MINNEAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- Uroplasty, Inc. and CL Medical of Lyon, France announced that CL Medical has received a 510(k) premarket clearance from the U.S. Food and Drug Administration (FDA) for its I-Stop(TM) TOMS sling for treatment of male stress urinary incontinence (SUI). The I-Stop TOMS sling is also CE-marked and approved for marketing in the European Union.
The I-Stop TOMS sling is a proprietary device manufactured by CL Medical. Uroplasty, the exclusive distributor of CL Medical products in the United States and the United Kingdom, plans to begin marketing the sling in early 2007.
In excess of two million men worldwide suffer from SUI, the uncontrolled leakage of urine when coughing or straining. Many of these men are prostate cancer survivors, having undergone surgery for the treatment of their cancer. These men often restrict their activities, limit their fluid intake or change their lifestyles in order to deal with this condition. There have been very few attractive medical alternatives available to these men with mild incontinence.
David B. Kaysen, President and CEO of Uroplasty said, “This tremendous product is a significant addition to our voiding dysfunctions’ product portfolio. The I-Stop TOMS sling will provide urologists with a viable, outpatient procedure to treat male SUI far less invasively than certain other procedures, such as artificial sphincters, at a lower cost.”
Kaysen added, “Our relationship with CL Medical continues to grow and develop as we partner to seek additional products to treat voiding dysfunctions. We believe that CL Medical produces the finest line of polypropylene female and male slings in the market. We will continue to work together to further develop unique and proprietary sling products.”
Vincent Goria, Chairman of CL Medical said, “We are very excited about receiving FDA clearance for our I-Stop TOMS sling. We believe that there is a large unmet need to treat male SUI with a minimally invasive sling. We also offer the I-Stop sling for the treatment of female SUI. Together we offer one of the broadest lines of minimally-invasive slings for the treatment of male and female SUI.”
Goria went on to say, “We believe that Uroplasty is an ideal partner for us. Together, we plan to immediately begin developing sales, marketing and training programs for the introduction of the I-Stop TOMS sling in the United States and the United Kingdom. With our success in France, where we have approximately 40 urologists trained and implanting the I-Stop TOMS sling, we are confident we can quickly gather the support of surgeons and key opinion leaders in the United States and the United Kingdom.”
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. Uroplasty’s minimally invasive products treat urinary incontinence and overactive bladder symptoms. We believe that our company is uniquely positioned because we offer a broad and diverse set of products to address the various preferences of doctors and patients, as well as the quality of life issues presented by voiding dysfunctions.
Uroplasty currently offers three medical devices for the treatment of incontinence and overactive bladder symptoms. Uroplasty’s products include:
-- Macroplastique(R), a minimally invasive, implantable soft tissue bulking agent for the treatment of stress urinary incontinence. When Macroplastique is injected into tissue around the urethra, it stabilizes and “bulks” tissues close to the urethra, thereby providing the surrounding muscles with increased capability to control the release of urine. -- I-Stop(TM), a minimally invasive biocompatible, polypropylene, tension-free sling for the treatment of female urinary incontinence. The I-Stop sling can correct stress urinary incontinence by providing tension-free hammock-type support for the urethra to prevent its downward movement and the associated leakage of urine. -- The Urgent(R) PC neuromodulation system, a minimally invasive device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. This product uses percutaneous tibial nerve stimulation to deliver an electrical pulse that travels to the sacral nerve plexus, a control center for bladder function.
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. We cannot assure that we can profitably market the I-Stop TOMS sling in the United States or the United Kingdom.
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/
