BEDFORD, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Hologic, Inc.
(Nasdaq: HOLX), a leading provider of specialized medical imaging equipment
for women's health, gave the radiology community it's first glimpse of the
company's full field digital breast tomosynthesis research system at the 2003
annual meeting of the Radiological Society of North America. At the meeting,
which began November 30, 2003, Hologic showcased its digital breast
tomosynthesis system along with some of the images acquired from initial
research projects utilizing the system.
Breast tomosynthesis allows a series of images in slices of 1 mm or less
to be acquired and reconstructed for 3-D viewing. This investigational
technology has the potential to reduce or eliminate overlapping tissue, which
can obscure a lesion. In addition, tomosynthesis may provide improved
diagnostic information. Hologic's research breast tomosynthesis systems are
being developed to be used as an add-on to the current Selenia full field
digital mammography platform.
According to Jack Cumming, Hologic's Chairman and CEO, "We believe that
breast tomosynthesis is clearly the wave of the future for digital
mammography, and Hologic plans to lead the way in development and
commercialization of this tremendously exciting new technology. Although
breast tomosynthesis is still in the early phases of research, we have been
very pleased with the rate of progress in our program and the high quality of
the initial images we have acquired in our research studies. Over the next
several months we plan to extend our research studies to investigate other
facets of this technology, the feasibility of reduced breast compression, and
utilization of breast tomosynthesis for needle localization and biopsy
procedures."
"Our research efforts will also continue to focus on determining the most
appropriate application for this technology," continued Cumming, "whether as
a screening and diagnostic modality or as an adjunct to conventional
mammography screening. We plan to significantly accelerate our research
programs in 2004, with a goal of submitting a marketing application to the
Food and Drug Administration in the near future."
The Hologic digital breast tomosynthesis system is currently available
only as a research unit for users of Hologic's Lorad Selenia full field
digital mammography system and is limited by federal law to investigational
use. In addition to ongoing research, Hologic is actively working with
several facilities to gain Institutional Review Board approval for expansion
of clinical investigational studies. Dr. Jay Stein, Hologic's Chief
Scientific Officer, has led development efforts for the system.
"I am very pleased with the progress of this program," said Dr. Stein.
"We set aggressive internal objectives for this technology, including the
ability to achieve rapid image reconstruction and scan times at a total dose
comparable to standard mammography exams. We believe we have achieved those
goals and now look forward to working with the medical community to optimize
this system and gather the data required for regulatory applications. I
believe this technology offers enormous potential to significantly improve
diagnostic accuracy in mammography, and we are anxious to advance development
and commercialization of this important technology."
About Hologic
Hologic, Inc. is a leading developer, manufacturer and supplier of medical
imaging systems dedicated to serving the healthcare needs of women, and a
leading developer of state-of-the-art digital imaging technology for general
radiography and mammography applications. Hologic's core business units are
focused on osteoporosis assessment, mammography and breast biopsy, direct-to-
digital X-ray for general radiography applications and mini C-arm imaging for
orthopedic applications. For more information, please visit http://www.hologic.com.
Forward Looking Disclaimer
This News Release contains forward-looking information that involves risks
and uncertainties, including statements regarding the Company's plans, goals,
objectives, expectations, intentions and beliefs. Such statements include,
without limitation, statements regarding: our goals, plans and focus for our
research, development and commercialization of our tomosynthesis system and
technology; the potential and our expectations regarding the performance of
that system and technology; and our goal of submitting a marketing application
for the system to the Food and Drug Administration in the near future. These
forward-looking statements are subject to known and unknown risks and
uncertainties that could cause actual results to differ materially from those
anticipated. The Company cannot assure that it will be able to complete the
development of its tomosynthesis system on a timely basis, if at all, or that
once developed, the system will perform as anticipated or be commercially
successful. Factors that could cause actual results to materially differ
include, without limitation: uncertainties inherent in the development of new
products and the enhancement of existing products, including technical and
regulatory risks, cost overruns and delays; the risk that newly introduced
products may contain undetected errors or defects or otherwise not perform as
anticipated; the Company's ability to predict accurately the demand for its
products, and products under development, and to develop strategies to address
its markets successfully; the early stage of market development for digital X-
ray products; manufacturing risks that may limit the Company's ability to
ramp-up commercial production of the Selenia and other of the Company's
digital products, including the Company's reliance on a single source of
supply for some key components of its products as well as the need to comply
with especially high standards for those components and in the manufacture of
digital X-ray products in general; reimbursement policies for the use of the
Company's products; risks relating to compliance with financial covenants
under the Company's working capital financing and leases; and technical
innovations that could render products marketed or under development by the
Company obsolete; competition. Other factors that could adversely affect the
Company's business and prospects are described in the Company's filings with
the Securities and Exchange Commission. Hologic expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to any
such statements to reflect any change in the Company's expectations or any
change in events, conditions or circumstances on which any such statement is
based.
Contact:
Glenn P. Muir Frances Crecco
Executive Vice President and CFO Manager, Investor Relations
Hologic, Inc. Hologic, Inc.
(781) 999-7300 (781) 999-7377
SOURCE Hologic, Inc.
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Related links:
http://www.hologic.com
CONTACT:
Glenn P. Muir, Executive Vice President and
CFO, +1-781-999-7300, or Frances Crecco, Manager, Investor
Relations, +1-781-999-7377, both of Hologic, Inc.
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