Anika Therapeutics has successfully completed the approval process for Hyalofast® under the new European Union Medical Device Regulation (EU MDR 2017/745).
As a result, the hyaluronic acid matrix Hyalofast® is among the first cartilage regeneration products to receive MDR certification and thus meets the highest current European standards for the quality and safety of medical devices.

As part of the approval process, clinical and preclinical data as well as safety information were thoroughly reviewed in a comprehensive procedure. This early MDR certification—achieved before the end of the transition period—highlights Anika Therapeutics’ strong commitment to product quality and safety, and emphasizes the importance of Hyalofast® within the U.S.-based manufacturer’s portfolio.

Plasmaconcept AG is pleased to announce this important milestone for Hyalofast®. It reinforces Anika Therapeutics’ dedication to regenerative therapies aimed at preserving mobility and quality of life—an ambition shared by Plasmaconcept AG, which works every day to improve the lives of patients suffering from joint pain and limited mobility.