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Hologic and Confirma Partner to Distribute
CADstream MRI CAD System to Mammography Market
Companies also announce integration
of CADstream MRI System with Lorad Selenia Digital Mammography System
BEDFORD, Mass., and Kirkland, Wash (November 20, 2003) - Hologic, Inc. (NASDAQ: HOLX) and Confirma, Inc. announced today that they are partnering to provide the mammography market with new tools for reading breast MRI studies. Mammographers are increasingly interested in reading breast MRI studies and providing their patients with integrated, multi - modality test results. The new agreement gives Hologic non-exclusive distribution rights for CADstream, Confirma's computer-aided-detection (CAD) system which automates the processing of data-intensive breast magnetic resonance imaging (MRI) studies and assists radiologists with study interpretation. Confirma is also completing the integration of its CADstream-processed breast MRI studies and system to function with Hologic's full-field digital Lorad Selenia system, to provide simultaneous mammography and breast MRI study viewing capability. This ability to view a breast MRI study in a similar position (or plane) as a mammogram should provide more detailed information in one review session. Confirma launched CADstream, the first CAD application designed exclusively for breast MRI, in January 2003. The CADstream platform is initially applied to breast MRI, which is being used more widely for determining the extent of breast disease (staging), evaluating surgical margins and monitoring response to treatment. Breast MRI is also recommended by the American Cancer Society and an increasing number of leading researchers as an adjunct to mammography for patients known to be at high risk for breast cancer. A population that may include up to 8.5 million women in the U.S. "This agreement with Confirma provides an excellent opportunity for us to make CADstream's superb technology available to our established market base, mammography professionals in women's imaging centers and hospitals throughout the United States," said Jack W. Cumming, Hologic's Chairman and CEO. "We believe radiologists will realize significant clinical and economic benefits using breast MRI with CADstream's automated image processing functions, including image registration." As clinical indications and study numbers expand, the amount of data produced per breast MRI exam has increased tremendously, with exams often producing 800 images. Physicians and MRI technologists spend a significant amount of time-sometimes one to two hours-manually processing and interpreting a breast MRI study. CADstream automates breast MR image processing functions and corrects for patient movement that may occur during a study acquisition. The result for radiology clinics is standardization in processing and interpretation, as well as enhancement of breast MRI study economics and quality control. Cumming added, "Putting better efficiency tools in the hands of the healthcare professionals can enhance the interpretation of breast imaging studies, ultimately resulting in improved patient care. We are pleased to add CADstream to our suite of product offerings, which are intended for use in the detection and fight against breast cancer. Confirma is an exciting CAD software company with a very flexible, expandable platform and we look forward to a long and productive relationship with them." "We are extremely pleased to be partnering with Hologic, an innovative developer of state-of-the-art digital imaging technology and recognized industry leader in the manufacture and distribution of mammography systems with superior image quality. Hologic's Lorad mammography product line has a rich history of innovative leading-edge technology for breast cancer detection. This distribution agreement will complement Confirma's direct sales force, making breast MRI and CADstream more easily accessible to mammographers, the physicians who are currently leading the growth in breast MRI study numbers," said Max Lyon, president and CEO, Confirma, Inc. "CADstream makes breast MRI feasible in a mammography setting and assists women's imaging centers in making breast MRI more accessible to women who can benefit from this valuable study." Hologic's product offerings include the Lorad SeleniaT, the industry's only FDA-approved full field digital mammography system using direct capture technology and the M-IV and Affinity Series of screen-film mammography systems. The company also provides both upright and prone stereotactic breast biopsy systems. CADstream, Confirma's first product, automates image processing of breast MRI studies; its analysis is based on the behavior over time of an IV-injected contrast agent. Automated features include image registration that corrects for patient movement, subtraction images, angiogenesis maps, real-time dynamic curves, multiplanar reformatting, maximum intensity projections (MIPs) and enhancing tissue volume summaries. CADstream automatically detects breast MRI studies once they are acquired, processes the studies according to customized, site-specific settings and then sends the study data to any networked PACS or PC for review and interpretation. About Confirma
Confirma, Inc. develops and markets computer-aided-detection (CAD) systems for medical imaging study analysis. Confirma's product, CADstream, is the first CAD system designed for MRI. CADstream provides higher quality imaging studies, lower costs for radiology practices, and improved communication tools for physicians and patients. In its initial application, CADstream is being used to assist in the analysis of breast MRI; the company plans future applications for other medical imaging studies. Confirma was recently awarded the 2003 Entrepreneurial Company Award by Frost & Sullivan for its innovative CAD technology. For more information, visit www.confirma.com or call 877-976-1226. 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 about Hologic's and Confirma’s plans, objectives, expectations and intentions. Such statements include, without limitation, statements regarding the relationship and anticipated benefits from Hologic's agreement with Confirma including the anticipated performance of the systems involved. These 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, Hologic's and Confirma’s limited experience in working together; Hologic's ability to predict accurately the demand for its products and to develop strategies to address its markets successfully; uncertainties inherent in Confirma’s development of new products and the enhancement of existing products, including technical and regulatory risks, such as the ability to obtain FDA approval 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; the early stage of market development for digital x-ray products; risks relating to Hologic's reliance on a single source of supply for some key components of its products; the need to comply with especially high standards in the manufacture of digital x-ray products; Hologic's ongoing ability to satisfy financial and other covenants in its credit and lease agreements; 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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