Regentis Biomaterials Publishes Data On Phase 2 Clinical Study Of GelrinC

Regentis Biomaterials Ltd., ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced publication of long-term follow-up results from its successfully concluded Phase II clinical trial of GelrinC® in the peer-reviewed journal Cartilage. The study, led by Prof. Siegfried Trattnig of Vienna University and colleagues, reports strong radiologic evidence of durable cartilage regeneration at 24 months.

Regentis is the first company to extensively use MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue), a validated MRI-based quantitative measure of cartilage quantity and quality as a secondary endpoint in a clinical study, and to have the U.S. Food and Drug Administration's (FDA) acceptance of this approach. In contrast to the predominantly subjective clinical endpoints commonly used in cartilage repair studies, Regentis deliberately selected objective, imaging-based endpoints as a rigorous measure of structural repair from the outset. Regentis is unique in having predefined MOCART as a prospective imaging and primary endpoint built into the protocol from day one, and in having the MOCART assessments conducted by the Vienna University-based team that developed the method which is widely regarded as the gold standard.

As such, Regentis is advancing what it believes is a more rigorous standard for assessing cartilage regeneration by emphasizing objective, quantitative structural outcomes alongside the current standard of care KOOS (Knee Injury and Osteoarthritis Outcome Score) which is a questionnaire-based patient-reported measure of pain.