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Thirteen Studies Evaluating Cytyc's NovaSure(R) System Presented at AAGL Annual Meeting
MARLBOROUGH, Mass., (Nov 15, 2005) - Cytyc Corporation, a leading women's health company, today announced that 13 studies evaluating the performance of the NovaSure(R) System for endometrial ablation were presented last week at the 34th Annual Meeting of the American Association of Gynecologic Laparoscopists (AAGL) in Chicago. The studies, conducted at a variety of institutions including medical centers, in-office clinics, and academic institutions, report on a wide range of benefits of the NovaSure System. Two presentations of long-term results demonstrated excellent efficacy and safety rates for the NovaSure System. Tamas Fulop, M.D., of St. Imre Teaching Hospital in Budapest, Hungary states that at seven-year follow-up, "Hysterectomy due to menorrhagia was avoided in 100% of cases and in 92% of cases for all other reasons." A five-year follow-up conducted by Adolf Gallinat, M.D., of the Center Gynecological Endoscopy, Hamburg, Germany, reported that pretreatment is not required, active bleeding during the time of the operative visit is not a limiting factor, and a reduction in bleeding to normal levels or less in 96 percent of patients. John Bertrand, M.D., of the University of Texas Southwestern, in Dallas, conducted a study on the use of NovaSure in an office setting environment. The author concluded that due to the short treatment time, low intra- and post-operative level of discomfort, lack of need for deep level sedation, and short recovery time, "NovaSure is a viable endometrial ablation procedure fully compatible with an office setting environment." Also, Anderson et al. developed an evidence-based protocol for in-office endometrial ablation utilizing the NovaSure System, based on available guidelines for office-based surgical procedures. Three studies were conducted by Robert Sabbah, M.D., and others of the Department of Obstetrics, Gynecology at Sacred Heart Hospital, University of Montreal, Canada. The first study demonstrated the feasibility and compatibility of Essure(R) sterilization following NovaSure endometrial ablation. Another evaluated the appearance of the uterine cavity one year following the NovaSure procedure and a third reported on the performance of NovaSure in patients with Type I and Type II fibroids. Hopkins et al. of the Mayo Clinic, Rochester, Minnesota, also presented a study reporting on the ease and safety of Essure sterilization following NovaSure endometrial ablation. Five studies comparing various global endometrial ablation devices included the NovaSure System were presented, among them a retrospective analysis of the efficacy of five endometrial ablation techniques conducted by Danee Young, M.D., of BESTCAREmed, Logan, Utah, that concluded, "...only NovaSure outperformed the gold standard of Rollarball ablation results at 1-year follow-up." Della Badia et al. of Drexel University College of Medicine evaluated serious adverse events associated with the use of endometrial ablation devices. Sharp et al. of University of Utah reported on global endometrial ablation injuries and associated risk factors. Dr. Nugent of the Center of Gynaegological Endoscopy Day Clinic, Hamburg, Germany, reported on long-term failure rates, rates of hysterectomy and late complications following endometrial ablation and concluded, "Even over a long period of time endometrial ablation keeps its position in the treatment of AUB (abnormal uterine bleeding). Hysterectomy rate is relatively low and late complications occur rarely." "It is very encouraging to see the significant number of scientific presentations that demonstrate the increasing interest in the NovaSure System by the U.S. and international medical community," said Daniel Levangie, Cytyc's executive vice president and chief commercial officer. "We believe that NovaSure is the best-in-class global endometrial ablation technology and are confident that rigorous scientific evaluations will continue to demonstrate the clear clinical benefits for physicians and their patients." It is estimated that between 7 and 10 million women in the United States suffer from excessive menstrual bleeding, for many of which, quality of life is compromised by chronic fatigue and anemia, embarrassing accidents, and restricted activity. Current treatment options include hormone therapy, which is effective only 50 percent of the time, hysterectomy, and endometrial ablation. Despite published studies that have demonstrated the clinical efficacy of NovaSure, thousands of excessive menstrual bleeding patients, who are unaware of endometrial ablation as a treatment option, undergo hysterectomy every year. Many women suffer the consequences of invasive surgery including sexual dysfunction, long recovery times, early onset of menopause and chronic pain. About HologicHologic, 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 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 product acceptance, management of growth and product diversification, entry into new market segments, risks associated with litigation, 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, 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 under the heading "Certain Factors Which May Affect Future Results" in its 2004 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.
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