Episurf Medical Receives CE Mark for Knee Implant
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 European Union (EU) regulatory authorities reviewed the product and its technical documentationand found the product successfully meets EU standards required for 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 knee cartilage damage in its early stages, which in turn helps restore movement and reduce pain.
In an ongoing clinical trial, several patients have received treatment with the company's implants.
Episurf Medical CEO Nina Bake said the approval allows the company to launch products in Europe and bring 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 Stockholm-based company initially will launch the product in the European market in stages, where 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.