Nine Major Presentations on Uroplasty Products at Society for Urodynamics and Female Urology 2010 Annual Meeting
02 3월 2010 - 8:30PM
PR Newswire (US)
MINNEAPOLIS, March 2 /PRNewswire-FirstCall/ -- Uroplasty, Inc.
(NYSE Amex: UPI), a medical device company developing,
manufacturing and marketing innovative proprietary products for the
treatment of voiding dysfunctions, today announced that at the
February 23-27, 2010 Annual Meeting of the Society for Urodynamics
and Female Urology (SUFU), in St. Petersburg, FL, nine
presentations were made on Uroplasty's Urgent ® PC
Neuromodulation System and Macroplastique ® urethral bulking
agent products. The high number of presentations illustrates the
growing awareness within the clinical community of Macroplastique
and Urgent PC and the benefits they provide patients. Urgent PC
presentations: -- "New Efficacy Data on Percutaneous Tibial Nerve
Stimulation: A Multi-Center, Randomized, Sham-Controlled Trial for
Overactive Bladder Syndrome" presented by Kenneth M. Peters, MD,
Beaumont Hospital, Royal Oak, MI. Referred to as the SUmiT trial,
this pivotal multi-center, 220-patient study demonstrated
Percutaneous Tibial Nerve Stimulation (PTNS) was significantly
superior to a validated sham procedure for overactive bladder
treatment. The full manuscript will appear in the April print issue
of THE JOURNAL OF UROLOGY ® and was e-published on February
22, 2010. -- "Comparative Effectiveness: Percutaneous Tibial Nerve
Stimulation (PTNS) and Sacral Nerve Stimulation (SNS) for
Overactive Bladder (OAB) Treatment" presented by Scott MacDiarmid,
MD, Alliance Urology Specialists, Greensboro, NC. This presentation
identified the clinical and cost effectiveness of PTNS compared to
sacral nerve stimulation. This is especially important in the
current healthcare climate that emphasizes evidence-based medical
practice with a foundation in comparative effectiveness. --
"Percutaneous Tibial Nerve Stimulation for the Treatment of
Overactive Bladder: Treatment Interval Frequency" presented by
Scott MacDiarmid, MD, Alliance Urology Specialists, Greensboro, NC.
The recently published 12-month OrBIT Trial showed sustained PTNS
efficacy after improvement from the initial 12 weekly treatments.
Patients treated subsequently at a media interval of 21 days
demonstrated sustained therapeutic effect of PTNS. -- "Percutaneous
Tibial Nerve Stimulation (PTNS), Pelvic Floor Rehabilitation (PFR)
and Electrical Stimulation (ES) in the Treatment of Urinary
Incontinence" presented by Earl Surwit, MD, University of Arizona,
Tucson, AZ. Dr. Surwit, a private practitioner, reported on the use
of an effective multi-modal treatment regimen utilizing PTNS
treatments for urinary incontinent patients. -- "Percutaneous
Tibial Nerve Stimulation Double-Blinded, Randomized,
Sham-Controlled Trial for Overactive Bladder: Effect on Fecal
Incontinence" presented by Kenneth M. Peters, MD, Beaumont
Hospital, Royal Oak, MI. Dr. Peters presented data from the SUmiT
Trial that demonstrated a positive effect for patients who had
fecal incontinence concurrent with overactive bladder syndrome.
"The SUmiT Trial clinical data along with the other presentations
and existing published clinical data reinforce the clinical
efficacy of our Urgent PC Neuromodulation System," said David
Kaysen, President and CEO of Uroplasty. "This initial presentation
by Dr. Kenneth Peters, lead investigator, of the pivotal
multi-center, randomized, double-blind SUmiT Trial is in advance of
the full-study publication in the April 2010 edition of THE JOURNAL
OF UROLOGY ®. These results were an important part of our CPT
code application for consideration by the American Medical
Association at their February 2010 meeting. The trial results add
to our portfolio of clinical data to present to the medical
directors of Medicare carriers and U.S. third-party payers to build
awareness for coverage and reimbursement for this unique and
efficacious therapy," continued Mr. Kaysen. "In addition, we will
be using the SUmiT data as a key component of our marketing efforts
related to Urgent PC both in the US as well as internationally,"
Kaysen added. Macroplastique presentations: -- "Durability of
Macroplastique ® Injection for Female Stress Urinary
Incontinence: Two Years Experience" presented by Jacques Corcos,
MD, McGill University, Montreal, Canada. The full manuscript will
appear in the April print issue of THE JOURNAL OF UROLOGY ®
and was e-published on February 22, 2010. These results
demonstrated Macroplastique's effectiveness as a viable long term
therapy for female stress urinary incontinence primarily due to
intrinsic sphincter deficiency. Substantial and durable results
were sustained over two years with 84% of the patients maintaining
significant improvement. -- "Long Term Durability of
Polydimethylsiloxane Injectable Bulking Agent
(Macroplastique ®) in Urethral Tissues: Animal Study
Histopathology" presented by William Wustenberg, DVM, AlterNetMD
Consulting, Farmington, MN. This presentation on microscopic tissue
response demonstrated that Macroplastique implants maintained
sustained anchoring within urethral tissues without migration or
dissipation. The durability of Macroplastique in tissue over time
provides evidence supporting the safety and effectiveness of the
material. -- "Improved Outcomes in Patients with Transient Urinary
Retention After Macroplastique Urethral Bulking Procedure"
presented by Elizabeth Williams, MD, Metropolitan Urology
Specialists, St. Paul, MN. The data presented demonstrated that
Macroplastique treatments performed in the physician's office, as
part of a community urology practice, yielded excellent patient
outcomes. -- "Urethral Bulking Agents Used in the United States:
How Are Their Studies Analyzed?" by Gamal Ghoniem, MD, Cleveland
Clinic, Weston, FL. This informative presentation demonstrated the
importance of analytic method when critically comparing treatment
outcomes of different urethral bulking agents for stress urinary
incontinence. Macroplastique performs well compared to other
urethral bulking agents even when clinical data are analyzed by
different statistical methods. "The safety, durability and efficacy
of Macroplastique were again reinforced by these clinical
presentations," said Mr. Kaysen. "Long the market leader in Europe,
Macroplastique is now becoming the premier urethral bulking agent
in the United States as well. We expect strong patient and provider
interest to continue with this product into the future as we
continue to increase our sales and marketing efforts here in the
US. The number of quality presentations at SUFU clearly expresses
the urology community's embrace of these therapies as a valuable
part of the urinary incontinence algorithm of care," concluded Mr.
Kaysen. 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 commercialization of our Urgent ® PC system,
which we believe is the only FDA-approved non-surgical
neurostimulation therapy for the treatment of urinary symptoms
often associated with overactive bladder (OAB). We also offer
Macroplastique ® Implants, a urethral bulking agent for the
treatment of adult female stress urinary incontinence. Please visit
Uroplasty, Inc. at http://www.uroplasty.com/. 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 effect the achievement of our
forward-looking statements in our Annual Report on Form 10-K filed
with the SEC. Further, we cannot assure you that we will timely
obtain, or even succeed at all at obtaining, a specific "listed"
CPT reimbursement code from the AMA for Urgent PC treatments, and
that even if we succeed at obtaining a CPT code third-party payers
will provide or continue to provide coverage and reimbursement, or
reimburse the providers an amount sufficient to cover their costs
and expenses. We further cannot assure that reimbursement or other
issues will not further impact our fiscal 2010 results. For Further
Information: Uroplasty, Inc. EVC Group --------------- ---------
David Kaysen, President and CEO, or Doug Sherk (Investors)
----------------------------------- ---------------------- Medi
Jiwani, Vice President, CFO, and Treasurer, 415.896.6820
------------------------------------- ------------ 952.426.6140
Chris Gale (Media) ------------ ------------------ 646.201.5431
------------ DATASOURCE: Uroplasty, Inc. CONTACT: David Kaysen,
President and CEO, or Medi Jiwani, VicePresident, CFO, and
Treasurer, both of Uroplasty, Inc., +1-952-426-6140; orInvestors,
Doug Sherk, +1-415-896-6820, or Media, Chris Gale,
+1-646-201-5431,both of EVC Group, for Uroplasty, Inc. Web Site:
http://www.uroplasty.com/
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