6 Jan 2020 07:00
AorTech International PLC
("AorTech", the "Company" or the "Group")
Heart Valve Development Update
AorTech International plc (AIM: AOR.L), the licensor of the world's leading long-term implantable biostable polymer (Elast-EonTM) and developer of medical devices utilising the key properties of Elast-EonTM, is pleased to update on the progress of the design for manufacture process for its polymeric heart valve.
In its interim results announced on 29 November 2019, the Company stated that it was continuing to make good progress on both valve design and design for manufacture and that feedback from the process was currently driving further improvements. AorTech has generated a substantial amount of heart valve related intellectual property, including the relationship between defects in polymeric leaflets as a result of manufacturing limitations and valve durability.
The design for manufacture project has been driven by a desire to eliminate both the design limitations and potential for defects of dip casting. The Company now believes that these limitations can be overcome by an alternative novel manufacturing process. Dip casting of valves can be successful, but is very difficult to both validate and achieve product consistency, thus placing a significant reliance on the quality control inspection procedures being able to identify any deficiencies in the heart valve leaflets.
Much of the novel method of manufacture identified may lead to the creation of valuable new intellectual property for the Company. As a result, the Company is unable to disclose any further details regarding the method of manufacture, but is very pleased to announce that it has now committed to the design and manufacture of the bespoke equipment upon which proof of concept prototype valves will be produced. The specialist equipment has also been designed to allow valve production to be industrialised going forward.
The objective of the project is to confirm the capabilities of the novel manufacturing technology that the Company is seeking to implement, which will then be followed by process optimisation, design freeze and a full set of ISO compliant testing programmes.
This is a significant commitment from AorTech as part of its ongoing Research and Development plans. AorTech is delighted to report that the costs to be incurred are being partly financed through it having secured grant aid from Scottish Enterprise.
Bill Brown, Chairman of AorTech, said: "This investment demonstrates the growing confidence in both the design of, and the novel manufacturing process for, the polymeric heart valve and we wish to thank Scottish Enterprise for their help and assistance towards this project. Through the design phase, our team has significantly improved valve performance and we are now targeting step changes in consistency and quality."
For further information contact:
AorTech International plc Tel: +44 (0)7730 718296
Bill Brown, Chairman
Shore Capital Tel: +44 (0)20 7408 4080
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 its behalf by Biomerics LLC in Utah, USA. 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. With over 6 million implants and over 10 years of successful clinical use, AorTech polymers are proven in long term life enabling applications.
In addition to continuing to exploit AorTech's Intellectual Property related to the world class biomaterial - Elast-Eon™, AorTech is now incorporating this material into a number of medical devices of our own design. Elast-Eon™ has first class long term blood contacting properties and, as a result, all of the initial products being developed are for the cardio vascular field. Each device is being designed to have improved clinical outcomes over current device technology, eliminating the use of animal sourced material whilst allowing procedures to remain the same, therefore avoiding having to retrain surgeons in new ways of operating.