CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA). This approval allows CryoLife to begin its pivotal clinical trial to gain approval to commercialize PerClot in the U.S. The Company plans to begin enrollment in the trial in the second quarter of 2014, and could potentially receive pre-market approval from the FDA by the end of 2015.
PerClot is a unique hemostat composed of absorbable polysaccharide granules and is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular and arteriolar bleeding by pressure, ligature and other conventional means is ineffective or impractical. PerClot has CE Mark designation, and CryoLife began distributing PerClot in several international markets in the fourth quarter of 2010.
The PerClot IDE is a prospective, multicenter, multidisciplinary, controlled clinical investigation. The study will include 320 patients across cardiac, general and urological surgical specialties. The primary objective of this investigation will be to collect clinical data concerning the safety and efficacy of PerClot versus C.R. Bard's Arista MPH Hemostat in multiple surgical disciplines when used as an adjunct to conventional means of achieving hemostasis such as pressure or ligature. The primary efficacy endpoint of this investigation will be achievement of hemostasis at the site of application at five minutes following application of the prescribed hemostatic agent. The secondary efficacy endpoint for this investigation will be hemostasis at the site of application evaluated at two minutes. Safety endpoints will include, but are not limited to, the incidence of reoperation due to bleeding, total hospitalization and procedure time, and the incidence of procedure complications and/or adverse events through final patient follow-up at three months.
"We're pleased to have received this approval, which will allow us to begin our U.S. clinical trial for PerClot," stated Steven G. Anderson, CryoLife president and chief executive officer. "Based on the anticipated enrollment and follow up timeline, we could potentially receive pre-market approval for PerClot by the end of 2015."
The U.S. hemostatic market is estimated to have been $780 million in 2013 growing to approximately $915 million by 2016, while the European market is estimated to have been $395 million in 2013 growing to approximately $468 million by 2016.