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Hologic Receives 510k Clearance To Use Hip Structure Analysis In DXA Systems
BEDFORD, Mass. (Sept 12, 2006) - Hologic, Inc. (NASDAQ: HOLX), today announced that the U.S. Food and Drug Administration (FDA) has cleared the incorporation of proprietary Hip Structure Analysis software for use in Hologic dual-energy x-ray (DXA) bone densitometers.
HSAT is a leading hip structure analysis method for DXA scans in research and pharmaceutical studies. HSA uses specialized software to examine the structural geometry of two-dimensional DXA scan images. This technology is designed to assist physicians in determining if a patient's bones have been weakened so as to require treatment and, if the patient is being treated, whether the patient's bones are getting stronger. This new feature represents a significant advance in densitometry as compared to conventional bone density scanners which only look at average density.
Thomas J. Beck, Sc.D., associate professor of radiology in The Johns Hopkins University School of Medicine, compares HSA and bone density to the situation faced by engineers in measuring the safety of a bridge. Engineers know that while the density of a bridge's supports significantly influences its safety, that factor alone is not enough to determine if the bridge is safe enough to cross.
Beck points out that the stresses of a bridge (or a bone) under a particular load are largely determined by the amount of material and its distribution within the structure. "Hip Structure Analysis algorithms allow us to calculate both the bone mineral density as well as the structural geometry that underlies bone strength from DXA measurements," Beck says. "The use of HSA should result in more definitive measures of bone health."
Beck and his colleagues in JHU's School of Medicine are widely recognized for their work in the development of biomechanical parameters of hip structure derived from densitometric information. Hologic's software builds upon technology developed by APL and recently acquired by Hologic.
"DXA systems have advanced well beyond bone mineral density measurements," says Brad Herrington, Hologic Vice President of Skeletal Health Imaging. "Clinicians have long sought the next generation of osteoporosis assessment tools to better predict femur fracture risk. Vertebral Fracture Assessment and Hip Structure Analysis have brought us into that generation. We thank Dr. Beck and his colleagues for having faith in Hologic and allowing us the exclusive use of their work for our bone densitometer systems."
While HSA represents an important breakthrough, in the beginning it will primarily be used in bone research. In studies, HSA may help researchers understand how the femur weakens with age and how pharmaceutical treatments work to reduce fracture risk at the hip.
HSA is a trademark of The Johns Hopkins University Applied Physics Laboratory.
About The Johns Hopkins University Applied Physics Laboratory
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, efficiency, cost and acceptance of HSA and Hologic's bone densitometer systems. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated. Hologic cannot assure that it will be able to obtain the necessary FDA approvals or clearances to integrate HSA into its bone densitometry products on a timely basis or within budget if at all, or that any such product, once developed will perform as anticipated or be successful. Without limiting the foregoing, 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, such as the ability to obtain FDA approval or clearances to market products developed, 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 to develop strategies to address its markets successfully; 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.