CollPlant Takes a Step Closer to Commercializing its Vergenix Flowable Gel Product for Treating Wounds: Receives Approval to Carry Out Clinical Trial
REHOVOT, Israel, June 16, 2014 /PRNewswire/ --
CollPlant (TASE: CLPT), developer and manufacturer of human collagen-based medical products announces that it has received approval from the Israeli Ministry of Health to carry out clinical trial with its Flowable Gel, an advanced and innovative product for the treatment of wounds. CollPlant plans to start the trial in the coming weeks.
For the conduction of the trial, CollPlant will cooperate with the Maccabi HMO, and the trial will take place at two Maccabi wound clinics in Israel. The objective of the clinical study is to demonstrate and confirm Vergenix™FG safety and performance. Patients with chronic leg ulcers will receive a single-product application and will be followed for 4 weeks. Wound size reduction, and product safety are the main study endpoints.
CollPlant's Vergenix™FG product is a collagen-based injectable gel for the management of wounds including pressure/venous/diabetic and chronic vascular ulcers, tunneled/undermined /Surgical / Trauma and Draining wounds. Advanced wound healing market is evaluated at USD 5 billion and is growing steadily.
Yehiel Tal, CollPlant's CEO: "We are very pleased to have received approval from the Ministry of Health to undertake this clinical trial. This trial is expected to last a few months and will significantly advance CollPlant towards launching our product in Europe and Israel, first. In the pre-clinical trials carried out over the last two years, we obtained very good results. Based on that, we anticipate excellent outcome from this trial. The Company's plan is to commence sales of the product in 2015. There is strong interest in our new product as well as in additional products in our pipeline and we are currently holding meetings and discussions with international leading potential distributors in order to choose the right distribution partners.
Vergenix[TM]FG is an advanced gel formulation based on rhCollagen, for the treatment of deep tunneled/undermined wounds, and wounds with irregular geometry. This injectable advanced gel formulation provides a pure human collagen scaffold filling the wound bed and providing maximal contact with the surrounding tissue. Vergenix[TM]FG provides complete coverage, managing wound closure, offers a non-allergenic and a pathogen-free scaffold for safe and successful wound management.
CollPlant is a medical device firm established in 2004 to focus on advancing regenerative medicine through its cutting-edge technology designed to generate and process proprietary recombinant human collagen, among other patent-protected recombinant proteins. CollPlant is developing a broad spectrum of biomaterials for a wide variety of medical markets, including orthopedics, wound healing, and general surgery. CollPlant's business model consists of own development and manufacturing of medical devices and their commercialization and distribution together with leading third parties alongside alliances with leading companies for joint development, manufacturing and marketing of additional
For more information about CollPlant, visit http://www.collplant.com
Chief Financial Officer
Released June 16, 2014