Hologic Receives Approvable Letter from the FDA for the LORAD(R) Full Field Digital Mammography System
BEDFORD, Mass., Oct 25, 2001 /PRNewswire via COMTEX/ -- Hologic, Inc. (Nasdaq: HOLX chart, msgs), a leading provider of
specialized medical imaging equipment for women's health and general radiographic applications, today announced it received an
approvable letter from the Food and Drug Administration (FDA) for the Company's Lorad(R) Full Field Digital Mammography System.
The Lorad division of Hologic is an industry leader in the production of high quality and technically advanced mammography and
breast biopsy systems. The Pre-market Application submission for this system was based on three years of clinical data gathered
and analyzed at some of the world's leading medical institutions.
The Lorad Full Field Digital Mammography System, utilizing CCD-based technology, is designed to generate digital mammographic
images that can be used for the screening and diagnosis of breast cancer. The American Cancer Society estimates that in 2001,
approximately 192,000 new cases of breast cancer will be diagnosed among women in the United States and 40,000 women will die
of breast cancer.
Commenting on the approvable letter, Jack Cumming, Hologic's President and CEO stated, "We are pleased with the FDA's finding
and look forward to working with them in the final phase of the review process. The FDA's forthright cooperation and responsiveness
through this extensive PMA review process has enabled the Company to achieve this first, and very important, milestone in our
digital mammography development program. We have undertaken a product development strategy dedicated to bringing the best
digital mammography system to market in the shortest time possible. This Full Field Digital Mammography System will serve as the
foundation for additional revolutionary advances in breast cancer detection."
Final marketing clearance for the Lorad Full Field Digital Mammography System is subject to labeling discussions, the agreement
on criteria on the use of the product and successful completion of a Good Manufacturing Practices (GMP) audit by the FDA of
Hologic's manufacturing facility in Bedford Massachusetts. The Company will continue to work with the FDA in this final phase of the
Pre-market Application review process.
Mr. Cumming also indicated that the Company is in the advanced stages of development of a second-generation digital
mammography system that incorporates its proprietary amorphous selenium DirectRay(R) direct-to-digital technology. The Company
believes this amorphous selenium-based full-field digital mammography system will be superior in performance to other modalities
currently available due to its enhanced image quality and dose utilization characteristics. This system will require additional
regulatory review by the FDA. The Company expects to work closely with the FDA to bring this second- generation system to
market as expeditiously as possible.
Pete Kershaw, Vice President and General Manager of Lorad said, "Our TEAM of scientists, engineers, regulatory and
manufacturing personnel should be commended on their contributions to the development of the Lorad Full Field Digital
Mammography System. The name Lorad has long been synonymous with the best in mammographic imaging systems and breast
biopsy devices. We believe that the migration into digital imaging will solidify our leadership in the field. With recent studies
indicating the five-year survival rate is almost 100% when breast cancer in detected at an early stage, the need to broaden the
access to mammography screening services has never been greater. This new system is a first step in addressing this need. From
a business opportunity standpoint, market studies estimate that the x-ray mammography market is expected to double to $567.2
million by 2007, driven by the emergence of full- field digital mammography. Our Full Field Digital Mammography System positions
us well to benefit from this anticipated growth." |
