Regentis Biomaterials Ltd. (NYSE American: RGNT) announced it has received approval from the European Notified Body to manufacture GelrinC® using its next-generation solvent-free manufacturing process. This milestone supports the product’s planned commercial launch in Europe, as the company prepares to address a significant unmet need in cartilage repair.
The new manufacturing process increases production yield by approximately 400%, producing five times more product from the same manufacturing volume. This improvement enhances manufacturing efficiency, scalability, and occupational and environmental safety. Extensive clinical testing has validated consistent product quality and clinical performance, ensuring that the next-generation GelrinC maintains its therapeutic efficacy.
GelrinC, which has already received CE Mark approval in Europe, is a proprietary, cell-free hydrogel implant designed to regenerate cartilage through a minimally invasive 10-minute procedure. The product aims to address a market of approximately 470,000 cases for cartilage knee repair annually in the U.S., where no off-the-shelf treatment is currently available. Regentis plans to support commercialization through its expanding European Centers of Excellence, surgeon training programs, and collaborations with leading orthopedic institutions, including Humanitas Research Hospital in Milan. The U.S. cartilage repair market is valued at approximately $3 billion.
The approval marks a critical step for Regentis as it moves toward broader market access. The company’s Gelrin platform technology, based on synchronized, degradable hydrogel implants, is designed to regenerate damaged or diseased tissue, including inflamed cartilage and bone. The new manufacturing process aligns with Regentis’ commitment to innovation and sustainability.
For more information, view the full press release at https://ibn.fm/Ths4h.
