BEDFORD, Mass., Sep. 13, 2004 /PRNewswire-FirstCall/ -- Hologic, Inc., (NASDAQ: HOLX), a leading provider of women's diagnostic imaging systems and state-of-the-art digital radiology systems, and iCAD, Inc. (NASDAQ: ICAD), which designs, develops and markets Computer Aided Detection (CAD) imaging technology and systems for the early detection of breast cancer, today announced receipt of approval from the United States Food and Drug Administration (FDA) to use iCAD's new Second Look Digital CAD technology with Hologic's full-field digital mammography (FFDM) system, the Lorad Selenia™. The Selenia system produces a digital x-ray image captured without film and is used for screening and diagnosis of breast cancer.
Second Look Digital is designed to assist radiologists in the early detection of breast cancer during a full-field digital mammography exam. Digital mammography is becoming widely adopted, and integration of CAD technology has been shown to enhance the radiologist's ability to identify potential cancerous lesions up to 15 months earlier than without the use of CAD. Marketing of the new Digital CAD software with the Selenia system is anticipated in the fourth quarter 2004 with initial shipments expected early next year.
"By combining Hologic's Selenia full-field digital mammography system with the iCAD software we believe we can provide physicians with the most advanced technology available in the quest for early breast cancer detection," said Jack Cumming, Hologic's Chairman and CEO. "Early detection can significantly improve a woman's chance of surviving breast cancer and we remain passionately committed to improving women's healthcare by providing a comprehensive portfolio of tools and innovations to aid in early detection."
The Selenia system incorporates a number of innovative features to enhance image quality, including Hologic's proprietary direct conversion detector and high transmission cellular grid technologies and an array of advanced image processing algorithms.
"We are pleased to be partnered with Hologic and excited about our FDA approval for our digital CAD software in combination with the Selenia FFDM system," said W. Scott Parr, President and CEO of iCAD, Inc. "Hologic, a worldwide leader in women's healthcare, has a large customer base with expansive distribution which should allow our combined technologies to advance globally and significantly impact the fight against breast cancer."
Hologic Inc. is a leading developer, manufacturer and supplier of medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of state-of-the-art digital imaging technology for general radiography and mammography applications. Hologic's core business units are focused on osteoporosis assessment, mammography and breast biopsy, direct-to- digital X-ray for general radiography applications and mini C-arm imaging for orthopedic applications.
iCAD develops, engineers, manufactures and markets computer aided detection (CAD) products for the early detection of breast cancer and other health-care related applications. Early detection of breast cancer can save lives and often permits less costly, less invasive and less disfiguring cancer treatment options than when the cancer is detected at a later stage.
iCAD is the only independent, integrated digitizer hardware and CAD software company offering computer aided detection solutions. As such, iCAD is able to reduce costs at each step in the CAD product design, production and assembly process. The Company believes its vertical integration of CAD and hardware development results in better integration of software and film digitizer components, lower production costs and reduced administrative overhead. These achievements have allowed iCAD to progressively enhance its CAD product line, while reducing the costs of CAD to many customers and allowing more women to realize the benefits inherent in the early detection of breast cancer. More information on iCAD's products can be found at http://www.icadmed.com/ .
Forward Looking Disclaimer
Certain statements contained in this News Release constitute "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Hologic's and iCAD's plans, objectives, expectations and intentions. Such statements include, without limitation, statements regarding the anticipated performance, marketing and shipment of the Selenia systems utilizing iCAD's technology. Such forward- looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Hologic or iCAD to be materially different from any future results, performance or achievements expressed or implied by such forward- looking statements. Such factors include, but are not limited to, the risk that newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated; the early stage of market development for digital X-ray products, and the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence, competition, and other risks detailed in Hologic's and iCAD's filings with the Securities and Exchange Commission. The words "believe," "demonstrate," "intend," "expect," "estimate," "anticipate," "likely," and similar expressions identify forward- looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. Hologic and iCAD expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Hologic's or iCAD's expectations or any change in events, conditions or circumstances on which any such statement is based.
Second Look is a registered trademark of iCAD, Inc. All rights reserved. Selenia is a trademark of Hologic, Inc. All rights reserved. Contact: Glenn P. Muir Frances Crecco Executive Vice President and CFO Director, Investor Relations Hologic, Inc. Hologic, Inc. (781) 999-7300 (781) 999-7377 Kevin McGrath iCAD, Inc./Cameron Associates (212) 245-4577
SOURCE: Hologic, Inc.
CONTACT: Glenn P. Muir, Executive Vice President and CFO, +1-781-999-
7300, or Frances Crecco Director, Investor Relations, +1-781-999-7377 both of
Hologic, Inc.; or Kevin McGrath of iCAD, Inc./Cameron Associates, +1-212-245-