CollPlant Ltd., a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, announced positive final clinical trial results for VergenixSTR, intended for the treatment of tendinopathy.

Management also announced that the VergenixSTR Technical File was submitted in December 2015, in anticipation of CE mark approval in Europe in Q2 2016.

The objective of the company's prospective, open label, single arm trial, conducted at three leading Israeli hospitals (Meir Medical Center, Assaf Harofeh Medical Center and Hadassah Hospital) was to demonstrate the safety and performance of VergenixSTR in 20 patients suffering from inflammation of the elbow tendon (i.e. tennis elbow). All patients were followed for a total of six months after initial 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, VergenixSTR patients (N=20) reported an average PRTEE score improvement of 55.8 per cent at six-month follow-up, VergenixSTR patients (N=20) reported a mean PRTEE score improvement of 58.1 per cent.

The performance of VergenixSTR also compared very favourably to published results of standard-of-care tennis elbow therapies. At three months, 80 per cent of VergenixSTR patients showed at least a 25per cent reduction in PRTEE score while, in a randomized, controlled trial comparing PRP and steroids, 67 per cent of PRP patients and 48 per cent of steroid patients had at least a 25per cent reduction in pain and disability. Further, at six months, 90 per cent of VergenixSTR patients showed at least a 25 per cent reduction in PRTEE score, while 68 per cent of PRP patients and 36per cent of patients given steroids had at least a 25 per cent reduction in pain and disability.

VergenixSTR, intended for the treatment of a range of tendon injuries, incorporates CollPlant's recombinant human collagen in combination with platelet-rich plasma 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.