SANUWAVE, Inc. Receives Conditional Approval from the FDA on Clinical Trial Plan for dermaPACE
5/8/2012 10:49:05 AM
ALPHARETTA, Ga.--(BUSINESS WIRE)--SANUWAVE Health, Inc. (OTCBB: SNWV) today reported that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE) Supplement for an additional clinical trial utilizing the Company’s dermaPACE® device in the treatment of diabetic foot ulcers. The Company estimates the clinical trial could be completed and submitted in support of a Premarket Approval (PMA) application for dermaPACE in as early as 20 months from trial initiation, assuming such data to be collected meets the agreed upon statistical and clinical plan of success.
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