780127--1/12/2006--SYNOVIS_LIFE_TECHNOLOGIES_

related topics

{product, liability, claim}

{customer, product, revenue}

{product, candidate, development}

{regulation, government, change}

{product, market, service}

{property, intellectual, protect}

{personnel, key, retain}

{operation, international, foreign}

{financial, litigation, operation}

WE MAY NOT BE ABLE TO MANAGE SIGNIFICANT CHANGES THAT ACCOMPANY FLUCTUATIONS IN REVENUES. WE FACE SIGNIFICANT COMPETITION FROM ESTABLISHED COMPETITORS IN THE MEDICAL DEVICE INDUSTRY. WE CANNOT PREDICT THE OUTCOME OF OUR CLINICAL TRIALS. WE ARE DEPENDENT ON THREE CUSTOMERS FOR A LARGE PERCENTAGE OF THE SALES IN OUR INTERVENTIONAL BUSINESS. WE MAY NOT BE ABLE TO ADEQUATELY ENFORCE OR PROTECT OUR INTELLECTUAL PROPERTY RIGHTS OR TO PROTECT OURSELVES AGAINST THE INFRINGEMENT CLAIMS OF OTHERS. OUR FAILURE TO OBTAIN REGULATORY CLEARANCE/APPROVAL AND MAINTAIN REGULATORY COMPLIANCE FOR ANY OF OUR PRODUCTS WOULD IMPACT OUR ABILITY TO GENERATE REVENUE FROM THOSE PRODUCTS. PERCEPTIONS ABOUT BOVINE SPONGIFORM ENCEPHALOPATHY MAY IMPACT OUR SALES. WE MAY FACE THE RISK OF PRODUCT LIABILITY CLAIMS AND PRODUCT RECALLS THAT COULD RESULT IN COSTLY AND TIME CONSUMING LITIGATION AND SIGNIFICANT LIABILITY. DUE TO THE UNPREDICTABILITY OF THE HEALTH CARE INDUSTRY, OUR CUSTOMERS MAY NOT BE ABLE TO RECEIVE THIRD PARTY REIMBURSEMENT FOR THE SURGICAL PROCEDURES UTILIZING OUR PRODUCTS. WE DEPEND ON HIGHLY SPECIALIZED EQUIPMENT TO MANUFACTURE OUR PRODUCTS AND LOSS OF OR DAMAGE TO OUR MANUFACTURING FACILITIES COULD RESULT IN SIGNIFICANT LOSSES. DISTRACTING MANAGEMENT TIME AND DIVERTING FINANCIAL RESOURCES. WE MAY NOT BE ABLE TO HIRE OR RETAIN KEY PERSONNEL.

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780127--1/12/2006--SYNOVIS_LIFE_TECHNOLOGIES__INC