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``Frozen'' CCS Shown to Perform as Well or Better Than ``Fresh'' Composite Cultured Skin - CCS - in Pre-Clinical Testing.


NEW YORK--(BUSINESS WIRE)--Oct. 12, 1999--

Ortec to Initiate Multi-Center Pilot Study Using "Frozen"

CCS (1) (Common Channel Signaling) A communications system in which one channel is used for signaling and different channels are used for voice/data transmission. Signaling System 7 (SS7) is a CCS system, also known as CCS7. See SS7.  on Donor Sites of Burn Patients

Ortec International, Inc. (Nasdaq:ORTC ORTC Old Republic Title Company
ORTC Operational Readiness Training Complex
) today announced that based on data from pre-clinical testing, which showed equivalent or better performance between the "fresh" and "frozen" versions of Composite Cultured Skin composite cultured skin Dermatology A skin substitute used to cover burn wounds and epidermolysis bullosa. See Artificial skin.  (CCS), the U.S. Food & Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted permission to proceed with a multi-center pilot trial using a cryopreserved version of its CCS on human donor site wounds. Pre-clinical test results demonstrated that after three months of storage, cell number, viability, metabolic activity and all other comparable requirements for "frozen" CCS were equivalent or better than "fresh" CCS. The Company believes that a frozen version of its fresh product will provide significant additional manufacturing and marketing advantages.

CCS is currently delivered "fresh" to hospitals and clinics with a shelf life similar to that of competitive fresh products. However, the Company believes that its cryopreservation cryopreservation /cryo·pres·er·va·tion/ (-prez?er-va´shun) maintenance of the viability of excised tissue or organs by storing at very low temperatures.

cry·o·pres·er·va·tion
n.
 process should provide a shelf life of at least six months, therein significantly improving manufacturing, inventory management and overall product cost. Furthermore, hospitals and clinics would have the ability to stock CCS in-house for on-demand availability, in lieu of depending on overnight shipments for scheduled procedures and emergency situations.

In completed pilot trials, Ortec demonstrated that "fresh" CCS successfully closed donor site wounds, on average, 12 days, or 48% faster than standard of care (13 days versus 25 days) (p equals 0.034) based on median healing time. For Ortec's pilot study, donor wound sites on patients ranged between 36 cm2 and 72 cm2 square, and ranged between 10/1000 inch and 12/1000 inch in depth. In addition, these patients were medically compromised as a result of burns covering up to 50% of their bodies. By comparison, published clinical studies using a competitive product in treatment of donor site wounds showed approximately one half the accelerated rate of healing experienced with CCS.

About Composite Cultured Skin (CCS)

CCS is not an artificial skin: it is, rather, a tissue engineered device consisting of two layers of human-derived skin cells (dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin.

der·mal or der·mic
adj.
Of or relating to the skin or dermis.
 and epidermal Epidermal
Referring to the thin outermost layer of the skin, itself made up of several layers, that covers and protects the underlying dermis (skin).

Mentioned in: Antiangiogenic Therapy, Histiocytosis X


epidermal
) supported within a porous collagen matrix, which is placed over the area needing skin regeneration. The Company believes that because CCS produces a multitude of growth factors which appear to promote migration of the patient*s own healthy cells into a wound site, CCS provides the most optimal environment for stimulating skin regeneration and wound-healing.

About Ortec International, Inc.

Ortec International, Inc. is a tissue-engineering company involved in the development of proprietary and patented technologies to stimulate the repair and regeneration of human tissue, such as skin. Ortec believes that its platform technology may extend to the development of other human tissue, such as tendons, ligaments, cartilage, bone, muscle and blood vessels Blood vessels

Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names.
.

Certain statements made in this news release that express the belief, potential anticipation or expectation , as well as other statements which are not historical fact, and statements relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 the clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality and performance insofar in·so·far  
adv.
To such an extent.

Adv. 1. insofar - to the degree or extent that; "insofar as it can be ascertained, the horse lung is comparable to that of man"; "so far as it is reasonably practical he should practice
 as they may apply prospectively, are "forward looking" statements within the meaning and pursuant to the Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 provisions of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 Reform Act of 1995 and involve risks and uncertainties. The Company*s actual results may differ significantly from the results discussed in this news 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.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 12, 1999
Words:685
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