Nine Major Presentations on Uroplasty Products at Society for Urodynamics and Female Urology 2010 Annual Meeting
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 UrgentÃ‚® PC Neuromodulation System and MacroplastiqueÃ‚® 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 UROLOGYÃ‚® 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 UROLOGYÃ‚®. 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.
- “Durability of MacroplastiqueÃ‚® 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 UROLOGYÃ‚® 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 (MacroplastiqueÃ‚®) 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 UrgentÃ‚® 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 MacroplastiqueÃ‚® Implants, a urethral bulking agent for the treatment of adult female stress urinary incontinence. Please visit Uroplasty, Inc. at www.uroplasty.com.
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 ------------
SOURCE Uroplasty, Inc.