Hologic Announces Fourth Quarter and Fiscal 2009 Operati...(y's 510(k) application for the MammoSite...),Health

Date:11/9/2009

y's 510(k) application for the MammoSite ML radiation therapy system for the treatment of early-stage breast cancer. With its multi-lumen design, this new device gives radiation oncologists the ability to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy. Hologic's MammoSite therapy system, first cleared by the FDA in 2002 as a single-lumen device, is the most widely used form of accelerated partial breast irradiation (APBI) in the United States. The MammoSite system is designed to provide the physician with the ability to deliver targeted radiation therapy directly to the area where cancer is most likely to recur, allowing a full course of radiation to be delivered in just five days and enhancing patient comfort. Additionally, targeted therapy of the breast limits radiation exposure to normal, healthy tissue. The Company began a limited launch of the new MammoSite ML last month, and we anticipate a full commercial launch during the current quarter (quarter ending December 26, 2009).

CE marking for our ThinPrep integrated imager:

The integrated imager represents the latest innovation in cervical cancer screening by combining proven ThinPrep imaging technology and slide review into a single, convenient stand-alone device. The ThinPrep integrated imager is designed to provide the small and medium volume laboratory access to effective and efficient cytology screening technology, while allowing them the flexibility to address their specific productivity and throughput needs. The majority of laboratories in Europe would fall into the small or medium category. The integrated imager is designed to enable the cytotechnologist to perform slide review effectively and efficiently. The integrated imager can also be used as a conventional microscope saving valuable lab space.

Financial Guidance:

The Company's guidance for fiscal 2010 re
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SOURCE Hologic, Inc. Copyright©2009 PR Newswire. All rights reserved

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