Study to support Urgent(R) PC clinical success and expanded reimbursement coverage
MINNEAPOLIS, Jan. 26 /PRNewswire-FirstCall/ -- Uroplasty, Inc. announced today the completion of patient enrollment in the randomized, controlled multicenter clinical study of its Urgent PC neuromodulation system for the treatment of overactive bladder (OAB) symptoms of urinary urgency, urge incontinence and frequency of urinary voids. A total of 214 patients have enrolled two months ahead of schedule in the clinical Study of Urgent PC vs. Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) at 22 centers throughout the United States.
The study is designed to directly compare the effectiveness of percutaneous tibial nerve stimulation (PTNS) using Urgent PC to a non-active sham. Uroplasty is undertaking this study primarily to expand and support third-party reimbursement coverage in the U.S. The study will evaluate reductions in urinary urgency, urge incontinence and frequency of urinary voids, as well as patient quality of life measures, and is expected to be completed by early fall of 2009.
“The early completion of enrollment in this trial illustrates the strong physician interest and patient acceptance of PTNS therapy at the participating centers,” said Dr. Kenneth M. Peters, Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Michigan, and the SUmiT study’s principal investigator. “We believe the study’s design will deliver to the medical community additional key scientific data on PTNS,” added Dr. Peters.
More than 33 million Americans suffer from OAB symptoms, which dramatically impact the quality of their lives. The Urgent PC system is a minimally invasive, office-based, nonsurgical PTNS device that treats these symptoms. The Company believes physicians, patients and many third party payers have embraced Urgent PC therapy as a clinically effective, low-cost, non-surgical, non-drug treatment alternative.
Dr. Peters, the lead investigator for this study, is internationally known for his work on neuromodulation, interstitial cystitis, and painful bladder syndrome. He has published several studies and written extensively on the effect of neuromodulation for treating voiding dysfunction, interstitial cystitis and pelvic pain, is a peer reviewer for several journals, and lectures internationally on the topic. He has used PTNS routinely for several years in his clinical practice.
“Our goal with the SUmiT study is to expand and support third-party reimbursement coverage for the Urgent PC procedure in the U.S. and we are extremely pleased with the early completion of patient enrollment,” said David Kaysen, President and CEO of Uroplasty. “Assuming the results of the study are positive, we anticipate applying to the AMA for a specific ‘listed’ CPT reimbursement code for Urgent PC treatments,” added Mr. Kaysen.
About the Urgent PC Neuromodulation System
The Urgent PC neuromodulation system is a proprietary, minimally invasive nerve stimulation device designed for office-based treatment of urge incontinence, urinary urgency and urinary frequency, symptoms often associated with overactive bladder. Application of neuromodulation therapy targets specific nerve tissue and disrupts the signals that lead to these symptoms. Uroplasty sells the Urgent PC system in the United States, Canada, and countries recognizing the CE mark. Outside of the United States, Urgent PC is also indicated for the treatment of fecal incontinence.
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 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 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.
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 the SUmiT clinical trial will produce favorable results, that even if it produces favorable results 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, or that even succeed at all at obtaining a specific “listed” CPT code from the AMA for Urgent PC treatments.
For more information about the Urgent(R) PC Neuromodulation System, please call 866-277-0466 or visit www.uroplasty.com.
For Further Information:
CONTACT: David Kaysen, President and CEO, or Medi Jiwani, Vice President,
CFO, and Treasurer, +1-952-426-6140, both of Uroplasty, Inc.; or Investors,
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//
