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. This milestone supports the product’s planned commercial launch in Europe, as 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 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 new manufacturing process is a key enabler for meeting anticipated demand.
Regentis Biomaterials Ltd is a regenerative medicine company dedicated to developing innovative tissue repair solutions. With an initial focus on orthopedic treatments, Regentis’ Gelrin platform technology, based on synchronized, degradable hydrogel implants, regenerates damaged or diseased tissue including inflamed cartilage and bone. 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 process. It 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 available.
The approval marks a significant step toward commercializing GelrinC(R) in Europe and eventually in the U.S. The improved manufacturing efficiency could reduce costs and increase availability of the product, potentially benefiting patients with cartilage defects. For more information, visit https://ibn.fm/Ths4h. The latest news and updates relating to RGNT are available at https://ibn.fm/RGNT.
