Stockholm based Episurf Medical has gained CE Mark certification for its personalised Episealer ® implant for the treatment of femoral condyle cartilage defects in the knee.
Based on Episurf’s unique patented technology, Episealer® femoral condyle is the company’s first commercial product. The product resembles a small metallic button with a hydroxyapatite backing which encourages bony intergation with the femur. The implant is customised to fit the individual topography of the patient’s femoral condyle, so in theory providing an implant which allows the retention of as much healthy cartilage as possible. The dual intent is to reduce pain while treating damaged articular cartilage at an early stage. Several patients have already been successfully treated in a clinical trial still, which continues.
So with the new approval, Episurf is now able to launch Episealer® femoral condyle onto the European market. The company says its launch will be initiated in phases and under controlled conditions with a limited number of qualified orthopedic clinics in strategically selected European countries.
“The approval is an important milestone for the company. It allows us to bring products onto the European market and to initiate the first phase of marketing for Episurf Medical. Combined with the recent rights issue worth 70 million SEK and signed distribution agreements in Switzerland and Poland gives us a strong position in this new approval for the launch of our product this fall, “said Nina Bake , CEO of Medical Episurf.
Source: Episurf Medical AB., PR Newswire