CollPlant announces clinical trial published regarding Vergenix STR
CollPlant announced a clinical trial published regarding its Vergenix STR in the treatment of tennis elbow. The peer reviewed paper titled, "First clinical experience with a new injectable recombinant human collagen scaffold combined with autologous platelet-rich plasma for the treatment of lateral epicondylar tendinopathy (tennis elbow)" was published in the Journal of Shoulder and Elbow Surgery. The clinical trial, which was concluded in August 2016, enrolled 40 patients and evaluated three key measures of tennis elbow at 6 months post-treatment. The mean Patient-Rated Tennis Elbow Evaluation score showed a 59% improvement (reduction) from baseline at 6 months. Grip strength increased by 28% from 28.8 kg at baseline to 36.8 kg at 6 months. In 68% of patients, improvements in sonographic tendon appearance were evident. No systemic or local severe adverse events were reported. "Based on the very favorable data reported, this study concluded that Vergenix STR demonstrated significant clinical improvements in patients with tennis elbow. Vergenix STR offers a unique, and effective method to treat a wide range of tendinopathies with just a single application to initiate the healing process," stated Yehiel Tal, CollPlant's Chief Executive Officer. "In the U.S. market alone, there are estimated to be over 3 million procedures annually to treat tendinopathy. We look forward to advancing Vergenix STR through the FDA approval process and into commercialization in the U.S." Vergenix STR has a CE mark and is currently sold in Europe. CollPlant plans to conduct a pre-submission meeting with the U.S. FDA in the coming weeks.