Admedus (ASX:AHZ) has won CE Mark approval in the European Union for its CardioCel 3D and VascuCel products which use its proprietary Adapt tissue technology, according to a report from ProactiveInvestors.
The Australian company plans to begin the first stage of a commercial launch of the devices in the region later this month, according to the report.
“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,” Dr. Tomasz Mroczek said, according to ProactiveInvestors.
“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,” CEO Wayne Patterson said, according to the report. “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 pediatric use to a wider patient population in the future.”
In June 2017, Admedus CEO Wayne Patterson spoke to MassDevice.com about his efforts to shift the company away from trends of overspending and towards profitability.