April 23, 2001--BEI Medical
Systems, Inc. (NASDAQ:BMED), announced today that it has received
approval from the U.S. Food and Drug Administration (FDA) to market in
the United States its proprietary device, the Hydro ThermAblator(R),
or HTA(R), a minimally invasive system for treating menorrhagia, or
dysfunctional uterine bleeding.
The treatment can be performed in a doctor's office. FDA approval
follows an extensive review by the agency of the Company's PMA
application, including Phase III randomized multi-center clinical
trial results. In the phase III clinical trial, 40% of the patients
for whom 12-month follow-up data was available had complete
elimination of their menstrual period and an additional 42% exhibited
a decrease in bleeding to normal levels or less. The Hydro
ThermAblator treats the lining of the uterus by circulating a heated
saline solution at low pressure throughout the uterus. Compared with
hysterectomy, treatment with the HTA results in shortened or
eliminated hospital stays, decreased recovery periods and fewer
postoperative complications than hysterectomy.
"We are delighted with the FDA's decision and are thankful for the
cooperation and professionalism demonstrated by the agency in
processing our application," said Richard W. Turner, president and CEO
of BEI Medical. "This PMA approval concludes an eight year effort by
the Company to bring this technology to the U.S. market. The HTA
treatment has exciting potential for the women's healthcare market. An
estimated 150,000 of the 600,000 hysterectomies performed annually in
the U.S. are to treat menorrhagia due to benign causes. Over 2.5
million women annually visit their gynecologists with the primary
complaint of excessive uterine bleeding," he said.
"Endometrial ablation has gained acceptance as an alternative to
hysterectomy for the treatment of uterine bleeding disorders from
benign causes that are resistant to hormonal manipulation," said Dr.
Stephen Corson, of Jefferson Medical College, Philadelphia, PA and
medical director of BEI Medical Systems. "The HTA is used to perform
endometrial ablation, a procedure which is intended to result in the
destruction of all or most of the endometrium, the lining of the
uterus and the source of menstrual bleeding, by circulating a heated
saline solution at low pressure throughout the uterus under direct
visual control. The heated saline solution is delivered through a
small sheath that includes a tiny telescope, permitting the physician
to view inside the uterus prior to and during treatment. This feature
and the low pressure used, results in a safe system which will reduce
the risk of patient injury. A gynecologist can typically perform the
treatment on an outpatient basis using local anesthesia in
approximately half an hour."
Dr. Milton Goldrath, an expert in the treatment of menorrhagia and
the inventor of the HTA, who was formerly Chief, of the Gynecology
Section at Sinai Hospital of Detroit and an Associate Professor in the
Department of Obstetrics and Gynecology Wayne State University School
of Medicine, said "We are convinced that this technique is safe, easy
to learn and effective. The treatment can be easily performed in the
doctor's office by a gynecologist with basic hysteroscopy skills.
There should be no barriers to a gynecologist with these skills
performing this procedure."
According to Dr. Philip Brooks of Cedars Sinai Medical Center, Los
Angeles, California one of the treatment sites in the Phase III
Clinical Study for the HTA, "The HTA is safe, user friendly and well
tolerated by the patients. I was able to treat all of my HTA patients
in the clinical trial, using only local anesthesia, in my office."
"I cannot tell you how thrilled I am," said Marci Feinstein, a
patient who has undergone HTA endometrial ablation. "The procedure was
so easy and took just 30 minutes. I had very little discomfort
afterwards."
At the American College of Obstetricians and Gynecologists 48th
Annual Clinical Meeting in May 2000, a number of prominent physicians
presented their observations on the benefits of the Hydro
ThermAblator. Among them was Dr. Joseph Krotec, MD, Thomas Jefferson
University, Philadelphia, PA, who stated, "The HTA system allows real
time observations during the procedure. The physician can watch as
tissue is being ablated and the patient can also observe the results
of the procedure".
Gynecologists will be able to use the existing CPT code for
hysteroscopic endometrial ablation when seeking reimbursement from
insurance and managed-care companies for HTA treatment. BEI Medical
Systems believes this should aid the process of adoption of the Hydro
ThermAblator by the gynecologic community.
BEI Medical Systems Company, Inc., is a company focused on
gynecology. The company has received marketing approval from the FDA
for its sole product, the Hydro ThermAblator (HTA), a proprietary
system intended for the treatment of menorrhagia (excessive uterine
bleeding). BEI Medical Systems, Hydro ThermAblator and HTA are
registered trademarks of BEI Medical Systems Company, Inc., in the
United States and certain foreign countries.
Best, Savant |
