This is a REPORTING worldwide & profitable company with NEWS!|
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
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
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
SOURCE Uroplasty, Inc.
/CONTACT: Daniel G. Holman, Chairman, CEO & President of Uroplasty, Inc.,
612-378-1180, fax 612-378-2027, e-mail firstname.lastname@example.org /
/Web site: uroplasty.com /
CO: Uroplasty, Inc.
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