The share price of CollPlant Holdings Ltd. (TASE: CLPT) is surging against today, after the company announced positive results in its clinical trial. CollPlant, which develops and produces collagen-based medical products, has announced positive final results in its clinical trial for Vergenix STR for the treatment of tendinopathy (tennis elbow). Company management notes that the technical file for the product was submitted in December 2015, and the company hopes that CE mark approval in Europe will be granted in the second quarter of 2016. CollPlant is based in Ness Ziona and led by CEO Yehiel Tal.
The goal of the open-label trial, which was conducted on a single arm at three hospitals in Israel (Meir Medical Center, Assaf Harofeh Medical Center and Hadassah Hospital), was to demonstrate the safety and effectiveness of Vergenix STR in 20 patients suffering from tennis elbow. All the patients were monitored for six months following the treatment. The product was evaluated according to the reduction in pain and recovery of motion in the arm. The specific and generally accepted Patient Related Tennis Elbow Evaluation questionnaire (“PRTEE”) was used in the evaluation.
An audit conducted for monitoring three months after treatment with the product reported an average improvement of 55.8% in the PRTEE score. An audit conducted for 20 patients in monitoring after six months reported 58.1% improvement.
The Vergenix STR results were also compared with the standard-of-care therapies for the condition. The results were compared with a well-known scientific trial comparing treatment of patients with PRP (platelet-rich plasma) injections with injections of Corticosteroid. It was found that in monitoring after three months, 80% of the patients treated with Vergenix STR showed at least a 25% reduction in PRTEE score, compared with 67% with the PRP product and 48% with Corticosteroid. The two trials define success as a reduction of at least 25% in PRTEE score.
The comparison also shows that after monitoring at six months, 90% of patients treated with Vergenix STR experienced at least 25% PRTEE improvement, compared with 68% of patients treated with PRP and 36% treated with Corticosteroid.
Published by Globes [online], Israel business news - www.globes-online.com - on February 4, 2016
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