CardioCel 3D and VascuCel receives regulatory approval in Europe

Medical technology company Admedus Ltd (ASX: AHZ) received regulatory approval (CE Mark) for its CardioCel® 3D product portfolio and its next generation collagen bioscaffold VascuCel® in Europe.

Regulatory approval is an important step forward as the Company continues to increase global sales of its ADAPT® tissue technology and to create future value through the rollout of its novel 3D technology.

The CardioCel 3D® product portfolio is the world's first and only shaped and proven fully acellular collagen bioscaffold. It is designed for highly complex congenital defect repairs and enables cardiac surgeons to achieve a more natural shape during aortic arch reconstruction; combined with the unique clinical benefits of calcification resistance, which is one of the most significant problems that clinicians face post procedure.

Admedus intends to commence the first phase of its commercial launch of CardioCel 3D® later this month, initially working with selected European Key Opinion Leaders already familiar with the clinical benefits of ADAPT® tissue technology. In the subsequent phase, there will be a broader peer to peer education program to benefit more patients.

“After our initial positive experience with ADAPT® we are excited to have the choice of these 3D shaped products that will produce better reconstructions for complex aortic arch repair surgeries,” said Professor Tomasz Mroczek, from the Department of Paediatric Cardiac Surgery, University Children's Hospital, Jagiellonian University Medical College in Kraków, Poland.

Wayne Paterson, CEO of Admedus said, “Obtaining CE Mark approval for the 3D portfolio is a further endorsement of the medical need and effectiveness of our 3D shaped collagen bioscaffold; a world first technology with proven anticalcification properties and zero DNA.

“Today’s approval of the 3D portfolio in Europe further reinforces the Company’s focus on global strategic growth with geographic expansion into key markets and portfolio expansion of ADAPT® tissue technology products,” said Mr Paterson.

Dr Kiran Bhirangi, CMO said, “Admedus’ ADAPT® tissue technology portfolio has published scientifically proven and peer reviewed clinical benefits leading to better outcomes for patients, surgeons and savings to overall healthcare expenditure.

“Our 3D portfolio continues to expand with new product launches scheduled for later in 2019, as well as ongoing progress on our single piece 3D aortic valve. The next phase of our 3D product strategy is the development of the first and only single piece 3D aortic valve. Interim data from the animal feasibility study has shown this has the potential to deliver significant clinical benefits and is differentiated from other TAVR products currently available,” said Dr Bhirangi.

“The 3D single piece aortic valve is unique in the industry and forms the backbone of the company’s TAVR developmental project which has been expedited. We have now confirmed that human clinical trials will commence earlier than planned, and the development project has already generated great interest within the global medical community as the ADAPT® portfolio of products expand from mainly paediatric use to a wider patient population in the future,” said Mr Paterson.

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