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Defining the Standard of Care in Women’s Health
Hologic at RSNA’07
Bedford, Mass (October 11, 2007) - Hologic, Inc. (NASDAQ: HOLX), a leading provider of state-of-the-art diagnostic and digital imaging systems for women's imaging and skeletal health, will be one of the largest exhibitors at the 93rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA). With the recent acquisition of BioLucent and the completion of the merger with Cytyc this October, Hologic will have more than doubled in size in 12 months. Hologic has always been a company that is ethically, emotionally and financially committed to helping improve the health of women. By joining forces with Cytyc, we enjoy a rare opportunity to make a greater difference in women’s health across the world. It is a responsibility we take very seriously. At RSNA’07, Hologic will continue to demonstrate its focus to enhance women's health through earlier and better detection, improved diagnosis, less invasive treatments, and improved patient outcomes. After the Cytyc merger, Hologic will hold the number one position in nine technology areas serving women’s health, including breast cancer diagnosis and treatment, cervical cancer screening, prenatal testing, and osteoporosis detection. And with the Cytyc merger, the company plans to aggressively bring the radiology community new products – like MammoSite®, targeted radiation therapy.
MammoSite works from the inside, meaning that a higher daily dose can be used for a shorter period of time – five days versus five to seven weeks. MammoSite places the radiation source inside the lumpectomy cavity. This delivers radiation to the area where cancer is most likely to recur. The therapy is given on an outpatient basis. No hospital stay is required.
The merger of Hologic and Cytyc is more than market leadership and bringing to market superior technology - it means having the drive and commitment to deliver world-class products and services. It means having the right team in place; experts driven by an unrelenting passion for what we do. And it means always remembering that we are here to serve the imaging, diagnosis and treatment needs of the radiology community at the highest level possible.
Hologic Women’s Imaging Solutions Selenia: The Most Popular Digital Mammography Solution on the Market Today Hologic digital mammography suites offer superior image capture, a more comfortable patient experience, and personalized workflow solutions that fully harness the power of digital mammography.
Digital mammography is one of the most important diagnostic breakthroughs in women’s healthcare. Hologic is one of the first to bring users an integrated breast imaging workflow solution that fully harnesses the power of digital technology. Hologic meets the demand for a complete solution that supports the way users really work – Selenia.
With the superb image quality of Selenia™, life-saving details are revealed that radiologists need to find cancer earlier. And, with Selenia, innovative technologies under development such as contrast enhanced mammography and breast tomosynthesis will be possible.
Selenia is by far the most popular digital mammography solution today with an estimated 56% of all installs in the U.S. in 2006. FDA monthly MQSA statistics show significant growth in the category – in the last 12 months digital mammography penetration grew 77% from 1,235 to 2,198 MQSA sites. Selenia also has a commanding presence in a significant number of international markets.
At RSNA’07 we’ll show how we are continuing to enhance Selenia with new features and workflow improvements. One example, is the Selenia S digital mammography system, a product specifically designed for the screening mammography facility or mobile environment. Selenia S uses the Hologic direct conversion detector, eliminating the need to convert x-rays to light producing an exceptionally sharp digital image with better contrast and detail. Selenia S can easily be upgraded to include all diagnostic tools available.
Another example is a new tungsten x-ray tube option for Selenia. The tungsten tube in combination with a special silver filter allows images to be acquired at a lower dose without compromising the superb image quality of Selenia. The silver filter’s intended use is for imaging thicker breasts with both lower dose and shorter exposure times to eliminate problems with patient motion. Hologic is the first company to introduce the use of the silver filter with a tungsten tube in digital mammography. Systems shipped with the tungsten tube option will be calibrated to have a minimum of 30% reduction in dose, for a 4.5 cm breast, compared to Selenia/Molybdenum systems. Users have the option of choosing even lower dose settings, based on individual site preferences.
SecurView Workstations: Powerful Flexibility and Advanced Diagnostics In mammography, image acquisition is just the first step, the Hologic SecurView™ line of diagnostic and technologist workstations support more confident diagnoses, save time and provide faster answers for patients. At RSNA’07 we’ll highlight new software and hardware upgrades that allow the user to present studies in exactly the manner the user specifies.
SecurViewDX, Hologic’s diagnostic workstation, has the intelligence to look at the image details and content for every procedure type and automatically hang the images in the order that users prefer. Set up is fast and intuitive. And since SecurViewDX allows users to change their workflow with drag and drop ease, SecurViewDX can create and store an unlimited number of hanging protocols for multiple radiologists without affecting a colleague’s settings. Share new and improved workflow protocols or standardize your department around best practices with complete ease.
SecurViewDX offers analysis and manipulation tools developed with input from radiologists. Customizable image layout and orientation allows images to be displayed in individualized protocols for diagnostic, screening or multiple modalities, including the ability to set laterality, and interactively mirror and flip images for evaluation and comparison. Intelligent roaming moves from one quadrant of the breast to the next, displaying every section at full resolution and skipping areas of the image where no breast tissue is present.
SecurViewDX makes it easy to view mammograms from any source, including
R2 CAD: The First and Latest in Mammography Computer Aided Detection Hologic R2 Computer-Aided Detection (CAD) solutions give users the most sophisticated pattern recognition software to help find cancers with greater certainty at an earlier stage.
R2 technology was the first CAD system approved by the FDA for use with film-based mammography in 1998 and for digital mammography in 2001. We estimate that more than ten million women had their mammograms interpreted with the aid of R2's CAD technology in the last 12 months.
R2 DigitalNow: The Bridge to a Digital Environment Transitioning a mammography center from film to digital mammography presents many challenges. At Hologic, we have been working with technologists and radiologists to study clinical workflow, to understand the demands of the reading environment, and to perfect the art of film scanning. From this collaboration with clinicians comes a range of powerful solutions to speed the conversion to a digital environment.
R2 DigitalNow offers major milestones in workflow and image quality, with flexible hardware and software solutions. DigitalNow provides the capability to scan films for soft-copy reading, archive images for future use, and get CAD results. As reading environments migrate from light boxes to soft-copy displays, radiologists are challenged by the need to compare digital mammograms to prior screen-film images. The bright light box makes monitors harder to see, and the constant need for the doctor to turn back and forth between the two studies promotes a poor workflow and reading environment. DigitalNow digitizes films for soft-copy display so that prior screen-film images are displayed on the workstation along with the current digital images and can be sent to an archival system for use in years to come. DigitalNow provides high image quality and superior film-handling capability to enhance workflow. If you have an existing R2 ImageChecker™ system, talk to Hologic at RSNA’07 to see if DigitalNow is an option for you. DigitalNow software can also be purchased as part of a complete new system, with or without ImageChecker CAD software. DigitalNow systems range from the advanced DMax laser film scanning system to the compact LS. Visitors to the Hologic pavilion will have the chance to see the digital mammography suite for now and for far into the future on 15 Selenia FFDM systems and 15 SecurView multimodality workstations, with CAD and DigitalNow scattered throughout the booth. R2 CT Lung CAD Inside the CAD center in Hologic’s booth you’ll also find the latest R2 ImageChecker CT/Lung technologies. Whether hunting for lung nodules or filling defects (which may be indicative of pulmonary embolism), Hologic has a solution for you. And if you haven’t seen R2’s unique temporal comparison capability, be sure to stop by. RSNA Digital Mammography Self-Assessment Workshop If you are at RSNA, sign up for a module or two in the Dr. Roland Holland and Henny Rijken Digital Mammography Workshop. A hit at RSNA '05 and ’06, the Hologic co-sponsored Digital Mammography Training and Self-Assessment Workshop is back again with more workstations, digital CAD and expanded teaching modules. Workshop participants have the unique opportunity for hands-on experience reading and manipulating screening digital mammography cases on high-end flat panel workstations. To register or obtain more information, log on to the www.RSNA.org website. MammoPad: Combining High-Tech with a Soft Touch A 2007 addition to the Hologic line of women’s health products is the MammoPad® breast cushion. MammoPad was developed to encourage more women to have regular, screening mammograms by addressing a key barrier: discomfort or fear of discomfort. MammoPad is the only technology proven to significantly reduce the discomfort women often experience during mammography. The cushion's grip-like surface holds breast tissue in place to ensure optimal breast positioning. In fact, when combined with positioning training, MammoPad is proven to increase tissue acquisition. The radiolucent cushion does not interfere with image quality and can be used with both digital and analog mammography. See us at RSNA and let’s discuss how you can offer women a truly “high-tech, soft-touch” experience when you combine MammoPad with digital mammography. We estimate that more than 14 million women have already benefited from MammoPad. See us at RSNA and let’s discuss how you can offer women a truly high tech, soft touch experience when combining MammoPad with digital mammography. Breast Cancer Biopsy Solutions Upright and Prone Advanced Biopsy Solutions for the Breast Biopsy Suite Over 3 million women worldwide undergo breast biopsy each year, and having the best clinical tools available is essential. Designed with user input and practical considerations in mind, Hologic breast biopsy tables and upright solutions include the MultiCare Platinum™, the most popular prone biopsy table on the market today, and the Digital StereoLoc II™ optimized to work with the Selenia system. Both systems offer exceptional image quality, pinpoint accuracy, and precise, efficient operation using leading-edge targeting and guidance technology. Suros ATEC and Celero: Compassionate Biopsy Solutions Hologic develops and delivers biopsy systems that are more compassionate, effective and easy to use. We design physician-inspired and patient-focused solutions that meet all of your clinical requirements. Having the best clinical tools is important. Having choices is crucial. Physicians should not be forced to cancel a procedure or turn away a patient because their biopsy options are limited. Providing more choices means the ability to serve virtually all women. At RSNA’07, Hologic will demonstrate the Suros ATEC® (Automated Tissue Excision and Collection) breast biopsy systems, a fast, safe and simple breast biopsy designed to access hard-to-reach targets and biopsy women with small breasts, increase your patient spectrum. A varied needle solution helps ensure care for every woman, including women with small breasts, dense breasts, implants, hard to reach lesions, and multiple lesions. ATEC can be used across all three traditional breast imaging modalities, x-ray, MRI or ultrasound, giving the physician the ability to select the right imaging modality for each patient’s clinical need. At the same time, standardizing on one platform helps ensure consistency, which contributes to everything from reduced support costs and training time, to improved exam efficiency and higher quality standards. ATEC breast biopsy and excision systems offer multiple clinical benefits, including diverse needle options to accommodate a wide variety of patient presentations, continuous pain management, and a fully closed system with tissue acquisition every 4.5 seconds. ATEC was engineered with your patient in mind and has been optimized for use with the MultiCare Platinum prone and StereoLoc II upright biopsy systems. New this year is the Suros Celero™ vacuum-assisted spring loaded core (SLC) biopsy device This fully disposable device is the first U.S. FDA-cleared SLC vacuum assisted core biopsy device for the breast ultrasound market. With the option of firing inside or outside the breast, the device is designed to access hard-to-reach lesions in the axilla, near the chest wall, near implants, or behind the nipple. The lightweight and ergonomic design of the handheld Celero and its highly echogenic aperture provide smooth penetration to lesions while reducing deflection and offers a clearly visible aperture location for target verification under ultrasound imaging prior to tissue acquisition. Celero securely holds the tissue sample in place while acquiring large cores. Early Celero clinical findings show that only two to three samples are needed for a diagnosis. While many physicians are accustomed to 6-10 needle insertions for spring loaded core biopsies, Celero requires only 2-3 insertions to gain the same results which provide a more compassionate biopsy for your patient. Another product line on display at RSNA’07 is the Suros family of markers including the ATEC TriMark™ and Suros CeleroMark™ biopsy site identifiers. These markers are compatible with the ATEC breast biopsy and excision system and Suros Celero ultrasound biopsy device, respectively. At least 70% of all breast biopsies require site identifiers with more than 800,000 used every year in the U.S. Hologic Skeletal Health Solutions Hologic sets the gold standard in osteoporosis assessment. In 2007 Hologic expanded its solutions to address the continuum of skeletal health care, from prevention to intervention. Our goal is to be a strong foundation for clinicians to rely on in their fight for better skeletal health. Discovery: A Lifetime of Strength in a 10 Second Scan Skeletal systems provide us with stability and power. Our Bones are solid, yet resilient; changing in density and dimension and continually renewing themselves throughout life. However, bones can become dangerously fragile. They can weaken from disease, smoking, lack of exercise, nutritional deficiencies, estrogen deficiency in women, and low testosterone levels in men, medication, age, and many other causes. While porous bones and fractures may not be visible from the outside, the effects can be devastating, even life-threatening. Low bone mass can afflict anyone: men and women, young and old, all nationalities. People may not know they have osteoporosis until it’s too late. Early detection and treatment can mean a lifetime of strength for all of your patients. In the U.S., more women die from effects of osteoporosis than from breast, uterine and cervical cancer combined. Yet 80% of women who need osteoporosis testing have not been tested and 30% of patients that are tested are misdiagnosed when only bone density testing is used. The Hologic Discovery™ system is the key to early detection. Discovery bone densitometers quickly and precisely measures the two primary diagnostic indicators of osteoporosis - bone mineral density and vertebral fractures. At RSNA’07, Hologic will demonstrate how the low dose Discovery is even better with new functionality, including Hip Structure Analysis*** , and the use of Abdominal Aortic Calcification (AAC) visualizations, as seen in Discovery IVA scans. AAC may be a strong predictor of coronary heart disease, stroke and other forms of cardiovascular disease. This new feature represents a significant advance in densitometry as compared to conventional bone density scanners, which only look at average bone density. Hip Structure Analysis 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. HSA, the leading hip structure analysis method for DXA scans in research and pharmaceutical studies, uses specialized software to examine the structural geometry of two-dimensional DXA scan images. Fluoroscan: Bringing Fine Detail to Extremity Imaging Extremity surgery demands visualization of the finest detail with the lowest x-ray dose. At RSNA'07, Hologic will demonstrate the Fluoroscan InSight™ mini C-arm - a system specifically designed to deliver high resolution, low dose images with a surgeon-friendly user interface and enhanced flexibility. The name “Fluoroscan” has been and continues to be synonymous with excellence in fluoroscopic imaging for extremity surgeons and podiatrists across the country. Designed for hospital OR and ER as well as Outpatient Surgery Centers and doctor’s offices, no other mini C-arm has a better reputation for image quality, flexibility and versatility than the Fluoroscan InSight mini C-arm. Hologic Works in Progress Breast Tomosynthesis with a Selenium Based Detector* Building on the findings of more than four years of diagnostic and screening clinical trials at six clinical sites, visitors will have the chance to self evaluate their skills in reading two dimension and three dimension images of the same patient and see if they can find a difference in cancer detection rates. A specially designed booth will allow visitors to see a demonstration of how two-dimensional and three-dimensional imaging (breast tomosynthesis) can be accomplished on a system much like the Hologic Selenia digital mammography system. Quantra: A Fully-Automated Breast Density Assessment Tool The scientific literature supports a correlation between breast density and risk of breast cancer. In fact, some researchers believe that breast density may be a more significant predictor of risk than a single first degree relative with breast cancer. At RSNA ’07, Hologic is seeking clinical input to help us evaluate a new fully automated tool to help assess breast density. Quantra™ uses a complex model of the x-ray imaging chain to calculate the amount of dense tissue penetrated at each pixel in the image, which is independent of how the image was acquired. Using images from Selenia, Quantra gives the total volume of fibro-glandular tissue in cubic centimeters, as well as the total volume of the breast, removing the vagaries due to human estimation. It is hoped that Quantra, in concert with breast parenchymal pattern information, will allow us to understand when the sensitivity of mammography is reduced due to the obscuring of lesions in dense areas of the breast. In addition, Quantra should allow exploration of the true relationship between breast density and the future risk of developing breast cancer. 3-D Imaging on Discovery Bone Densitometers* Clinicians have long realized the importance of 3-D femur analysis to the measurement of bone strength. However, clinical and research applications with CT have been limited by the high radiation dose necessary and the difficulty in accurate and reproducible segmentation of bone from soft tissue. Utilizing Hologic’s exclusive rotating C-arm on its Discovery system, images of the femur can be acquired at different angles, allowing reconstruction of a three dimensional image. It is hoped that 3D imaging will pave the way for true volumetric density measurements, as well as accurate structural analysis of the femur. Moreover, Hologic believes 3D hip measurement will provide a powerful new tool for measuring the strength of the femur and more accurately determining the risk of future fractures. At RSNA'07, Hologic will update users on its collaboration with The Johns Hopkins University Center for Computer-Integrated Surgical Systems and Technology on 3-D modeling of the hip using the Hologic Discovery bone densitometer. *FDA clearance pending **Caution. Investigational device limited by Federal Law to investigational use. ***Hip Structure Analysis is a trademark of The Johns Hopkins University Applied Physics Laboratory About Hologic, Inc. 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 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 expected performance and benefits of its products and products under development. 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: risks 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; intellectual property litigation, 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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