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INAMED Files Amendment with FDA for BioDimensional Style 410 Matrix Cohesive Gel Implant PMA
Business Wire, Nov 18, 2005
SANTA BARBARA, Calif. -- INAMED Corporation (NASDAQ:IMDC), a global healthcare company, today announced that it has submitted an amendment to its cohesive gel breast implant (BioDimensional(TM) Style 410 Matrix) premarket approval application (PMA) currently under review by the Food and Drug Administration (FDA). The Style 410 PMA was submitted to the FDA in December 2004.
Among other information submitted to the FDA, the Company provided 3-year follow-up data from the Style 410 Core Study cohort and new 5-9-year rupture prevalence data from a European study.
"We are pleased to have submitted this amendment to our Style 410 PMA," said Nick Teti, Chairman, President and Chief Executive Officer. "We look forward to continuing our discussions with the FDA regarding this important product."
The innovative BioDimensional Style 410 is the next generation of cohesive gel implant in INAMED's pipeline undergoing U.S. clinical studies. The product is designed for memory and shape retention and has been available internationally for almost 10 years.
About INAMED Corporation
INAMED is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. Current products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the LAP-BAND(R) System for morbid obesity. The Company's website is www.Inamed.com.
Forward-Looking Statements
This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ or differ materially from those described in the forward-looking statements. INAMED is providing this information as of November 17, 2005, and expressly disclaims any duty to update information contained in this press release.
This press release contains additional forward-looking statements about INAMED's U.S. silicone breast implant clinical studies and certain investigational devices, including without limitation, clinical data obtained from the studies and clinical data submitted to the FDA. These forward-looking statements involve risks and uncertainties, including unknown risks associated with the investigational devices that are the subject of INAMED's clinical studies, including the Style 410 implant, which could cause actual results to differ materially from those expressed or implied here. Readers are referred to the documents filed by INAMED with the Securities and Exchange Commission, specifically the most recent reports which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.
The information contained in this press release is a statement of INAMED's present intention, belief or expectation and is based upon, among other things, the existing regulatory environment, industry conditions, market conditions and prices, the economy in general, and INAMED's assumptions. INAMED may change its intention, belief or expectation, at any time and without notice, based upon any changes in such factors, assumptions or otherwise. INAMED undertakes no obligation to review or confirm analysts' expectations or estimates or to state publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
By including any information in this press release, INAMED does not necessarily acknowledge that disclosure of such information is required by applicable law or that the information is material.
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