Printer Friendly
The Free Library
14,582,672 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

BEI Medical Systems Reports Results of Clinical Trials At FIGO World Congress; Gynecologists Speak About Hydro ThermAblator Treatment.


Business Editors & Medical Writers

TETERBORO, N.J.--(BUSINESS WIRE)--Sept. 14, 2000

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 BMED British Mediterranean Airways
BMed Bachelor of Medicine
BMEd Bachelor of Mathematics Education
), reports positive reaction to gynecologists' presentations about its Hydro ThermAblator(R) ("HTA(R)") at the 16th FIGO World Congress of Gynecology and Obstetrics which was held recently at the Washington Convention Center The Washington Convention Center has been the name of two convention centers in Washington, D.C. The old Washington Convention Center was located at 909 H Street NW and was in use from 1983 until 2004. , Washington, DC.

The HTA is an investigational device for the treatment of excessive uterine bleeding and is currently in 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  under an investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  ("IDE") approved by 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.
").

Richard W. Turner, president and chief executive officer of BEI Medical Systems, stated that, "We are pleased with the interest the HTA received at the show following the presentations by three gynecologists who addressed the Congress and presented papers about the HTA. Gynecologists attending the show expressed particular interest in the HTA's ability to provide direct visualization of the uterine cavity through a hysteroscope and its ability to treat abnormally sized and shaped uterine cavities."

Dr. Franklin Loffer, a leading U.S. gynecologist gynecologist /gy·ne·col·o·gist/ (-kol´ah-jist) a person skilled in gynecology.

gy·ne·col·o·gist
n.
A physician specializing in gynecology.
 and a participant in the HTA clinical trial, reported on the preliminary results of patients in the trial 12 months following treatment. This 12 month post-treatment follow-up data is to be included in the company's PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
 (pre-market approval) submission to the FDA. Another noted U.S. gynecologist, Dr. Jay M. Berman, who also participated in the Phase III clinical trial, presented a paper in which he compared clinical and economic outcomes for hospital-based abdominal hysterectomy and traditional rollerball ablation to endometrial ablation using the HTA in an outpatient surgery center and in the office setting. Dr. Berman is on the faculty of Wayne State University School of Medicine The Wayne State University School of Medicine (WSUSOM) is the largest single-campus medical school in the United States with more than 1,000 medical students. In addition to undergraduate medical education, the school offers master’s degree, Ph.D. and M.D.-Ph.D. , in Detroit, Michigan, and also has a private practice in obstetrics and gynecology obstetrics and gynecology

Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system.
 in Southfield, Michigan.

Finally, Dr. Mohamed Hefni a gynecologist in the United Kingdom who has been using the HTA, presented a paper based on 51 patients he had treated in the United Kingdom with the HTA and the follow-up of 31 of the patients for 9 to 18 months. Dr. Hefni reported 55 percent of these patients had no menstrual bleeding, and an additional 32 percent had only light menstrual bleeding following treatment with the HTA for their excessive menstrual bleeding.

Mr. Turner stated, "Filing of the 12 month post-treatment follow-up data as the final portion of the company's Phase III PMA with the FDA is imminent, pending final review by the company's outside counsel and the Clinical Research Organization."

BEI Medical Systems Company, Inc., based in Teterboro, NJ, 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 menorraghia, 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.

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.
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Sep 14, 2000
Words:587
Previous Article:Yipes Appoints Vice President of Operations.
Next Article:Comverse Infosys Announces STAR-GATE Enhancement For Monitoring Packet Data Networks.
Topics:



Related Articles
BEI Medical Systems Announces That Its Hydro ThermAblator Will be Subject of Three Presentations At FIGO World Congress; Preliminary 12-Month Data to...
BEI Medical Systems Reports Preliminary Results of Trials for Its HTA Treatment for Excessive Uterine Bleeding.
Patient Bill of Rights 2001.
"Bloody Dr.Neale" was an abortionist (England).(Brief Article)
'ABORTION PILL' NOT YET A FREQUENT CHOICE.(L.A. Life)
AMA BACKS DISCLOSURE OF HMO GAG CLAUSES.(News)
Identifying worthy medical research.
Hormone therapy: health protection lessons from the Women's Health initiative.(My Body, My Health!)
Gynecologists v. radiologists.(Tilting at Windmills)(Brief Article)
Companies still hiding drug trial data, medical journals say.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles