News Releases

MARLBOROUGH, Mass., Nov. 25, 2016 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) will highlight its portfolio of innovative, award-winning breast cancer screening and interventional products, including the new Affirm™ prone breast biopsy system, at the 102^nd Scientific Assembly and Annual Meeeting of the Radiological Society of North America (RSNA) at McCormick Place in Chicago from Nov. 27 to Dec. 2. With more than 60 papers, presentations and courses focusing on 3D MAMMOGRAPHY™ exams, Hologic's product and educational offerings at RSNA underscore the continued importance of tomosynthesis technologies, while driving innovation and education in breast health.

"It's always an honor to spend the week with many of the world's most respected radiologists, but this RSNA, we are particularly excited to allow hands-on experiences with our Affirm prone breast biopsy system, our latest advancement in breast biopsy technology," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "As the only manufacturer with a core focus on innovating and advancing breast health, we are committed to introducing new products, like the Affirm prone system, that offer unique patient and user benefits and address workflow challenges, enhancing the overall healthcare experience."

Available for demonstrations for the first time since receiving FDA clearance earlier this year, the Affirm prone breast biopsy system — the first dedicated prone biopsy system that is upgradable to allow for 3D^™ imaging-guided breast biopsies — marks the first significant step forward in prone biopsy technology since systems were first introduced more than 20 years ago. The Affirm prone system, which was recently recognized by Aunt Minnie as a finalist in its 2016 Best New Radiology Device category, provides clinicians with added confidence through superior imaging, 3D^™ biopsy capability, faster and easier workflow, and seamless, 360-degree access to the breast.¹ Early clinical and patient feedback has been positive, with more than 95 percent of patients indicating in a recent post-procedure survey that the biopsy experience was faster, more comfortable and less painful than expected.²

Hologic also has continued to expand its Affirm^™ upright biopsy system with the launch of the Affirm^™ lateral arm biopsy accessory, which will be available for demonstrations at RSNA for the first time since its launch. This versatile, easy-to-use device enables needle access parallel to the detector, allowing physicians to target challenging lesions confidently and successfully biopsy thinly compressed breasts.

Hologic, which was ranked this month as the highest-scoring imaging equipment manufacturer for mammography in the 2016 Best in KLAS: Medical Equipment report for the seventh consecutive year, will showcase its complete line of screening and interventional products at RSNA, including several key products highlighted in clinical studies this year:

• The Genius™ 3D MAMMOGRAPHY™ exam, only available on the Selenia^® Dimensions^® system, is Hologic's breast tomosynthesis exam, which has been shown to reduce recall rates, increase invasive cancer detection and find invasive cancer earlier through a significant body of literature published this year in major research journals, including JAMA, JAMA Oncology, and The Breast. ^3,4,5

• Low Dose 3D MAMMOGRAHY™ exams with C-View™ Software result in less time under compression, increasing patient comfort at a lower radiation dose. Recent clinical studies, published this year in Lancet Oncology and Radiology, have shown that screening exams using C-View 2D images result in comparable clinical performance to traditional 3D MAMMOGRAPHY™ exams.^6,7

• I-View™ Software for Contrast-Enhanced 2D Digital Mammography (CEDM) exams are performed following a mammogram and/or ultrasound, as an alternative to breast MRI, to learn more about a suspicious area and determine surgical therapy for breast cancer patients. Recent literature published on CEDM in the Annals of Surgical Oncology illustrates the promising potential for facilities' bottom lines, as well as the patient experience, by using I-View software. ⁸

Additionally, Hologic will offer several 3D MAMMOGRAPHY™ exam-related educational events at RSNA:

• RSNA Satellite Symposium, "Addressing the Clinical Need for 3D^TM Breast Biopsy Technologies: Prone and Upright Solutions," on Sunday, November 27 from 1:30 p.m. – 3:00 p.m.
• 60-Minute Hands-On Workshop, "3D™ Image Guided Prone Breast Biopsy: A Seasoned Perspective," on Sunday, November 27 from 10:30 a.m. – 11:30 a.m. and Monday, November 28 from 12:15 p.m. – 1:15 p.m.
• Advanced 75-Minute Hands-On Workshop, "Optimizing Tomosynthesis: Strategies for Improving Mammographic Outcomes," on Monday, November 28 from 3:30 p.m. – 4:45 p.m. and Tuesday, November 29 from 12:00 p.m. – 1:15 p.m.

RSNA is an international society of radiologists, medical physicists and other medical professionals with 55,000 members from more than 140 countries. The RSNA Annual Meeting is expected to attract more than 60,000 attendees.

For additional information on Hologic's Affirm prone biopsy system or other solutions, visit Hologic's booth at RSNA, located in the McCormick Place South Building – Level 3, Exhibit # 4111. For each station visited in the Hologic booth, the Company will donate $1 to Bright Pink, the only national non-profit focused on the prevention and early detection of breast and ovarian cancer in young women, as part of its "Explore for Charity" program.

About Hologic
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.

Hologic, 3D, 3D Mammography, Affirm, C-View, Dimensions, Genius, I-View, Selenia, and The Science of Sure and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

Forward-looking Statement Disclaimer:
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.

Media Contact:
Jane Mazur
508.263.8764 (direct)
585.355.5978 (mobile)
jane.mazur@hologic.com

Investor Contact:
Michael Watts
858.410.8588
michael.watts@hologic.com 

¹ Compared to the MultiCare^® Platinum system

² Data on file 2016. Hologic survey of 165 patients post procedure at 3 hospitals.

³ Elizabeth Rafferty, MD, Melissa Durand, MD, Emily Conant, MD, Debra Somers Copit, MD, Sarah M. Friedewald, MD, Donna M. Plecha, MD, and Dave P. Miller, MS. "Breast cancer screening using tomosynthesis and digital mammography in dense and nondense breasts," JAMA. 2016;315(16):1784-1786.

⁴ Elizabeth S. McDonald, MD, PhD; Andrew Oustimov, MPH; Susan P. Weinstein, MD; Marie B. Synnestvedt, PhD; Mitchell Schnall, MD, PhD, and Emily F. Conant, MD. Effectiveness of Digital Breast Tomosynthesis Compared with Digital Mammography. JAMA Oncol. 2016;2(6):1-7. Doi:10:10.1001/jamoncol. 2015.5536.

⁵ Hodgson R, Heywang-Kobrunner S, Harvey S, et al. Systematic Review of 3D Mammography for Breast Cancer Screening. The Breast. 2016;27:52-61 [epub ahead of print].

⁶ Bernardi D, Pellegrini M, Valentini M, et al. "Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population-based prospective study." The Lancet Oncology. Epub 2016 June 23.

⁷ Zuckerman S, Conant E, Keller B, et al. "Implementation of Synthesized Two-dimensional Mammography in a Population-based Digital Breast Tomosynthesis Screening Program." Radiology. 10.1148/radiol.2016160366

⁸ Ali-Mucheru M, Pockaj B, Patel B, et al. "Contrast-Enhanced Digital Mammography in the Surgical Management of Breast Cancer."Annals of Surgical Oncology. Epub 2016 September 15. DOI 10.1245/s10434-016-5567-7

SOURCE Hologic, Inc.