Admedus stated that the regulatory approval is an important step to increase the sale of its ADAPT tissue technology and in creating value by rolling out its new 3D technology.

The CardioCel 3D product portfolio is claimed to be the first and only shaped and acellular collagen bioscaffold. It has been designed to handle complex congenital defect repairs, enabling cardiac surgeons to achieve a natural shape during aortic arch reconstruction.

The company intends to begin the first phase of commercial launch of CardioCel 3D later this month and is presently working with selected European Key Opinion Leaders already familiar with the clinical benefits of ADAPT tissue technology. In the next phases, broader peer to peer education program will be conducted.

Admedus CEO Wayne Paterson 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.”

Admedus chief medical officer Kiran Bhirangi 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.”

Last July, the company signed an exclusive distribution agreement with Medical Instruments to distribute its ADAPT technology in Italy.

As part of the agreement, Medical Instruments will initially distribute Admedus’ non-toxic and non-caclifying ADAPT bio-scaffold CardioCel for treating of congenital and structural heart defects and disease.