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CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million
Date:7/24/2014

gal action, and further actions required to be taken in response to such inspections could adversely affect the availability of our products and tissues and our cost structure; the FDA has indicated that it is considering regulating our CryoValve SG pulmonary valve tissue as a class III medical device, which could ultimately negatively impact revenues from and the profitability of those tissues; there is no guarantee that we will complete our PerClot Topical commercialization and distribution efforts in accordance with our expected timeframes; even if we complete such commercialization and distribution efforts timely, we may be unsuccessful in our efforts to sell PerClot Topical in the U.S. or for specific markets or indications; there is also no guarantee that the FDA will approve the surgical version of PerClot for distribution in the U.S. in accordance with our expected timeframe, or at all; clinical trials are subject to a number of risks, including unanticipated reactions or results, delays, and cost overages, and we may ultimately be unsuccessful in our clinical trials and/or may be unable to obtain FDA approval to market the surgical version of PerClot in the U.S.; there is no guarantee that we will be able to attain the levels of revenue and margin that we anticipate for the surgical version of PerClot and/or PerClot Topical; the estimated U.S. and European topical and total hemostatic markets may ultimately be smaller and/or more difficult, time-consuming, and/or expensive to penetrate than the Company anticipates; our declaratory judgment action against C.R. Bard, Inc. will be expensive, and it may continue for longer and be costlier than we anticipate; although we have included in our 2014 guidance our best estimates regarding the amount of legal costs we will incur in connection with this action during 2014, legal costs and the timing of their incurrence are difficult to predict with any degree of certainty, we may incur costs associated wi
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