Presentations to highlight durability and efficacy of urethral bulking agents

Nov 17 2009

Uroplasty, Inc. (AMEX: UPI), a medical device company developing, manufacturing and marketing innovative proprietary products for the treatment of voiding dysfunctions, today announced that nine abstracts outlining study results submitted by various researchers have been accepted for presentation at the 2010 Annual Meeting of the Society for Urodynamics and Female Urology (SUFU), February 23-27, 2010 in St. Petersburg, FL. Presentations accepted were for both Uroplasty's Urgent® PC Neuromodulation System and Macroplastique® urethral bulking agent products.

Accepted Urgent® PC presentations include:

• "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. Uroplasty commonly refers to this clinical study as the SUmiT trial.
• "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.
• "Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder: Treatment Interval Frequency" presented by Scott MacDiarmid MD, Alliance Urology Specialists, Greensboro, NC. These results are from the 12-month OrBIT Trial.
• "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.
• "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.

"The additional clinical study data presented on our Urgent PC Neuromodulation System strongly support the efficacy of this innovative and minimally invasive therapy," said David Kaysen, President and CEO of Uroplasty. "This will be the first presentation by Dr. Kenneth M. Peters, lead investigator, of the results of the recently completed SUmiT Trial. This pivotal randomized, double-blind study compared PTNS to a validated sham procedure for OAB treatment. We will use these results in support of our application to obtain a unique CPT code for Urgent PC treatments. We will also continue to present these high quality studies to the medical directors of U.S. third-party payers to build awareness for coverage and reimbursement for this unique and efficacious therapy," continued Mr. Kaysen.

Accepted Macroplastique presentations include:

• "Durability of Macroplastique® Injection for Female Stress Urinary Incontinence: Two Years Experience" presented by Jacques Corcos, MD, McGill University, Montreal, Canada.
• "Long Term Durability of Polydimethylsiloxane Injectable Bulking Agent (Macroplastique®) in Urethral Tissues: Animal Study Histopathology" presented by William Wustenberg, DVM, AlterNetMD Consulting, Farmington, MN.
• "Improved Outcomes in Patients with Transient Urinary Retention After Macroplastique Urethral Bulking Procedure" presented by Elizabeth Williams, MD, Metropolitan Urology Specialists, St. Paul, MN.
• "Urethral Bulking Agents Used in the United States: How Are They Analyzed?" by Gamal Ghoniem, MD, Cleveland Clinic, Weston, FL.

"The presentations highlight the durability and efficacy of Macroplastique, our 'Gold Standard' urethral bulking agent. As the long-standing market leader in Europe, Macroplastique has quickly gained acceptance with physicians and increased market share in the U.S. We anticipate the strong interest in this product segment to continue to grow as physicians and patients search for lasting solutions for female stress urinary incontinence," concluded Mr. Kaysen.