Healthcare Industry News: neuromodulation
News Release - October 15, 2012
Uroplasty Announces Implanted Tibial Nerve Stimulator Long-Term Study Presentation at International Continence SocietyMINNETONKA, Minn., Oct. 15, 2012 -- (Healthcare Sales & Marketing Network) -- Uroplasty, Inc. (UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today announced that the results of a long-term clinical pilot study using an implantable tibial nerve stimulation device will be presented at the Annual Meeting of the International Continence Society (ICS), October 15-19, 2012 in Beijing, China. Uroplasty acquired rights to the technology for this device when it acquired rights to its Urgent® PC product.
Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-Year Follow-up Study reviews the long term safety and durability of the device in seven patients who were implanted in 2003. Follow-up visits with the patients demonstrated that 3 of 7 have safely continued to use the device regularly over 9 years with sustained overactive bladder (OAB) symptom improvement and continued improvement in their quality of life. Another patient has successfully restarted using the device after participating in this follow-up study. There were no displacements or defects of the implants demonstrated on X-ray. All patients described the device as easy to handle.
"After nine years of clinical experience with an implanted subcutaneous tibial nerve stimulator, we have demonstrated that it is a durable therapy for treating OAB patients," said Professor John Heesakkers, Department of Urology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. "We are pleased to report that many patients have sustained their OAB symptom improvement. Moreover we demonstrated that the device is very safe."
"There are several key advantages to an implantable tibial nerve stimulator," said David Kaysen, Uroplasty CEO and President. "This device allows the patients to continue therapy at home according to the schedule that works best for them using a very low profile device that appears to have few if any adverse events. Based upon these promising results, Uroplasty has begun a Research and Development initiative to bring a version of this implantable tibial nerve neuromodulation device to the market. As we announced previously, we plan to first acquire a CE mark and commercialize the device in Europe before starting the regulatory process in the United States. Patients will receive their initial therapy with the Uroplasty Urgent® PC neuromodulation System before being offered the option of an implant."
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 neuromodulation System, which we believe is the only FDA-approved minimally invasive nerve stimulation device designed for office-based treatment of overactive bladder and the associated symptoms of urinary urgency, urinary frequency and urge incontinence.
We also offer Macroplastique® 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.
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 safety and efficacy of an implantable tibial nerve stimulator can be demonstrated in larger clinical trials; that we will be able to obtain the necessary approvals to commercialize an implantable device; that we will be able to profitably commercialize an implantable device; 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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