CryoLife, Inc.(" CryoLife," the "Company," "we," or "us"), incorporated in 1984 in Florida, develops, manufactures, and commercializes medical devices for cardiac and vascular applications and preserves and distributes human tissues for transplantation. CryoLife'ssurgical sealants and hemostats include BioGlue® Surgical Adhesive ("BioGlue"), BioFoam® Surgical Matrix ("BioFoam"), and PerClot®, an absorbable powdered hemostat, which the Company distributes for Starch Medical, Inc.("SMI") in the European Community and other select international markets. CryoLife'ssubsidiary, Cardiogenesis Corporation("Cardiogenesis"), specializes in the treatment of coronary artery disease using a laser console system and single use, fiber-optic handpieces to treat patients with severe angina. CryoLifeand its subsidiary, Hemosphere, Inc.("Hemosphere"), market the Hemodialysis Reliable Outflow Graft ("HeRO® Graft"), which is a solution for end-stage renal disease in certain hemodialysis patients. The cardiac and vascular human tissues distributed by CryoLifeinclude the CryoValve® SG pulmonary heart valve ("CryoValve SGPV") and the CryoPatch® SG pulmonary cardiac patch tissue ("CryoPatch SG"), both processed using CryoLife'sproprietary SynerGraft® technology. The quarter ended June 30, 2013was marked by several new regulatory approvals, which the Company received in June. The Company was awarded a CE Mark for the HeRO Graft, and the first HeRO Graft clinical case in Europewas performed in July 2013. The surgeons performing this initial case will establish the first HeRO Graft training center in Europe, which will support the Company's controlled market introduction of the product during the second half of 2013, followed by a broader European launch in 2014. CryoLifealso received conditional approval of its investigational device exemption ("IDE") for PerClot from the U.S. Food and Drug Administration("FDA"). IDE approval would allow the Company to begin clinical trials for the purpose of obtaining Premarket Approval ("PMA") to distribute PerClot in the U.S. As part of the conditional approval for the PerClot IDE, the Company must make certain revisions to the investigational study protocol, clinical product labeling, and Patient Informed Consent forms. The Company anticipates refiling the IDE submission in the third quarter of 2013. Subject to satisfaction of the FDA'sconditions, the Company plans to begin enrollment in the pivotal trial in the fourth quarter of 2013 or the first quarter of 2014. In June the Company also received PMA supplement approval from the FDAfor its redesigned Sologrip® and PEARL minimally invasive laser fiber-optic handpieces. The Company began distributing this new handpiece design exclusively at the end of the second quarter of 2013.