MINNEAPOLIS, Feb. 15, 2012 /PRNewswire/ -- Uroplasty, Inc.
(NASDAQ:UPI), a medical device company that develops, manufactures
and markets innovative proprietary products to treat voiding
dysfunctions, today announced the first enrollment of patients in
the CONFIDeNT clinical study in the United Kingdom.
This large multi-center, placebo-controlled study will enroll
over 200 patients in up to 20 centers across the UK. Using
Uroplasty's minimally-invasive Urgent® PC Neuromodulation System,
the study will compare percutaneous tibial nerve stimulation (PTNS)
treatments to a sham device for patients suffering from fecal
incontinence. Outside of the U.S., Urgent PC has a CE Mark for
treating fecal incontinence. This is one of several studies
currently being conducted throughout Europe to demonstrate the effectiveness of
Urgent PC for treating this debilitating and often under-treated,
under-reported condition.
"This new physician-initiated study in the UK is indicative of
the interest in using Urgent PC to treat fecal incontinence," said
David B. Kaysen, President and CEO
of Uroplasty, Inc. "The interest in PTNS treatments from
internationally known researchers emphasizes the on-going need for
effective therapies to treat this very difficult and challenging
condition. For many patients, effective treatment for this
oftentimes socially isolating condition may well transform their
lives."
The Chief Investigator of the CONFIDeNT study in the UK is Prof.
C.H. Knowles, BChir, PhD, FRCS (Gen
Surg), Professor of Surgical Research and Hon. Consultant,
Colorectal Surgeon, Academic Surgical Unit, Centre for Digestive
Diseases, Blizard Institute, Barts and the London School of
Medicine and Dentistry, Queen Mary University, London. Prof. Knowles stated, "The CONFIDeNT
study is a major effort to fully understand how PTNS using Urgent
PC, a new and unique technology, can be used to treat patients
suffering from this debilitating disease of fecal
incontinence. In addition to Uroplasty's support, we
appreciate the grant support of the NHS and National Institute for
Health Research (Health Technology Assessment programme) in the UK
along with the clinicians associated with Enteric's clinical
network."
In the UK, the National Institute of Health estimated in 2007
that 6% of the population under 40 years of age experienced a
problem with fecal incontinence either daily or weekly. The rate
was 15% in women and 6% to 10% in men over 40 living in the
community (noninstitutionalized). In the U.S., a 2009 study
estimated that 5% to 10% of the population experienced fecal
incontinence, equating to approximately 15 to 30 million
individuals affected in the US.
"Uroplasty is committed to actively work with the key
researchers involved in Urgent PC research projects across
Europe. It is premature to discuss the time frames for the
completion of these studies because patient enrollment rates are
difficult to predict. We may present additional information
as study milestones are achieved," Mr. Kaysen concluded.
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned
subsidiaries in The Netherlands
and the United Kingdom, is a
medical device company that develops, manufactures and markets
innovative proprietary products for the treatment of voiding
dysfunctions. Our focus is the continued commercialization of our
Urgent® PC Neuromodulation System, the only FDA-cleared
neuromodulation system that delivers posterior tibial nerve
stimulation (PTNS) for the office-based treatment of overactive
bladder and associated symptoms of urgency, frequency and urge
incontinence. We also offer Macroplastique® Implants, an injectable
urethral bulking agent for the treatment of adult female stress
urinary incontinence primarily due to intrinsic sphincter
deficiency. For more information on the company and its products,
please visit Uroplasty, Inc. at www.uroplasty.com.
For
Further Information:
Uroplasty,
Inc.
David
Kaysen, President and CEO, or
Medi
Jiwani, Vice President, CFO, Treasurer
952.426.6140
|
EVC
Group
Doug
Sherk/Jenifer Kirtland (Investors), 415.568.9349
Chris Gale
(Media), 646.201.5431
|
SOURCE Uroplasty, Inc.