieved. The Group's regulatory team has already started to construct the 510k FDA submission pack to facilitate a smooth regulatory pathway towards approval.

Cardiac and Vascular Patches

Development of the large bore vascular graft was the most technically challenging of the initial two products in RUA Vascular's medical device portfolio. The technology developed for the grafts has now been applied to the coronary and vascular patches and a manufacturing method designed and developed that can produce patches of the sizes and characteristics required by the market. Prototype patches have been manufactured using the new and novel method and the regulatory pathway will run in parallel with that for the large bore vascular graft with commercial launch anticipated around the same time.

Commercial Implications

RUA Medical Devices, the Group's end-to-end contract developer and manufacturing business, will be the sub-contract manufacturer of the devices developed for RUA Vascular. Over the last two years, RUA Medical Devices has made substantial investment in its infrastructure and clean room capacity in anticipation of the need to manufacture medical devices both for third party customers and for RUA Vascular. RUA Medical Devices is currently at no more than 33% of total manufacturing capacity and, as a result, little additional infrastructure or overhead will be required to manufacture and commercialise the RUA Vascular products. Initial costings of both grafts and patches indicate a gross margin potential of between 70% and 80%.

It is the Group's intention to bring its patches and grafts to market through a combination of distribution and OEM supply agreements. It is anticipated that negotiation of these commercial agreements will be further progressed at the same time as regulatory testing is being undertaken with the objective of enabling commercial sales to begin as soon after regulatory approval has been granted as practicable.

Further updates will be provided on each of the Group's vascular grafts and cardiac/vascular patches as appropriate.

Bill Brown, Chairman of RUA Life Sciences, commented : "Achieving design freeze on this important product line is a major step along the path of creating a profitable medical device company and moves the RUA Vascular business from being an early stage development project to a later stage business with near term revenue and profit potential. "

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-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.

 

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