Company Update

24 January 2019

AorTech International plc

("AorTech" or the "Company")

Company Update 

AorTech is pleased to provide an update on recent developments, an addition to its patent portfolio, the appointment of a new Company Secretary and the move of the Company's administration office.

Heart Valve Project

AorTech's novel "Leaflet Builder" software utilising Computational Fluid Dynamics has been completed and has successfully replicated, not just the leaflet design described in AorTech's patents, but has also accommodated any correction factors required to simulate the last design iteration of the AorTech valve. The "Leaflet Builder" outputs are able to be seamlessly exported to both CAD and Finite Element Analysis ("FEA") tools to facilitate manufacturing and testing requirements. The next stage of development is the creation of a detailed FEA mesh to verify the outputs on historic designs and recreate the base model from which "Leaflet Builder" can optimise the valve design by adjusting a number of correction factors. Importantly, "Leaflet Builder" can generate leaflets to the required specification for any size of valve or any change to the shape of the valve frame.

Work has now started on planning the future manufacturing process with the objective of designing a process, and specifying the machinery required, to manufacture valves of a consistently high quality and by a process that is verifiable from a regulatory perspective that minimises manufacturing costs and will be scalable to allow commercial volumes to be produced.

Textile Projects

Our partners at RUA Medical have successfully manufactured yarn which has been specifically designed for both our patch and grafts products. The yarn has now been converted into textile and the initial results have been very encouraging and more than meet our initial expectations. A very early prototype graft has been manufactured which has demonstrated the required ability to be crimped and heat set. Development work will continue to optimise the textile substrate for both the patches and grafts before the application of ElastEonTM polymer sealant. AorTech believes that the process of designing the yarn and textile for specific use, rather than designing a graft around existing yarn technology, is a major improvement in graft development and, as such, the new products will represent a major improvement over technology currently available in the market.

Patent Issue

AorTech is pleased to announce that the US Patent and Trademark Office has issued notice that Patent Number 10,195,834 entitled "BONDING PROCESS" will be issued on 5 February 2019. The invention relates to a process for bonding a silicone or silicone-based material to a polyurethane and use of the bonded silicone-polyurethane in the manufacture of biomaterials, devices, articles or implants, in particular long term implantable medical devices.

Company Secretary

After over 14 years' service, David Parsons recently retired as both Company Secretary and from providing administration services to the Company. AorTech is pleased that it has appointed Kate Full as Company Secretary and her business, Tayside Accounting Services Limited, has assumed responsibility for the Company's accounting and general administration function. As a result, AorTech's administration office has now moved from Surrey to Unit 26, Prospect Business Centre, Gemini Crescent, Dundee DD1 1TY which is very conveniently located close to the offices of our development partners, Vascular Flow Technologies Limited.

AorTech is pleased to welcome Kate and her team on board and wishes to thank and publicly acknowledge David Parsons for his many years of dedication and professionalism and wish him well in retirement.

Bill Brown, Chairman of AorTech said: "I am delighted with the progress being made on the development of both the Heart Valve and the Textile based products. The work being done by our partners is more than meeting our expectations and we look forward to the further developments anticipated over the coming months." 

For further information contact:

AorTech International plc Tel: +44 (0)7730 718296 

Bill Brown, Chairman

Stockdale Securities Limited Tel: +44 20 7601 6100 

Tom Griffiths/David Coaten

About AorTech:

AorTech has developed biostable, implantable polymers, including Elast-Eon™ and ECSil™ the world's leading long-term implantable co-polymers, now manufactured on their behalf by Biomerics LLC in Utah, USA. With several million implants and seven years of successful clinical use, AorTech polymers are being developed and used in cardiology and urological applications, including pacing leads, cardiac cannulae, stents and neuro stimulation devices. Devices manufactured from AorTech polymers have numerous US FDA PMA approvals, 510ks, CE Marks, Australian TGA and Japanese Ministry of Health approvals.

Elast-Eon™ and ECSil™'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. A range of materials in a variety of application-specific formulations for use in medical devices and components are available. 

In addition to the licensing of biostable polymers, AorTech is now developing medical devices utilising the key properties of its world class polymers.