CollPlant Holdings Ltd. (TASE: CLPT), which develops and manufactures medical products based on recombinant human collagen, has announced successful interim results in the trial of its gel product for the treatment of chronic wounds and surgical incisions. The company's share price rose 14% following the announcement.
The interim results are part of the development of Vergenix, a wound-healing gel. The trial, which is being carried out at a number of health fund wound clinics in Israel, is a clinical trial with no control group. The purpose of the trial is to prove the product's safety and assess its performance on patients suffering from difficult-to-heal chronic leg wounds. According to the trial protocols, patients receive one-time medical treatment with the product, accompanied by a four-month follow-up procedure. The product's performance is judged by a number of measures, the most important of which is the percent of wound closures.
As of the report date, the company had concluded its recruitment of patients, and had treated 10 of the 20 patients taking part in the trial. Analysis of the interim results demonstrated excellent wound closing rates of 80-100% among a large majority of the patients within four weeks of beginning treatment. It was also demonstrated that the company's product was safe for use on humans.
The trial is being conducted according to the accepted standards, and with the approval required for conducting clinical trials. The company intends to utilize the clinical information collected about the product in the framework of the trial in the request it plans to submit in the coming months for approval of marketing the product in Europe. The initial target market, patients with diabetic ulcers, is estimated at $500 million a year. The wound healing market for which the product is designed amounts to $5 billion annually.
CollPlant CEO Yehiel Tal said, "In 2015, we're focusing on commercializing the company's products, including submission of requests for CE certification for two products already this year. The successful interim results for the product support implementation of this strategy, and are moving the company forward towards entry into the wound-healing market. At the same time, the company is also going ahead with two additional products, one for healing tendon inflammations, now in a clinical trial and slated for CE approval this year, and one for healing bones and stitching spinal column vertebrate that includes a bone-building protein made by Pfizer. This product pipeline is aiming at markets estimated in the billions of dollars annually."
Published by Globes [online], Israel business news - www.globes-online.com - on March 18, 2015
© Copyright of Globes Publisher Itonut (1983) Ltd. 2015