MINNEAPOLIS, June 21 /PRNewswire-FirstCall/ -- Uroplasty, Inc. announced their second major approval for the Company’s next-generation Urgent(R) PC Neuromodulation System. AMTAC Certification Services, Uroplasty’s Notified Body, granted European CE marking and approved the Company’s request to sell this new model of the Urgent PC in Europe for the treatment of overactive bladder symptoms and for the treatment of fecal incontinence. Regulatory clearance from the U.S. FDA is currently pending.
The Urgent PC system was redesigned to create a product that provides enhanced ease of use and visual and auditory feedback during device operation.
European sales personnel expressed enthusiasm for the new design during their pre-launch training program. David Kaysen, President and CEO, shared their excitement to begin selling the new device. “We have a highly motivated sales group, including our Uroplasty sales managers, our direct representatives in the United Kingdom, and our partnership with distributors in 40 countries around the world. In addition, the therapeutic efficacy of the Urgent PC is well documented in European publications. With this strong sales team and the clinical foundation established with the prior device, we have tremendous opportunities as we expand our user group with our next generation Urgent PC system.”
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, including urinary and fecal incontinence, overactive bladder and vesicoureteral reflux.
The Urgent(R) PC Neuromodulation System is a proprietary, minimally invasive nerve stimulation device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. Application of neuromodulation therapy targets specific nerve tissue and disrupts the signals that lead to the symptoms of overactive bladder. Uroplasty sells the Urgent PC system in the United States, in Canada and in countries recognizing the CE mark. Outside the United States, the Urgent PC is also indicated for the treatment of fecal incontinence.
The I-STOP(TM) Mid-Urethral Sling is a biocompatible, tension-free sling used to treat female stress urinary incontinence. The I-STOP sling provides a hammock-like support for the urethra to prevent urine leakage associated with activities such as coughing, laughing, lifting or jumping. Uroplasty sells the I-STOP Sling in the United Kingdom and in the United States.
Macroplastique(R) Implants, Uroplasty’s patented soft tissue bulking agent, is used to treat both female and male urinary incontinence and to treat vesicoureteral reflux in children. When Macroplastique is injected into tissue, it stabilizes and “bulks” the tissue, providing the surrounding muscles with increased capability to control the flow of urine. Additionally, Uroplasty markets soft tissue bulking agents for specific indications such as PTQ(TM) Implants for the treatment of fecal incontinence, VOX(R) Implants for the treatment of vocal cord rehabilitation and Bioplastique(R) for augmentation or restoration of soft tissue defects in plastic surgery indications. Uroplasty’s bulking products are sold outside the United States.
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for certain forward-looking statements. This press release contains forward-looking statements, which reflect our views regarding future events and financial performance. These forward-looking statements are subject to certain risks and uncertainties, including those identified below, which could cause actual results to differ materially from historical results or those anticipated. The words “aim,” “believe,” “expect,” “anticipate,” “intend,” “estimate” and other expressions, which indicate future events and trends, identify forward-looking statements. Actual future results and trends may differ materially from historical results or those anticipated depending upon a variety of factors, including, but not limited to: the effect of government regulation, including when and if we receive approval for marketing products in the United States; the impact of international currency fluctuations on our cash flows and operating results; the impact of technological innovation and competition; acceptance of our products by physicians and patients, our historical reliance on a single product for most of our current sales; our ability to commercialize our recently licensed product lines; our intellectual property and the ability to prevent competitors from infringing our rights; the ability to receive third party reimbursement for our products; the results of clinical trials; our continued losses and the possible need to raise additional capital in the future; our ability to manage our international operations; our ability to hire and retain key technical and sales personnel; our dependence on key suppliers; future changes in applicable accounting rules; and volatility in our stock price.
FOR FURTHER INFORMATION: visit Uroplasty’s web page at http://www.uroplasty.com or contact Mr. Kaysen.
UROPLASTY, INC. David B. Kaysen, President / CEO 5420 Feltl Road Minnetonka, Minnesota 55343 Tel: 952.426.6140 Fax: 952.426.6199 E-mail: dave.kaysen@uroplasty.com
Uroplasty, Inc.
CONTACT: David B. Kaysen, President-CEO, Uroplasty, Inc., Tel:+1-952-426-6140, or Fax: +1-952-426-6199, or dave.kaysen@uroplasty.com
Web site: http://www.uroplasty.com/
