November 04, 2008

Hologic Receives CE Mark for the Celero Vacuum-Assisted, Spring Loaded Core Biopsy Device for the Breast Ultrasound Market

BEDFORD, Mass. (November 4, 2008)- Hologic, Inc. (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that it has received CE Mark approval for the Celero® vacuum-assisted, spring loaded core biopsy device. Celero is the first U.S. FDA-cleared vacuum-assisted core biopsy device for the breast ultrasound market. The company has also received CE Mark approval for the CeleroMark™ and CeleroMark-2S biopsy site identifiers, as well as the Celero Intro-12 introducer, clearing the way for sales in the European Union (EU) and all countries recognizing the CE Mark. Some of the unique features of the Celero device are patented.

Hologic is further registering the Celero device in markets in Latin and South America, the Middle East and Asia. The Celero device was approved by the FDA in April 2007.

More than one million women undergo surgical procedures each year to diagnose an abnormality found during mammography , and more than 700,000 ultrasound-guided core needle biopsy procedures are performed annually, primarily with spring loaded core devices. Over the past decade, ultrasound-guided large-core needle biopsy has become a reliable and acceptable alternative to surgical biopsy for the classification of breast lesions. In France, Germany, Italy and the UK alone, ultrasound-guided needle procedures account for more than half of all image-guided breast biopsies.

"Over the past year, we have seen a shift toward disposable biopsy devices in Europe, and we are excited to bring the completely disposable and cost-effective Celero device to the international market," said David P. Harding, Senior Vice President and General Manager, Interventional Breast Solutions, Hologic, Inc. "Today, clinicians and patients alike look to minimally invasive breast biopsy techniques as a way of reducing the time, cost and trauma associated with surgery as a diagnostic procedure without sacrificing histological accuracy. We are confident that the international availability of the Celero device can help increase the number of women who can avoid surgery and opt for a minimally invasive biopsy procedure to diagnose breast lesions."

With the option of firing inside or outside the breast, the Celero device is designed to access hard-to-reach lesions in the axilla, near the chest wall, near implants or behind the nipple. The lightweight design of the handheld Celero device and its highly echogenic needle provides smooth penetration to lesions while reducing deflection and offers a visible aperture location for target verification under ultrasound imaging prior to tissue acquisition. The Celero device is designed to securely hold the tissue sample in place while acquiring large cores. Research shows that with the Celero device, only two to three samples are needed for a diagnosis In addition, the Celero device requires only two to three insertions to gain the same results, as opposed to more needle insertions for other spring loaded core biopsies.

"The Celero device provides physicians with a sophisticated and flexible way to obtain tissue samples without compromising the patient's comfort," said Melcior Sentis, M.D., head of breast imaging at UDIAT Diagnostic Center in Sabadell, Spain. "The coaxial technique is an improvement over existing technologies that enables us to conduct more accurate and less invasive biopsies, and I am confident it will be well received on the international market."

About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, 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, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and products that cover molecular diagnostic reagents for a variety of DNA and RNA analysis applications.

Forward Looking Disclaimer
This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the effect and adoption of the use of the Celero vacuum assisted spring loaded biopsy device. There can be no assurance that the device will achieve the benefits demonstrated in the studies cited herein and 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 Celero device can only be determined on a case-by-case basis depending on the particular circumstances of the procedure and patient in question. Thus there can be no assurance of general adoption of this technology by the medical community. 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 Hologic's expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect Hologic's business and prospects are described in Hologic's filings with the Securities and Exchange Commission.

Contact:
Jim Culley, Ph.D. Tom Burich
Director of Marketing Director of International Business Interventional Breast Solutions
Hologic, Inc. Hologic, Inc.
Tel: 781.999.7583 Tel: 317.344.7549




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