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Santa Barbara, Calif., March 12, 2003 - Inamed Corporation (Nasdaq: IMDC), a global healthcare company and the market leader in the popular dermal filler market, today announced that it has received approval from the U.S. Food and Drug Administration to begin marketing and distribution of its new CosmoDerm™ and CosmoPlast™ human collagen products. CosmoDerm and CosmoPlast have been approved for the correction of facial wrinkles, acne scars and other soft tissue contour deficiencies, as well as for restoration of the lip border. CosmoDerm and CosmoPlast are the first commercially available, FDA-approved dermal fillers in the United States that do not require a skin test prior to use. Based on more than 20 years of research into the science of the skin, CosmoDerm and CosmoPlast are new, innovative treatments for facial rejuvenation. CosmoDerm and CosmoPlast contain human collagen purified from human dermal tissue and manufactured under controlled laboratory conditions. CosmoDerm and CosmoPlast do not require a pre-treatment skin test and are uniquely formulated with an anesthetic for patient comfort. As a result, CosmoDerm and CosmoPlast provide new options to meet the need for a same-day, single-visit treatment. "These approvals represent a significant milestone for Inamed's facial aesthetics business and for the Corporation overall," said Nick Teti, Chairman, President and CEO of Inamed Corporation. "CosmoDerm and CosmoPlast are the first of several important products emerging from our facial aesthetics pipeline that we plan to introduce over the next few years to meet the needs of the cosmetic dermatology market." "CosmoDerm and CosmoPlast are powerful additions to our current franchise of products for the growing facial rejuvenation market in the United States. These two new products will strengthen our leadership position in dermal fillers," added Hani Zeini, Executive Vice President, Inamed Aesthetics, North America. "As CosmoDerm and CosmoPlast are the first dermal fillers to be approved by the FDA that do not require a skin test, they will address the need for a same day, single visit treatment. We see these products as significant additions to our existing dermal filler franchise with the potential to change the landscape of the facial rejuvenation market."
CosmoDerm is the non-cross-linked formulation used in the treatment of superficial lines, whereas CosmoPlast is cross-linked and is primarily used in the treatment of more pronounced wrinkles. CosmoDerm and CosmoPlast previously received regulatory approval from the Canadian health authorities in December 2002.
This press release contains projections and other forward-looking statements, including, without limitation, express and implied statements regarding Inamed's anticipated product development strategy. 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 Corporation 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 and bovine and human collagen-based products; failure to protect Inamed's intellectual property; adverse changes in the regulatory or legislative environment (both in the US and internationally) affecting our business; and failure 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. ### Media Contact INAMED Corporation If You Found this Article Helpful You May Enjoy this article: A remarkable Breakthrough For the Effects of Aging on Our Face! Check out our extensive list of Cosmetic Surgery Educational Articles and Over 150 Links on Cosmetic Surgery!!
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