Four-Year Follow-Up Results: MammoSite® Radiation Therapy System Cancer Recurrence Rates Comparable to Standard Radiation Therapy

BEDFORD, Mass., Sept. 29, 2008 /PRNewswire-FirstCall/ --Hologic, Inc. (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 a four-year analysis of the Hologic MammoSite radiation therapy system has found that breast cancer recurrence rates following the delivery of accelerated partial breast irradiation with the MammoSite system continue to be comparable to the rates reported with standard radiation therapy. The study was presented by Dr. Peter Beitsch of Medical City Dallas Hospital at the American Society of Therapeutic Radiology and Oncology (ASTRO) Annual Meeting in September. Dr. Beitsch and his colleagues analyzed data from patients enrolled in the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial.

The researchers reported that their analysis of the overall registry population, which includes a total of 1,440 patients with a median follow-up of 42 months, showed a three-year actuarial rate of Ipsilateral Breast Tumor Recurrence (IBTR) of 2.7 percent. Another important finding of the study was the low incidence of axillary recurrence (0.6 percent). The researchers concluded that treatment with the MammoSite system resulted in acceptable IBTR and axillary recurrence rates comparable with standard whole breast radiation therapy and excellent breast cancer-specific survival.

"As more long-term data on the use of the MammoSite therapy becomes available, we continue to be encouraged," Dr. Beitsch reported. "With many patients in the registry now four years out from treatment, we feel the recurrence rates are comparable to whole breast radiation and the survival rates are very impressive. We look forward to continuing to follow this group of patients as they represent the largest data set available on this important therapy."

The MammoSite device is a balloon catheter that is inserted into the cavity created by a lumpectomy (i.e., the surgical removal of a breast tumor). The MammoSite system delivers radiation from inside the lumpectomy cavity over a course of five days and targets radiation to the area where tumors are most likely to recur, while reducing exposure to healthy tissue. Since its introduction in 2002, more than 45,000 breast cancer patients have received partial breast irradiation utilizing the MammoSite system. Patients typically treated with MammoSite include those with early breast stage cancer, who are over 45 years of age, with a tumor size of three centimeters or less and no nodal involvement.

The American Society of Breast Surgeons MammoSite Registry includes a total of 1,440 patients with early-stage breast cancer, who were undergoing breast-conserving therapy and were treated with the MammoSite system between May 2002 and July 2004. Of the total, 87 percent of the patients had invasive breast cancer and 13 percent had been diagnosed with ductal carcinoma in situ. Dr. Beitsch as well as Dr. Frank Vicini, Dr. Victor Zannis, Dr. Pat Whitworth, Dr. Bruce Haffty, Dr. Ricky Fine, Dr. Henry Kuerer and Dr. Martin Lyden contributed to this research.

The MammoSite Breast Brachytherapy Registry Trial was supported in part by a grant from Hologic to the American Society of Breast Surgeons and Biostat International Inc.

About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, 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, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and products that cover molecular diagnostic reagents for a variety of DNA and RNA analysis applications.

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 contains forward-looking information that involves risks and uncertainties, including statements about the effect of the use of Hologic's MammoSite Radiation Therapy System on breast cancer patients. There can be no assurance that the effects demonstrated in the study described herein will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of Hologic's MammoSite Radiation Therapy System on patients with breast cancer can only be determined on a case-by-case basis depending on the particular circumstances of the patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such data or statements presented herein to reflect any change in Hologic'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 Hologic's business and prospects are described in Hologic's filings with the Securities and Exchange Commission.


James D. Culley, Ph.D.
Corporate Marketing
Hologic, Inc.
Tel: 781.999.7583

Olga Karagiannis
Corporate Marketing
Hologic, Inc.
Tel: 781.761.7069