Quarterly report pursuant to Section 13 or 15(d)

Business and Liquidity (Policies)

Business and Liquidity (Policies)
9 Months Ended
Sep. 30, 2012
Business and Liquidity  

For the nine months ended September 30, 2012, the Company incurred a loss from continuing operations of approximately $3,230,000, and used cash in operations of $2,564,000.  At September 30, 2012, the Company had an accumulated deficit of $110,115,000.  Management expects that quarterly losses and negative cash flows will continue during 2012 and beyond. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.


Based upon the current financial condition of the Company and the expectation of continued quarterly losses during 2012, management is currently investigating ways to raise additional capital that can be completed in the next few months. Subsequent to December 31, 2011, the Company reported that it had engaged a financial advisor to assist the Company in this effort. The Company was able to raise an additional $1,000,000 in capital before issuance costs on July 2, 2012, through the completion of additional financing by the closing on the second tranche of convertible notes with GCP IV LLC (the “Investors” or “Holders”) (see Note 11).  The Company will also continue to review its other expense areas to determine whether additional reductions in discretionary spending can be achieved.


The Company also believes that the publication of positive clinical results from two independent investigator-sponsored clinical trials in Italy, which show RenalGuard to be both a safe and effective product for reducing the incidence of Contrast-Induced Nephropathy (“CIN”) in at-risk patients, presents a substantial opportunity for it to increase its sales and achieve profitable results in the next few years, provided, among other factors, the Company is able to raise the additional capital it needs in the near term to sustain its operations and expand its RenalGuard sales and marketing programs and obtain approval by the U.S. Food and Drug Administration (“FDA”) to market RenalGuard in the United States.

Revenue Recognition

The Company recognizes revenue when the following basic revenue recognition criteria have been met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services rendered; (3) the price to the buyer is fixed or determinable; and (4) collectability is reasonably assured. Determination of criteria (3) and (4) are based on management’s judgments regarding the fixed nature of the price to the buyer charged for products delivered or services rendered and collectability of the sales price. The Company assesses credit worthiness of customers based upon prior history with the customer and assessment of financial condition. The Company’s shipping terms are customarily Free On Board (“FOB”) shipping point. The Company records revenue at the time of shipment if all other revenue recognition criteria have been met. As of September 30, 2012 and December 31, 2011, the Company had deferred revenue of $394,000 and $277,000, respectively of revenues related to shipments to its distributor in Italy, Artech, because not all revenue recognition criteria were met.  During the three and nine months ended September 30, 2012, the Company recognized $65,000 and $126,000, respectively, in revenue of previously deferred revenue upon the receipt of cash from the customer.