CollPlant Ltd. (TASE:CLPT; OTC:CQPTY), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, announce that it has completed the recruitment of all 20 patients for its clinical trial of Vergenix™FG (Flowable Gel), indicated for the treatment of chronic, hard-to-heal wounds.
As announced in August, CollPlant submitted an application for CE Marketing of Vergenix™ FG in Europe, and reported positive interim trial results comparing the clinical performance of Vergenix™FG with published scientific literature on other, commercially available wound products.
Commenting on today’s news, Yehiel Tal, Chief Executive Officer of CollPlant, stated, “Previously reported positive interim data showing that Vergenix™FG can provide faster wound healing in patients with diabetic foot ulcers after a one-time application, indicates that the product may have significant potential advantages over competing therapies in this multi-billion dollar advanced wound healing market. Completion of patient recruitment represents the achievement of yet another important milestone in the development of Vergenix™FG and brings us closer to our ultimate goal of commercialization. Toward that end, in anticipation of possible CE Marking, CollPlant is now actively involved in identifying a European marketing partner for the product.”
Published Interim results from the Vergenix™FG trial showed that the majority of patients, 11 out of 16, achieved wound closure of between 80% and 100% within four weeks, with eight of the 16 patients achieving full wound closure within just four weeks.
CollPlant also reported an analysis comparing the clinical performance of Vergenix™FG with published scientific literature from other, commercially available wound products, which indicates a number of distinct advantages. First is the speed of wound closure, with 50% of the patients treated with Vergenix™FG achieving full wound closure within four weeks. The remarkable jump-start of healing achieved by Vergenix™FG in CollPlant’s’ clinical trial is of particular importance, since chronic wounds that are hard-to-heal were included in the trial. Moreover, as Vergenix™FG requires just one application, compared to most products currently in use, which require multiple treatments, Vergenix™FG offers a major competitive advantage in terms of cost and ease of use. The company noted that data analysis is based on other companies scientific publications, regarding other wound management products, in comparison to the company’s product data as presented in the interim results report. Management noted that final results and analysis from the trial are expected to be published by the end of 2015.
Vergenix™FG is an advanced gel formulation based on rhCollagen, for the treatment of acute and chronic wounds. This injectable advanced gel formulation provides a pure human collagen scaffold, filling the wound bed and providing maximal contact with the surrounding tissue. Vergenix™FG provides complete coverage, managing wound closure and offering a non-allergenic and a pathogen-free scaffold, for safe and successful wound management.
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.