CollPlant Takes Significant Steps Towards Sales in Europe
Receives CE mark approval for its first wound healing product
NESS ZIONA, Israel, December 17, 2012 /PRNewswire/ --
CollPlant (TASE:CLPT) designer and manufacturer of medical products based on a recombinant protein sourced from tobacco plants, announced today that it 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.
Yehiel Tal, CollPlant's CEO: "Receipt of this approval is a significant achievement for CollPlant and constitutes a regulatory breakthrough. This is another objective for 2012 that was achieved successfully. 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.
About the Vergenix®WD (Wound Dressing):
Vergenix®WD is a wound healing dressing, designated to treat, using standard and accepted procedures, acute and chronic wounds, such as burns, pressure sores, venous ulcers, diabetic ulcers, second-degree burns, abrasions, surgical incisions, hemorrhaging wounds and others. Similar products are available, but contain animal- or cadaver-derived collagen. The wound healing market size is estimated billions of dollars and is showing constantly rising trends.
About Vergenix®FG (Flowable Gel):
Vergenix®FG is an injectable gel intended for the treatment of chronic tunneling, hard-to-heal wounds, including diabetic ulcers, venous ulcers and pressure sores. This product is based on recombinant human collagen produced by CollPlant and in a study conducted by the company, has proven better performance than the leading, competing marketed product, as reported in December 2011.
CollPlant is a medical device company 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, cardiology and general surgery. CollPlant's business model is based on strategic alliances with leading companies toward joint development and marketing of products, alongside in-house development and commercialization of other products and their distribution by third parties.
Disclaimer: The company's plans with regards to CE marking and timetables relating to realization of the aformentioned expected developments and, the signing of commercial agreement during 2013, hold true to the date of this release and should be regarded as forward-looking statements as defined by the Securities Exchange Act. All and/or some of these targets may not be realized or may be realized in a manner significantly different from that originally expected, which may, among other reasons, be due to elements beyond the company's control, including changes in market conditions and the competitive and business environments, trial results that will be performed by CollPlant, regulatory requirements relating to trials conducted by CollPlant, and realization of any of the risk factors applying to the company.
Released December 17, 2012