HERZLIYA, Israel, July 15, 2026
Regentis Biomaterials announced that it has received approval from the European Notified Body for its next-generation solvent-free manufacturing process for GelrinC®, the company’s cell-free hydrogel implant for knee cartilage repair. The newly approved process increases manufacturing yield by approximately 400%, enabling production of five times more product from the same manufacturing volume while improving scalability, manufacturing efficiency, and environmental safety ahead of GelrinC’s commercial launch across Europe.
Manufacturing Innovation Supports Commercial Scale-Up
The newly approved solvent-free manufacturing process significantly enhances GelrinC production by increasing output while reducing manufacturing costs and improving occupational and environmental safety. According to Regentis, extensive validation confirmed that the new process consistently maintains product quality and clinical performance, providing a scalable manufacturing platform to support long-term commercial growth as demand increases across European markets.
GelrinC Offers Off-the-Shelf Cartilage Regeneration
GelrinC® is a cell-free, ready-to-use hydrogel implant designed to regenerate damaged knee cartilage through a synchronized erosion and tissue regeneration process. Unlike traditional cell-based cartilage repair procedures that require tissue harvesting, laboratory expansion, and multiple surgeries, GelrinC can be implanted in a single 10-minute procedure. The product is designed to provide sustained cartilage repair, pain relief, and functional improvement while simplifying treatment for orthopedic surgeons and patients.
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European Commercial Launch Progresses Alongside U.S. Clinical Development
GelrinC has already received CE Mark approval for commercialization in the European Union and is being introduced through Regentis’ expanding network of European Centers of Excellence, surgeon training initiatives, and collaborations with leading orthopedic institutions, including Humanitas Research Hospital in Milan. Meanwhile, the company’s pivotal U.S. FDA clinical study has surpassed 50% patient enrollment, supporting future regulatory approval efforts in the United States while expanding the global development of its regenerative medicine platform.
Source: Regentis Biomaterials press release
