Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors , including that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn , we may be unable to raise sufficient funds in the future to implement our business plan and / or commence our planned U.S. clinical trial for RenalGuard , the current clinical trial in Italy and the planned future U.S. clinical trial for RenalGuard as a safe and effective prevention device for contrast induced nephropathy may not be completed in a timely fashion , if at all , or , if these clinical trials are completed , they may not produce clinically significant or meaningful results , the RenalGuard product may not be commercially accepted , operational changes , competitive developments may affect the market for our products , regulatory approval requirements may affect the market for our products , and additional risk factors described in the " Forward Looking Statements " section of our Annual Report on Form 10-K for the year ended December 31 , 2008 , and our other SEC reports .