Hologic Announces Six-year Follow-up Results from the MammoSite Targeted Breast Irradiation Registry Study

BEDFORD, Mass., Oct. 4, 2011 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that the six-year follow-up results from the MammoSite Registry Study continue to show promising results for breast cancer patients. The results were presented at the American Society of Radiation Oncology (ASTRO) meeting in Miami, Florida, October 3.(1) Hologic featured its next-generation MammoSite ML (multi-lumen) radiation therapy system at ASTRO, the largest radiation oncology medical show in the world.

The American Society of Breast Surgeons (ASBS) MammoSite Registry of  more than 1,400 patients shows "excellent/good" cosmetic results in 90.4 percent of the cases. Hologic's MammoSite system is the only breast brachytherapy balloon system with six years of follow-up registry data.

According to Peter Beitsch, M.D., FACS, a surgeon at the Dallas Breast Center in Texas and lead author of the study, "The ASBS MammoSite Registry has contributed to the acceptance of Accelerated Partial Breast Irradiation (APBI) across this country and the world by the reassuring long-term data on local control, lack of risk of regional recurrence in the era of the sentinel node biopsy, and the comparable long-term survival after whole breast irradiation."

Carter Houghton, Vice President and General Manager of Hologic's Interventional Breast Solutions business, added, "The MammoSite Registry data provides further evidence supporting the use of MammoSite in early stage breast cancer patients. We are very pleased that the positive patient outcomes have remained strong over the course of six years with no statistically significant deterioration in the rate of excellent to good cosmetic results with time."  

(1) Beitsch, P., et al.  The American Society of Breast Surgery MammoSite Registry: Factors Associated with Optimal Long-Term Cosmetic Results.  ASTRO Annual Meeting 2011.

About MammoSite Radiation Therapy

Hologic's MammoSite radiation therapy system, first cleared for sale in the U.S. in 2002, is the most widely utilized and accepted method of APBI in the United States. With its new multi-lumen design, the MammoSite ML system 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 MammoSite therapy, 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.

The MammoSite and MammoSite ML systems are capable of meeting all dosimetric parameters of Section 13.1.4 of the NSABP-39/RTOG 0413 protocol amended in April 2011.

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 reagents for a variety of DNA and RNA analysis applications. For more information, visit www.hologic.com.

Hologic and MammoSite 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 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 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.