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Lifecell Corporation receives 510(k) clearance for tissue repair product |
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14 Jun 2007 |
LifeCell Corporation, announced today that the Company received 510(k) clearance from the United States Food and Drug Administration for Strattice™ tissue matrix
BRANCHBURG, NJ, USA | June 13, 2007 | LifeCell Corporation (NASDAQ: LIFC), announced today that the Company received 510(k) clearance from the United States Food and Drug Administration for Strattice™ tissue matrix, a novel soft tissue repair product. Like AlloDerm®, the Company’s flagship reconstructive surgical product, Strattice™ is intended for use in soft tissue repair procedures including breast reconstruction and hernia repair.
“In animal studies sponsored by LifeCell, Strattice™ performed essentially equivalent to AlloDerm®, demonstrating that it allows for tissue regeneration,” commented David McQuillan, Ph.D., LifeCell’s Vice President of Research. “Strattice™ is a sterile porcine-derived tissue matrix that has been processed using the Company’s proprietary technology,” he added.
“Strattice™ 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™ 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™ product should be available to surgeons on a limited basis later this year, with a commercial launch anticipated in early 2008.
About LifeCell
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™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.
SOURCE: LifeCell Corporation |
