Clinical Success Demonstrated, with Improvement in Pain and Functionality at Three and Six-month Follow-ups
Ness Ziona, Israel, February 4, 2016 – CollPlant Ltd. (TASE:CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, today announced positive final clinical trial results for VergenixTMSTR, 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 VergenixTMSTR 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% At six-month follow-up, VergenixSTR patients (N=20) reported a mean PRTEE score improvement of 58.1%. The performance of VergenixTMSTR also compared very favorably to published results of standard- of-care tennis elbow therapies (1). At three months, 80% of VergenixSTR patients showed at least a 25% reduction in PRTEE score while, in a randomized, controlled trial comparing PRP and steroids, 67% of PRP patients and 48% of steroid patients had at least a 25% reduction in pain and disability(2). Further, at six months, 90% of VergenixSTR patients showed at least a 25% reduction in PRTEE score, while 68% of PRP patients and 36% of patients given steroids had at least a 25% 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 1-year follow up. Peerbooms et Al, The America Journal of Sports Medicine Vol. 38 No 2 2010 (2) Protocol for both studies, VergenixTMSTR’s and PRP vs. steroids, classifies an index of at least 25% reduction in pain and disability, as success.
About VergenixTMSTR VergenixTMSTR, 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.
CollPlant is a clinical-stage regenerative medicine company leveraging its proprietary, plant-based rhCollagen technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary recombinant human collagen (rhCollagen), among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: VergenixTMSTR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; VergenixTMFG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and; VergenixTMBVF (Bone Void Filler), for use in spinal fusion procedures and trauma. CollPlant’s business strategy includes proprietary development and manufacturing of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacturing and marketing of additional products.
For more information about CollPlant, visit http://www.collplant.com
Contact at CollPlant:
Eran Rotem Chief Financial Officer Tel: + 972-73-2325600/612 Email: Eran@collplant.com
Contact at Rx Communications Group, LLC
Paula Schwartz (for US Investors) Managing Director Tel: 917-322-2216 Email: pschwartz@RxIR.com