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 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, 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, this approval marks a significant step forward in scaling production capabilities. The solvent-free process not only boosts yield but also enhances occupational and environmental safety, addressing key manufacturing challenges. The improved efficiency is expected to support broader adoption of GelrinC in Europe and pave the way for U.S. market entry.
Regentis Biomaterials Ltd is a regenerative medicine company dedicated to developing innovative tissue repair solutions. 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 company’s Gelrin platform technology is based on synchronized, degradable hydrogel implants that regenerate damaged or diseased tissue.
For more details, visit the full press release 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.
