Single administration of collagen filler may boost wound healing
CollPlant Ltd. (Israel) has announced that its plant-based rhCollagen product resulted in an average of 80% wound closure within 4 weeks following a single administration in all patients treated in the final results of its clinical trial.
CollPlant Ltd., a clinical-stage regenerative medicine company based in Israel, has announced that Vergenix®FG (Flowable Gel), which uses plant-based rhCollagen technology for treatment of wounds, is safe and effective for human use.
The open, single-arm study analyzed the safety of Vergenix®FG and its performance in patients with chronic, hard-to-heal lower-limb ulcers — diabetic foot ulcers represent approximately a quarter of the chronic wound market. The trial was carried out in several wound clinics in Israel.
The 20 participants received a single treatment and were followed for 4 weeks, with the researchers investigating results such as percentage of wound closure achieved. Final results demonstrated 80% average wound closure, with 45% of the patients achieving full wound closure. In a 2014 study published in International Wound Journal where patients with comparable wounds were treated with the current standard of care for 12 weeks, only 24% of patients achieved complete wound closure.
Yehiel Tal, Chief Executive Officer of CollPlant, commented: “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.”
Earlier this year CollPlant announced that it had submitted its CE Technical File to the European Notified Body to obtain CE Marking for Vergenixâ„¢FG. “CollPlant is now establishing the infrastructure for sales commencement in Europe in anticipation of CE Marking achieved,” Tal continued. CollPlant also believes that the product may have application for boosting tissue repair of surgical wounds.