BEI Medical Systems Reports Preliminary Results of Trials for Its HTA Treatment for Excessive Uterine Bleeding.Business Editors TETERBORO, N.J.--(BUSINESS WIRE)--Sept. 6, 2000 BEI Bei (pā, bā), river, c.200 mi (320 km) long, formed by the union of two headstreams in the Nanling Mts., N Guangdong prov., S China. It flows S into the Xi River, E of Guangzhou, to form the Pearl River delta. 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 BMED British Mediterranean Airways BMed Bachelor of Medicine BMEd Bachelor of Mathematics Education ), announced preliminary results of the twelve-month post-treatment review of the Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for the Company's Hydro ThermAblator(R)("HTA HTA Health Technology Assessment HTA Hipertension Arterial (Spanish: Hypertension) HTA HTML Application HTA Help the Aged HTA Human Tissue Authority (UK) HTA Hochschule für Technik und Architektur ") system to treat menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea. men·or·rha·gia n. See hypermenorrhea. , or excessive uterine bleeding. Dr. Franklin Loffer, one of the country's leading gynecologists and a participant in the HTA clinical trial, reported the preliminary results yesterday at the 16th FIGO FIGO Fédération Internationale de Gynécologie Obstétrique (International Federation of Gynecology and Obstetrics) World Congress of Gynecology and Obstetrics meeting in Washington, D.C. Dr. Loffer reported that the Company will be reporting to 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. ") that the HTA, which is being studied as a treatment for women suffering from menorrhagia, produced an average of over 80 percent reduction in uterine bleeding among 166 women who were treated with the HTA during the clinical trial and whose progress was followed for 12 months. Dr. Loffer also reported that the HTA completely eliminated menstrual bleeding in approximately 40 percent of the patients treated. All of the treatments were conducted on an outpatient basis (without an overnight hospital stay) and many of the patients were treated in the doctors' offices, often with the use of local anesthetic local anesthetic n. An agent that, when applied directly to mucous membranes or when injected about the nerves, produces loss of sensation by inhibiting nerve excitation or conduction. , he said. The entire HTA procedure required fewer than 30 minutes, on average, Dr. Loffer reported. Richard W. Turner, president and chief executive officer of BEI Medical Systems, stated, "We are extremely pleased with the results of the clinical trial and plan to submit this information to the FDA in mid-September 2000. The submission of this data will complete the final portion of the modular pre-market approval submission with the FDA, seeking authorization to market the Hydro ThermAblator as a treatment for women suffering from menorrhagia. We continue to anticipate final FDA review of the HTA in early 2001." The FDA has notified the company that it does not have any additional questions regarding the second module covering the quality systems and manufacturing practices related to the HTA, which was submitted earlier this year. BEI Medical Systems Company, Inc., is a development stage company focused on gynecology. The company is conducting a clinical trial of its sole product, the Hydro ThermAblator, or HTA system, a proprietary system that is intended to treat menorrhagia, or excessive uterine bleeding. 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 additional information, please visit the company's web site at www.beimedical.com. Except for historical information, this news release may be deemed to contain forward-looking statements that involve risks and uncertainties, including statements with respect to: timely development; acceptance and pricing of the HTA system; whether the HTA proves to be safe and effective in U.S. and international clinical trials under applicable regulatory guidelines; receipt of required FDA approval; the impact of competitive products and pricing; and general economic conditions as they affect BEI Medical's customers, as well as other risks detailed from time to time in the company's reports to the Securities and Exchange Commission, including the company's Form 10-K Annual Report. |
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