Regentis Biomaterials (NYSE American: RGNT) announced it has received approval from the European Notified Body to manufacture GelrinC using its next-generation solvent-free manufacturing process, a milestone that 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, 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. The company 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 for Regentis as it prepares to bring GelrinC to market. The solvent-free process not only boosts yield but also enhances occupational and environmental safety, aligning with broader industry trends toward sustainable manufacturing. Regentis, a regenerative medicine company, focuses on innovative tissue repair solutions, with GelrinC being its lead product. The implant is designed to regenerate damaged or diseased tissue, including inflamed cartilage and bone, in a controlled and synchronous process. 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.
To view the full press release, visit https://ibn.fm/Ths4h. For more information about Regentis, see the company’s newsroom at https://ibn.fm/RGNT. Forward-looking statements in this article involve risks and uncertainties, as detailed in the company’s SEC filings.
