Another Clinical Trial for CollPlant: Trials for Vergenix®STR Have Begun - a Human Collagen-based Product for Tendon Repair
"The product is aimed at a target market estimated at 2 billion US dollars, and is designed to provide a high-quality and safe answer for patients suffering from tendinopathy," said Yechiel Tal, CollPlant's CEO
REHOVOT, Israel, January 12, 2015 /PRNewswire/ --
CollPlant (TASE: CLPT), developer and manufacturer of human collagen-based medical products, announces that it has begun human clinical trials with its tendon repair product " Vergenix®STR ", and has recruited and treated the first two patients.
Vergenix®STR is intended for the treatment of tendonitis caused mainly due to strenuous activity. Vergenix®STR is based on the human collagen sourced from the tobacco plant and is mixed with a concentration of platelet-rich plasma derived from the patient's blood. The product is introduced into the injured area by a one-time injection.
The purpose of the trial is to confirm the product's safety, and to assess its performance in patients suffering from "tennis elbow". The efficacy of the treatment will be reviewed through several indicators, i.e reduction of pain, tendon healing and improvement in motion. The trial will take place in 3 major hospitals in Israel, where 20 patients will receive a one-time treatment using the product. All patients will have a 6-month clinical follow up.
This clinical trial constitutes part of CollPlant's work plan to apply for CE approval to market Vergenix®STR in Europe. The Company intends to begin the sale of the product in Europe in 2015, and is making preparations accordingly.
Yechiel Tal, CollPlant's CEO: "We are pleased to update on the beginning of the clinical trial, which is a significant milestone in our plan to commercialize the Vergenix®STR product worldwide. The product is aimed at a target market estimated at 2 billion US dollars, and is designed to provide a high-quality and safe answer for patients suffering from tendinopathy."
In addition, CollPlant updated that following its announcement made late November 2014 on the beginning of the Vergenix®FG clinical trial in wound healing, thus far the Company has recruited a third of the patients required for the trial, which is progressing according to the Company's plans.
About Vergenix™STR - a tendon healing product:
Vergenix™STR is a product for treating tendon injuries, based on CollPlant's recombinant human collagen in combination with platelet-rich plasma derived from the patient's blood. Following its injection into the injured site, the product transitions from a fluid to a solid phase, whereupon, it releases, in a controlled fashion, platelet-derived proteins. These proteins, in combination with collagen, induce the healing effect.
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 its 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 products.
For more information about CollPlant, visit http://www.collplant.com
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Released January 12, 2015