Regentis Biomaterials Secures European Approval for Next-Generation GelrinC Manufacturing Process

Regentis Biomaterials (NYSE American: RGNT) announced today that it has received approval from the European Notified Body to manufacture GelrinC(R) using its next-generation solvent-free manufacturing process. This milestone supports the product’s planned commercial launch in Europe. 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 company noted that no off-the-shelf treatment is currently available for the approximately 470,000 cases of cartilage knee repair annually in the U.S.

The approval marks a significant advancement in manufacturing capability. By eliminating solvents, the process enhances worker safety and reduces environmental impact while dramatically boosting output. This scalability is critical for meeting anticipated demand in Europe and eventual entry into the U.S. market. Regentis plans to leverage its Gelrin platform technology, based on synchronized, degradable hydrogel implants that regenerate damaged or diseased tissue including inflamed cartilage and bone.

Regentis Biomaterials Ltd is a regenerative medicine company dedicated to developing innovative tissue repair solutions that restore health and enhance quality of life. With an initial focus on orthopedic treatments, the company’s lead product GelrinC(R) is a cell-free, off-the-shelf hydrogel that is eroded and resorbed in the knee, allowing surrounding cells to regenerate cartilage in a controlled and synchronous process. The latest news and updates relating to RGNT are available in the company’s newsroom at https://ibn.fm/RGNT.