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Five Studies Evaluating Cytyc's NovaSure System Presented at AAGL Meeting
MARLBOROUGH, Mass., (Nov 15, 2004) - Cytyc Corporation today announced that five studies evaluating safety, clinical performance, and ease-of-use for its NovaSure(R) System for endometrial ablation were presented at the 33rd Annual Meeting of the American Association of Gynecologic Laparoscopists (AAGL) held in San Francisco, November 10 - 13. The results indicate that NovaSure is safe and effective in treating excessive menstrual bleeding in patients with Type I and Type II fibroids, compatible with an office setting, and that Essure(R) hysteroscopic sterilization is achievable following the procedure. A study by Tamas Fulop, M.D., of St. Imre Teaching Hospital in Budapest, Hungary, performed a five-year clinical study that measured the safety and efficacy of NovaSure to treat excessive menstrual bleeding. The results showed 97 percent of patients achieved reduction in bleeding to normal levels or less, with more than two-thirds reporting amenorrhea, the complete cessation of bleeding. Hysterectomy due to excessive menstrual bleeding was avoided in 100 percent of cases. Richard J. Gimpelson, M.D., associate clinical professor in the Department of Obstetrics, Gynecology & Women's Health at St. Louis University School of Medicine, presented these data at the meeting on Dr. Fulop's behalf. Dr. Gimpelson concluded, "Considering the risks and complications associated with hysterectomy, NovaSure is an excellent alternative to provide positive patient outcomes in treating excessive menstrual bleeding." Results from a second study that followed more than 100 patients with excessive menstrual bleeding for three years after receiving the NovaSure procedure were presented by Lead Investigator Adolf Gallinat, M.D., of Tagelskilini Altonaer Strabe in Hamburg, Germany. Consistent with Dr. Fulop's study, 97 percent of patients reported a reduction in bleeding to normal levels or less. A study led by Robert Sabbah, M.D., and G. Desaulniers, M.D., of the Department of Obstetrics, Gynecology at Sacred Heart Hospital, University of Montreal, Canada, found NovaSure to be 96 percent effective in treating abnormal bleeding in patients with Type I and Type II fibroids, with 71 percent of patients reporting amenorrhea and an additional 25 percent of patients reporting reduction in bleeding to normal levels or less. In another study led by Dr. Sabbah, preliminary results suggested hysteroscopic sterilization is achievable with Essure(R) after receiving the NovaSure procedure. John Bertrand, M.D., of Walnut Hill Obstetrics/Gynecology Associates in Dallas, Texas, examined the outcome of performing NovaSure in an office environment. Patients reported minimal intra- and post-operative discomfort, no intra- or post-operative complications, and 100 percent reported at least some reduction in bleeding. Peter S. Pyatak, M.D., of Virginia Physicians for Women in Richmond, Virginia, presented multicenter data at the meeting on Dr. Bertrand's behalf. Dr. Pyatak concluded, "NovaSure is a viable endometrial ablation procedure when performed in an office setting." "The clinical results presented this week are encouraging for the women who unnecessarily undergo hysterectomy every year to alleviate the pain and suffering of excessive menstrual bleeding," said Eugene Skalnyi, M.D., vice president medical affairs, Cytyc Surgical Products. "For these women and the millions more who suffer in silence, Cytyc will continue to offer a safe and effective, long-term treatment alternative." It is estimated that 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 the Company's financial condition, operating results and future economic performance, and management's expectations regarding 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 proprietary technology, uncertainty of product development efforts and the success of investments in emerging technologies, product acceptance, management of growth, risks associated with litigation and the effective integration of acquired businesses and technologies, competition and competitive pricing pressures, risks associated with the FDA regulatory approval processes and any healthcare reimbursement policies, and other risks detailed in the Company's filings with the Securities and Exchange Commission, included under the heading "Certain Factors Which May Affect Future Results" in its 2003 Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q filed with the Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in Company 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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