The PharmaLex Group, a leading expert provider of development consulting & scientific affairs, regulatory affairs, pharmacovigilance as well as quality and compliance services, announced that CO.DON AG has recently received EU marketing authorization for Spherox – an articular cartilage product (classified as an ATMP).
Spherox is intended for minimally invasive treatment of cartilage damage to joints with exclusively corporeal cartilage cells. The product has been successfully tested in Germany since 1997, having been used in over 150 clinics and on over 11,000 patients, demonstrating a positive dynamic and low risk profile.
Dr. Bernd Wegener, chairman of the supervisory board, CO.DON AG explained: "EU-wide approval for the articular cartilage repair therapy is a key strategic goal of CO.DON AG. This great success is the result of the work of all employees of CO.DON AG. I would like to take this opportunity to thank them all for their efforts.” Dirk Hessel, CEO, CO.DON AG, added: “Once the marketing authorization has been granted, a decisive objective regarding the EU-wide approval has been reached. We are ready to treat the first patients within and outside of Germany. We hope to be able to meet the high demand for the advanced treatment methods available across the EU today, especially since there is no equivalent product offered on the market.”
CO.DON AG has been working with PharmaLex since 2013 as their trusted partner for regulatory affairs and development consulting. PharmaLex has supported CO.DON AG during all strategic phases’ e.g. regulatory strategy development, application and guiding CO.DON through the marketing authorization process. The successful market authorization is a testament to a successful partnership.
CO.DON AG is one of the leading specialists worldwide in cell cultivation for the regenerative treatment of articular cartilage defects and spinal disc defects.