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SANUWAVE, Inc. Reports First Quarter Financial Results


5/15/2012 10:39:47 AM

ALPHARETTA, Ga.--(BUSINESS WIRE)--SANUWAVE Health, Inc. (OTCBB: SNWV) today reported financial results for the three months ended March 31, 2012 and provided a business update. Christopher M. Cashman, President and CEO of SANUWAVE, said, “As recently announced, we have been granted conditional approval by the U.S. Food and Drug Administration (FDA) of our Investigational Device Exemption (IDE) Supplement for an additional clinical trial utilizing our dermaPACE® device in the treatment of diabetic foot ulcers. We believe 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. The Company has already identified clinical study sites and is in the process of qualifying them for participation. Patient enrollment is expected to begin once Institutional Review Board (IRB) approvals and appropriate funding to conduct the study are in place, which is forecasted to occur as early as the third quarter of this year.”

Read at BioSpace.com

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