Regentis Biomaterials Ltd. (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 significant step in Regentis’ strategy to bring GelrinC to market. According to the company, the new process not only increases yield but also enhances occupational and environmental safety by eliminating solvents. This improvement is crucial for scaling up production to meet anticipated demand. The company’s focus on the U.S. market is notable, with approximately 470,000 cases of cartilage knee repair annually in the U.S. where no off-the-shelf treatment is currently available.
Regentis is a regenerative medicine company dedicated to developing innovative tissue repair solutions. Its Gelrin platform technology, based on synchronized, degradable hydrogel implants, aims to regenerate damaged or diseased tissue including inflamed cartilage and bone. The company’s lead product, GelrinC, is designed to be eroded and resorbed in the knee, allowing surrounding cells to regenerate cartilage in a controlled process.
For more information, visit the company’s newsroom at https://ibn.fm/RGNT.
