LifeCell Voluntarily Recalls Product From One Tissue Recovery Organization
Posted on: Friday, 7 October 2005, 15:00 CDT
BRANCHBURG, N.J., Oct. 7 /PRNewswire-FirstCall/ -- LifeCell Corporation initiated a voluntary recall of certain AlloDerm(R), Repliform(R) and GraftJacket(R) product from the marketplace on September 30, 2005. The recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization. Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS). LifeCell promptly notified the FDA and all relevant hospitals and medical professionals. All other BTS inventory remains on hold until the discrepancies in the donor documentation can be resolved. LifeCell works with more than 40 other tissue recovery organizations that are not affected by this recall.
"While no adverse events have been reported we took this prudent and precautionary measure because LifeCell is committed to patient safety and quality," stated Paul G. Thomas, Chairman of the Board, President and Chief Executive Officer for LifeCell.
LifeCell does not expect that the recall will have a material impact on its third quarter product revenues. If the company is unable to resolve the questions regarding donor documentation, it will not distribute the BTS inventory. The inability to distribute this product would result in a charge to operating income of approximately $1.5 million. As a result of the uncertainties caused by the recall, LifeCell is withdrawing its 2005 annual financial guidance. The company expects to provide updated 2005 financial guidance in connection with the release of its third quarter operating results.
Independently, a story was published in today's edition of the New York Daily News which reports on alleged criminal acts by BTS. "If the allegations in the news article are proven true, we are sickened and outraged by BTS' activities," Thomas said.
About LifeCell
LifeCell develops and markets products made from human tissue for use in reconstructive, orthopedic and urogynecologic surgical procedures. The Company's patented technology produces a unique regenerative human tissue matrix -- a complex three-dimensional structure that contains an array of proteins, growth factor binding sites and vascular channels -- that provides a complete template for the regeneration of normal human tissue. LifeCell's current products include: AlloDerm(R) for plastic reconstructive, general surgical, burn and periodontal procedures; Cymetra(R), a particulate form of AlloDerm(R) suitable for injection; GraftJacket(R) and GraftJacket(R) Xpress for orthopedic applications and lower extremity wounds; AlloCraft(TM)DBM, for bone grafting procedures; and Repliform(R) for urogynecologic surgical procedures. LifeCell markets AlloDerm for plastic reconstructive, general surgical and burn applications through its direct sales organization. The Company's strategic sales and marketing partners include: Wright Medical Group, Inc. for GraftJacket, Stryker Corporation for AlloCraftDBM, Boston Scientific for Repliform, and BioHorizons for periodontal applications of AlloDerm. The Company's research and development initiatives include programs focused on extending the use of its regenerative tissue matrix products into new surgical applications, leveraging its core technology to other tissues, including non-human tissues and expanding its product line in the rapidly growing biologic market. LifeCell maintains a website at http://www.lifecell.com/.
Forward-looking Statements
This release also contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, such as the Company's outlook for 2005 operating results. Forward- looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including the risk factors detailed in the Company's reports as filed with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2004. The Company assumes no obligation to update the information contained in this news release.
LifeCell Corporation
CONTACT: Steven T. Sobieski, Chief Financial Officer, LifeCellCorporation, +1-908-947-1106, ssobieski@lifecell.com; Kevin McGrath, CameronAssociates, +1-212-245-8800, kevin@cameronassoc.com, for LifeCell Corporation
Web site: http://www.lifecell.com/
Source: PRNewswire-FirstCall
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