1013606--3/10/2009--ENDOLOGIX_INC

related topics

{product, liability, claim}

{product, market, service}

{product, candidate, development}

{property, intellectual, protect}

{stock, price, operating}

{acquisition, growth, future}

{customer, product, revenue}

{personnel, key, retain}

{condition, economic, financial}

{operation, natural, condition}

{debt, indebtedness, cash}

{operation, international, foreign}

{control, financial, internal}

Our international operations subject us to certain operating risks, which could adversely impact our net sales, results of operations and financial condition. If our products or processes infringe upon the intellectual property of third parties, the sale of our products may be challenged and we may have to defend costly and time-consuming infringement claims. If third-party payors do not provide reimbursement for the use of the Powerlink System, our revenues may be negatively impacted. Current challenges in the commercial and credit environment may adversely affect our business and financial condition Our operating results may vary significantly from quarter to quarter, which may negatively impact our stock price in the future. Our future success depends on our ability to develop, receive regulatory clearance or approval for, and introduce new products or product enhancements that will be accepted by the market in a timely manner. 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. Our business is subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improved 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. If we fail to develop and maintain our direct sales force, our business could suffer. Our third-party distributors may not effectively distribute our products. We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are better able to develop and market products that are safer, more effective, less costly, easier to use, or otherwise more attractive than any products that we may develop, our ability to generate revenue will be reduced or eliminated. Our dependence upon key personnel to operate our business puts us at risk of a loss of expertise if key personnel were to leave us. If we fail to properly manage our anticipated growth, our business could suffer. We are required to maintain compliance with financial and other restrictive covenants in our credit facility which can restrict our ability to operate our business, and if we fail to comply with those covenants, our outstanding indebtedness may be accelerated or the terms of the credit facility may become more onerous. We have a history of operating losses and may be required to obtain additional funds. We rely solely on an in-house process to manufacture our graft material for the Powerlink System, and any disruption in our ability to produce this material could delay or prevent us from producing the product for sale. If we are unable to protect our intellectual property, our business may be negatively affected. If we are unable to effectively manage our inventory held on consignment by our intended customers, we will not achieve our expected results. We may face product liability claims that could result in costly litigation and significant liabilities. Our operations are currently conducted at a single location that may be at risk from earthquakes or other natural disasters. The price of our stock may fluctuate unpredictably in response to factors unrelated to our operating performance.

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1013606--3/10/2009--ENDOLOGIX_INC_/DE/