Healthcare Industry News: neuromodulation
News Release - May 10, 2013
Uroplasty Announces STEP Study 3-Year Results Demonstrate Sustained Therapeutic Effects Of Percutaneous Tibial Nerve StimulationOAB patients treated with Urgent® PC over 36 months sustained their urinary symptom improvement
MINNEAPOLIS, May 10, 2013 -- (Healthcare Sales & Marketing Network) -- Uroplasty, Inc. (UPI), a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today highlighted the 3-year results of the STEP Study on percutaneous tibial nerve stimulation (PTNS) treatments for overactive bladder (OAB) using Uroplasty's Urgent® PC neuromodulation System. The study will be published in the June 2013 print edition of The Journal of Urology and the article is now available on line at www.jurology.com.
Dr. M. Kenneth Peters, Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Michigan, led this multi-center, long term study. Patients who initially responded to 12 weekly Urgent PC treatments were followed for 36 months and received Urgent PC therapy throughout. Patients received an average of 1.1 treatments per month and sustained statistically significant improvements in voiding frequency, urinary urge incontinence episodes, nighttime voids, urgency episodes and voids with moderate to severe urgency, voiding volume and quality of life measures compared to before they began treatment with Urgent PC. There were no serious adverse events reported throughout the study.
"We are pleased that this long-term study demonstrates the durability of the effect of PTNS over 3 years," said Dr. Kenneth Peters, lead investigator. "This study demonstrates that with on-going therapy OAB patients can continue to sustain improvement in their OAB symptoms. This is a chronic condition for which there is currently no cure. With continuing therapy, patients' symptoms can be controlled at a level that positively impacts their quality of life. The recent AUA/SUFU OAB Guidelines affirm that for those patients for whom OAB drug therapy and other conservative therapies have not worked, PTNS is an ideal option."
"PTNS is an established part of the OAB algorithm of care. These long-term results confirm the role of PTNS in providing real benefits to patients," said Nancy Kolb, Uroplasty Vice President of Global Marketing. "This study, along with the many others in the world literature demonstrates that PTNS is effective, safe and durable. Using this study and other data, we will continue to promote the role of PTNS within the OAB paradigm of care."
About the Urgent® PC neuromodulation System
The Urgent PC neuromodulation System is proprietary, minimally invasive, percutaneous tibial nerve stimulation (PTNS) device designed for office-based treatment of overactive bladder (OAB) and the associated symptoms of urinary urgency, urinary frequency and urge incontinence.
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom is a global medical company committed to offering transformative treatment options to specialty physicians. Our products are designed to help providers change the lives of their voiding dysfunction patients and strengthen the efficiency of their practices. Our focus is the continued commercialization of our Urgent® PC neuromodulation System, the only FDA-cleared system that delivers percutaneous tibial nerve stimulation (PTNS) for the office-based treatment of overactive bladder and associated symptoms of urgency, frequency and urge incontinence. We also offer Macroplastique®, 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.
This press release contains forward-looking statements that 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, we cannot be certain that the rate of reimbursement for PTNS treatments will be adequate to justify the cost of our product, that other Medicare carriers or private payers will provide coverage for this treatment, or that any of the other risks identified in our 10-K will not adversely affect our expectations as described in these forward-looking statements.
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