Sweden-based Episurf Medical has secured CE Mark approval for its Episealer Femoral Condyle, a personalized implant that helps in treating the damage in knee cartilage.
The company obtained CE Mark after the product and its technical documentation were reviewed by regulatory authorities and it was found that the product successfully met EU standards required for a medical equipment.
Episealer Femoral Condyle is claimed to be the company's first commercial product based on its patented technology in which small-sized and personalized implants grow in the bone, and fix the cartilage damage in the knee right in the early stage itself, which in turn helps in restoring movement and reducing pain.
In an ongoing clinical trial, several patients have received treatment with the company's implants.
Episurf Medical CEO Nina Bake said that the approval is an important milestone, allowing the company to launch products in Europe and bringing Episurf Medical into the first phase of commercialization.
"This new approval, in combination with a recent 70 million SEK rights issue and signed distribution contracts in Switzerland and Poland, puts us in a strong position for our product launch this fall," Bake added.
The company will initially launch the product in the European market in stages, where in it will be made available to a limited number of orthopedic clinics in select countries.
Meanwhile, Episurf plans to establish distribution contracts in other selected markets.
Image: Episurf's implant the Episealer. Photo: Courtesy of PRNewsWire.
