Clinical studies, regulatory filings, and commercialization. Potential regulatory issues that could delay, suspend, or terminate clinical studies, regulatory approvals for sales, uncertain timeline costs, and the results of trials and the development of new products; our ability to plan, and manage cost reduction or operational efficiency initiatives; the scope and validity of intellectual property rights applicable to products being developed, additional cost or resources necessary to address these existing or potential claims, the procedures related to the safety and regulatory issues that could slow or suspend sales.The rate of adoption of our systems and the rate of use of our catheters at customers that have purchased our systems; our ability to successfully manage our manufacturing and operating expenses; the scope and validity of intellectual property rights applicable to our products; competition from other companies; the effect of credit, financial and general economic conditions on capital spending by potential purchasers of our systems; additional cost and resources necessary to address existing and potential claims and proceedings related to the restatement of our financial statements; our ability to remediate material weakness in internal controls over financial reporting and other risks detailed in the Risk Factors section of our periodic SEC filings, including our quarterly report on Form 10-Q for the three months ended September 30, 2010 as filed with the SEC on November 9, 2010 of this year.
Hansen Medical CEO Discusses Q4 2010 - Earnings Call Transcript
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