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. 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 efficiency, scalability, and occupational and environmental safety. Extensive clinical testing validated consistent product quality and clinical performance.
GelrinC(R), which 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 company 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, with about 470,000 cases annually where no off-the-shelf treatment is available.
“This approval represents a significant step forward in our ability to scale production and meet the anticipated demand for GelrinC in Europe and beyond,” said a company spokesperson. “The solvent-free process not only enhances yield but also aligns with our commitment to sustainability and safety.”
For more details, the full press release is available at https://ibn.fm/Ths4h. The latest news and updates relating to RGNT are available in the company’s newsroom at https://ibn.fm/RGNT.
