BEI Medical Systems Receives PMA Supplement Approval for Sheath Assembly.

Business Editors/Health & Medical Writers

TETERBORO, N.J.--(BW HealthWire)--Jan. 17, 2002

BEI Medical Systems Company, Inc. (Nasdaq:BMED) today announced that the U.S. Food and Drug Administration (FDA) has approved a Premarket Approval Application (PMA) supplement permitting modifications to the assembly of the sheath used in the Hydro ThermAblator (HTA) procedure set.

This approval allows BEI to incorporate streamlined, cost effective manufacturing practices, while maintaining its high level of product quality and consistency.

"The allowance of this modification is an important step in our ongoing objective to reduce production costs of the HTA single-patient-use procedure set, which is expected to result in eventual savings of approximately 50% as production volumes accelerate," stated Richard Turner, Ph.D, president and chief executive officer. "We expect the new sheath assembly to be implemented during the second half of fiscal year 2002, once sterilization validation and the transition to manufacturing of the modified design are completed."

Hydro ThermAblator(R) (HTA) and Menorrhagia 

Menorrhagia is defined as excessive menstrual bleeding. It often occurs in the absence of uterine fibroids or tumors and hormonal treatment is often unsatisfactory. The condition is responsible for approximately 150,000 of the 600,000 hysterectomies performed annually in the United States, but many women who do not seek hysterectomy for relief may suffer in silence until the occurrence of menopause. In April 2001, the U.S. Food and Drug Administration approved the HTA system, which uses circulating heated saline to ablate the endometrium, or the lining of the uterus, to decrease or eliminate abnormal uterine bleeding. The portable HTA control unit features a control panel with step-by-step prompts, while gravity flow safely limits the maximum fluid pressure to the patient. HTA therapy includes direct visual control of transcervical access and visualization throughout the duration of the procedure.

In our Phase III clinical trial, treatment using the HTA completely eliminated uterine bleeding in 40% of the patients whose condition was reviewed 12 months following treatment, while an additional 42% exhibited a decrease in uterine bleeding to normal levels or less as defined by the FDA. HTA treatment resulted in an overall average reduction in uterine bleeding of 84.8%. As announced in November 2001, for those women who were available for follow-up and whose condition was reviewed 24 months following treatment, 47.6% had complete cessation of uterine bleeding and an additional 44.2% had a reduction in uterine bleeding to normal levels or less. In addition, at 24 months following treatment, 95.5% of patients were satisfied with the results of their HTA treatment and 92.5% of patients reported alleviation of menstrual discomfort.

About BEI Medical Systems

BEI Medical Systems Company, Inc. is a company focused on gynecology. The Company received FDA approval to market its sole product, the Hydro ThermAblator, or HTA, a proprietary system that is intended to treat menorrhagia, or dysfunctional uterine bleeding in April 2001. 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.

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements may be deemed to include information that is not historical, including without limitation, statements based on our current expectations, assumptions, estimates and projections about our Company and our industry, including statements with respect to the timely acceptance, commercialization and pricing of our Hydro ThermAblator or HTA, the establishment of a qualified sales representative network, the impact of our cost reduction programs on the cost of the HTA procedure set, the impact of competitive products and pricing, the ability of the Company to satisfy the conditions of the FDA approval and on-going regulatory requirements, the efficacy of future HTA treatments and general economic conditions as they affect our customers. Readers are cautioned that the forward-looking statements reflect management's analysis only as of the date hereof, and we assume no obligation to update these statements. Actual events or results may differ materially from the results discussed in or implied by the forward-looking statements. In addition to the factors set forth elsewhere in this press release, factors that might cause such a difference include, but are not limited to, risks related to the Company's ability to raise additional capital, and those risks and uncertainties discussed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the period ended September 29, 2001.