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New Data Presented On The Renessa(R) Treatment For Female Stress Urinary Incontinence
Novasys Medical, Inc., a
developer of innovative therapies in women's health, announced that
six month data from its post-market, prospective open label study to
evaluate the long term durability of the Renessa(R) treatment for stress
urinary incontinence (SUI) in women was presented at the Western Section
meeting of the American Urological Association (AUA). A total of 137 women
in the trial have been treated at 13 different sites across the United
States. The patients will be followed for three years post-treatment.
Denise Elser, M.D., a urogynecologist practicing in Oak Lawn, Illinois
and the principal investigator in the trial, presented the data in
Scottsdale, AZ. "The non-surgical Renessa procedure offers women suffering
from the isolating effects of SUI a safe, effective alternative between
conservative treatments such as Kegel exercises and biofeedback, and more
invasive surgical therapies," Dr. Elser said. "Women are looking for an
alternative to exercise and surgery. My patients and I have been very
pleased with the safety and results of this noninvasive treatment," she
continued. The trial results will also be presented during a poster session
at the upcoming Global Congress of Minimally Invasive Gynecology in
Washington, DC.
Highlights of the six month results include:
-- 74% of women showed an improvement in their symptoms with 63% of women
reducing their episodes to less than half
-- 74% of women reported improvement in their quality of life
"This multi-center three year prospective trial is expected to confirm the outcomes seen in our previous U.S. Pivotal Trial," said Charles S.
Carignan, M.D., Chief Medical Officer of Novasys Medical. "The six month
results so far not only validate our earlier studies, but outcomes have
been better in a slightly more severely affected population of women. And
as has been the case in all four previous studies and in our commercial
experience, there have been no serious adverse events reported," he states.
The company previously reported long term clinical outcomes from its
U.S. Pivotal Trial which confirmed an improvement in quality of life and a
reduction in the frequency and severity of incontinence episodes in the
majority of women almost 4 years after treatment.
SUI is the involuntary leakage of urine associated with laughing,
coughing, sneezing and recreational activities. The condition is caused by
a variety of factors, most commonly childbirth, and often restricts the
social, professional, and personal lives of an estimated 15 million women
in the U.S. alone. With currently available surgical and non-surgical SUI
therapies, many patients and physicians have concerns about safety,
recovery, compliance, and/or effectiveness. In fact, it is estimated that
approximately 80% of women with SUI do not seek treatment of any kind due
to concerns over recovery time, possible complications or lack of
confidence in the effectiveness of available options. The Renessa procedure
offers women a new non-surgical approach to the effective treatment of SUI.
The FDA-cleared Renessa System includes a small probe which a physician
passes through the natural opening of the urethra (transurethral). The
probe heats multiple small treatment sites in the submucosa of the bladder
neck and upper urethra, denaturing collagen in the tissue. Upon healing,
the treated tissue is firmer, resulting in increased resistance to
involuntary leakage at times of increased abdominal pressure, such as
laughing, coughing or during exercise, thereby reducing or eliminating
leaks.
The Renessa treatment can be performed in the convenience of a
physician's office using local anesthesia. There are no incisions, bandages
or dressings required. Recovery is rapid and comfortable, with minimal
post-procedure limitations.
About Novasys Medical
Novasys Medical, Inc. is a privately held, venture-backed company which
develops innovative therapies in women's health. The company's initial
focus is the development and commercialization of the Renessa System, a
proprietary, non-surgical approach to the treatment of female stress
urinary incontinence (SUI).
Novasys Medical, Inc.
http://www.novasysmedical.com
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