First patient enrolled in CryoLife's PerClot IDE clinical trial

CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today the enrollment of the first patient in its PerClot Investigational Device Exemption (IDE) clinical trial, the Company's pivotal clinical trial to gain approval to commercialize PerClot in the U.S.

"The first patient enrolled in the PerClot IDE clinical trial is a positive milestone for the Company and our strategy to expand indications for our products," stated Pat Mackin, CryoLife Chairman, President, and Chief Executive Officer. "We will be working to bring other trial sites online in the coming months, positioning us to complete enrollment in the trial in the first half of 2016. With a three-month follow-up period, we would anticipate obtaining FDA approval for PerClot in the second half of 2017."

"As surgeons, we are continually confronted with controlling surgical bleeding," stated Arthur Coffey, MD, Cardiac Surgeon and PI for the PerClot IDE at Indiana University Health. "We are excited to have the opportunity to evaluate this innovative technology, using a validated bleeding scale, for its ability to control bleeding during cardiac and general surgery." Michael House, MD, General Surgeon at Indiana University Health commented that "this trial is the first of its kind and represents the future for evaluating hemostatic devices desiring market approval. We are excited to announce enrollment of the first patient into this important clinical trial to evaluate PerClot in the U.S."

The PerClot IDE is a multicenter, multidisciplinary, controlled clinical investigation. The study will include 324 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 seven 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 five 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.