Healthcare Industry News: Digital Radiography
News Release - May 4, 2006
Hologic Receives FDA Clearance to Use Discovery DXA System for Detecting Cardiovascular DiseaseBEDFORD, Mass., May 4 (HSMN NewsFeed) -- Hologic, Inc. (Nasdaq: HOLX ), a leading provider of state-of-the-art diagnostic and digital imaging systems directed towards women's health, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to use information from the Hologic Discovery(TM) Dual Energy X-ray Absorptiometry (DXA) system as a predictor of coronary heart disease, stroke, and other forms of cardiovascular disease. The new indication, visualization of Abdominal Aortic Calcification (AAC), targets the number one cause of morbidity and mortality in older women and men -- heart disease and stroke.
Discovery quickly and precisely measures the two primary diagnostic indicators of osteoporosis -- bone mineral density and vertebral fractures. The FDA's clearance, based on clinical data, means that doctors can use the information from a standard low dose, 10 second Instant Vertebral Assessment (IVA) osteoporosis test, to visualize the presence of AAC, which is associated with cardiovascular disease.
"Abdominal aortic calcification is strongly associated with cardiovascular disease including heart attacks and strokes," says Douglas Kiel, MD MPH, Associate Professor of Medicine, Harvard Medical School, Director of Medical Research at Hebrew SeniorLife, and an investigator in the Framingham Heart Study. "These abdominal aortic calcifications can be seen in IVA scans, and if present, have significant implication for the care of the patient. AAC is particularly valuable since it contributes independently of traditional clinical risk factors such as cholesterol, blood pressure, diabetes and age to the prediction of heart attack risk. Additionally, AAC seems to be a particularly strong risk factor in postmenopausal women, which is the population that is also in greatest need of osteoporosis assessment."
"This new indication is a major step forward in helping maintain the quality of life of older people -- particularly women," notes Jack Cumming, Chairman and CEO of Hologic. "The risk of coronary heart disease and stroke increases with age. It's the leading causes of death of women in America and most developed countries, with approximately 39 percent of all female deaths in the U.S. occurring from cardiovascular disease. Dr. Kiel and his colleagues at the Framingham Study have contributed to the establishment of the relationship between AAC and cardiovascular disease. We are appreciative to Dr. Kiel that he recognized and helped us to develop this new use for our Discovery system."
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of innovative imaging technology for Digital Radiography and breast imaging. Hologic's core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C-arm and extremity MRI imaging for orthopedic applications. For more information visit http://www.hologic.com.
Forward Looking Disclaimer
This News Release contains forward-looking information that involves risks and uncertainties, including statements about Hologic's plans, objectives, expectations and intentions. Such statements include, without limitation, statements regarding the anticipated performance and benefits of the Discovery(TM) Dual Energy X-ray Absorptiometry (DXA) system. Forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated. 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; Hologic'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; technical innovations that could render products marketed or under development by Hologic obsolete; competition; and reimbursement policies for the use of Hologic's products. Other factors that could adversely affect Hologic's business and prospects are described in Hologic'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 Hologic's expectations or any change in events, conditions or circumstances on which any such statement is based.
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