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Uroplasty Receives Approval to Begin a U.S. Clinical Trial of Macroplastique(R) for Female Stress Urinary Incontinence
MINNEAPOLIS, Aug. 3 /PRNewswire/ -- Uroplasty, Inc. (OTC Bulletin Board: UROP) announced today that it received an Investigational Device Exemption ("IDE") from the Food and Drug Administration ("FDA") to begin a U.S. clinical study of Macroplastique Implants for the treatment of female stress urinary incontinence. Stress urinary incontinence is the most common form of incontinence found in women and is treatable. When Macroplastique is implanted into the tissue surrounding the urethra in the area of the bladder neck, a patient's continence may be improved or eliminated by enhancing existing sphincter function. Macroplastique is an injectable bulking agent marketed outside the United States to treat stress urinary incontinence in females, incontinence in males due to prostate surgery, and vesicoureteral reflux in children (back flow of urine from the bladder to the kidney). It was introduced to the European marketplace in 1991 and since that time has been used to treat over 20,000 patients. Macroplastique is available throughout Europe, Canada, Australia and several Middle Eastern, Latin American, and Pacific Rim countries. The IDE approval paves the way for a pivotal United States multicenter clinical trial to begin in the fall of 1999. In an attempt to provide assistance in understanding its anticipated future financial performance, the Company may from time to time make written or oral "forward-looking statements" such as may be contained in this news release and elsewhere. "Forward-looking statements" are, however, by their very nature, subject to known and unknown risks and uncertainties relating to the Company's future performance that may cause the actual results, performance or achievements of the Company, or the industry, to differ materially from those expressed or implied in any such "forward-looking statements." Investors are cautioned that any "forward-looking statements" made by the Company here or elsewhere are qualified by and subject to the warnings and cautionary statements contained above and in the "Risk Factors" and "Forward Looking Statements" sections of its Annual Report on Form 10-KSB to the SEC for the year ended March 31, 1999. For further information on the company visit the web page at uroplasty.com
SOURCE Uroplasty, Inc. -0- 8/3/99 /CONTACT: Daniel G. Holman, Chairman, CEO & President of Uroplasty, Inc., 612-378-1180, fax 612-378-2027, e-mail danielh@uroplasty.com / /Web site: uroplasty.com / (UROP)
CO: Uroplasty, Inc. ST: Minnesota IN: MTC SU: PDT
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