Healthcare Industry News: GRAFTJACKET
News Release - June 13, 2007
LifeCell Corporation Receives 510(k) Clearance for Tissue Repair ProductRANCHBURG, N.J., June 13 (HSMN NewsFeed) -- LifeCell Corporation (Nasdaq: LIFC ), announced today that the Company received 510(k) clearance from the United States Food and Drug Administration for Strattice(TM) tissue matrix, a novel soft tissue repair product. Like AlloDerm®, the Company's flagship reconstructive surgical product, Strattice(TM) is intended for use in soft tissue repair procedures including breast reconstruction and hernia repair.
"In animal studies sponsored by LifeCell, Strattice(TM) performed essentially equivalent to AlloDerm®, demonstrating that it allows for tissue regeneration," commented David McQuillan, Ph.D., LifeCell's Vice President of Research. "Strattice(TM) is a sterile porcine-derived tissue matrix that has been processed using the Company's proprietary technology," he added.
"Strattice(TM) broadens our current technology platform and provides an opportunity to leverage our leadership position in biological solutions for soft tissue repair," commented Paul Thomas, President and Chief Executive Officer of LifeCell Corporation. "Commercialization of Strattice(TM) will allow us to expand our business into global markets, which was extremely difficult with our human-derived products," he added.
In preparation for commercial launch, the Company is planning to initiate several clinical studies. The Strattice(TM) product should be available to surgeons on a limited basis later this year, with a commercial launch anticipated in early 2008.
LifeCell develops and markets innovative tissue repair products for use in reconstructive, orthopedic and urogynecologic surgical procedures. LifeCell's currently marketed products include: AlloDerm® for plastic reconstructive, general surgical, burn and periodontal procedures; Cymetra®, a particulate form of AlloDerm® suitable for injection; GRAFTJACKET® for orthopedic applications and lower extremity wounds; AlloCraft(TM)DBM, for bone grafting procedures; and Repliform® for urogynecologic surgical procedures. The Company's research and development initiatives include programs focused on extending the use of its regenerative tissue matrix products into new surgical applications, as well as leveraging its core technology to other tissues, including non-human tissues, and expanding its product line in the rapidly growing biosurgery market. LifeCell maintains a website at www.lifecell.com.
This news release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, such as our ability to expand our business into global markets, initiate several clinical studies in preparation for commercial launch, , make Strattice(TM) available to surgeons on a limited basis later this year and execute a commercial launch of Strattice(TM) in early 2008. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward- looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. These forward- looking statements may not be realized due to a variety of factors, including, without limitation: the failure to maintain or increase revenues from the sale of our AlloDerm products; the failure to comply with government regulations, including the FDA; claims for damages by third-parties, including product liability claims; our dependence on a limited number of sources for human cadaveric tissue; negative publicity about the use of donated human tissue in medical procedures; our ability to increase market penetration of our current products and to develop and commercialize new products; changes in third party reimbursement practices; the failure of third party sales representatives and distributors to adequately promote, market and sell our products; our inability to protect our intellectual property; the effects of competition; and the other factors listed under "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2006. We assumes no obligation to update the information contained in this news release.
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