AorTech to test 'novel method' for heart valve manufacture

AorTech International, the licensor of long-term implantable biostable polymer ‘Elast-Eon’ and a developer of medical devices using the key properties of Elast-Eon, updated the market on its progress with the manufacture process design for its polymeric heart valve.

The AIM-traded firm had said in its interim results on 29 November 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.

It said it had 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 had been driven by a desire to eliminate both the design limitations and the potential for defects of dip casting, it said on Monday.

It explained that it now believed that those limitations can be overcome by an alternative, “novel” manufacturing process.

Dip casting of valves could be successful, the board said, but was “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 could lead to the creation of valuable new intellectual property for the company, AorTech claimed.

As a result, it said it was unable to disclose any further details regarding the method of manufacture, but explained it was “very pleased” to announce that it had now committed to the design and manufacture of the bespoke equipment upon which proof-of-concept prototype valves would be produced.

The specialist equipment had also been designed to allow valve production to be industrialised going forward.

AorTech said the objective of the project was to confirm the capabilities of the novel manufacturing technology that it was seeking to implement, which would then be followed by process optimisation, design freeze and a full set of ISO-compliant testing programmes.

The directors said it was a “significant commitment” from the company, as part of its ongoing research and development plans.

It confirmed that the costs to be incurred were being partly financed through it having secured grant aid from Scottish Enterprise.

“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,” said chairman Bill Brown.

“Through the design phase, our team has significantly improved valve performance and we are now targeting step changes in consistency and quality.”

At 0908 GMT, shares in AorTech International were down 4% at 96p.