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DAVSTAR SUPPORTS FDA HIGHER CLINICAL STANDARDS

 NEWPORT BEACH, Calif., March 9 /PRNewswire/ -- Davstar Industries Ltd. (AMEX: DVS) today announced it agrees with a recent Wall Street Journal article, published March 5, 1993, regarding the steps the Food and Drug Administration is taking to enforce higher clinical and scientific standards of market approval documentation for medical device 510(k) pre-market submissions.
 "Last July, Davstar anticipated the pending regulatory climate that would require higher clinical testing standards for a system like our DriStar(TM) Urinary Incontinence System (DriStar)," said Jerry Silver, president of Davstar. "For this reason, Davstar engaged the nation's second-largest contract FDA regulatory and clinical research firm, Advanced BioSearch Associates (ABA), Danville, Calif., to work with us. ABA has been in business for 14 years and has achieved 100 percent success in receiving FDA market approval for its clients."
 Howard Asher, president of ABA, agrees with higher standards. Asher also contacted the FDA and clarified the urinary incontinent device described in the FDA's report was for a collagen implantable urinary device and not the DriStar System. "ABA determined that the clinical testing requirements for the DriStar fell under the Investigational Device Exemption (IDE) regulation of a Non- Significant Risk medical device," Asher said. "As such, ABA constructed a randomized, cross-over prospective clinical study in accordance with the strictest scientific standards of IDE regulations. This study will achieve the high clinical standard that the FDA is seeking.
 "We currently anticipate the DriStar clinical study should be completed by the end of April and will be submitted to the FDA for market approval after a comprehensive scientific analysis of the data," said Asher.
 Direct all inquiries to Roberta LeGendre, Davstar Industries Ltd., One Newport Place, 1301 Dove St., Suite 360, Newport Beach, CA 92660.
 -0- 3/9/93
 /CONTACT: Roberta LeGendre of Davstar Industries, 714-852-8492/
 (DVS)


CO: Davstar Industries Ltd. ST: California IN: MTC SU:

JL-KJ -- LA023 -- 4620 03/09/93 15:35 EST
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Publication:PR Newswire
Date:Mar 9, 1993
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