Episealer Femoral Condyle to be sold in Europe
Episurf Medical has received CE certification for its personalised implant, the Episealer Femoral Condyle, which treats cartilage damage in the knee, restoring movement and reducing pain.
CE certification was obtained after the product and its technical documentation underwent review by regulatory authorities and successfully demonstrated that it met EU standards for medical equipment. CE certification means Episurf Medical has the formal approval required to market and sell the product in the EU.
"The approval is an important milestone for the company, allowing us to launch products in Europe and bringing Episurf Medical into the first phase of commercialisation,” said Nina Bake, company chief executive.
To ensure high quality and to provide maximum safety for patients and surgeons, the launch of the product will be rolled out in stages under controlled conditions to a limited number of qualified orthopedic clinics in strategically-selected European countries.While this first phase is underway, Episurf will continue working to establish distribution contracts in other selected markets.
Episealer Femoral Condyle is the company's first commercial product based on Episurf’s unique patented technology, in which small personalised implants grow in the bone, fixing cartilage damage at an early stage, restoring movement and reducing pain. Several patients have already successfully received treatment with Episurf’s implants in an ongoing clinical trial.