Navigation Links
Patient Enrollment in Urgent(R) PC SUmiT Clinical Trial Completed Ahead of Schedule

Study to support Urgent(R) PC clinical success and expanded reimbursement coverage

MINNEAPOLIS, Jan. 26 /PRNewswire-FirstCall/ -- Uroplasty, Inc. (Amex: UPI) 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

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

For Further Information:

    Uroplasty, Inc.                               EVC Group
    David Kaysen, President and CEO, or           Doug Sherk (Investors)
    Medi Jiwani, Vice President, CFO, and         415.896.6820
     Treasurer,                                   Chris Gale (Media)
    952.426.6140                                  646.201.5431

SOURCE Uroplasty, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
3. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
5. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
6. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
7. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
8. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
9. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
10. Many Heart Attack Patients Dont Get Best Emergency Treatment
11. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
Post Your Comments:
(Date:11/26/2015)... India , November 26, 2015 ... --> adds ... Report" and "Investigation Report on China ... and 2021 forecasts data and information ... . ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Marker Testing Market: Supplier ... to their offering.  --> ... of the  "2016 Future Horizons and ...
(Date:11/25/2015)...  The American Academy of Pediatrics (AAP), American ... March of Dimes cheered today,s signature into law ... of 2015 (S.799), which takes much-needed strides ... to drugs, such as opioids, and to improve ... organizations have worked together leading advocacy efforts for ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 27, 2015 , ... Intellitec Solutions announced today that they ... Recognized as Microsoft’s official group for end users of Dynamics SL ERP software, ... industry experts and representatives. Intellitec Solutions’ membership status demonstrates their ongoing commitment to ...
(Date:11/27/2015)... Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... Commission on Accreditation of Allied Health Education Programs (CAAHEP) awarded accreditation to its Diagnostic ... list of CAAHEP accredited colleges, as only one of twelve colleges and universities in ...
(Date:11/27/2015)... ... ... Indosoft Inc., developer and distributor of the world-class Asterisk ... Term Support) into its Q-Suite 5.10 product line. , Making the change to ... of Asterisk that will receive not only security fixes, but feature and bug ...
(Date:11/26/2015)... , ... November 26, 2015 , ... ... Express Travel Representative. As a franchise owner, Somu now offers travelers, value and ... destination wedding packages, private cruise sales, as well as, cabin upgrades and special ...
(Date:11/26/2015)... ... 2015 , ... WorldCare International, Inc., the first company to ... Benefits Conference. The Employee Benefits Conference was hosted by the International Foundation of ... 2015. The conference was held at the Hawaii Convention Center in Honolulu, Oahu, ...
Breaking Medicine News(10 mins):