BERLIN & TELTOW, Germany--(BUSINESS WIRE)--CO.DON AG has launched the European Spherox product, which is authorised by the European Medicines Agency (EMA) for distribution across Europe, with the start of marketing activities in Germany.
Spherox will replace a product previously offered by CO.DON AG in the German market. The cell-based medicinal product is 100% autologous and free of additives, and therefore it sets the stage for the highest level of personalised healing. The procedure is minimally invasive. Spherox produces hyaline-like cartilage and repairs knee cartilage defects of up to 10 cm2. Knee pain is reduced significantly and the quality of life for patients sustainably improved. The results of recent trials provide evidence of the effect and therapeutic superiority of Spherox with microfracture, even for small defects.
Dirk Hessel, CEO of CO.DON AG: "Marketing authorisation ensures that Spherox is available for patients and reimbursed in Germany. At the same time, it defines high standards for manufacturing, use and distribution. We have implemented the EMA requirements in our internal processes and are looking forward to continuing meeting strong demands for a safe and durable, regenerative therapy for knee cartilage defects. We are starting in our home market and will be moving into selected European countries in the very near future. Our product is currently the only cell-based medicinal product for the regenerative treatment of knee cartilage defects that is available and authorised EU-wide"
About CO.DON AG: CO.DON AG develops, produces and markets autologous cell therapies for the minimally invasive repair of knee cartilage defects following trauma or degeneration. The medicinal product is a cell therapy product that uses only the patient's own cartilage cells ("autologous chondrocytes"). The method has been used for more than 10 years in over 150 clinics to treat more than 11,000 patients. In Germany, the statutory health insurance companies have reimbursed the treatment of knee and hip joints since 2007. In July 2017 the company received EU marketing authorisation for its articular cartilage product, which is distributed under the name of Spherox. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Dirk Hessel (CEO), Ralf M. Jakobs (CFO).
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