863680--3/31/2009--CARDIOGENESIS_CORP

related topics

{product, liability, claim}

{property, intellectual, protect}

{stock, price, share}

{product, candidate, development}

{customer, product, revenue}

{product, market, service}

{stock, price, operating}

{regulation, change, law}

{operation, natural, condition}

{provision, law, control}

{control, financial, internal}

{personnel, key, retain}

{operation, international, foreign}

{acquisition, growth, future}

{regulation, government, change}

Our ability to maintain revenues and operating income and achieve growth in sales and operating income in the future is dependent upon physician awareness of our products as a safe, efficacious and appropriate treatment for their patients. We may not be able to successfully market our products if third party reimbursement for the procedures performed with our products is not available for our health care provider customers. If we fail to maintain regulatory approvals and clearances, or are unable to obtain, or experience significant delays in obtaining, FDA clearances or approvals for our future products or product modifications, our ability to commercially distribute and market these products could suffer. If we, our suppliers, or our manufacturers fail to comply with ongoing FDA or other foreign regulatory authority requirements, our business may be negatively impacted. In the future, the FDA could restrict the current uses of our TMR System and thereby restrict our ability to generate revenues. We may fail to comply with international regulatory requirements and could be subject to regulatory delays, fines or other penalties. We purchase some of the key components of our products from single suppliers. The loss of these suppliers could prevent or delay shipments of our products or delay our clinical trials or otherwise adversely affect our business. If our independent contract manufacturers fail to timely deliver to us sufficient quantities of some of our products and components in a timely manner, our operations may be harmed. If clinical trials of our current or future product candidates do not produce results necessary to support regulatory clearance or approval in the United States or elsewhere, we will be unable to commercialize these products. If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval for or commercialize our products. Our third-party distributors may not effectively distribute our products. The use, misuse or off-label use of our products may harm our image in the marketplace or result in injuries that lead to product liability suits, which could be costly to our business or result in FDA sanctions if we are deemed to have engaged in such promotion. Expansion of our business may put added pressure on our management and operational infrastructure affecting our ability to meet any increased demand for our products and possibly having an adverse effect on our operating results. Our operating results are expected to fluctuate and quarter-to-quarter comparisons of our results may not indicate future performance. Potential acquisitions or strategic relationships may be more costly or less profitable than anticipated and may adversely affect the price of our stock. Our international operations subject us to certain operating risks, which could adversely impact our net sales, results of operations and financial condition. Our operations are currently conducted at a single location that may be at risk from earthquakes or other natural disasters. Our stock is currently listed on the Pink Sheets which may have an unfavorable impact on our stock price and liquidity. Applicability of penny stock rules to broker-dealer sales of our common stock could have a negative effect on the liquidity and market price of our common stock. The price of our common stock may fluctuate significantly, which may result in losses for investors. We face competition from products of our competitors which could limit market acceptance of our products and render our products obsolete. Third party intellectual property rights may limit the development and protection of our intellectual property, which could adversely affect our competitive position. We have been named as a defendant in a patent infringement lawsuit and costly litigation may be necessary to protect or defend our intellectual property rights. We rely on patent and trade secret laws, which are complex and may be difficult to enforce. We may suffer losses from product liability claims if our products cause harm to patients. We depend heavily on key personnel and turnover of key employees and senior management could harm our business. Future sales of our common stock could lower our stock price. Provisions of our articles of incorporation as well as our rights agreement could discourage potential acquisition proposals and could deter or prevent a change of control. Changes in, or interpretations of, accounting rules and regulations could result in unfavorable accounting charges. Our internal controls over financial reporting may not be effective, which could have a significant and adverse effect on our business.

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863680--3/31/2009--CARDIOGENESIS_CORP_/CA