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Hologic Unveils Revolutionary New Technology At RSNA 2003 BEDFORD, Mass. (December 2, 2003) - Hologic, Inc. (NASDAQ: HOLX) a leading provider of specialized medical imaging equipment for women's health, gave the radiology community it's first glimpse of the company's full field digital breast tomosynthesis research system at the 2003 annual meeting of the Radiological Society of North America. At the meeting, which began November 30, 2003, Hologic showcased its digital breast tomosynthesis system along with some of the images acquired from initial research projects utilizing the system. Breast tomosynthesis allows a series of images in slices of 1 mm or less to be acquired and reconstructed for 3-D viewing. This investigational technology has the potential to reduce or eliminate overlapping tissue, which can obscure a lesion. In addition, tomosynthesis may provide improved diagnostic information. Hologic's research breast tomosynthesis systems are being developed to be used as an add-on to the current Selenia full field digital mammography platform. According to Jack Cumming, Hologic's Chairman and CEO, "We believe that breast tomosynthesis is clearly the wave of the future for digital mammography, and Hologic plans to lead the way in development and commercialization of this tremendously exciting new technology. Although breast tomosynthesis is still in the early phases of research, we have been very pleased with the rate of progress in our program and the high quality of the initial images we have acquired in our research studies. Over the next several months we plan to extend our research studies to investigate other facets of this technology, the feasibility of reduced breast compression, and utilization of breast tomosynthesis for needle localization and biopsy procedures." "Our research efforts will also continue to focus on determining the most appropriate application for this technology," continued Cumming, "whether as a screening and diagnostic modality or as an adjunct to conventional mammography screening. We plan to significantly accelerate our research programs in 2004, with a goal of submitting a marketing application to the Food and Drug Administration in the near future." The Hologic digital breast tomosynthesis system is currently available only as a research unit for users of Hologic's Lorad Selenia full field digital mammography system and is limited by federal law to investigational use. . In addition to ongoing research, Hologic is actively working with several facilities to gain Institutional Review Board approval for expansion of clinical investigational studies. Dr. Jay Stein, Hologic's Chief Scientific Officer, has led development efforts for the system. "I am very pleased with the progress of this program," said Dr. Stein. "We set aggressive internal objectives for this technology, including the ability to achieve rapid image reconstruction and scan times at a total dose comparable to standard mammography exams. We believe we have achieved those goals and now look forward to working with the medical community to optimize this system and gather the data required for regulatory applications. I believe this technology offers enormous potential to significantly improve diagnostic accuracy in mammography, and we are anxious to advance development and commercialization of this important technology." About Hologic
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.
Forward Looking Disclaimer
This News Release contains forward-looking information that involves risks and uncertainties, including statements regarding the Company's plans, goals, objectives, expectations, intentions and beliefs. Such statements include, without limitation, statements regarding: our goals, plans and focus for our research, development and commercialization of our tomosynthesis system and technology; the potential and our expectations regarding the performance of that system and technology; and our goal of submitting a marketing application for the system to the Food and Drug Administration in the near future. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated. The Company cannot assure that it will be able to complete the development of its tomosynthesis system on a timely basis, if at all, or that once developed, the system will perform as anticipated or be commercially successful. Factors that could cause actual results to materially differ include, without limitation: uncertainties inherent in the development of new products and the enhancement of existing products, including technical and regulatory risks, cost overruns and delays; the risk that newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated; the Company's ability to predict accurately the demand for its products, and products under development, and to develop strategies to address its markets successfully; the early stage of market development for digital x-ray products; manufacturing risks that may limit the Company’s ability to ramp-up commercial production of the Selenia and other of the Company’s digital products, including the Company's reliance on a single source of supply for some key components of its products as well as the need to comply with especially high standards for those components and in the manufacture of digital x-ray products in general; reimbursement policies for the use of the Company's products; risks relating to compliance with financial covenants under the Company’s working capital financing and leases; and technical innovations that could render products marketed or under development by the Company obsolete; competition. 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 any such statements to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such statement is based.
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