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Hologic and R2 Technology Sign Definitive Agreement To Integrate R2 CAD Technology
With Hologic's LORAD Selenia Full Field Digital Mammography System Agreement Between Technology Leaders Grants Hologic Worldwide Distribution Rights for R2's OmniCAD Digital and Film-Based Mammography Suite of Products Customized For Selenia Digital Mammography System BEDFORD, Mass. and SUNNYVALE CA.,(July 31, 2003) - Hologic, Inc., (NASDAQ: HOLX) a leading provider of women's diagnostic imaging systems and state-of-the-art digital radiology systems, and R2 Technology, Inc., a pioneer in computer aided detection (CAD) technology, today announced the companies have signed a definitive agreement covering development and distribution of R2's ImageChecker® CAD technology, customized for Hologic's Lorad Selenia full field digital mammography system. The agreement is for an initial term of five years with two one-year renewal options. Under the terms of the agreement, R2, with assistance from Hologic, will customize its ImageChecker system for use with the Selenia system and Hologic will receive worldwide distribution rights to sell the customized product in combination with its Selenia system. In addition, Hologic, a leader in the mammography acquisition device market, will have distribution rights for R2 CAD products that are designed to be used with conventional film-based mammography systems that are able to be upgraded to digital mammography systems. These film-based CAD products will be sold in conjunction with Hologic's digital-ready conventional screen-film mammography products. According to Jack Cumming, Hologic's Chairman and CEO, "Finalizing this agreement with R2 Technology, the CAD market leader, formalizes the commitment of both companies to merge our premier technologies together in a package that we believe will provide physicians and the women they serve the best platform available for the early detection of breast cancer. R2 Technology has established itself as the preeminent provider of innovative, cutting-edge CAD solutions. The opportunity to work cooperatively with them to create and distribute this unique product offering will enhance and strengthen the role of both companies as segment technology leaders. We look forward to continuing our long and productive working partnership with our R2 colleagues." The R2 OmniCAD digital suite of products, which will be introduced as part of this collaboration, will give digital customers all current and future capabilities available to analog customers. The OmniCAD digital suite is designed with an open architecture so that, as new features are added they can be customized for Hologic customers. This may include features such as temporal comparison or normalization software that enables the optimization of mammograms acquired on different systems at different times for analysis, quantification and display. The integration of R2's ImageChecker CAD technology and Hologic's Selenia products will require Food & Drug Administration (FDA) approval for clinical use in the United States. The companies are currently working together to prepare the information needed for the submission to FDA for marketing approval. The Selenia system is the only FDA-approved full field digital mammography product using amorphous selenium, direct conversion technology. Amorphous selenium technology directly converts x-ray beams to electric signals and preserves image sharpness by eliminating image degradation due to light scatter. The Selenia system has a number of other unique features to improve performance and image quality, including the industry's largest digital detector, which allows more than 95% of all mammographic images to be taken with a single exposure, and Hologic's exclusive High Transmission Cellular (HTC®) Grid, which reduces radiation scatter and provides higher contrast images. The Selenia received FDA marketing clearance in October 2002. The R2 ImageChecker CAD is approved by the FDA for use in both film-based and digital mammography to assist in minimizing false negative readings. CAD is used by an increasing numbers of radiologists as "a second pair of eyes" when reading a woman's mammogram. Analogous to a spellchecker system on a personal computer, this technology uses computer algorithms to identify areas on the mammogram containing physical characteristics that may warrant a second review by the radiologist. Clinical trials have demonstrated that use of the ImageChecker system as an adjunct to review by the radiologist can improve breast cancer detection rates up to 23.4 percent. "We are very pleased to enter into this agreement with Hologic, a recognized market leader in mammography," said Michael S. Klein, president and CEO of R2 Technology. "It provides a framework for our collaboration to integrate our existing technologies, as well as a structure for working together on future product enhancements. Hologic is well known for their extensive experience in providing innovative and cutting-edge technology focused on the early detection of breast cancer. Hologic's established base of screen-film mammography customers and its growing base of digital customers presents a very exciting pathway for us to make this customized CAD product available to a growing base of users. We anticipate and look forward to expanding our highly dynamic and fruitful association with Hologic." To date, R2 has shipped more than 1,000 film and digital-based systems worldwide and more than 6.5 million women have had their mammograms interpreted with the aid of the ImageChecker CAD system. 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. About R2 Technology
R2 Technology, Inc., headquartered in Sunnyvale, Calif, is a recognized leader in the development and commercialization of computer-aided detection (CAD), an innovative technology that assists radiologists in the early detection of breast cancer and other cancer-related lesions. R2's CAD software has been integrated with the ImageChecker processing and visual display system, and is being used successfully by hospitals and imaging centers as an aid to radiologists for more accurate detection of breast cancer. As a medical software company, R2 is developing CAD systems for a variety of imaging modalities and disease states, including lung cancer. 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 relationship and anticipated benefits from Hologic's agreement with R2 and the anticipated performance of the customized systems developed under the agreement with R2. 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 R2's limited experience in working together, including the risk that R2 may not be able to customize its technology as contemplated by the development agreement on a timely basis, or within budget, if at all; other 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 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; Hologic's ability to predict accurately the demand for its products and to develop strategies to address its markets successfully; 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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