Regentis carried out a Pilot/Phase II study of 56 patients that were treated with GelrinC and followed up for up to four years in multiple sites in Northern Europe and Israel. The primary efficacy endpoints were superior changes from baseline for overall Knee injury and Osteoarthritis Outcome Score (KOOS) scores and KOOS pain subscale. The primary efficacy end points were met; the improvements observed in the (“KOOS”) and visual analog scale (“VAS”) pain measurement scores taken over two years were superior (100% greater improvement) to those seen with the traditional microfracture (the current “gold” standard) procedure. Additionally, patients continued to report further improvement and greater pain reduction of their knee and associated problems using GelrinC for four years. No serious adverse events were observed for the product in the completed Pilot study.
Based on these results, the FDA granted Regentis an investigational device exemption, or IDE, for our pivotal trial, permitting PMA submission with two-year follow-up data of 80 patients, with an additional 40 patients to be treated thereafter. The pivotal trial is currently being conducted in the United States and Europe, under the FDA’s sanctioned protocol, is an open label study, with one arm only (treatment), using our own historical control (microfracture). To-date, we have treated 47 patients out of the 80 initial patients.