BEDFORD, Mass., September 24, 2009 - 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 United Kingdom's National Institute for Health and Clinical Excellence (NICE), in its updated guidance for hysteroscopic sterilization, supports the use of Hologic's Adiana® permanent
contraception system. NICE, a part of the National Health Service (NHS), is an independent organization responsible for providing national guidance on treatments and care for those using the NHS in the United Kingdom. The Adiana system received CE marking approval in January 2009 and U.S. Food and Drug Administration (FDA) approval in July 2009. The Adiana system is designed to provide women a minimally-invasive, non-incision alternative to traditional, surgical means of permanent
The updated guidance concludes that the data on the safety and efficacy of hysteroscopic sterilization by tubal cannulation and placement of intrafallopian implants supports the use of the Adiana procedure in the U.K.
"This is an important milestone for Hologic and our GYN surgical products business in the U.K.," said Tony Kingsley, senior vice president, GYN surgical products at Hologic. "With more than 50 NHS surgeons now trained to perform the Adiana procedure, the updated NICE guidance should further support our efforts to establish Hologic's minimally-invasive, safe and effective Adiana system in the U.K."
About the Adiana Permanent Contraception System
The Adiana permanent contraception system is minimally-invasive, requires no incisions and can be performed in the comfort of the doctor's office using local anesthesia. Patients are normally able to return to work or resume their daily activities within one day. In contrast, traditional methods of permanent contraception, such as tubal ligation, require more invasive surgical procedures, usually are conducted in a hospital under general anesthesia and typically require four to five days of
recovery. As a result, these more invasive surgical procedures can pose serious risk of complications, including anesthesia-related problems and damage to organs or blood vessels.
During the Adiana procedure, a slender, flexible instrument is passed through the body's natural openings to deliver a low level of radiofrequency (RF) energy to a small section of each fallopian tube. A tiny, soft insert, about the size of a grain of rice, is then placed in each fallopian tube in the location where the energy was applied. During the three months following the procedure, the patient continues to use temporary birth control while new tissue grows in and around the Adiana
inserts, eventually blocking the fallopian tubes. At three months, a special x-ray test (called a hysterosalpingogram or HSG) is performed to confirm the fallopian tubes are completely blocked and the patient may begin relying on Adiana for permanent contraception.
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.
Forward Looking Statement Disclaimer
This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the effect and adoption of the use of the Adiana 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 Adiana system can only be determined on a case-by-case basis depending on the particular
circumstances of the procedure and patient in question. Thus there can be no assurance of general adoption of this technology by the medical community. 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 Adiana are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.
|Deborah R. Gordon
|Vice President, Investor Relations