784199--2/19/2009--CRYOLIFE_INC

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{property, intellectual, protect}
{competitive, industry, competition}
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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 May Receive A Form 483 Notice Of Observations, A Warning Letter, Or Other Similar Communication From The FDA And We May Be Unable To Address The Concerns Raised By The FDA In Such Correspondence or Communication, Or Addressing The Concerns May Be Costly Or Could Materially and Adversely Affect Our Operations. SynerGraft Processed Human Pulmonary Heart Valves and Other SynerGraft Products May Not Be Accepted By The Marketplace. SynerGraft Processed Human Pulmonary Heart Valves Have A One Year Shelf Life. We Are Dependent On The Availability Of Sufficient Quantities Of Tissue From Human Donors. Our CryoValve SG Pulmonary Human Heart Valve Post-clearance Study May Not Provide Expected Results. The FDA Has Previously Issued A Recall Of Certain Of Our Products And Has The Ability To Inspect Our Facilities, Suspend Our Operations, And Issue A Recall Of Our Products In The Future. Our Products And The Tissues We Process Allegedly Have Caused And May In The Future Cause Injury To Patients, And We Have Been And May Be Exposed To Product Liability Claims And Additional Regulatory Scrutiny As A Result. 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. 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. We May Be Unable To Successfully Market Hemostase. Our Credit Facility Limits Our Ability To Pursue Significant Acquisitions. Our Failure To Adequately Comply With Government Regulations Could Result In Loss Of Revenues And Customers As Well As Additional Compliance Expense. Continued Deflation Of Foreign Currencies Relative To The U.S. Dollar Could Materially and Adversely Impact Our Business. The Financial and Credit Liquidity Crisis May Adversely Affect Our Ability To Borrow Money Or Raise Capital. Current Economic Conditions May Impact Demand For Our Products and Tissues. Intense Competition May Affect Our Ability To Operate Profitably. There Are Limitations On The Use Of Our Net Operating Loss Carryforwards. Key Growth Strategies Identified As A Result Of Our Strategic Review May Not Generate The Anticipated Benefits. 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 Products And Services In Development, And Our New Products And Services May Not Achieve Market Acceptance. Regulatory Action Outside Of The U.S. Has Affected Our Business In The Past And May Also Affect Our Business In The Future. Physicians Have Been And May Continue To Be Reluctant To Implant Our Preserved Tissues Or Use Our Other Products. In The Past, We Have Experienced Operating Losses And Negative Cash Flows, And We Must Continue To Address The Underlying Causes In Order To Continue To Operate Profitably And Generate Positive Cash Flows. 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 Will Be Unable To Increase Our Revenues. Future Health Care Reimbursement Methods And Policies May Affect The Availability, Amount, And Timing Of Our Revenues. Rapid Technological Change Could Cause Our Services And Products To Become Obsolete. Extensive Government Regulation May Adversely Affect Our Ability To Develop And Sell Products And Services. 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 Are Not Likely To Pay Common Stock Dividends In The Foreseeable Future, And We May Not Be Able To Pay Cash Dividends On Our Capital Stock Due To Legal or Contractual Restrictions.

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