New Publication Highlights 2-Year Durability and Effectiveness of Macroplastique(R)
03 3월 2010 - 9:49PM
PR Newswire (US)
MINNEAPOLIS, March 3 /PRNewswire-FirstCall/ -- Uroplasty, Inc.
(NYSE Amex: UPI) highlighted results from a two-year, multicenter
clinical study of Macroplastique that will be published in the
April 2010 print edition of The Journal of Urology(R). The 24-month
study evaluated the durability of Macroplastique for stress urinary
incontinence in women with previously documented success at 12
months. Substantial, durable results were sustained during 2 years
with 84% of patients maintaining significant improvement from their
12-month assessment. Additionally, 67% of the patients implanted
with Macroplastique were dry at the 24-month follow-up visit. "This
study clearly demonstrates that Macroplastique provides a high
level of long-term effectiveness," said Uroplasty Chief Executive
Officer and President David Kaysen. "The effectiveness means major
improvements in quality of life for women who previously suffered
from unwanted urinary leakage. While other urethral bulking agents
may be absorbed into the body, potentially diminishing their
clinical benefit, Macroplastique is composed of a permanent
silicone elastomer that contributes to sustained, measurable
patient improvement," added Mr. Kaysen. The study, titled
"Durability of Urethral Bulking Agent Injection for Female Stress
Urinary Incontinence: 2-Year Multicenter Study Results" followed 67
Macroplastique patients with successful outcomes at 12 months for
up to 24 months. Highlights of the study include: -- 84% of
patients had sustained success from 12 months to 24 months -- 67%
of patients were dry at 24 months -- Of the 38 dry patients at 12
months, 87% maintained their cure at 24 months -- 41% who were
considered improved at 12 months were dry at 24 months -- Overall
"Incontinence Quality of Life" scores and all subscale scores
showed statistically significant improvements -- Patient and
physician assessments rated 85% of patients dry or markedly
improved at 24 months "This long term, multicenter study of
Macroplastique demonstrated sustained results over two years," said
Dr. Gamal Ghoniem of the Cleveland Clinic Florida and the study's
primary author. "Using widely accepted outcome measures, we
confirmed that patients sustained clinical improvements over a
prolonged period of time. This positively impacted their quality of
life and delayed the need for further treatment. This study further
supports the strong scientific evidence of the effectiveness of
Macroplastique for the treatment of stress urinary incontinence,"
concluded Dr. Ghoniem. Macroplastique is an injectable soft-tissue
urethral bulking agent for treating adult female stress urinary
incontinence primarily due to intrinsic sphincter deficiency.
Macroplastique is made up of two parts - a water-soluble gel that
is absorbed and removed from the body in urine and a synthetic,
rubber-like, silicone elastomer implant material that is permanent
and not absorbed by the body. This permanent material causes the
bulking effect around the urethra after implantation. "The study
highlighted the durability and efficacy of Macroplastique, which
has been the leading urethral bulking agent in Europe for over 18
years," added Mr. Kaysen. "Macroplastique is being used by
urologists across the United Stated because it offers sustained
clinical results. We anticipate the Macroplastique market share to
continue to grow as physicians and patients search for lasting
solutions for female stress urinary incontinence," concluded Mr.
Kaysen. In addition to Dr. Ghoniem, the contributing authors
included Dr. Jacques Corcos, McGill Urology Associates, Montreal,
Canada, Dr. Craig Comiter, University of Arizona, Dr. O. Lenaine
Westney, University of Texas, and Dr. Sender Herschorn, University
of Toronto, Canada. 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 primary focus is the continued commercialization
of our Urgent(R) PC system, which we believe is the only
FDA-approved minimally invasive nerve stimulation device designed
for office-based treatment of urinary urgency, urinary frequency
and urge incontinence - symptoms often associated with overactive
bladder. We also offer Macroplastique(R) Implants, an injectable
bulking agent for the treatment of adult female stress urinary
incontinence primarily due to intrinsic sphincter deficiency.
Please visit Uroplasty, Inc. at http://uroplasty.com/. For complete
information regarding Macroplastique indications,
contraindications, warnings, precautions, instructions for use,
storage, adverse reactions and disclaimer of warranties, please
refer to the instructions for use brochure available at the
Uroplasty website. Forward-Looking Information This press release
contains forward-looking statements, which reflect our best
estimates regarding future events and financial performance. These
forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from our
anticipated results. We discuss in detail the factors that may
affect the achievement of our forward- looking statements in our
Annual Report on Form 10-K filed with the SEC. In particular, our
ability to continue to grow the market share of Macroplastique is
subject to a number risks, including the risk that superior
technology is developed for the control of adult female urinary
incontinency, that competitors with superior personnel and
financial resources are able to better market their products, or
that physicians select other products because of delivery methods
or otherwise. For Further Information: Uroplasty, Inc. EVC Group
David Kaysen, President and CEO, Doug Sherk (Investors) or Medi
Jiwani, Vice President, 415.896.6820 CFO, and Treasurer, Chris Gale
(Media) 952.426.6140 646.201.5431 DATASOURCE: Uroplasty, Inc.
CONTACT: David Kaysen, President and CEO, or Medi Jiwani, Vice
President,CFO, and Treasurer, +1-952-426-6140; Doug Sherk
(Investors), +1-415-896-6820,Chris Gale (Media), +1-646-201-5431
Web site: http://www.evcgroup.com/
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