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 and addresses a U.S. cartilage repair market valued at approximately $3 billion.
The company reported that the new process increases production yield by approximately 400%, producing five times more product from the same manufacturing volume. This improvement enhances manufacturing 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. 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.
“This approval marks a significant step forward in our ability to bring GelrinC to patients in Europe,” said a company representative. The solvent-free process not only boosts yield but also improves safety for workers and the environment, aligning with Regentis' commitment to sustainable manufacturing.
For more details, view the full press release at https://ibn.fm/Ths4h.
Regentis Biomaterials Ltd. is a regenerative medicine company dedicated to developing innovative tissue repair solutions. Its Gelrin platform technology, based on synchronized, degradable hydrogel implants, regenerates damaged or diseased tissue including inflamed cartilage and bone. GelrinC(R) 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 latest news and updates relating to RGNT are available in the company’s newsroom at https://ibn.fm/RGNT.
