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.
About CollPlant
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:
|
Eran Rotem
|
Paula Schwartz (for
US Investors)
|
Chief Financial
Officer
|
Senior Vice
President
|
Tel: +
972-73-2325600/612
|
Tel:
917-322-2216
|
Email:
Eran@collplant.com
|
Email:
pschwartz@rxir.com
|
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SOURCE CollPlant Ltd.