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Three Studies Evaluating Cytyc's NovaSure System Presented at ACOG Annual Meeting
BOXBOROUGH, Mass., May 10, 2004 - Cytyc Corporation today announced that three studies evaluating the safety, efficacy and clinical performance of its NovaSure(R) System for endometrial ablation were presented last week at the 52nd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) in Philadelphia. The studies describe a range of benefits including improved patient outcomes, improved patient satisfaction rates, and reduced operating room and recovery time. A study by Richard Gimpelson, M.D., of St. Louis University School of Medicine, presented two- and three-year results from a multi-center clinical study that compared the efficacy of NovaSure endometrial ablation versus loop resection with rollerball ablation as the control. Results showed increased success rates with NovaSure as well as shorter procedure times. The author concluded that the NovaSure procedure yields high amenorrhea and patient satisfaction rates without the need for endometrial pretreatment. A second study comparing intraoperative and postoperative pain level in patients treated with the NovaSure System versus the ThermaChoice(R) UBT endometrial ablation technique, was presented by Philippe Laberge M.D., of Pavillon CHUL, Quebec, Canada. The results of the study indicate that patients treated with the NovaSure System experience significantly less intraoperative and postoperative pain than patients treated with the ThermaChoice UBT System. Dr. Gimpelson also presented a study comparing four of the commercially available global endometrial ablation devices, based on the U.S. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data (SSED) for each device. The review included the NovaSure System, ThermaChoice UBT, HydroThermablator(R) and Her Option(R). The author concluded, "Based on SSED data, it appears that NovaSure yields the highest amenorrhea, success, and patients satisfaction rates" of the devices included in this study. NovaSure is also the only endometrial ablation system approved for use without endometrial pretreatment. Cytyc also conducted an educational symposium titled "Endometrial Ablation: The Art of Managing Abnormal Uterine Bleeding." More than 300 physicians attended the symposium. The program outlined the pathophysiology, diagnosis and treatment options for abnormal uterine bleeding and presented a clinical overview of the NovaSure System. Endometrial ablation in an office setting was also discussed. "The scientific evidence continues to confirm the benefits and advantages of the NovaSure System for endometrial ablation," said James Linder, M.D., Cytyc's chief medical officer. "We will continue to collect and present clinical data as we expand implementation of this innovative technology for the treatment of excessive menstrual bleeding." It is estimated that as many as 7 million pre-menopausal women between the ages of 35-55 suffer from menorrhagia and 2.5 million women seek treatment for this condition each year. Current treatment options include hormone therapy, hysterectomy, and endometrial ablation. Published studies have demonstrated the clinical efficacy of the NovaSure System and the potential cost-effectiveness of endometrial ablation compared to hysterectomy. 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, 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, including under the heading "Certain Factors Which May Affect Future Results" in its 2003 Annual Report on Form 10-K. 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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