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CryoLife to Distribute FDA-approved Hemostatic Agent Under Private Label
Date:4/17/2008

s dependent on revenues from BioGlue, competitive pressures and tissue availability may adversely affect the Company's ability to grow revenues, the Company's efforts to develop and introduce new products outside the U.S. may be unsuccessful, the Company's efforts to improve procurement and tissue processing yields may not continue to prove effective, the possibility that the FDA or foreign regulatory bodies could impose restrictions on the Company's operations, require a recall, or prevent the Company from processing and distributing tissues or manufacturing and distributing other products, FDA and other approvals for products in development may not be obtained, and if obtained, may be costly and require lengthy review periods, products and services under development may not be commercially feasible, CryoValve SG may not perform as well as expected or provide all the benefits anticipated, demand for CryoValve SG may not reach anticipated levels, and accordingly, the Company may choose not to process the majority of its pulmonary valves with the Company's SynerGraft technology, the SynerGraft post-clearance study requested by the FDA may not provide the expected positive results, that the Company's products and the tissues the Company processes allegedly have caused and may in the future cause injury to patients and the Company has been and may be exposed to product liability claims and additional regulatory scrutiny as a result, that uncertainties related to patents and protection of proprietary technology may affect the availability, amount and timing of the Company's revenues, that pending or future litigation cannot be settled on terms acceptable to the Company, that the Company may not have sufficient resources to pay punitive damages (which are not covered by insurance) or other liabilities in excess of its available insurance, that the Company may not have sufficient borrowing or other capital availability to fund its business, that the Company may be unable
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