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Surgeons Present AlloDerm Benefits at Seventh International Symposium on Facial Plastic Surgery; AlloDerm Versatility Demonstrated Through Multiple Uses in Facial Surgery.


THE WOODLANDS, Texas--(BW HealthWire)--June 24, 1998--LifeCell Corp. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:LIFC) today announced that five surgeons made presentations on the benefits of AlloDerm(R) acellular acellular /acel·lu·lar/ (a-sel´u-ler) not cellular in structure.

a·cel·lu·lar
adj.
1. Containing no cells; not made of cells.

2. Devoid of cells; noncellular.
 dermal graft dermal graft
n.
A skin graft made with a thin split-thickness graft of dermis.
 at the Seventh International Symposium on Facial Plastic Surgery recently held in Orlando.

These presentations indicate that the use of AlloDerm in multiple surgical procedures was often equivalent to the current "gold standard," the use of the patient's own tissue, to correct soft tissue defects. Additionally, the diversity of clinical uses of AlloDerm demonstrated the wide versatility of the product in soft tissue reconstruction.

"These presentations by distinguished surgeons from across the United States demonstrate the growing awareness of the benefits of AlloDerm in multiple facial surgical procedures," commented one of the presenting surgeons, Russell W.H. Kridel, MD, FACS FACS Fellow of the American College of Surgeons.

FACS
abbr.
Fellow of the American College of Surgeons



FACS

fluorescence-activated cell sorter.
, Associate Clinical Professor, Department of Otolaryngology-Head and Neck Surgery, at the University of Texas Health Science Center and a private practitioner.

"We highlighted the benefits of AlloDerm as a facial sling and in scar revision, rhinoplasty Rhinoplasty Definition

The term rhinoplasty means "nose molding" or "nose forming." It refers to a procedure in plastic surgery in which the structure of the nose is changed.
, nasal septal septal /sep·tal/ (sep´tal) pertaining to a septum.

sep·tal
adj.
Of or relating to a septum or septa.
 perforation per·fo·ra·tion
n.
1. The act of perforating or the state of being perforated.

2. An abnormal opening in a hollow organ or viscus, as one made by rupture or injury.


Perforation
A hole.
 repair, eyelid eyelid /eye·lid/ (-lid) either of two movable folds (upper and lower) protecting the anterior surface of the eyeball.

eye·lid or eye-lid
n.
 reconstruction, cheiloplasty and soft tissue correction."

The clinical results presented at the Symposium demonstrate that AlloDerm may be used in a variety of facial surgical procedures and performs as well as transplanted grafts of the patient's own tissue, the currently accepted "gold standard" for soft tissue repair.

Additionally, the use of AlloDerm did not require the creation of a second wound site, which can lead to complications such as pain and infection.

At the Symposium, Brian P. Maloney, MD, FACS, a private practitioner from Atlanta, presented the preliminary results of a multi-center clinical study conducted in conjunction with others on the use of AlloDerm in lip reconstruction procedures. The results of the study indicated that AlloDerm persisted in the lips for a period of time comparable to the persistence of the patient's own tissue when implanted into the patient's lips.

Other presentations by surgeons focused on additional uses of AlloDerm in facial surgery. For example, stroke, cancer surgery or trauma can result in facial paralysis, distorting a person's facial function and appearance. One surgeon at the Symposium presented the use of AlloDerm as a facial sling in patients to improve facial symmetry and function.

Another presentation demonstrated the use of AlloDerm to repair eyelid defects, restoring normal eyelid function. AlloDerm was used to correct complications arising from eyelid surgery that led to scarring and contracture contracture /con·trac·ture/ (-cher) abnormal shortening of muscle tissue, rendering the muscle highly resistant to passive stretching. , preventing proper closure of the eyelid over the eye.

Additionally, clinical experience with AlloDerm in rhinoplasty and nasal septal perforation repair were discussed at the Symposium. For example, nasal septal perforations may result from repeated nasal surgery, trauma, disease or chemical exposure. The use of the patient's own tissue to repair the hole requires a painful donor site donor site,
n the portion of the body from which an organ or tissue is removed for transplant or grafting.
 and does not provide as thick a graft as does AlloDerm.

Surgeons at the Symposium demonstrated that AlloDerm provides an alternative to the use of the patient's own tissue, allowing proper closure of the perforation without the associated donor site wound.

"The presentations at the Symposium demonstrate that AlloDerm may widely be used to correct multiple soft tissue defects," commented Paul M. Frison, LifeCell Chairman, president and chief executive officer.

"AlloDerm has been transplanted in over 25,000 patients and been used in over 40 separate types of clinical procedures. AlloDerm is classified by the 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.
 as human tissue for the repair or replacement of damaged or inadequate integumental Adj. 1. integumental - of or relating to the integument
integumentary
 tissue and is currently being sold in the United States and certain other countries.

"The product's FDA classification allows the surgeon to use it in virtually any surgical procedure that formerly used the patient's own tissue, avoiding the need for a second wound on the patient. The two year shelf-life of the product allows the hospital to stock the product in the operating room operating room
n. Abbr. OR
A room equipped for performing surgical operations.
 and use it as needed."

AlloDerm is a decellularized nonimmunogenic connective tissue graft derived from donated human dermis dermis: see skin. . Through a patented process, cells that would cause rejection of the donated tissue are removed and the essential matrix characteristics of the tissue are preserved, such that the patient's body will accept AlloDerm as its own tissue.

When transplanted to a patient, the AlloDerm 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.
 matrix is incorporated into the surrounding tissue and is repopulated with the patient's own cells. Moreover, the AlloDerm matrix guides the new cells to remodel and maintain the matrix, establishing a new functional living tissue.

LifeCell Corp. is a bioengineering company engaged in the development and commercialization of tissue regeneration and cell preservation products. LifeCell's first commercial product, AlloDerm(R) acellular dermal graft, is used in reconstructive plastic, dental and burn surgery.

In addition to AlloDerm grafts, the company's current tissue graft development programs include the LifeCell(R) heart valve, vascular grafts and nerve connective tissue. LifeCell's product development programs also include ThromboSol(TM), a formulation for extending the shelf life of transfusable platelets. for additional information about the company, visit LifeCell's Web site at http://www.lifecell.com.

Certain of the statements contained in this news release are forward-looking statements. While these statements reflect the company's current beliefs, they are subject to uncertainties and risks that could cause actual results to differ materially. These factors include, but are not limited to, the uncertainty of product development, of clinical trials, of regulatory approvals and of patent protection; the demand for the company's products and services; economic and competitive conditions and products; and other risks detailed in the company's Annual Report on Form 10-K/A for the year ended Dec. 31, 1997.

CONTACT: LifeCell Corp.

J. Donald Payne, 281/367-5368
COPYRIGHT 1998 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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