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CryoLife 2013 First Quarter Revenues Grew 10 Percent to a Record $35.5 Million
Date:4/30/2013

which we cannot market BioGlue, our products and tissues are subject to many significant risks, and we have 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 have also received a letter from the Human Tissue Authority in London, UK, whereby it has 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 have 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 tissue preservation service revenues could be adversely impacted for the rest of 2013 or longer, 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., if we sell PerClot in the U.S., we will likely be sued for patent infringement, which will be expensive, and if we lose, we may be prohibited from selling PerClot or may have to pay substantial royalties or damages when we sell PerClot, after receiving the FDA's response to our application, we filed a revised IDE application for PerClot and we received questions from the FDA related to this filing, we are working to address the questions, but there is no guarantee that we can obtain FDA approval when anticipated, if at all, we have inherited certain risks and uncertainties related to Cardiogenesis' and Hemosphere's businesses, including that may be unable to maintain r
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SOURCE CryoLife, Inc.
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Related medicine technology :

1. CryoLife Announces Release Date and Teleconference Call Details for 2013 First Quarter Financial Results
2. CryoLife Receives FDA Clearance For Next Generation HeRO Device
3. CryoLife Expands Stock Repurchase Program
4. CryoLife 2012 Annual Revenues Grew to a Record $131.7 Million
5. CryoLife Announces Quarterly Cash Dividend for the First Quarter 2013
6. CryoLife Announces Release Date and Teleconference Call Details for 2012 Fourth Quarter and Year End Financial Results
7. CryoLife Receives Expanded Indication for BioFoam in Europe
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9. CryoLife Reports 13% Revenue Growth for Third Quarter 2012
10. CryoLife Announces Initiation of Quarterly Cash Dividend
11. CryoLife Reports 13% Revenue Growth for Second Quarter 2012
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