Episurf Medical, a Sweden-based medical technology provider, has secured CE mark approval for its personalised knee implant, called Episealer Femoral Condyle, which will enable the firm to sell the product in Europe.
The certification was given by the European regulatory authorities after they reviewed the knee implant and its technical documents.
Episurf Medical CEO Nina Bake said that the approval is an important milestone, allowing the firm to launch products in Europe and bringing it into the first phase of commercialisation.
"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.
Episurf said that its Episealer Femoral Condyle is the first commercial product based on its patented technology.
Through this technology, small personalised implants grow in the bone and help in fixing cartilage damage right in the early stage, which in turn helps in restoring movement and reducing pain for the patient.
The implants are claimed to be specially designed to offer minimal intervention and an optimum fit for individual knee injury cases.
Several patients have undergone treatments with its implants during an ongoing clinical trial.
The new implant will be launched only in stages under controlled conditions to a restricted number of orthopaedic clinics in selected European markets.
While the first phase of the launch is underway, the company will work towards establishing distribution contracts in other selected countries.
Besides the Episealer implant, the company offers surgical drilling template Epiguide, which aids in the treatment of localised cartilage damage in joints.
Image: The Episealer implant is designed to offer minimal intervention and an optimum fit for individual knee injury cases. Image courtesy of Episurf Medical.