BEI MEDICAL REPORTS HYDRO THERMABLATOR DATA PROMISING.BEI Medical Systems Company, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BMED) presentations about its Hydro ThermAblator(R)(HTA(R)), a new treatment for menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea. men·or·rha·gia n. See hypermenorrhea. , or dysfunctional uterine bleeding Dysfunctional Uterine Bleeding Definition Dysfunctional uterine bleeding is irregular, abnormal uterine bleeding that is not caused by a tumor, infection, or pregnancy. , were well received at the Global Congress of Gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology. Endoscopy, sponsored by the American Association of Gynecologic Laparoscopists (AAGL). "This was the first time we presented our clinical trial data to an audience of predominately American gynecologists, and we were pleased with the reception of the data," said Richard W. Turner, BEI president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "The presentations included information about the HTA's amenorrhea amenorrhea (āmĕn'ərē`a, əmĕn'–), cessation of menstruation. Primary amenorrhea is a delay in or a failure to start menstruation; secondary amenorrhea is an unexpected stop to the menstrual cycle. rate, direct visualization capability, the ability to treat uteri larger than 10.5 centimeters and the ability to treat uteri with some benign abnormalities." The HTA is not yet approved for sale in the United States. The company has filed for pre-market approval with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) seeking approval to market the HTA and anticipates final FDA review in early 2001. Two presentations discussed the suitability of using the HTA procedure in doctors' offices under local anesthesia. One was by Dr. Philip Brooks of Cedars-Sinai Medical Center Cedars-Sinai Medical Center is a world-renowned hospital located in Los Angeles, California. History Cedars-Sinai is the result of a merger in 1961 between two major Los Angeles hospitals, Cedars of Lebanon and Mount Sinai Home for the Incurables, with Steve Broidy as , Los Angeles, California, who described his experiences in performing all of his procedures under local anesthesia during the clinical trial. The other was by Dr. Martin Farrugia of Whipps Cross Hospital, London, who showed a video of a procedure during which one of his patients was able to speak to him during the procedure, watch the procedure on a video monitor, get up immediately when it was over and leave the treatment room. The HTA incorporates a tiny telescope that allows the physician to view the procedure on a video monitor during the entire course of treatment. The HTA is a minimally invasive treatment that alters the lining of the uterus, which is the source of menstrual bleeding, by circulating a heated saline solution at low pressure throughout the uterus. During the clinical trial, the procedure often resulted in a significant reduction of bleeding and, in 40% of the cases followed by BEI through the twelve months following treatment in the clinical trial, the complete elimination of a woman's period. The procedure may be performed on an outpatient basis in a doctor's office in most cases in approximately half an hour. BEI Medical Systems Company, Inc., is a development-stage company that focuses on gynecology. Its sole product is the Hydro ThermAblator, or HTA, a proprietary system intended to treat menorrhagia, or dysfunctional uterine bleeding, due to benign causes. BEI Medical Systems(R), Hydro ThermAblator(R) and HTA(R) are registered trademarks of BEI Medical Systems Company, Inc., in the United States and certain foreign countries. For more information, call 201/727-4900. |
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