The Episealer® Femoral Twin is Episurf’s first “self certified CE-mark” product via the company’s recently granted ISO 13458:2012 and Annex II certification. The product has already attracted interest from European clinics and eight pre-orders have been received.
Stockholm, 2015-09-07 08:00 CEST (GLOBE NEWSWIRE) —
The Episealer® Femoral Twin is a patient-specific implant for the treatment of larger and more elongated cartilage and underlying bone defects in the condyle and trochlea area. The treatment is aimed to help patients suffering from pain and reduced mobility due to cartilage damage to return to an active lifestyle.
‘’Episurf now has three patient specific products on the market which complement each other and thus allow us to meet the need for treating different types of lesions in the knee joint. This also means that our sales teams in Europe have an additional product within the Episealer range to offer clinics and surgeons,’’ says Rosemary Cunningham Thomas, CEO, Episurf Medical.
In June 2015, Episurf Medical received the ISO 13485:2012 and Annex II certification which allows the company to CE-mark its own products. This enables the company to have better control over its development projects and processes, which now can be shortened by 6-10 months, allowing new products to reach the market faster.
“Thanks to the ISO and Annex II certification we received in June, we were able to get the CE approval for the Episealer® Femoral Twin within less than 3 months. This gives us a golden opportunity and a fantastic position to utilize our accelerated direct sales and marketing efforts in key European markets to be responsive to the needs of surgeons, and at a faster pace, develop and introduce new Episurf products,’’ says Rosemary Cunningham Thomas, CEO, Episurf Medical.
About Episurf Medical
Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are in development for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system will enable implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention.
Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com. The information in this press release is such that Episurf Medical AB is required to disclose in accordance with the Securities Markets Act and/or the Financial Instruments Trading Act.
For more information, please contact:
Rosemary Cunningham Thomas, CEO, Episurf Medical
Tel: +46 (0) 70-7655892
Tel: +44 (0) 7803-753603