LifeCell Corporation makes announcement.

THE WOODLANDS, Texas--(BUSINESS WIRE)--March 15, 1996--LifeCell Corporation (Nasdaq:LIFC) today reported that it has received a follow-up letter from the Food and Drug Administration (FDA) regarding the Company's response to a previous FDA inquiry as to the labeling and appropriate classification of AlloDerm universal tissue grafts. The FDA's Office of Compliance, Dental, ENT and Ophthalmic Devices Branch of the Center for Devices and Radiological Health (CDRH), indicated that some divisions within the agency remained of the view that the product should be regulated as a device; however, the letter also stated that the FDA is engaged in the evolution of new policies involving human tissue products such as AlloDerm grafts and suggested LifeCell contact the Ombudsman's Office directly to discuss these jurisdictional issues in more detail.

"We are continuing to cooperate fully regarding the FDA's inquiry as to the regulatory classification of AlloDerm processed human tissue products," stated Paul Frison, LifeCell's president and chief executive officer. "This letter was anticipated as part of the FDA's evaluation process and we are pleased to have the opportunity to present the supporting data for our position to the FDA's Ombudsman's Office. We do not anticipate that the discussions with the FDA will have any materially adverse effect on our current daily operations while these issues are being resolved."

LifeCell previously responded to the CDRH's initial inquiry in November 1995 that it believes that AlloDerm processed allograft dermis is a processed human tissue intended for transplantation and, therefore, regulated under volume 21 Code of Federal Regulation (CFR), Part 1270, Human Tissue for Transplantation. LifeCell has marketed AlloDerm tissue for over two years as a skin graft for third-degree burns and has not received any previous notification from the FDA regarding possible reclassification of human skin tissue as a medical device.

The patented AlloDerm process for donated allograft (cadaveric) skin removes cells that stimulate immune rejection and preserves the native biochemical and structural composition of human dermis. Transplanted AlloDerm tissue permanently engrafts and becomes repopulated with the recipient patient's own cells. AlloDerm tissue grafts are used clinically to augment skin grafting of third-degree burn patients, reducing the thickness of skin required from the patient's own body, in periodontal (gum) grafting procedures and in plastic and reconstructive surgery.

LifeCell Corporation develops and commercializes universal tissue grafts and blood preservation products. LifeCell's first commercial product, AlloDerm universal dermal tissue graft, is used in the treatment of third-degree burns, in periodontal surgery and in plastic and reconstructive surgery. In addition to AlloDerm tissue grafts, the Company's current universal tissue graft development programs include heart valves and vascular conduits. LifeCell's product development programs also include ThromboSol, a formulation for extending the shelf-life of transfusable platelets.

CONTACT: LifeCell Corporation, The Woodlands

Jane Lea Hicks, 713/367-5368