Jan. 30, 2007 -- Cytyc Corporation, a leading provider of surgical and diagnostic products targeting cancer diagnostics and women's health, today announced that a new clinical guideline for Heavy Menstrual Bleeding (HMB), published this month by the UK National Institute for Health and Clinical Excellence (NICE), recommends endometrial ablation as preferable to hysterectomy for the treatment of most women who suffer from heavy menstrual bleeding alone. The new guideline was developed by the National Collaborating Centre for Women's And Children's Health, which is based in the Royal College of Obstetricians and Gynecologists.
The document provides recommendations on diagnosis and a care pathway for HMB, as well as information on a variety of treatment options. The new Clinical Guideline provides a review of various endometrial resection and second-generation endometrial ablation techniques such as Cytyc's NovaSure(R) Endometrial Ablation System, described as "bipolar radiofrequency endometrial ablation." The report highlights a study showing that the NovaSure System demonstrated higher amenorrhea rates and greater overall patient satisfaction with treatment outcome at 12 months compared to thermal balloon endometrial ablation (TBEA).
"This is an important clinical milestone for the NovaSure System in the UK and we commend the NICE for acknowledging the benefits of second generation endometrial ablation techniques, such as the NovaSure System, and the importance of patient choice," said Ellen Sheets, M.D., Cytyc's chief medical officer.
Additional recommendations contained in the Guideline include:
- Endometrial ablation should be considered where bleeding is having a severe impact on a woman's quality of life, and she does not want to conceive in the future.
- Endometrial ablation may be offered as an initial treatment for HMB after full discussion with the woman of the risks and benefits and of other treatment options.
- All women considering endometrial ablation should have access to a second-generation ablation technique.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of innovative imaging technology for digital radiography and breast imaging. Hologic's core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C-arm and extremity MRI imaging for orthopedic applications. Cytyc's products cover a range of cancer and women's health applications, including cervical cancer screening, preterm birth screening, treatment of excessive menstrual bleeding, radiation treatment of patients with early-stage breast cancer.
Forward-looking statements in this press release are made pursuant to the provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements relating to Cytyc's future financial condition, operating results and economic performance, and management's expectations regarding key customer relationships, future growth opportunities, product acceptance and business strategy, constitute forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from those statements. Risks and uncertainties include, among others, dependence on key personnel and customers as well as reliance on proprietary technology, uncertainty of product development efforts and timelines, management of growth, product diversification, and organizational change, entry into new market segments domestically and new markets internationally, risks associated with litigation, the successful consummation of planned acquisition transactions, the effective integration of acquired businesses and technologies, competition and competitive pricing pressures, risks associated with the FDA regulatory approval processes and healthcare reimbursement policies in the United States and abroad, introduction of technologies that are disruptive to Cytyc's business and operations, the impact of new accounting requirements and governmental rules and regulations, as well as other risks detailed in Cytyc's filings with the Securities and Exchange Commission, including those under the heading "Risk Factors" in its 2005 Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q filed with the Commission. Cytyc cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Cytyc disclaims any obligation to publicly update or revise any such statements to reflect any change in its expectations or events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Deborah R. Gordon
Vice President, Investor Relations
Director, Investor Relations