824068--3/12/2010--ATS_MEDICAL

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{cost, operation, labor}

{product, market, service}

{operation, international, foreign}

{acquisition, growth, future}

{competitive, industry, competition}

{condition, economic, financial}

{tax, income, asset}

{regulation, government, change}

{stock, price, operating}

{interest, director, officer}

{financial, litigation, operation}

We have a history of net losses and of regularly raising funds and incurring debt to fund our net losses. If our current cash and investment balances are inadequate to carry us to profitability, we may need to raise equity or incur additional debt in the future. If we are unable to obtain adequate financing, we may be unable to continue our operations. The recent U.S. and global economic downturn could have adverse effects on our business and our company. We are subject to extensive governmental regulation, which is costly, time consuming and can subject us to unanticipated delays or could ultimately preclude us from marketing and selling our products, and we are subject to risks relating to non-FDA-approved, or off label, use of our products. Healthcare reform legislation could adversely affect our revenue and financial condition. Our business could be seriously harmed if third-party payers do not reimburse the costs for our products. Foreign currency fluctuations and other risks inherent in doing business in international markets could adversely affect our operating results. The markets in which we compete are highly competitive, and a number of our competitors are larger and have more financial resources. If we do not compete effectively, our business will be harmed. Without the timely introduction of new and improved products, new products or technologies could emerge that render our products noncompetitive and obsolete. We ultimately may experience a delay in introducing, or may not successfully complete the development of, products that are currently under development, resulting in harm to our business. If we are unsuccessful in clinical trials, our lack of success could have a material adverse effect on our prospects. If we acquire other companies or businesses, we will be subject to risks that could hurt our business. Any termination of our right to manufacture pyrolytic carbon components under our carbon technology agreement with Carbomedics, or any delay or interruption in our manufacturing of these components, could delay product delivery or force us to cease operations. We may encounter litigation that could have a material impact on our business. We may face product liability claims, which could result in losses in excess of our insurance coverage and which could negatively affect our ability to attract and retain customers. Our business would be adversely affected if we are not able to protect our intellectual property rights. We may be sued by third parties claiming that our products infringe on their intellectual property rights. Any such suits could result in significant litigation or licensing expenses or we might be prevented from selling our products. If the value of our goodwill or other intangible assets become impaired, it could materially reduce the value of our assets and reduce our net income for the year in which the related impairment charges occur. We use a combination of direct sales persons and independent sales representatives to sell our products. If our sales strategy is not successful, we may not be able to continue our operations. We currently depend on the marketing and sales efforts of international independent distributors. Because we have limited manufacturing experience with some of our products, we may not realize the expected cost savings related to manufacturing our own products. In addition, we could experience production delays and significant additional costs. The price of our common stock has been volatile, which may result in losses to investors.

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824068--3/12/2010--ATS_MEDICAL_INC