Healthcare Industry News:  endometrial biopsy 


 News Release - November 15, 2006

Eight Studies Evaluating Cytyc's Novasure(R) System Presented at AAGL Meeting

MARLBOROUGH, Mass.--(HSMN NewsFeed)--Cytyc Corporation (Nasdaq: CYTC ) today announced that a total of eight studies evaluating performance of the NovaSure® System for endometrial ablation were presented at the 33rd Annual Meeting of the American Association of Gynecologic Laparoscopists (AAGL) in Las Vegas. The studies covered a range of performance characteristics and patient populations. The studies included two evaluating the use of the NovaSure System in an in-office setting, and one presenting five-year follow-up data on the efficacy of the NovaSure System for the treatment of abnormal uterine bleeding using second generation endometrial ablation.

David Kreuze, M.D., presented a study assessing the ability of performing the NovaSure Endometrial Ablation in-office under local anesthesia. The study included 30 patients with refractory menorrhagia. All patients were treated with NovaSure Endometrial Ablation with no endometrial pre-treatment of any kind. Patients were instructed to take a mild tranquilizer and an analgesic prior to arriving at the office. At the office a local anesthetic (para-cervical block) was administered prior to the procedure. The author reported that 29 of the 30 patients were treated successfully and 87 percent reported minimal or moderate discomfort. All treated patients were released within 15 minutes of procedure completion.

Robert Southwick, M.D., and Amy VanEss, R.N., presented a similar study, which assessed the safety, tolerability, and efficacy of NovaSure Endometrial Ablation performed in-office with minimal anesthesia. The prospective study included 78 women with severe menorrhagia secondary to dysfunctional uterine bleeding (DUB). All patients underwent pre-procedure endometrial biopsy and hysteroscopy. The patients did not receive any drug or mechanical pre-treatment to thin the endometrium prior to the procedure. Patients were advised to take a mild anti-anxiety and an analgesic orally before arrival and were given a local anesthetic at the office prior to the ablation. NovaSure Endometrial Ablation was successfully performed in-office with local anesthetic on 94 percent of patients (73/78). Three patients were not eligible for ablation and the NovaSure procedure was successfully performed on two others in the operating room. Results for the 73 patients showed average pain scores similar to pain experienced during menses. The patients treated with NovaSure Endometrial Ablation had a mean satisfaction score of 4.79 on a scale where one is dissatisfied and five is extremely satisfied and 72 of 73 patients said they would recommend the procedure to a friend.

A study by Bongers et al., from Maxima Medical Centre, in Veldhoven, The Netherlands, presented five-year follow-up data comparing the NovaSure System and ThermaChoice® balloon ablation for the treatment of pre-menopausal women with menorrhagia. The study included 126 patients randomized at a ratio of two to one, NovaSure System versus ThermaChoice. Five-year follow-up data was available for 80 percent of the NovaSure System arm and 72 percent of the ThermaChoice arm. Results showed that at five years post-treatment, hysterectomy was avoided in 91 percent of the patients treated with the NovaSure Endometrial Abalation System and 89 percent of patients treated with ThermaChoice. Amenorrhea rates were 68 percent in the NovaSure arm and 36 percent in the ThermaChoice balloon arm. The authors concluded that the NovaSure System is an effective and safe second-generation device, and yielded better amenorrhea and patient satisfaction rates when compared to ThermaChoice.

"The studies presented at this meeting clearly demonstrate that use of the NovaSure Endometrial Ablation System in an office setting under local anesthesia is a viable alternative for many patients and their physicians," said Ellen Sheets, M.D., Cytyc's chief medical officer. "In addition, the five-year follow-up data presented at this meeting suggests that NovaSure provides a greater long term amenorrhea rate as compared to the balloon technology and validates the efficacy of NovaSure technology in avoiding costly and invasive hysterectomies for the treatment of menorrhagia."

Cytyc Corporation is a leading provider of best-in-class medical technology that enables physicians and laboratories to improve patients' lives throughout the world. Cytyc provides diagnostic and minimally invasive surgical products targeting cancer and women's health. The ThinPrep® System is the most widely used method for cervical cancer screening in the United States. The ThinPrep System consists of the ThinPrep® 2000 Processor, ThinPrep®3000 Processor, ThinPrep® Imaging System, and related reagents, filters, and other supplies. The ThinPrep System also provides the platform from which the Company launched its expansion into breast cancer risk assessment with the FirstCyte® Breast Test. The NovaSure® Impedance Controlled Endometrial Ablation System, or the NovaSure® System, is an innovative endometrial ablation device to treat menorrhagia, or excessive menstrual bleeding. The MammoSite® Radiation Therapy System is a single-use device for the treatment of breast cancer that positions radiation sources directly into the post-lumpectomy site to optimize radiation treatment delivery while minimizing damage to healthy tissue. The GliaSite® Radiation Therapy System is for the treatment of malignant brain tumors.

Cytyc is traded on The Nasdaq Stock Market under the symbol CYTC. Cytyc, ThinPrep, FirstCyte, NovaSure, MammoSite, and GliaSite are registered trademarks of Cytyc Corporation. ThermaChoice is a registered trademark of Johnson & Johnson Corporation.

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.

Source: Cytyc

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