Here is some new news.
Wednesday December 24, 8:08 am Eastern Time
Company Press Release
SOURCE: Ortec International, Inc.
Ortec to Initiate Donor Site Clinical Trial; Two Additional Trials
Expected to Begin First Quarter 1998
NEW YORK, Dec. 19 /PRNewswire/ -- Ortec International, Inc. announced today that it has been granted
permission by the FDA to begin a pilot study using its Composite Cultured Skin (CCS) product for donor site
wounds. The study will be conducted at Washington Hospital and will involve up to twenty patients. Donor sites
will be the third FDA clinical trial which is currently being conducted by Ortec using its CCS.
Donor sites are wounds created during autografting where skin is harvested for use elsewhere on the patient. It
is estimated that 100,000 such procedures are performed each year. Autografts are currently extensively used
in the treatment of burn patients.
As previously announced, CCS was used in a single time compassionate use granted by the FDA to treat
donor sites in a 16 year old. Over five and a half units of CCS were placed on donor sites on this one patient.
The results of this procedure will be presented at the American Burn Association meeting in March 1998 by Dr.
Jane Petro, the surgeon who performed this procedure, Co-Director of the Burn Unit at Westchester Medical
Center.
Steven Katz, Ph.D., CEO of Ortec, commenting on commencing the donor site study said, ''The initiation of the
study is a significant milestone for Ortec towards achieving its goal of demonstrating the application of our
CCS platform technology in a wide range of wound healing indications. Ortec's previous experience in using
CCS in covering donor sites in EB patients encourages us to pursue this indication.''
Ortec expects to begin clinical trials within the next sixty days using CCS in two additional wound healing
indications: venous ulcers and diabetic ulcers. The addition of these indications would bring the total FDA
clinical trials which are being conducted by Ortec and which involve CCS to five.
In addition to the newly announced donor site trial, CCS is currently being used in a multi-center pivotal clinical
trial for the treatment of severe burns and in a pilot trial for the treatment of chronic dermal ulcers of EB patients,
which is being conducted at Rockefeller University Hospital.
Ortec intends to, as well, pursue application of its CCS in reconstructive and cosmetic surgeries.
Certain statements made in this press release which express the ''belief, ''anticipation'' or ''expectation,'' as
well as other statements which are not historical fact, and statements relating to the clinical trials and their
results, design, 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 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.
SOURCE: Ortec International, Inc. |
