News & Events zu Regentis Biomaterials Ltd (RGNT)RGNTRegentis Biomaterials Ltd

Regentis Biomaterials Gains Strong Interest from Surgeons at International Joint Preservation Summit

Regentis Biomaterials announced strong interest and engagement from orthopedic surgeons, physicians and cartilage repair specialists who visited the Company's booth at the 8th International Cartilage Regeneration & Joint Preservation Society Summit, held October 8-10, 2026, in Porto, Portugal. The Summit, themed "Joint Preservation: The Regenerative Era is Underway," brought together international experts to discuss advances in cartilage regeneration, joint preservation and emerging regenerative therapies. Regentis representatives engaged with physicians and surgeons regarding GelrinC, the Company's CE Mark-approved, cell-free hydrogel implant designed to regenerate damaged knee cartilage. Discussions at the Company's booth focused on GelrinC's clinical results, its ready-to-use, off-the-shelf design, and its potential to simplify cartilage repair compared with traditional surgical approaches. GelrinC is delivered in a single procedure of approximately 10 minutes, without the need for cell harvesting or laboratory processing. Based on the results of the Company's Phase II study, GelrinC demonstrated approximately 100% greater improvement in overall KOOS scores compared with historical microfracture controls at two years, with subsequent MRI analyses showing results consistent with durable, native-like cartilage regeneration. "The strong interest and quality of our interactions with surgeons and cartilage repair specialists at ICRS were extremely encouraging," said Ehud Geller, CEO. "We had valuable discussions with physicians who understand the limitations of existing cartilage repair procedures and are interested in new regenerative approaches that can offer meaningful benefits to patients while simplifying treatment for surgeons. We believe this level of engagement reflects growing awareness of GelrinC and its potential to help address a significant unmet need in knee cartilage repair. With GelrinC already CE Mark approved in Europe, we are focused on translating physician interest into broader clinical adoption as we advance our commercialization preparations. Our expanding network of European Centers of Excellence is an important part of that strategy, supporting surgeon education, training and clinical collaboration. At the same time, our European clinical sites are contributing to our ongoing U.S. FDA pivotal trial, providing an additional opportunity for leading surgeons to gain experience with GelrinC."

GelrinC Clinical Trial Enrollment Expected to Complete by Year-End

"During the first half of 2026, we continued to advance GelrinC on multiple fronts as we build toward important clinical and commercial milestones in the U.S. and Europe," said Ehud Geller, CEO. "Interest in GelrinC from physicians, patients and clinical centers continues to build, and we are encouraged by the engagement we are seeing as we expand the number of active clinical sites in the United States and Europe. Based on the current pace of enrollment, we now expect to complete full enrollment of 80 patients in our U.S. pivotal trial on or around the end of this year, compared with our previous expectation of the third quarter. This timing reflects the practical pace of site activation and patient recruitment in the U.S. and Europe. Enthusiasm for GelrinC is building in Europe, where we have CE Mark approval, as we prepare for commercialization. We are engaging with physicians and clinical centers and advancing surgeon training through our European Centers of Excellence to support adoption of the procedure. Progress in both the U.S. and Europe reinforces our confidence in GelrinC's potential to provide a simple, off-the-shelf regenerative treatment for patients suffering from painful articular cartilage injuries."

Regentis Biomaterials Receives Approval to Manufacture GelrinC

Regentis Biomaterials announced it has received approval from the European Notified Body to manufacture GelrinC using its next-generation solvent-free manufacturing process. The approval comes as Regentis prepares for the commercial launch of GelrinC in Europe, enabling the Company to manufacture commercial product using a process that increases production yield by approximately 400%, delivering five times more product from the same manufacturing volume while improving manufacturing efficiency and scalability.