CryoLife Receives FDA Clearance for PerClot Topical Hemostatic Powder in the U.S.

CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received 510(k) clearance for PerClot Topical hemostatic powder from the U.S. Food and Drug Administration (FDA). This clearance allows CryoLife to begin commercialization of PerClot Topical hemostatic powder in the U.S. The Company plans to begin shipping PerClot Topical hemostatic powder in June of this year.Cryolife logo. "We are pleased to have received 510(k) clearance for PerClot Topical in the U.S.," stated Steven G. Anderson, CryoLife president and chief executive officer. "We expect to begin commercialization efforts in June and to focus on the ENT specialty through a combination of our existing sales force and distributors experienced with a competitive product. Many of our existing hospital customers also have large ENT practices, providing a natural opportunity for PerClot Topical. Longer term, we believe we will be able to expand PerClot Topical to additional markets such as the emergency room." PerClot Topical is a unique hemostat composed of polysaccharide granules and is intended for use as a topical dressing for the temporary treatment of mildly bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological, etc.), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. PerClot Topical is ready to use, requiring no mixing and/or other components and does not need special handling or storage conditions. Preclinical evaluations have shown the effectiveness of PerClot Topical to be comparable to the current popular choice of surgical hemostatic materials.PerClot Topical is the same product as PerClot, which has received an Investigational Device Exemption (IDE) from the FDA for a pivotal clinical trial for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. The Company plans to begin enrollment in the pivotal clinical trial for PerClot in the second quarter of 2014, and could potentially receive pre-market approval from the FDA by the end of 2015.Management estimates the U.S. hemostatic market for PerClot Topical in procedures included in the 510(k) clearance to be in excess of $100 million, while the U.S. hemostatic market for all procedures is estimated to have been $780 million in 2013, growing to approximately $915 million by 2016 and the European market is estimated to have been $395 million in 2013, growing to approximately $468 million by 2016.[1]Declaratory Judgment ActionCryoLife also announced today that it has filed a declaratory judgment action against C.R. Bard, Inc. and certain of its subsidiaries (collectively, Bard) in federal court, requesting that the court confirm that CryoLife's anticipated sales of PerClot (once it has received final FDA approval) and certain of its derivative products (including PerClot Topical) will not infringe upon patents held by Bard. CryoLife filed the declaratory judgment action in the U.S. District Court for the District of Delaware.Mr. Anderson noted, "We believe that our sales of PerClot Topical and PerClot (once approved by the FDA) will not infringe the Bard patent, and we are optimistic that the court will affirm our position."