BEI MEDICAL REPORTS HYDRO THERMABLATOR DATA PROMISING.
"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. "The presentations included information about the HTA's amenorrhea 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) 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, 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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|Comment:||BEI MEDICAL REPORTS HYDRO THERMABLATOR DATA PROMISING.|
|Publication:||Biotech Equipment Update|
|Article Type:||Brief Article|
|Date:||Jan 1, 2001|
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