319240--3/6/2009--IRIS_INTERNATIONAL

related topics

{product, liability, claim}

{product, market, service}

{operation, international, foreign}

{property, intellectual, protect}

{regulation, government, change}

{acquisition, growth, future}

{product, candidate, development}

{stock, price, share}

{stock, price, operating}

{personnel, key, retain}

{customer, product, revenue}

{tax, income, asset}

{operation, natural, condition}

{condition, economic, financial}

{competitive, industry, competition}

Risks Related to Our Business Adverse conditions in the global economy and disruption of financial markets could negatively impact our customers and therefore our results of operations. Our success depends largely on the continued acceptance of our iQ and iChem product lines. If we fail to obtain, or experience significant delays in obtaining, regulatory clearances or approvals for our products or product enhancements, our ability to commercially distribute and market our products could suffer. Modifications to our products may require new regulatory clearances or approvals or may require us to recall or cease marketing our products until clearances are obtained. Any failure to introduce our future products and systems successfully into the market could adversely affect our business. If we choose to acquire new businesses, products or technologies, we may experience difficulty in the identification or integration of any such acquisition, and our business may suffer. If we do not establish strategic partnerships in the molecular diagnostic market, we will have to undertake commercialization efforts on our own, which would be costly and may impair our ability to commercialize our products in the molecular diagnostic market. Changes in reimbursement fees or lower than anticipated reimbursement for diagnostics tests could reduce demand and the price at which we can sell our products. If we fail to meet changing demands of technology, we may not continue to be able to compete successfully with our competitors. Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain. The medical device industry is characterized by patent litigation, and we could become subject to litigation that could be costly, result in the diversion of our management s time and efforts, require us to pay damages or prevent us from selling our products. We operate in a consolidating industry that creates barriers to our market penetration. Changes in government regulation of the healthcare industry could adversely affect our business. We may not be able to realize the deferred tax asset relating to our tax net operating loss carry forward. We rely on independent and some single-source suppliers for key components of our instruments. Any delay or disruption in the supply of components may prevent us from selling our products and negatively impact our operations. We face intense competition and our failure to compete effectively, particularly against larger, more established companies will cause our business to suffer. We may not be able to maintain contracts with Group Purchasing Organizations, or GPOs Our success depends on our ability to attract, retain and motivate management and other skilled employees. The expense and potential unavailability of insurance coverage for us, our customers or our products may have an adverse effect on our financial position and results of operations. We have product liability insurance that covers our products and business operation, but we may need to increase and expand this coverage commensurate with our expanding business. Our facilities are located near known earthquake fault zones, and the occurrence of an earthquake or other catastrophic disaster could damage our facilities and equipment, which could cause us to curtail or cease operations. If we are unable to manage our growth, our results could suffer. To market and sell our products, we depend on third-party distributors, and they may not be successful. Our sales in international markets are subject to a variety of laws and political and economic risks that may adversely impact our sales and results of operations in certain regions. We are subject to currency fluctuations. Risks Related to Ownership of Our Common Stock We have adopted a number of anti-takeover measures that may depress the price of our common stock. Our quarterly sales and operating results may fluctuate in future periods, and if we fail to meet expectations the price of our common stock may decline.

Full 10-K form ▸

319240--3/6/2009--IRIS_INTERNATIONAL_INC