European authorities have extended the CE Mark approval on Implanet's entire range of Madison™ knee prostheses for a further four years, through May 2024.
This extension supports the company's ability to obtain clearance for its product ranges under the new European Medical Device Regulation by 2024, and enhances the company's negotiations to divest its knee product.
Implanet's JAZZ® (spinal) and Madison devices have obtained FDA 510(k) clearance and are approved under the CE Mark as well as the ANVISA authorization in Brazil.
Ludovic Lastennet, CEO of Implanet, said, “We are delighted to announce that we have met this key regulatory milestone and secured all our CE marking into 2024. Despite the challenges associated with the Covid-19 pandemic and increasingly stringent regulations covering medical devices, Implanet has remained mobilized and provided the authorities with all the elements demonstrating the clinical quality of its product ranges.
"Moreover, we are still involved in exclusive negotiations to sell our Knee range, the development of which is further enhanced thanks to this CE marking renewal. Our next objective is to accelerate our growth and devote ourselves 100% to the treatment of spinal disorders to establish our positioning as a powerful player in this sector, both in France and abroad.”