Admedus Ltd (ASX:AHZ) has been granted the final step for approval of the first-in-human study by the external competent authority, Federal Agency for Medicines and Health Products (FAMHP) of Belgium.
This means the study can go ahead as planned this month.
Chief executive officer Wayne Paterson said: “Now that we have final approval to commence the study, we can move forward according to our plan with Professor Bart Meuris and his team at the University Hospitals Leuven, Belgium, to perform this important study.
“The study will give us valuable information that will help progress our path to market.”
Renowned heart surgeon
Professor Bar Meuris, a renowned surgeon at the University Hospitals in Leuven, Belgium, is conducting the clinical trial sponsored by Admedus Regen Pty Ltd, a wholly-owned subsidiary of Admedus.
Fifteen patients will be enrolled in the study and will be followed up for six months after receiving implantation of the ADAPT® single-piece 3D aortic valve.
The results from the study are expected to be available between the first quarter of 2021 and the third quarter of 2021.
Milestone payment secured
Admedus recently completed the technology transfer of its unique sterilisation method as part of its ADAPT tissue treatment process to 4C Medical Technologies, Inc.
4C Medical is a Minnesota-based developer of AltaValve, a minimally invasive device for mitral valve repair.
The technology transfer follows 4C Medical validating the process.
4C Medical will now pay an additional $US1 million ($US 0.44 million previously received) to use the technology to sterilise the ADAPT tissue incorporated in its transcatheter mitral valve replacement (TMVR) AltaValve system device.