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 stated in the company's press release. 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.
According to the company, GelrinC 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 of the next-generation manufacturing process is a significant step forward in scaling production to meet potential demand. Regentis Biomaterials Ltd is a regenerative medicine company dedicated to developing innovative tissue repair solutions, with an initial focus on orthopedic treatments.
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.
