Hologic Announces Long-term, Five-year Results from MammoSite® ASBS Registry Study

BEDFORD, Mass., Nov. 1, 2010 /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, today announced the long-term, five-year results from the American Society of Breast Surgeons (ASBS) MammoSite® Breast Brachytherapy Registry Trial (ASBS Registry) while showcasing the MammoSite ML (multi-lumen) system at the 52nd ASTRO (American Society for Radiation Oncology) Annual Meeting in San Diego October 31 through November 4, 2010. The ASBS Registry Trial represents the largest compilation of MammoSite patients to date and demonstrates promising results for breast cancer patients.  The MammoSite system is the only breast brachytherapy balloon with five-year efficacy data.  Of the 1,449 patients (1,440 treated) with early-stage breast cancer, 37 patients had an ipsilateral breast tumor recurrence (IBTR), for a five-year actuarial rate of 3.80 percent.  A subset analysis of the first 400 consecutive cases had a median follow-up of 60.5 months and demonstrated a five-year actuarial rate of IBTR of 3.04 percent. 

According to Frank Vicini, M.D., principal investigator of the study, "The data are promising and add further clinical support for the use of accelerated partial breast irradiation in appropriate patients."

Carter Houghton, Vice President and General Manager of Hologic's Interventional Breast Solutions business, added, "The five-year ASBS Registry findings are a significant milestone for the MammoSite technology.  Good local cancer control rates and cosmetic results are critical outcomes in breast cancer therapy.  We look forward to expanding the utilization of accelerated partial breast irradiation by breast cancer patients that may have previously been disqualified for treatment."

The study concludes that treatment efficacy, cosmesis, and toxicity five years after treatment with APBI using the MammoSite device are good and similar to those reported with other forms of APBI with similar follow-up.*

*Vicini F, et al.  Five-year analysis of treatment efficacy and cosmesis by the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial in patients treated with accelerated partial breast irradiation. International Journal of Radiation Oncology, Biology, Physics

About MammoSite Radiation Therapy

Hologic's MammoSite therapy system, first cleared by the FDA in 2002, is the most widely utilized and accepted method of accelerated partial breast irradiation (APBI) in the United States. With its multi-lumen design, the new MammoSite ML device gives radiation oncologists the ability to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy.

By employing the MammoSite system, the radiation oncologist can deliver targeted radiation therapy directly to the area where cancer is most likely to recur, allowing a full course of radiation to be delivered in just five days. Additionally, targeted therapy of the breast limits radiation exposure to normal, healthy tissue. This targeting helps minimize side effects such as skin discoloration and scarring, burning, fatigue, and damage to surrounding organs.

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, radiation treatment for early-stage breast cancer, breast MRI, cervical cancer screening, treatment for menorrhagia, 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, MammoSite 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 the MammoSite radiation therapy system. There can be no assurance that the system will achieve the benefits described herein and 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 MammoSite radiation therapy system can only be determined on a case-by-case basis depending on the particular circumstances of the procedure and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein 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. Certain factors that could adversely affect the Company's business and prospects are described in Hologic filings with the Securities and Exchange Commission.

SOURCE Hologic, Inc.