CollPlant Launched a Clinical Trial With Vergenix®FG; A Gel Based on a Human Collagen for the Treatment of Chronic Wounds
Yehiel Tal: "The trial is a major milestone towards commercialization of the Company's products in global markets"
REHOVOT, Israel, December 1, 2014 /PRNewswire/ --
CollPlant (TASE: CLPT), a developer and manufacturer of human collagen-based medical products announced that it has enrolled and treated the first patient in its Vergenix®FG clinical trial in Israel.
The Vergenix®FG gel is an advanced gel formulation based on rhCollagen, intended for chronic wounds including diabetic foot ulcers, pressure and venous ulcers, and surgical and trauma wounds. The product is based on a human collagen produced in tobacco plants using a patented technology owned by CollPlant.
The objective of the trial is to evaluate the safety of the product, and its performance on patients suffering from lower limb chronic wounds. The effectiveness of the treatment will be primarily assessed by the percentage of wound closure. The trial is expected to spread over a few months and will take place at three wounds clinics of one of the leading HMOs in Israel. Twenty patients suffering from lower limb chronic wounds will receive one-time treatment with the product. Each patient will be monitored over 4 weeks.
The Company plan is to commence sales of the product in Europe in 2015, and accordingly CollPlant is in dialog with international partners for distribution in Europe. The advanced wound care market, for which this product is intended, is estimated at USD 5 billion.
Yehiel Tal, CEO of CollPlant: "We are very pleased to be commencing the clinical trial of Vergenix®FG which is based on a unique technology that has the potential to significantly improve the quality of life outcomes for patients with lower limb chronic wounds. The trial is a major milestone in our plan to commercialize the Company's products in global markets. The product provides a solution for the urgent and vital need to be able treat patients with chronic wounds. In parallel with the start of the trial, we are now preparing to apply for the CE Mark for marketing the product in Europe"
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®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
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Released December 1, 2014