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BIOPLASTY SUBMITS INVESTIGATIONAL DEVICE EXEMPTION (IDE) FOR ITS MISTI GOLD BREAST IMPLANTS

 BIOPLASTY SUBMITS INVESTIGATIONAL DEVICE EXEMPTION (IDE)
 FOR ITS MISTI GOLD BREAST IMPLANTS
 ST. PAUL, Minn., Feb. 4 /PRNewswire/ -- Bioplasty, Inc. (NASDAQ: BIOP) announced today that it has filed an Investigational Device Exemption (IDE) with the United States Food and Drug Administration (FDA). The filing of the IDE is an essential first step in beginning clinical evaluations.
 The MISTI GOLD(TM) Bio-Oncotic(TM) Gel Mammary Prosthesis is a proprietary product of Bioplasty, Inc. It combines the MISTI(R) surface patterned solid silicone shell with the recently patented Bio-Oncotic Gel, an alternative filling material for mammary prostheses. Bio- Oncotic Gel is an organic polymer composed of water, salts and a low molecular weight polymer (plasdone).
 Low molecular weight plasdones have been successfully used in injectable and ingestible medications throughout the world since the 1930s. Bio-Oncotic Gel is designed to be excreted from the body in a matter of days in the event of shell rupture, and it has radiolucent properties.
 To date, thousands of MISTI GOLD Bio-Oncotic Gel Mammary Prostheses have been implanted, both in the United States and in Europe.
 Bioplasty announced on Dec. 18, 1991, that it had been assigned U.S. Patent number 5,067,965 relating to the alternative gel-filling material used in the company's MISTI GOLD breast implants.
 After receiving approval from the FDA for the IDE, clinical evaluations of MISTI GOLD Bio-Oncotic Gel Mammary Prostheses will continue in multiple clinical sites across the United States. A number of implants necessary to establish safety and efficacy will be performed. The company decided to file an IDE at this time because it expects the FDA to not reverse its PMA filing decision on the MISTI GOLD.
 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- 2/4/92
 /CONTACT: Arthur A. Beisang, CEO, or Timothy P. Lawin, president, both of Bioplasty, 612-636-4112/
 (BIOP) CO: Bioplasty, Inc. ST: Minnesota IN: MTC SU:


AL -- MN007 -- 6729 02/04/92 13:10 EST
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Publication:PR Newswire
Date:Feb 4, 1992
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