European approval for key Admedus products

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

The company said the approval is an important step to increase global sales of its ADAPT tissue technology.

The CardioCel 3D product portfolio is an innovative 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.

Admedus said it 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 ADAPT tissue technology. 

“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 Poland.

According to Wayne Paterson, CEO of Admedus, “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.

"Todays 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.”

Dr Kiran Bhirangi, Admedus chief medical officer, 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.