FDA Clears Hologic's MammoSite(R) ML Radiation Therapy System for the Treatment of...

FDA Clears Hologic's MammoSite(R) ML Radiation Therapy System for the
Treatment of Early-Stage Breast Cancer
The MammoSite ML (multi-lumen) device offers more women the option of
completing their radiation treatment in just five days

BEDFORD, Mass., Sept. 1 /PRNewswire-FirstCall/ -- 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 the U.S. Food and
Drug Administration (FDA) cleared the Company's 510K application for the
MammoSite((R)) ML radiation therapy system. With its multi-lumen design, this
new 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.

Hologic's MammoSite therapy system, first cleared by the FDA in 2002 as a
single-lumen device, is the most widely used form of accelerated partial
breast irradiation (APBI) in the United States. It has been used to treat more
than 50,000 breast cancer patients in the U.S.

By employing the MammoSite system, the physician can deliver targeted
radiation therapy directly to the area where cancer is most likely to
recur,(i) 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.

In 2008, approximately 240,000 cases of breast cancer were confirmed in the
U.S. Fortunately, today more than half of breast cancers are diagnosed when
the disease is still in its localized stage.(ii) Early detection allows breast
cancer patients to choose breast conservation therapy, which preserves the
breast by relying on tumor excision via lumpectomy, followed by radiation
therapy, to reduce the likelihood of recurrence. According to the National
Institutes of Health, breast-conserving surgery plus radiation therapy is
preferable to total mastectomy because it provides survival equivalence while
preserving the breast.(iii)

The MammoSite systems are comprised of an inflatable balloon catheter in which
a radioactive source is introduced for therapy delivery. The inflatable
balloon is inserted into the surgical cavity remaining after removal of the
tumor. This local placement of the balloon provides for therapeutic delivery
of a five-day course of radiation to the tissue most likely to contain
residual cancerous cells following surgery, while reducing radiation exposure
to adjacent healthy tissue. Using the MammoSite multi-lumen catheter, the
radiation oncologist has the ability to shift the radiation dose to the areas
that need it most and shift the dose away from areas that do not require it.

"An increasing number of surgeons, radiation oncologists, and patients are
choosing the accelerated treatment available with MammoSite," said David
Harding, senior vice president of Hologic's interventional breast solutions
business. "Now, with MammoSite ML, five-day targeted radiation therapy is also
available to women with early-stage tumors close to the skin or chest wall who
may not have been good candidates for traditional balloon brachytherapy. This
is another significant milestone for Hologic and our interventional breast
solutions business. With FDA clearance of the MammoSite ML radiation therapy
system, we are now able to provide surgeons and radiation oncologists with a
device designed to both maximize patient comfort and enable greater physician
flexibility in delivering targeted radiation therapy directly to the areas
where breast cancers are most likely to recur."

The Company expects to commercially launch MammoSite ML during the first
quarter of fiscal year 2010 (quarter ending December 26, 2009). Please see
www.mammosite.com for additional information on the MammoSite targeted
radiation therapy system.

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, 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.

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 and
MammoSite ML targeted radiation therapy systems. There can be no assurance the
systems 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 targeted radiation therapy
systems can only be determined on a case-by-case basis depending on the
particular circumstances 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.

Hologic and MammoSite are trademarks and/or registered trademarks of Hologic,
Inc., and/or its subsidiaries in the United States and/or other countries.

(i) King TA, Bolton, JS, Kuske RR et al. Long-term results of wide-field
brachytherapy as the sole method of radiation therapy after segmental
mastectomy for T(is,1,2) breast cancer. Am J Surg. 2000; 180:299-304.

(ii) American Cancer Society, Breast Cancer Facts and Figures: 2007-2008.

(iii) Consensus statement on treatment of early-stage breast cancer. National
Institutes of Health, 1992.

Contact: For Investors: For Media:
Deborah R. Gordon Anne Rivers
Vice President, Investor Relations Corporate Marketing
Hologic, Inc. Hologic, Inc.
(781) 999-7716 (508) 263-8765
womenshealth@hologic.com

SOURCE Hologic, Inc.

Investors: Deborah R. Gordon, Vice President, Investor Relations,
+1-781-999-7716, or Media: Anne Rivers, Corporate Marketing, +1-508-263-8765,
womenshealth@hologic.com, both of Hologic, Inc.