COLLPLANT: POSITIVE RESULTS FOR TENDINOPATHY PRODUCT (Orthopedics This Week)
CollPlant Ltd., an Israeli regenerative medicine company, is announcing good things for its tendinopathy treatment product, VergenixSTR. The company, which is on schedule to receive CE mark approval for this product in the third quarter of 2016, uses plant-based technology.
As indicated in the August 17, 2016 news release, “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 VergenixSTR 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, VergenixSTR patients (N=39) reported an average PRTEE score improvement of 51% over baseline. At six-month follow-up, VergenixSTR patients (N=36) reported a mean PRTEE score improvement of 59% over baseline.”
“The performance of VergenixSTR also compared favorably to published results of corticosteroid injection, which is the standard-of-care therapy for tennis elbow. At three months following treatment, 74% of VergenixSTR 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. Further, at six month follow-up, 86% of VergenixSTR patients reported a 25% or better PRTEE score improvement, while 36% of steroid patients showed at least a 25% reduction in pain and disability.”
CollPlant CEO Yehiel Talof told OTW, “VergenixSTR is based on CollPlant’s proprietary plant-derived recombinant human collagen (rhCollagen). The product offers an effective treatment for tendinopathy by enabling a sustained release of PRP related growth factors (e.g., PDGF [plant-derived growth factor], VEGF [vascular endothelial growth factor]) at the injury site over a period of several weeks. VergenixSTR demonstrated excellent outcome in the clinical study for the treatment of tendonitis.
“In addition to tendinopathy, we plan on expanding the indications to intraoperative procedures such as partial/full tendon ruptures (e.g., ACL [anterior cruciate ligament], RCR [rotator cuff repair]), meniscus and cartilage repair. CollPlant is currently developing a BioInk for 3D bio printing of tissues and organs which is based on the rhCollagen platform. Another activity is development of hard tissue repair product which enables sustained release of growth factor for spinal fusion and trauma indications.”