Hologic Breast Tomosynthesis System Wins Top Award in Medical Design Excellence Competition

Hologic Breast Tomosynthesis System Wins Top Award in Medical Design Excellence Competition
Selenia Dimensions is the first commercial mammography system approved to use 2D and 3D (breast tomosynthesis) technologies for breast cancer screening and diagnosis

BEDFORD, Mass., June, 16, 2011 /PRNewswire/ — Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that its Selenia Dimensions 2D/3D mammography system won a gold Medical Design Excellence Award (MDEA) at the Medical Design and Manufacturing East 2011 Conference and Exposition.

The Medical Design Excellence Award recognizes Hologic for innovation in design and engineering for Selenia Dimensions, the first commercially available tomosynthesis system for breast cancer screening and diagnosis. Unlike prior-generation mammography systems which generate two-dimensional (2D) images, a breast tomosynthesis system produces three-dimensional (3D) images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density.

The Hologic system gives radiologists the option of offering their patients a conventional 2D digital mammogram and a 3D tomosynthesis exam – all in one compression, in just seconds.

In clinical studies Hologic submitted to the U.S. Food and Drug Administration (FDA), radiologists reading 2D mammography plus 3D breast tomosynthesis images compared to 2D images alone demonstrated superior clinical performance in specificity, the confidence to rule out breast cancer without recalling the patient for further study, and also demonstrated improved sensitivity, the proportion of mammograms which include breast cancers that were correctly diagnosed.*

In accepting the award for Hologic, Ian Shaw, Director of Breast Health Advanced Product Development, noted, “The Medical Design Excellence Award is welcome recognition for the achievements of the many people behind the scenes who are responsible for developing the Selenia Dimensions mammography system.” Farm Design, Inc., a New England medical product development company, assisted Hologic with the industrial design, human factors, engineering and user interface of the product.

Hologic’s 2D/3D breast tomosynthesis systems are available for sale worldwide. Selenia Dimensions 3D tomosynthesis was approved for sale in the United States by the FDA on February 11, 2011.

This is the fourth time a Hologic product has won a top award in the MDEA program. The Company’s Sentinelle Vanguard breast imaging and interventional coil won gold in 2010. The Sentinelle breast imaging coil transforms a Magnetic Resonance Imaging (MRI) scanner into a powerful breast imaging and interventional tool. Hologic’s ThinPrep imaging system won gold in 2004. The ThinPrep imaging system is a fully integrated, interactive computer system that assists cytotechnologists and cytopathologists in the primary screening and diagnosis of cervical cancer using ThinPrep Pap test slides. The MammoSite radiation therapy system won gold in 2003. The MammoSite catheter and balloon assembly delivers radiation from within the tumor–resected cavity after breast conservation therapy. MammoSite targeted radiation therapy works from the inside, meaning that a higher daily dose can be used for a shorter period of time – 5 days versus 5 to 7 weeks.
About the Medical Design Excellence Awards

Since its inception in 1998, the Medical Design Excellence Awards (MDEA) program has become the premier competition for the medical technology community, recognizing both the design achievements and healthcare contributions of medical product manufacturers, their suppliers, and the many people behind the scenes who are responsible for the groundbreaking innovations that are changing the face of healthcare. MDEA winning entries excel in the areas of product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.
About Hologic, Inc.

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic’s core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast magnetic resonance imaging, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications. For more information, visit www.hologic.com.

Hologic, Dimensions, MammoSite, Selenia, Sentinelle, ThinPrep, Vanguard and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

*The Hologic clinical studies presented to the FDA as part of the Company’s Pre Market Approval submission compared the results of radiologists reading digital mammograms from Hologic’s Selenia Dimensions system in combination mode (2D+3D tomosynthesis) to reading Hologic’s 2D mammograms alone.


Media Contacts:
Olga Karagiannis
Hologic, Inc.
Corporate Marketing
781.761.7069
Olga.Karagiannis@hologic.com
Anne Rivers
Hologic, Inc.
Corporate Marketing
508.263.8765
Anne.Rivers@hologic.com