Ortec International, Inc.
(OTC Bulletin Board: ORTN), a company focused on advancing regenerative
medicine through the development of cellular technology and advanced
biomaterial products, announced today that it has begun a pre-clinical
study in rabbits to evaluate the capabilities of the Fibrin MB system to
accomplish the full cycle of steps required to use a patient's own stem
cells therapeutically to regenerate large gaps in long bone tissue. The
study involves a collaboration between the laboratories of Dr. Raphael
Gorodetsky (Hadassah Ein-Kerem and Hapto Biotech, Israel) and Dr. Iri
Libergal of the Department of Orthopedics at Hadassah Ein-Kerem Medical
Center in Jerusalem, Israel. Complete results of the study are expected
within six to eight months.
Commenting on the initiation of the study, Ron Lipstein, Ortec's Vice
Chairman and CEO, said, "The launch of this study is another key step
toward accelerating the development and commercialization of the practical
tissue regeneration therapeutic capabilities of our recently acquired
Fibrin Microbead technology. We expect this study will provide us with the
data from which we can design a clinical protocol and initiate a human
clinical trial for this orthopedic indication."
The Fibrin Microbead technology developed at Hapto Biotech, Israel,
Ortec's wholly owned subsidiary, is a proprietary matrix for the isolation,
expansion and differentiation of matrix dependent cells, including
Mesenchymal-type adult stem cells, and their potential reimplantation into
the patient.
About Ortec International, Inc.
Ortec International, Inc. (ORTN) is a company focused on advancing
regenerative medicine and stem cell therapy through the development and
commercialization of innovative products by combining advanced cell
technology and advanced biomaterials. Ortec's lead product is OrCel(R)
(Bilayered Cellular Matrix). Ortec's current focus is the application of
OrCel(R) to heal chronic and acute wounds. OrCel(R) is composed of a
collagen sponge seeded with allogeneic epidermal and dermal cells. These
cells secrete growth factors and cytokines normally found in acute human
wounds and are believed to have a beneficial role in promoting tissue
repair.
A pivotal clinical trial evaluating a cryopreserved version of OrCel(R)
in the treatment of venous leg ulcers has been completed and a Pre Market
Approval (PMA) application has been filed. Ortec has recently completed
patient enrollment in a confirmatory trial and the data from this trial are
expected to be integrated with the results of the pivotal clinical trial
and submitted as a clinical supplement to its PMA filing. Ortec has already
obtained FDA approvals for use of a non-frozen version of OrCel(R) in the
treatment of Epidermolysis Bullosa and donor sites in burn patients. In
addition, the FDA has granted Ortec approval to initiate a pivotal (Phase
III) trial evaluating OrCel(R) for the treatment of diabetic foot ulcers.
Ortec recently acquired two fibrin derived advanced biomaterial
technologies, Fibrin MB and Haptides(TM). Fibrin MB has the potential to
play a significant role in advancing stem cell therapy having demonstrated
the ability to efficiently recover adult stem cells and allow for their
growth, differentiation, and potential reimplantation into the patient.
Haptides(TM) utilize proprietary synthetic peptides that mimic the
mechanism of cell attachment to fibrin. These peptides have demonstrated
the ability to significantly enhance cell attraction and attachment
providing the potential to use Haptides(TM) in the development of product
opportunities applicable to the cosmetic tissue augmentation, wound
healing, orthopedics, and drug delivery markets.
For more information, visit Ortec's website at
ortecinternational.
This news release may contain "forward-looking statements" for the
purposes of the United States Securities and Exchange Commission's "safe
harbor" provisions under the Private Securities Litigation Reform Act of
1995 and Rule 3B-6 under The Exchange Act. Without limitation, statements
regarding expected FDA approvals, clinical trial results, product
performance, expectations with respect to sales, gross margins, research
and development expenditures, earnings per share, capital expenditures,
collaborations, or other expansion opportunities would be "forward-looking
statements." These statements may be identified by words such as "expects,"
"anticipates," "intends," "estimates," "believes" or similar expressions in
connection with any discussion of future financial and operating
performance. The forward- looking statements contained herein involve risks
and uncertainties that may cause results to differ materially from the
Company's expectations including but not limited to, global economic
trends, competitive pricing or product developments, government legislation
and/or regulations, technology, manufacturing, legal and patent issues,
suppliers, capital availability, personnel changes, cancellation or delays
in renewal of contracts, and lack of suitable raw materials or packaging
materials. Investors are cautioned to review risk factors in the Company's
filings with the United States Securities and Exchange Commission.
Ortec International, Inc.
ortecinternational
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