Hologic : American Society for Radiation Oncology (ASTRO) Publishes New Evidence-Based Consensus Statement on Accelerated Partial Breast Irradiation (APBI)

MARLBOROUGH, Mass., November 18, 2016 /PRNewswire / -- Hologic Inc. (Nasdaq: HOLX) announced today that new guidelines published by the American Society for Radiation Oncology (ASTRO) recommend Accelerated Partial Breast Irradiation (APBI) as a treatment option for women with early-stage breast cancer beginning at age 50, a change from the previous consensus statement that recommended APBI for patients over age 60.

Radiation therapy disrupts the growth of cells by delivering high-energy beams of radiation to the breast where the cancer occurred, and can be given in two primary ways: whole breast irradiation or partial breast irradiation. Many women and their doctors want to limit treatment to the area immediately around the cancer to limit radiation exposure and target the area where the cancer is most likely to recur. APBI, or brachytherapy, uses a higher dose of radiation, but limits its exposure to the site surrounding the cancer. As a result, the treatment can be completed in less time - typically five days - compared to conventional external-beam radiation therapy, which takes five to seven weeks to complete.
The consensus statement, prepared by ASTRO's APBI update task force of eight leading physicians from major healthcare institutions in the United States and Europe, was based on published evidence and expert opinion. There was universal agreement that the published clinical evidence supports expanding the age range for APBI to patients beginning at age 50, and including younger patients, starting at age 40, who meet other clinical criteria of suitability.
'Today, more invasive breast cancers are being found earlier than ever before, thanks to advances in screening technology like the Genius™ 3D MAMMOGRAPHY™ exam,' said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. 'But women who are diagnosed with early-stage cancer are often left without a quick and easy treatment protocol. These new guidelines enable more patients to have early breast cancers treated with little or no change in physical appearance and minimal disruption to their lives.'
Hologic's 5-day targeted radiation therapy solutions, the MammoSite® targeted radiation therapy system and the Contura® multi-lumen balloon catheter, are a widely utilized and accepted method of APBI. The treatment works inside the breast, targeting the area where cancer is most likely to recur, sparing healthy tissue and organs from the effects of radiation.1

'Providing breast cancer treatments that marry a positive patient experience with successful clinical outcomes is something every oncologist hopes to accomplish,' said Martin E. Keisch, MD, a board-certified radiation oncologist at Cancer Healthcare Associates in Miami. 'Therapies like APBI give women options that lessen the side effects associated with whole breast radiation techniques while, in my opinion, offering equal outcomes. It is not just about a shorter treatment course; it is about less radiation and less toxicity. Broadening the range of patients qualified to receive this treatment will help us give patients their lives back sooner, and that's a very good thing.'

With seven years of positive clinical evidence, and more than 90,000 women successfully treated, patient consensus around the procedure is very positive.2, According to Marlene, a breast cancer survivor from San Jose, California, 'I highly recommend MammoSite Radiation for anyone that is a candidate; it was less stress and meant getting on with life so much sooner for my family and myself. It's beautiful to be done with treatments in five days instead of weeks.'
Women from across the country who have undergone 5-day targeted radiation therapy have volunteered to talk with other women about their experiences. Learn more at http://5daytherapy.com.

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 Mammography, Contura, Dimensions, Genius, MammoSite, Selenia, and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

Genius™ 3D MAMMOGRAPHY™ exams are only available on the Hologic Selenia® Dimensions® mammography system.

The safety and effectiveness of the MammoSite Radiation Therapy System (RTS), MammoSite ML Radiation Therapy System and the Contura Applicator as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of use of Hologic's MammoSite Radiation Therapy System and the Contura® multi-lumen balloon catheter on breast cancer patients. There can be no assurance the systems will achieve the benefits described here, or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that the systems will achieve any expected level of sales or market share. Hologic expressly disclaims any obligation to release publicly any updates to the data or statements presented here to reflect any change in the Company's 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

King TA, et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for Tis, 1,2, breast cancer. Am J Surg. 2000;180:299-304.

Data on file - based on sales history from 2005-2016.

Benitez PR, Keisch ME, Vicini F, Stolier A, Scroggins T, Walker A, et al. Five-year results: the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg. 2007;194:456-62.