CollPlant Reports Positive Interim Trial Results for Vergenix®FG Wound Healing Gel
Results Show a Rate of 80% to 100% Wound Closure Within Just Four Weeks in the Vast Majority of Patients Treated
REHOVOT, Israel, March 19, 2015 /PRNewswire/ -- CollPlant Ltd. (TASE: CLPT; OTC: CQPTY), a medical device company leveraging its groundbreaking, plant-based technology to develop a broad spectrum of biomaterials incorporating proprietary recombinant human collagen (rhCollagen) for use in orthopedics, wound healing and general surgery, today announced positive interim trial results for Vergenix®FG (Flowable Gel), designed for the treatment of chronic, hard to heal wounds and surgical incisions.
The 20-patient, open, single arm trial is being conducted at a number of HMO wound clinics within Israel. The trial objective is to prove the safety of treatment with Vergenix®FG and to assess its performance in patients with chronic, hard to heal leg ulcers. All patients in the trial receive a one-time treatment with Vergenix®FG, followed by a four week follow-up procedure. Product performance is examined according to several indicators, chief among them being the percentage of wound closure achieved.
In the vast majority of the ten patients treated thus far, interim results show wound closure rates of between 80% and 100%, within four weeks of treatment. Trial results also demonstrate that Vergenix®FG is safe for use on human subjects.
Yehiel Tal, Chief Executive Officer of CollPlant, stated, "Our goal this year is to focus on commercializing two of the Company's lead products, including filing applications for CE Mark approval to begin sales in Europe. The successful interim results achieved with Vergenix®FG support the realization of this strategy and promote the Company in its entry into the wound healing market. As we continue to progress the development of Vergenix®FG, we are also working toward commercialization of our Soft Tissue Repair product for the treatment of tendon inflammation. In parallel, we continue to develop a third lead product, a Bone Void Filler for the treatment of posterolateral spinal fusion and for trauma, combining bone morphogenetic protein, which addresses a multi-billion dollar worldwide market."
The estimated annual first target market, for treatment of patients with diabetic foot ulcers, is approximately $500 million, with the total advanced wound healing market estimated at $5 billion.
The Company's clinical trial for Vergenix®FG is being carried out in accordance with accepted standards and under the approvals required for conducting a clinical trial in Israel, and the Company intends to utilize the clinical data collected when filing for CE Mark approval in Europe in the coming months.
In January, the Company reported that it had begun a clinical trial on human subjects with the Vergenix®STR product for the treatment of tendon inflammation. Based on the trial, the Company intends to apply for CE approval by the third quarter of 2015. The goal for the beginning of sales of the product in Europe is late 2015. The market size is estimated at $2 billion per year.
CollPlant is a medical device firm established in 2004 focused on advancing regenerative medicine through cutting-edge technology designed to generate and process proprietary recombinant human collagen (rhCollagen), 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. These include: Vergenix™STR (Soft Tissue Repair Matrix), indicated for the treatment of tendinopathy; Vergenix™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and; Vergenix™BVF (Bone Void Filler), indicated for spinal fusion procedures in posterolateral approach. 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
Contact at CollPlant:
Contact at Rx Communications Group, LLC:
Paula Schwartz (for US Investors)
Chief Financial Officer
Senior Vice President
Tel: + 972-73-2325600/612
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SOURCE CollPlant Ltd.
Released March 19, 2015