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Inamed Receives FDA Letter Requesting Additional Information for Its Style 410 Cohesive Gel Breast Implant PMA Application
Business Wire, April 4, 2005
SANTA BARBARA, Calif. -- Inamed Corporation (NASDAQ:IMDC), a global healthcare company, announced that it has received a letter from the U.S. Food and Drug Administration (FDA) with respect to its Style 410 cohesive gel-filled breast implants premarket approval (PMA) application.
The letter outlines the additional information that Inamed must provide before the FDA can complete its review of Inamed's Style 410 PMA. According to the letter, submission of this requested information is necessary in order for the FDA to determine whether there is reasonable assurance that the Style 410 breast implants are safe and effective for their intended use.
"We acknowledge and appreciate the review to date of our Style 410 PMA by the Food and Drug Administration," said Nick Teti, Chairman, Chief Executive Officer and President of Inamed. "As has been our ongoing practice, we intend to work closely and cooperatively with the FDA in providing the additional information that will allow it to complete the review of our Style 410 PMA."
The Style 410 is Inamed's next generation cohesive gel-filled breast implant. It is designed for memory and shape retention, and is marketed internationally as the Bio-Dimensional(TM) Cohesive Gel(TM) Matrix (Style 410). The Style 410 breast implants are the preferred choice of breast implants by physicians and patients in countries where they are commercially available.
The Style 410 breast implants are not part of Inamed's PMA application to be considered at the FDA's Medical Devices Advisory Committee meeting on April 11-13, 2005, and the letter has no impact on the timing or substance of the matters to be considered at the April meeting.
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.
These 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 web site 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 April 4, 2005, and expressly disclaims any duty to update information contained in this press release.
This press release contains additional forward-looking statements, including, without limitation, consideration of Inamed's Style 410 cohesive gel-filled breast implant premarket approval application filed with the FDA and certain communications received from the U.S. Food and Drug Administration related to the PMA. These forward-looking statements involve risks and uncertainties, including risks that approval of Inamed's PMA for the Style 410 cohesive gel-filled breast implants may be delayed or eventually denied, 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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