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CryoLife Reports Record Second Quarter Revenues
Date:7/25/2013

red in the U.S. and most of the rest of the world, and competitors have obtained FDA approval for indications in which BioGlue has been used off-label and for which we cannot market BioGlue, our products and tissues are subject to many significant risks, and we received a warning letter from the FDA relating to our processing, preservation, and distribution of human tissue and the manufacture of medical devices and our failure to adequately address the concerns raised by the FDA in the warning letter could result in additional action being taken by the FDA, including without limitation, a recall, injunction, or legal action, which could adversely impact our revenues, profits, and liquidity, we also received a letter from the Human Tissue Authority in London, UK, whereby it suspended Europa's license to import human tissue, due to concerns related to the FDA warning letter, and directed Europa to issue a recall for tissues previously distributed which had not been implanted, and if we are unable to address the concerns raised by the HTA and the suspension of the import license granted by the HTA is not lifted, our preservation service revenues could be adversely impacted, we have also received a Form 483 from the FDA related to Cardiogenesis, the Cardiogenesis Form 483 contains observations concerning labeling, complaint handling, and field actions, if we are unable to address the FDA's observations in the Cardiogenesis Form 483, we may be subject to additional regulatory actions by the FDA, and actions required to be taken in response to the Cardiogenesis Form 483 could adversely impact our revascularization technologies revenues, financial condition, profitability, and cash flows, our investment in our distribution and license and manufacturing agreements with Starch Medical, Inc. is subject to significant risks, and our ability to fully realize our investment is dependent on our ability to sell PerClot in the U.S., we received conditional approval of
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Related medicine technology :

1. CryoLife Announces Release Date and Teleconference Call Details for 2013 Second Quarter Financial Results
2. CryoLife Enhances International Presence with Appointment of Andres Sarmiento as Latin America Sales Manager
3. CryoLife 2013 First Quarter Revenues Grew 10 Percent to a Record $35.5 Million
4. CryoLife Announces Release Date and Teleconference Call Details for 2013 First Quarter Financial Results
5. CryoLife Receives FDA Clearance For Next Generation HeRO Device
6. CryoLife Expands Stock Repurchase Program
7. CryoLife 2012 Annual Revenues Grew to a Record $131.7 Million
8. CryoLife Announces Quarterly Cash Dividend for the First Quarter 2013
9. CryoLife Announces Release Date and Teleconference Call Details for 2012 Fourth Quarter and Year End Financial Results
10. CryoLife Receives Expanded Indication for BioFoam in Europe
11. CryoLife to Participate in Lazard Capital Markets 9th Annual Healthcare Conference
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