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(press release from INAMED Corporation)
SANTA BARBARA, Calif.--Aug. 19, 2004--INAMED Corporation (Nasdaq:IMDC), a global health care company, announced today that it has submitted its formal response to the January, 2004 not approvable letter it received from the FDA concerning the Premarket Approval Application (PMA) for its silicone gel-filled breast implants. In this supplemental submission, additional retrospective and prospective data have been included as requested by the FDA in its letter and in its revised guidance for information to be included in PMAs for breast implants. Inamed's PMA was recommended for approval by the FDA Advisory Committee for General and Plastic Surgery Devices in October, 2003. In January, the FDA issued a not approvable letter to the company requesting additional information, and also revised the guidance for the information to be included in PMAs for breast implants. "We believe our response addresses the revised guidance for breast implants, and includes information sought in the letter we received in January," said Nick Teti, Chairman, President and CEO of Inamed Corporation. "We look ahead to a continued dialogue with the FDA as we jointly work to move our PMA for silicone gel-filled breast implants forward." Additionally, Inamed's next generation cohesive gel breast implants, designed for memory and shape retention, are now in the third year of patient follow-up. The PMA submission for these innovative bio-dimensional gel matrix products is expected to be filed by the end of 2004. These products are marketed around the world as the Bio-Dimensional(TM) Cohesive Gel(TM) Matrix (Style 410) and are overwhelmingly the preferred choice for breast implants by physicians and patients in areas where they are available. About INAMED Corporation INAMED (Nasdaq:IMDC) 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 materially from those described in the forward-looking statements. Inamed is providing this information as of August 19, 2004, and expressly disclaims any duty to update information contained in this press release. Forward-looking statements in this press release include, without limitation, express and implied statements regarding Inamed's anticipated sales, research and development, product development and regulatory approval. These forward-looking statements involve risks and uncertainties 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, including but not limited to: exposure to product liability and intellectual property claims; exposure to liabilities that may not be adequately covered by insurance or for which there is no insurance; potential negative publicity concerning product safety; potential fluctuations in quarterly and annual results; the effect of changing accounting and public reporting rules and regulations; volatility of Inamed's stock price; changes in the economy and consumer spending; competition from existing and/or new products; failure or delay of clinical trials; uncertainty in receiving timely regulatory approval or market acceptance for new products; dependence on a single supplier for each of Inamed's silicone raw materials, bovine and human collagen-based products, hyaluronic acid-based products, and botulinum toxin Type A products; failure to protect Inamed's intellectual property; adverse changes in the regulatory or legislative environment (both in the U.S. and internationally) affecting our business; and failure of some or all of our collaborative partners to perform. 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, in Inamed's assumptions or otherwise. Inamed undertakes no obligation to review or confirm analysts' expectations or estimates or to release 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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