BEDFORD, Mass., July 27, 2010 /PRNewswire-FirstCall/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that the Company's Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system has been scheduled to be reviewed by the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) on September 24, 2010 as part of the Company's pre-market approval ("PMA") application. The PMA application being reviewed was originally filed in 2008 and subsequently updated with additional data, and seeks approval of the use of the system for both screening and diagnostics. In addition, the Company is conducting a number of additional clinical trials for a separate FDA submission expected to be filed at a later date. Hologic's 3-D imaging technology, "Selenia Dimensions," is available commercially in more than a dozen countries, including countries in Europe, the Middle East, South America, Asia and Australia. In North America, commercial Selenia Dimensions systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional (2-D) only system that is upgradeable to do breast tomosynthesis (3-D) imaging when and if the product is approved by the FDA.
The Hologic Selenia Dimensions digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a 2-D image, breast tomosynthesis produces a 3-D image.
"Over the past several years, Hologic has been diligently working on new technologies, most notably the development of breast tomosynthesis," said Rob Cascella, President and Chief Executive Officer. "This Panel review of our Selenia Dimensions breast tomosynthesis system is part of the FDA process of assessing this remarkable new technology. The system is specifically designed to address the primary limitation of 2-D digital mammography, namely the superposition of normal breast anatomy that may mask a breast cancer. We believe tomosynthesis represents the next phase in breast cancer detection - fast, high-quality 3-D imaging of the breast. We are thrilled to have a Panel date set for September as an important step in the review of our next-generation technology."
Company management will discuss this Panel date in more detail during our scheduled conference call on Monday, August 2, 2010, at 5:00 p.m. (Eastern) for our third quarter fiscal 2010 operating results. Interested participants may listen to the call by dialing 888-503-8177 or 719-325-2318 for international callers and referencing access code 3392847 approximately 15 minutes prior to the call.
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications. For more information, visit www.hologic.com.
Hologic, Dimensions and Selenia, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
Forward Looking Disclaimer
This News Release contains forward-looking information that involves known and unknown risks and uncertainties, including statements about the expected timing of the Panel review of Hologic's Selenia Dimensions digital breast tomosynthesis system, and the anticipated benefits of that system. The Panel review is only one step in the FDA's review process and can be rescheduled or cancelled at any time. Hologic is unable to predict the outcome of the Panel review, and there can be no assurance that the Panel will recommend that the FDA approve Hologic's system for either screening or diagnostics. Even if the Panel were to make such recommendation, there can be no assurance that the FDA would approve Hologic's system for either use on a timely basis, if at all. In addition, even if approved, the FDA could impose conditions to such approval that would significantly limit the use or commercialization of the system. Moreover, there can be no assurance the system will achieve the anticipated benefits described herein, or that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Among other things, newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated. The risks and uncertainties included above are not exhaustive. Other factors that could adversely affect the Company's business and prospects are described in the Company's filings with the Securities and Exchange Commission. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.
Vice President, Investor Relations
First Call Analyst:
FCMN Contact: Deborah.Gordon@hologic.com
SOURCE: Hologic, Inc.