*NEWS*
Just saw the following news after the close today:
biz.yahoo.com
Tuesday December 15, 4:05 pm Eastern Time
Company Press Release
Ortec's Composite Cultured Skin -CCS- Shown to be Excellent Alternative to
Autograft in Hand Reconstruction and Donor Sites
Results of Use of Ortec's CCS Reported in British Journal of Plastic Surgery
NEW YORK--(BUSINESS WIRE)--December 15, 1998--(NASDAQ: Small Cap:
ORTC) The current edition of the The British Journal of Plastic Surgery
published the results of 28 operations using Ortec's Composite Cultured Skin (CCS) as
a total or partial substitute for autografts (patient's own skin) in donor site
wounds and as a replacement for skin removed during hand reconstruction in
Epidermolysis Bullosa (EB) patients. CCS was shown to perform as well or superior
to autografts in the treatment of these patients.
According to the report, in thirteen operations in which donor site wounds were
covered with CCS, the donor areas had dermal regeneration, maintained stability
and yielded good quality skin. Moreover, there was no significant postoperative pain
requiring narcotic intervention, which contrasted dramatically with those patients
whose donor sites were treated with standard of care. In the latter group, moderate pain
persisted for twenty-four to seventy-two hours, requiring narcotic
intervention. In addition, in two of the patients, the donor sites previously treated with
CCS were subsequently reharvested, yielding good quality skin for use in
additional hand surgeries required by these patients.
The British Journal of Plastic Surgery also reported that CCS was successfully used
alongside autografts in fifteen out of sixteen hand reconstructive surgeries. The
CCS sites were completely healed two weeks postoperatively, with biopsies
demonstrating the presence of epidermis and neodermis, while the autografts were
usually visibly healing within one week. At four weeks, there was no difference in
appearance between the two grafts. Morphologic and functional results with CCS
in all patients were judged to be good to excellent. Moreover, by approximately a two
to one time margin, the sites treated with CCS delayed recurrence and,
thereby, delayed the requirement for additional hand surgeries as compared to those
sites treated with autograft.
Commenting on the published results, Steven Katz, Ph.D., CEO of Ortec said, ''The
results reported are consistent with our expectations, and support our view that
CCS will play a major role in the acute and chronic wound care arena.''
The scientific paper was written by Dr. Mark Eisenberg, Executive Vice President of
Research and Development of Ortec International, and Dr. Don Llelwyn, a
pediatric surgeon, who performed all the surgeries in a trial conducted at the Prince of
Wales Hospital in Sydney, Australia.
Ortec International is a tissue engineering company involved in the development of
proprietary and patented technology to stimulate the repair and regeneration of
human tissues, such as skin. Ortec's technology consists of a patented biologically active
wound dressing, Composite Cultured Skin (CCS), consisting of a
bioengineered bovine collagen matrix seeded with epidermal and dermal cells. CCS is
currently in clinical trials for treatment of donor site wounds and venous skin
ulcers and has completed a clinical trial using CCS for the treatment of chronic dermal
skin ulcers in Epidermolysis Bullosa (EB) patients. Ortec believes that CCS
may have wide commercial applications for the treatment of burns, diabetic and venous
skin ulcers and serious skin diseases, such as EB, as well as for
reconstructive and cosmetic surgery.
Certain statements made in this press release which express the belief, potential
anticipation or expectation, as well as other statements which are not historical fact,
and statements relating to the clinical trials and their results, design, FDA product
approvals, features, functionality and performance insofar as they may apply
prospectively, are forward-looking statements within the meaning and pursuant to the
Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and
involve risks and uncertainties. The Company's actual results may differ significantly
from the results discussed in this press release or in other forward-looking
statements presented by management. Factors that might cause such a difference include
but are not limited to, development by the Company's competitors of new
technologies or products that are more effective than the Company's, risks of failure of
clinical trials, dependence on and retention of key personnel, protection of
proprietary technology, compliance with U.S. Food and Drug Administration
regulations, continued availability of raw material for the Company's products,
availability of product liability insurance in the event of commercialization of the
Company's products, ability to effect transition from pilot-scale manufacturing to
large-scale commercial production of products, uncertainty as to the availability of
additional capital on acceptable terms, if at all, and the demand for the Company's
products, if and when commercially available.
Contact:
Ron Lipstein, Chief Financial Officer
Ortec International, Inc.
Tel: (212) 740-6999
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