CollPlant Gets CE Mark
CollPlant (TASE:CLPT) has received CE mark approval for European sale and marketing of its Vergenix®WD product, a company-developed wound healing product. Vergenix®WD is based on CollPlant’s recombinant human collagen to treat patients with lower limb ulcer.
Vergenix®WD is the world’s first medical device containing a recombinant product sourced from plants, that has been approved for sale and marketing in Europe paving the way toward obtaining approval for the company’s pipeline products. The company plans to distribute wound healing products in Europe, through a local distributing network, where Vergenix®FG, a Flowable Gel indicated for the treatment of diabetic ulcers, will be the first product to be sold.
In August 2012, CollPlant announced the successful results of a wound healing clinical trial. The objective of the trial was to prove the safety and performance of Vergenix®WD. The trial, which has since been completed, obtained its main objective, namely, proof of the safety of its use, and outstanding healing was achieved, proving the capacities of the product. CollPlant will continue as planned with an objective of signing a commercial agreement in 2013 with a strategic partner.