Admedus Limited (ASX:AHZ) today announced the successful...

Admedus Limited (ASX:AHZ) today announced the successful conclusion of its CardioCel 3D expanded evaluation program and its intention to commence sales of this new flagship product in North America from 1 February 2018.

The successful evaluation phase of CardioCel 3D has also led to a potential line extension for the VascuCel product range, with Admedus submitting a Note to File for the development of a new three-dimensional scaffold product to be used in peripheral vascular repair.

These are exciting developments for Admedus which further demonstrate the versatility and reliability of its clinically superior ADAPT technology platform.

Earlier this year, Admedus received FDA 510(k) clearance to market CardioCel 3D in North America, this led to an expanded evaluation program to gather expert data before the product’s full commercial introduction.

The program has been very successful, with a significant number of highly complex congenital heart defect (CHD) arch repair cases completed across seven key reference centres across North America and Australia.

Throughout the evaluation program, world-leading physicians have expressed positive feedback and enthusiasm for the benefits of CardioCel 3D, including, its optimized arch shape, off-the-shelf availability, non-antigenic response and unique calcification resistance.

“We have taken a strategic and measured approach with CardioCel 3D to ensure the product is backed by the best possible science. The evaluation program has provided us with extensive clinical data and we’re extremely excited by the results,” said Admedus CEO Wayne Paterson.

We have worked closely with leading surgeons and Admedus staff have been in attendance for the majority of operations as advisers. Therefore, we can now bring CardioCel 3D to market with complete confidence and look forward to releasing it for sale in North America from 1 February 2018.”

“The 3D evaluation program also provided valuable data and experience that presented an exciting opportunity to develop another three-dimensional product (half pipe) for potential use in peripheral vascular repair as an extension of our VascuCel range,” added Paterson.

“These are both important developments that further validate the enormous potential of Admedus ADAPT beyond the flat tissue space as we look towards a future in high-value 3D applications of our proprietary technology,” Paterson said.