National Government Services Issues Positive Coverage for Percutaneous Tibial Nerve Stimulation
MINNEAPOLIS, Aug. 11, 2014 /PRNewswire/ — Uroplasty, Inc. (NASDAQ: UPI), a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today announced that National Government Services (NGS) has issued a positive coverage decision for Posterior Tibial Nerve Stimulation (PTNS) for the treatment of urinary urgency, urinary frequency and urge incontinence associated with overactive bladder (OAB). Coverage for the proprietary Urgent PC® device was effective August 10, 2014.
NGS, a Medicare Administrative Contractor, provides medical and drug benefits to approximately 10 million Medicare beneficiaries in the states of New York, Illinois, Massachusetts, Wisconsin, Minnesota, Connecticut, Maine, New Hampshire, Rhode Island and Vermont.
There are over 50 million Medicare beneficiaries in the United States and all of these individuals now have access to PTNS, the only non-drug, non-surgical treatment for those who suffer from the symptoms of overactive bladder. Urgent PC is a recommended third line treatment within the OAB treatment guidelines for patients who have not responded or cannot tolerate behavioral intervention and pharmacologic agents. The treatment guidelines are issued jointly by the American Urology Association (AUA) and Society for Urodynamics and Female Urology (SUFU).
“We are pleased with the NGS positive coverage decision and excited that access to PTNS is now in place for all Medicare beneficiaries across the country. Through the efforts and collaboration of an independent physician coalition from across all ten states, NGS was able to recognize the medical necessity of PTNS and its value to patients and physicians trying to manage the symptoms of OAB,” said Dan Merz, Vice President of Healthcare Affairs. “We look forward to bringing PTNS back to the many patients who had coverage in the past and to a whole new group of patients in New York and Connecticut who have never had access.”
The Company will initiate increased sales and marketing efforts for PTNS in markets served by NGS during the remainder of fiscal 2015, with the Company expecting a meaningful impact on U.S. Urgent PC sales starting in fiscal 2016. The Company expects to update its fiscal 2015 guidance when it reports second quarter results.
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a global 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 commercially available, FDA-cleared system that delivers percutaneous tibial nerve stimulation (PTNS) for the office-based treatment of overactive bladder (OAB). OAB is a chronic condition that affects approximately 42 million U.S. adults. The symptoms include urinary 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.
Statements contained in this release that relate to future events are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current expectations of future events and often can be identified by words such as “continues,” “expects,” “intends,” “should,” “will,” “may,” “believes,” “could,” “hopes,” “objective,” “looking ahead,” “future,” other words of similar meaning or the use of future dates. Uncertainties and risks may cause our actual results to be materially different than those expressed in or implied by our forward-looking statements. Such uncertainties and risks include, among others, that we cannot be certain that we will ever achieve sustained profitability, 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 existing carriers and payers will not change their coverage decisions, and that the rate of adoption of our products by new customers will continue. More detailed information on these and other factors that could affect our actual results are described in our filings with the Securities and Exchange Commission, including our most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. We undertake no obligation to update our forward-looking statements.
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SOURCE Uroplasty, Inc.