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BIOPLASTY PURSUES U.S. REGULATORY APPROVAL FOR UROPLASTIQUE(TM) FOR THE TREATMENT OF URINARY INCONTINENCE

BIOPLASTY PURSUES U.S. REGULATORY APPROVAL FOR UROPLASTIQUE(TM) FOR THE
 TREATMENT OF URINARY INCONTINENCE
 ST. PAUL, Minn., Jan. 16 /PRNewswire/ -- Bioplasty, Inc. (NASDAQ: BIOP) announced today that based on the success of one year European clinical evaluations of its new product Uroplastique(TM) Micro- Implants used in the treatment of urinary incontinence, it has filed an Investigational Device Exemption (IDE) with the United States Food and Drug Administration (FDA) to commence clinical evaluations in this country. The filing of the IDE is an essential first step in beginning clinical evaluations.
 Uroplastique is a proprietary product of Bioplasty, Inc. It is comprised of millions of micro-implant particles disbursed in a biocompatible medium. The minimally invasive Uroplastique treatment can be accomplished under local anesthetic. Upon final marketing approval by the FDA, the product could replace many of the extensive surgical operations commonly used for correction of urinary incontinence. Uroplastique is designed to be injected submucosally at the bladder neck to bulk up tissue and correct stress urinary incontinence.
 The potential market for the treatment of urinary incontinence has been estimated to be in the hundreds of millions of dollars annually. The potential number of patients that could benefit from treatment with Uroplastique could be in the hundreds of thousands annually. According to a 1988 report from the National Institute of Health, 50 percent of the community-dwelling elderly population may have some form of incontinence. It has also been estimated that 5 percent of nursing home patients are there only because their incontinence is too unmanageable for their families.
 After receiving approval from the FDA for the IDE, clinical evaluations of Uroplastique Micro-Implants would occur in several major United States teaching institutions. A minimum of approximately one hundred patients will be enrolled and followed to evaluate safety and effectiveness.
 Noted urologist, Dr. John F. Buckley, F.R.C.S., who practices at the Incontinence Center at Glasgow Hospital, Scotland, has experienced significant success with Uroplastique. In a paper presented in Boston, Mass. at The Society For Minimally Invasive Therapy Meeting in Nov. 1991, Buckley reported a 90 percent improvement rate and an 80 percent cure rate in patients who had reflux or incontinence treated by submucosal injection of Uroplastique.
 Bioplasty, Inc. has more than 20 years of experience in the development, manufacturing and marketing of plastic surgery products worldwide. Bioplasty's stock is currently traded on the NASDAQ National Market System under the symbol "BIOP."
 -0- 1/16/92
 /CONTACT: Arthur A. Beisang, CEO, or Timothy P. Lawin, president, 612-636-4112, both of Bioplasty/
 (BIOP) CO: Bioplasty, Inc. ST: Minnesota IN: MTC SU:


AL -- MN011 -- 0578 01/16/92 14:03 EST
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Publication:PR Newswire
Date:Jan 16, 1992
Words:438
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