The Company anticipates receiving CE mark approval for Vergenix™STR in the third quarter of 2016.
The prospective, open label, single-arm trial was conducted at three leading Israeli hospitals (Meir Medical Center, Assaf Harofeh Medical Center and Hadassah Hospital), and the trial's objective was to demonstrate the safety and performance of Vergenix™STR in 40 patients suffering from inflammation of the elbow tendon, commonly referred to as tennis elbow.
All patients were followed for a total of six months after a single treatment. Product performance was assessed by measuring reduction in pain and recovery of motion, as reported by the specific Patient Related Tennis Elbow Evaluation questionnaire ("PRTEE").
At three months following treatment, Vergenix™STR patients (N=39) reported an average PRTEE score improvement of 51% over baseline. At six-month follow-up, Vergenix™STR patients (N=36) reported a mean PRTEE score improvement of 59% over baseline.
The performance of Vergenix™STR also compared favorably to published results of corticosteroid injection, which is the standard-of-care therapy for tennis elbow(1). At three months following treatment, 74% of Vergenix™STR patients reported a 25% or better PRTEE score improvement while, in the published controlled trial, 48% of steroid patients showed at least a 25% reduction in pain and disability(2).
Further, at six month follow-up, 86% of Vergenix™STR patients reported a 25% or better PRTEE score improvement, while 36% of steroid patients showed at least a 25% reduction in pain and disability.
An additional analysis utilizing a threshold of at least 50% improvement in PRTEE score showed that at three months following treatment, 62% of Vergenix™STR patients showed at least a 50% improvement in PRTEE score while, in the published controlled trial, 33% of steroid patients had at least a 50% reduction in pain and disability(3).
At six month follow-up, 64% of Vergenix™STR patients showed at least a 50% improvement in PRTEE score, while 17% of steroid patients showed at least a 50 % reduction in pain and disability.
(1) Positive Effect of an Autologous Platelet Concentrate in Lateral Epicondylitis in Double-Blind Randomized Controlled Trial. Platelet-Rich Plasma versus Corticosteroid injection with a one-year follow up. Peerbooms et Al, The America Journal of Sports Medicine Vol. 38 No 2 2010
(2) Protocol for both studies follow-up periods defined trial success as achieving at least 25% reduction in pain and disability.
(3) Protocol for both studies follow-up periods defined trial success as achieving at least 50% reduction in pain and disability.
Yehiel Tal, Chief Executive Officer of CollPlant, stated, "We are very pleased with the final extended trial results, which we believe illustrate the significant potential advantages of Vergenix™STR over steroids, which are traditionally used as first line treatment for tendinopathy patients.
“CollPlant is making substantial progress towards commercialization, and we look forward to receiving CE Mark approval later this quarter, and making Vergenix™STR available to patients as soon as possible."
Vergenix™ STR, intended for the treatment of a range of tendon injuries, incorporates CollPlant's recombinant human collagen in combination with platelet-rich plasma (PRP) derived from the patient's blood.
Following its injection into the injured site, the product transitions from a fluid to a solid phase, whereupon, it releases, in a controlled fashion, platelet-derived proteins. These proteins, in combination with collagen, induce the healing effect on the tendon.
