SANTA BARBARA, Calif.--(BUSINESS WIRE)--July 18, 2005--INAMED Corporation (NASDAQ:IMDC): Company modified its responsive gel implant PMA by:
- Separating data for round and Style 153 investigational devices
- Including 10-12 year European rupture prevalence data
- Company ends availability of Style 153 for U.S. clinical studies
- Company in final discussions with FDA for expanding access to BioDimensional(TM) Style 410 Matrix cohesive gel implant to supplant Style 153 breast implant
- Company intends to update its Style 410 PMA to include 3-year follow-up data and new 5-9 year European rupture prevalence data
INAMED Corporation (NASDAQ:IMDC), a global healthcare company, today provided an update with respect to certain of its silicone gel-filled breast implant regulatory activities and clinical studies. The Food and Drug Administration (FDA) is currently reviewing the company's responsive gel implant and its cohesive gel implant (BioDimensional(TM) Style 410 Matrix) premarket approval applications (PMAs).
After consideration of the outcome of the April 2005 FDA Advisory Panel meeting and in consultation with the FDA, the company modified its responsive gel PMA by separating data for eight round and the shaped Style 153 investigational devices. This PMA modification also included new 10-12 year European data for these styles.
The company also decided to voluntarily end the availability of the Style 153 as an investigational device in clinical studies. Patient follow-up in the company's clinical studies will continue with respect to all of the investigational devices, including the Style 153, and pursuant to the existing protocols, including monitoring and collecting clinical data from the patients through the studies' conclusions. The Style 153 accounted for approximately $3.4 million (less than 1%) of the company's total revenues in 2004.
To meet the prospective needs of reconstruction and revision patients who desire a shaped implant, INAMED is in final discussions with the FDA to allow expanded access to its Style 410 silicone gel implants. The Style 410 implant has been available internationally for almost 10 years and, based on its Form Stable(TM) cohesive gel matrix, provides multiple shape and projection options.
The Style 410 PMA was submitted to the FDA in December, 2004. The company continues to work with the FDA and is in the process of preparing additional supplemental data for submission, including complete 3-year follow up data (including the second MRI time point) from the Style 410 Core Study, as well as European 5-9 year rupture prevalence data.
The company will be providing an update on its worldwide breast implant franchise during its second quarter earnings call scheduled for July 27, 2005.
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.
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 July 18th, 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, clinical data submitted and anticipated to be submitted to the Food and Drug Administration (FDA), and discussions with the FDA concerning expanded access to INAMED's Style 410 implant. These forward-looking statements involve risks and uncertainties, including risks that the FDA may not allow, or INAMED and the FDA can not reach agreement on the conditions applicable to, expanded access to the Style 410 implants, as well as unknown risks associated with the investigational devices that are the subject of INAMED's clinical studies, including the Style 153 implant, the round implants and the Style 410 implants, 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 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.