1178104--9/18/2009--CARDICA

related topics

{product, candidate, development}

{stock, price, operating}

{product, liability, claim}

{customer, product, revenue}

{personnel, key, retain}

{property, intellectual, protect}

{debt, indebtedness, cash}

{stock, price, share}

{product, market, service}

{control, financial, internal}

{regulation, change, law}

{operation, natural, condition}

{regulation, government, change}

{cost, regulation, environmental}

{operation, international, foreign}

We have a history of net losses, which we expect to continue for the foreseeable future, and we are unable to predict the extent of future losses or when we will become profitable, if at all. If we do not generate sufficient cash flow through increased revenue or raising additional capital, then we may not be able to meet our debt obligation that becomes due in 2010. Existing creditors have rights to our assets that are senior to our stockholders. Our quarterly operating results and stock price may fluctuate significantly. Risks Related to Our Business We are dependent upon the success of our current products, and we have U.S. regulatory clearance for our C-Port and PAS-Port systems only. We cannot be certain that the C-Port and PAS-Port systems will be successfully commercialized in the United States. If we are unable to successfully commercialize our products in the United States, our ability to generate higher revenue will be significantly delayed or halted, and our business will be harmed. Our products may never gain any significant degree of market acceptance, and a lack of market acceptance would have a material adverse effect on our business. Our PAS-Port and C-Port systems, as well as our other and future products, may still face future development and regulatory difficulties. If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our product candidates may be delayed and, as a result, our stock price may decline. Our manufacturing facilities, and those of our suppliers, must comply with applicable regulatory requirements. Failure to obtain or maintain regulatory approval of our manufacturing facilities would harm our business and our results of operations. If we are unable to establish sales and marketing capabilities or enter into and maintain arrangements with third parties to market and sell our products, our business may be harmed. Lack of third-party coverage and reimbursement for our products could delay or limit their adoption. We have limited data regarding the safety and efficacy of the PAS-Port and C-Port systems, and have only recently commenced U.S. commercialization of our C-Port and PAS-Port systems. Any data that is generated in the future may not be positive or consistent with our existing data, which would affect market acceptance and the rate at which our devices are adopted. Our current and planned clinical trials may not begin on time, or at all, and may not be completed on schedule, or at all. If the third parties on whom we rely to conduct our clinical trials do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our product candidates. Because one customer accounts for a substantial portion of our product sales, the loss of this significant customer would cause a substantial decline in our revenue. If our competitors have products that are approved in advance of ours, marketed more effectively or demonstrated to be more effective than ours, our commercial opportunity will be reduced or eliminated and our business will be harmed. We are dependent upon a number of key suppliers, including single source suppliers, the loss of which would materially harm our business. We have limited manufacturing experience and may encounter difficulties in increasing production to provide an adequate supply to customers. If we fail to retain key personnel, or to retain our executive management team, we may be unable to successfully develop or commercialize our products. We may in the future be a party to patent litigation and administrative proceedings that could be costly and could interfere with our ability to sell our products. Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively. Our products face the risk of technological obsolescence, which, if realized, could have a material adverse effect on our business. We may not be successful in our efforts to expand our product portfolio, and our failure to do so could cause our business and prospects to suffer. We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and, if we are unable to fully comply with such laws, could face substantial penalties. We could be exposed to significant product liability claims, which could be time consuming and costly to defend, divert management attention, and adversely impact our ability to obtain and maintain insurance coverage. The expense and potential unavailability of insurance coverage for our company or our customers could adversely affect our ability to sell our products, which would adversely affect our business. We sell our systems internationally and are subject to various risks relating to these international activities, which could adversely affect our revenue. We are dependent upon key personnel, the loss of any of which could have a material adverse affect on our business. Our operations are currently conducted at a single location that may be at risk from earthquakes, terror attacks or other disasters. If we use hazardous materials in a manner that causes injury, we may be liable for damages. We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or off-label uses. Risks Related to Our Common Stock We may not be able to maintain our listing on The NASDAQ Global Market, which would adversely affect the price and liquidity of our common stock. The price of our common stock may continue to be volatile, and the value of an investment in our common stock may decline. The ownership of our common stock is highly concentrated, and your interests may conflict with the interests of our existing stockholders. Evolving regulation of corporate governance and public disclosure will result in additional expenses and continuing uncertainty. Our future operating results may be below securities analysts or investors expectations, which could cause our stock price to decline.

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1178104--9/18/2009--CARDICA_INC