Surgery Performed Today at Westchester County Medical Center
Using CCS to Cover Donor Sites
NEW YORK, Aug. 28 /PRNewswire/ -- Ortec International, Inc. (Nasdaq: ORTC)
announced today that its CCS(TM) product has been used during urgent surgery
of a South American child who suffers from severe Epidermolysis Bullosa (EB),
under allowance from the FDA as a single time compassionate use application.
CCS was used in a reconstructive procedure performed by Dr. Jane Petro,
Co-Director of the Burn Unit at Westchester Medical Center. The procedure was
performed on a child who recently arrived from Buenos Aires, Argentina in
order to correct an abundant build up of scar tissue around his eyes, which is
symptomatic of this disorder. If not corrected in a timely manner, scarring
in this area prohibits eyelid function and predisposes one to corneal damage
and blindness. The child had previously undergone multiple surgeries in an
attempt to manage this excessive scar build up. In these previous operations,
autografts (skin from his own body) were used to cover the wounds created from
these surgeries. However, these wounds did not heal. In today's surgery, CCS
was used to cover the previously unhealed areas, as well as the newly created
autograft site, to enhance wound closure on those sites.
Epidermolysis Bullosa is a rare, inherited disorder characterized by
severe blistering and sloughing of the top layers of the skin. These patients
are prone to chronic infections involving the skin and soft tissues.
Outwardly, they are marked by devastating chronic scarring, affecting their
ability to function at home, in school or at work. In addition, there are
vast systemic effects leading, for example, to ulcerations and chronic
scarring of the inner lining of the digestive system. These internal
pathologic features predispose those affected to malnutrition and weaknesses
in immune function as well. Because EB patients' wounds often fail to heal
and are subject to cycles of recurrent breakdown, they are highly susceptible
to development of very aggressive skin cancer. All of these factors
contribute to the increased morbidity and mortality associated with the
disorder.
Management of these patients requires a multi-faceted approach, most
notably focused on meticulous wound care. To restore manual function and
improve quality of life, EB patients do undergo staged reconstructive
procedures. Since these patients possess such fragile, "tissue paper"-like
skin (particularly in the unscarred regions which would otherwise qualify for
an autograft), they present a significant surgical challenge even to the most
experienced clinician.
Dr. Petro, a plastic surgeon with extensive experience in soft tissue
reconstruction for EB patients, remarked, "I am pleased with what my team was
able to accomplish during this procedure. We revised both eyelids enabling
the patient now to close his eyes completely. In addition, the patient
underwent reconstruction of the right hand so as to restore use of his
fingers. Correction of these scar defects will have a significant impact on
this patient's quality of life." She added, "I am thankful to Ortec for
supplying the CCS to cover this patient's donor wounds. The availability of
Ortec's CCS device, once granted by the FDA, would enable us to address
further reconstructive needs of this patient as well as others who suffer from
this devastating disorder."
Ortec International is a biotechnology medical device company involved in
the development of propriety and patented technology to stimulate the repair
and regeneration of human tissues, such as skin. Ortec's technology consists
of a patented biologically active dressing (CCS) consisting of a bioengineered
bovine collagen matrix seeded with epidermal and dermal cells. CCS is
currently in pivotal clinical trials for the treatment ofsevere burns without
the use of autografts (the patient's own skin) and in a pilot trial for the
treatment of chronic dermal ulcers of Epidermolysis Bullosa (EB) patients.
CCS may have wide commercial applications for the treatment of burns, skin
ulcers and serious skin diseases, such as EB, as well as for reconstructive
and cosmetic surgeries.
Certain statements made in this press release relating to a specific
surgical procedure and clinical trial results are forward-looking and are made
pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act
of 1995. Such statements involve risks and uncertainties which may cause
results to differ materially from those set forth in these statements. In
addition the economic, competitive, governmental, technological, and other
factors identified in the Company's filing with Securities and Exchange
Commission could affect such results.
SOURCE Ortec International
-0- 08/28/97
/CONTACT: Ron Lipstein, CFO of Ortec International, 212-740-6999/
(ORTC)
CO: Ortec International
ST: New York
IN: MTC
SU: PDT |
