Regentis Biomaterials (NYSE American: RGNT) announced it has received approval from the European Notified Body to manufacture GelrinC(R) using its next-generation solvent-free manufacturing process, a milestone that supports the product’s planned commercial launch in Europe. The company said the new process increases production yield by approximately 400%, producing five times more product from the same manufacturing volume while improving manufacturing efficiency, scalability and occupational and environmental safety. Extensive clinical testing validated consistent product quality and clinical performance.
GelrinC(R), 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. Regentis said commercialization will be supported through its expanding European Centers of Excellence, surgeon training programs and collaborations with leading orthopedic institutions, including Humanitas Research Hospital in Milan, targeting a U.S. cartilage repair market valued at approximately $3 billion.
The approval marks a critical step for Regentis as it prepares to bring GelrinC to European patients. The improved manufacturing process not only increases output but also enhances occupational and environmental safety by eliminating solvents. This efficiency gain is expected to support broader market access and potentially lower costs. The company is targeting a U.S. cartilage repair market of approximately 470,000 cases annually, where no off-the-shelf treatment is currently available.
Regentis Biomaterials is a regenerative medicine company focused on developing tissue repair solutions. Its Gelrin platform technology uses synchronized, degradable hydrogel implants to regenerate damaged tissue, including cartilage and bone. GelrinC is intended to address a significant unmet need in orthopedic care. For more details on the announcement, visit https://ibn.fm/Ths4h. The latest news and updates regarding Regentis are available in the company’s newsroom at https://ibn.fm/RGNT.
