NESS-ZIONA, Israel, November 30, 2015 /PRNewswire/ --
CollPlant Ltd. (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, announced positive final trial results for Vergenix®FG (Flowable Gel), designed for the treatment of chronic, hard to heal wounds and surgical wounds.
The 20 patient, open, single arm trial was conducted at a number of wound clinics within Israel. The trial objective was achieved, demonstrating the safety of Vergenix®FG and its performance in patients with chronic, hard to heal lower limb ulcers. All patients in the trial received a one-time treatment with Vergenix®FG, followed by a four-week follow-up. Product performance was examined according to several indicators, including the percentage of wound closure achieved.
Trial final results demonstrated that Vergenix®FG is safe and effective for use on human subjects. Of note, in all 20 patients treated, final results show average wound closure rates of 80%. Full wound closure was observed in nine of the 20 patients (45% of the patients) after four weeks following the single administration, and the median was 94% wound closure. In contrast, according to scientific study published in 2014 in the International Wound Journal, treatment of patients with wounds comparable in severity to the wounds treated in Vergenix™FG trial, using the current standard of care resulted in complete wound closure after 12 weeks of treatment in just 24% of patients.
Yehiel Tal, Chief Executive Officer of CollPlant, stated, "We are very pleased with the final trial results. CollPlant is making substantial progress towards commercialization of its first two proprietary products, and these study results illustrate several significant advantages of our product, most particularly, the rapid wound closure achieved in a single treatment. CollPlant is now establishing the infrastructure for sales commencement in Europe in anticipation of CE Marking achieved."
Diabetic foot ulcers only represent about one quarter of the total chronic wound market, indicating that the target market for VergenixFG is several magnitudes greater than the diabetic foot ulcer market alone. CollPlant also sees the opportunity for expansion of VergenixFG beyond chronic wounds into the treatment of surgical wounds. The National Center for Health Statistics reported a total of 51.4 million inpatient surgical procedures took place in the United States in 2010. This data implies on the large surgical wound potential market that could benefit from an advanced wound care product such as VergenixFG to facilitate healing."
Earlier this year CollPlant announced that it had submitted its CE Technical File to the European Notified Body to obtain CE Marking for Vergenix™FG.
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: Vergenix™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; Vergenix™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and; Vergenix™BVF (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:
Chief Financial Officer
Contact at Rx Communications Group, LLC:
Paula Schwartz (for US Investors)
Senior Vice President
SOURCE CollPlant Ltd