CE Mark approval paves way for Admedus to market tissue technology into Europe
Admedus has received regulatory approval (CE Mark) for its CardioCel 3D product portfolio and its next generation collagen bioscaffold VascuCel, in Europe.
Medical technology company Admedus (ASX: AHZ) has moved closer to increasing global sales of its Adapt tissue technology after receiving regulatory approval from European authorities for its CardioCel 3D and VascuCel products.
The approval was in the form of CE Mark certification – which indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area – and allows Admedus to commence marketing efforts into the region.
Admedus said it would embark on the first-stage commercial launch of CardioCel 3D with select industry players already familiar with the clinical benefits of Adapt and eventually progress to a broader peer-to-peer education program.
“Obtaining CE Mark approval is further endorsement of the medical need and effectiveness of our 3D-shaped collagen bioscaffold,” said chief executive officer Wayne Paterson.
“It also allows us to continue with our [planned] expansion into key markets and portfolio expansion.”
Tissue technology
CardioCel 3D and VascuCel products form part of the Adapt tissue technology portfolio developed by Admedus and are used by cardiac surgeons to treat patients with congenital heart defects and those in need of heart valve, vessel and cardiovascular repairs and peripheral vascular reconstruction.
Admedus claims Adapt products to be “the best in their field” and the only one of their kind to have achieved nine years without calcification or degradation – a significant benefit to patients who would otherwise be forced to undergo recurrent operations.
CardioCel 3D is presently the world’s only pre-shaped and proven fully-acellular collagen bioscaffold and has been designed for highly-complex congenital defect repairs, enabling surgeons to achieve a more natural shape during aortic arch reconstruction.
The product maintains a level of calcification resistance, which is one of the most common problems faced by the medical field post-procedure.
VascuCel has been marketed as a “next generation” collagen bioscaffold, offering optimised healing and clinical performance, enhanced procedural efficiency and improved handling in a range of vascular surgical procedures.
Mr Paterson said the Adapt portfolio has proven to have significant clinical benefits leading to better outcomes for patients, surgeons and savings to overall healthcare expenditure.
At midday, shares in Admedus were up 42.86% to $0.05.