Regentis Biomaterials Receives European Regulatory Approval For New GelrinC Manufacturing Process
The approval comes as Regentis prepares for the commercial launch of GelrinC® in Europe, enabling the Company to manufacture commercial product using a process that increases production yield by approximately 400%, delivering five times more product from the same manufacturing volume while improving manufacturing efficiency and scalability. The solvent-free process also improves occupational and environmental safety. Extensive clinical testing of the new manufacturing process has validated consistent production quality and clinical performance.
The approval comes as Regentis prepares for the commercial launch of GelrinC® in Europe, enabling the Company to manufacture commercial product using a process that increases production yield by approximately 400%, delivering five times more product from the same manufacturing volume while improving manufacturing efficiency and scalability.
The solvent-free process also improves occupational and environmental safety.
Extensive clinical testing of the new manufacturing process has validated consistent production quality and clinical performance.