784199--2/19/2010--CRYOLIFE

related topics

{product, liability, claim}

{regulation, government, change}

{operation, international, foreign}

{product, candidate, development}

{property, intellectual, protect}

{debt, indebtedness, cash}

{acquisition, growth, future}

{stock, price, operating}

{operation, natural, condition}

{stock, price, share}

{provision, law, control}

{control, financial, internal}

{product, market, service}

{investment, property, distribution}

{tax, income, asset}

{competitive, industry, competition}

{loss, insurance, financial}

{personnel, key, retain}

{financial, litigation, operation}

{condition, economic, financial}

Risks Relating To Our Business We Are Significantly Dependent On Our Revenues From BioGlue And Are Subject To A Variety Of Risks Affecting This Product. We Are Subject To Stringent Domestic And Foreign Regulation Which May Impede The Approval Process Of Our Tissues And Products, Hinder Our Development Activities And Manufacturing Processes And, In Some Cases, Result In The Recall Or Seizure Of Previously Cleared Or Approved Tissues And Products. CryoLife s Proposed Acquisition Of Medafor Poses A Number Of Risks. The Lawsuit We Filed Against Medafor Regarding Our Distribution Agreement With Medafor May Adversely Impact Our Relationship With Medafor And Could Hinder Our Distribution Of HemoStase Or Prevent Us From Distributing HemoStase. Healthcare Policy Changes, Including Pending Proposals To Reform The U.S. Healthcare System, May Have A Material Adverse Effect On Us. Uncertainties Related To Patents And Protection Of Proprietary Technology May Adversely Affect The Value Of Our Intellectual Property. Uncertainties Related To Patents And Protection Of Proprietary Technology For Products Distributed By CryoLife May Adversely Affect The Ability Of CryoLife To Distribute Those Products. The Tissues We Process And Our Products Allegedly Have Caused And May In The Future Cause Injury To Patients, And We Have Been And May Be Exposed To Tissue Processing And Product Liability Claims And Additional Regulatory Scrutiny As A Result. We Are Dependent On The Availability Of Sufficient Quantities Of Tissue From Human Donors. Our CryoValve SGPV Post-Clearance Study May Not Provide Expected Results. Demand For Our Tissues And Products Could Decrease In The Future, Which Could Have A Material Adverse Effect On Our Business. The Success Of Many Of Our Tissues And Products Depends Upon Strong Relationships With Physicians. Consolidation In The Healthcare Industry Could Lead To Demands For Price Concessions Or Limits Or Eliminate Our Ability To Sell To Certain Of Our Significant Market Segments. Our Existing Insurance Policies May Not Be Sufficient To Cover Our Actual Claims Liability. We May Be Unable To Obtain Adequate Insurance At A Reasonable Cost, If At All. The Loss Of Any Of Our Sole-Source Suppliers Could Have An Adverse Effect On Our Revenues, Financial Condition, Profitability, And Cash Flows. Intense Competition May Affect Our Ability To Operate Profitably. Regulatory Action Outside Of The U.S. Has Affected Our Business In The Past And May Affect Our Business In The Future. Rapid Technological Change Could Cause Our Services And Products To Become Obsolete. Continued Fluctuation Of Foreign Currencies Relative To The U.S. Dollar Could Materially And Adversely Impact Our Business. Our Credit Facility Limits Our Ability To Pursue Significant Acquisitions. Key Growth Strategies May Not Generate The Anticipated Benefits. There Are Limitations On The Use Of Our Net Operating Loss Carryforwards. Our Ability To Borrow Under Our Credit Facility May Be Limited. We May Not Be Successful In Obtaining Necessary Clinical Results And Regulatory Approvals For Services And Products In Development, And Our New Services And Products May Not Achieve Market Acceptance. Extensive Government Regulation May Adversely Affect Our Ability To Develop And Market Services And Products. Investments In New Technologies And Acquisitions Of Products Or Distribution Rights May Not Be Successful. If We Are Not Successful In Expanding Our Business Activities In International Markets, We May Be Unable To Increase Our Revenues. We Are Not Insured Against All Potential Losses. Natural Disasters Or Other Catastrophes Could Adversely Affect Our Business, Financial Condition, And Profitability. We Are Dependent On Our Key Personnel. Risks Related To Our Common Stock Trading Prices For Our Common Stock, And For The Securities Of Biotechnology Companies In General, Have Been, And May Continue To Be, Volatile. Anti-Takeover Provisions May Discourage Or Make More Difficult An Attempt To Obtain Control Of CryoLife. We Have Not Paid Cash Dividends On Our Capital Stock And May Be Unable To Do So Due To Legal Or Contractual Restrictions.

Full 10-K form ▸

784199--2/19/2010--CRYOLIFE_INC