Profile: CryoLife Inc (CRY.N)
30 Oct 2014
CryoLife, Inc. (CryoLife,), incorporated in January 19,1984, is a biological medical device company. The Company preserves and distributes human tissues for transplantation and develops, manufactures, and commercializes medical devices for cardiac and vascular applications. The cardiac and vascular human tissues distributed by CryoLife include the CryoValve SG pulmonary heart valve (CryoValve SGPV) and the CryoPatch SG pulmonary cardiac patch tissue (CryoPatch SG), both processed using CryoLife’s SynerGraft technology. The Company operates in two segments: preservation services and medical devices segment. The preservation services segment includes services revenues from the preservation of cardiac and vascular tissues during the year ended December 31, 2011. The medical devices segment includes revenues from product sales of BioGlue, BioFoam, PerClot, HemoStase and revascularization technologies, as well as sales of other medical devices. CryoLife’s surgical sealants and hemostats include BioGlue Surgical Adhesive (BioGlue), BioFoam Surgical Matrix (BioFoam) and PerClot, an absorbable powdered hemostat. In August 2014, the Company acquired distribution rights to PhotoFix, a bovine pericardial patch stabilized using a dye-mediated photo-fixation process that requires no glutaraldehyde from Genesee BioMedical, Inc., a Denver, Colorado-based manufacturer of cardiac surgery instruments and devices.
CryoLife distributes preserved human cardiac and vascular tissues to implanting institutions throughout the United States (U.S), Canada and Europe. CryoLife processes and preserves cardiac and vascular tissues using processing and freezing techniques, or cryopreservation. The Company’s preservation process involves the recovery of tissue from deceased human donors by tissue banks and organ procurement organizations (OTPOs), the delivery, of such tissue to the Company, the screening, dissection, disinfection, processing, and preservation of the tissue by the Company, and the storage and shipment of the preserved tissue.
The human heart valves and cardiac patch tissues preserved by the Company are used in cardiac reconstruction and heart valve replacement surgeries. The Company preserves human aortic and pulmonary heart valves for implantation by cardiac surgeons. In addition, the Company preserves human cardiac patches for surgeons. The Company preserves human cardiac patches in three primarily anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch. As of December 31, 2011, CryoLife shipped approximately 77,600 heart valves and cardiac patch tissues, including approximately 3,000 shipments during 2011.
The human vascular tissues preserved by the Company, including the CryoVein and CryoArtery, are used to treat a variety of vascular reconstructions, such as peripheral bypass, hemodialysis access and aortic infections. The Company preserves small diameter human saphenous vein conduits (3 millimeter to 6 millimeter) for use in peripheral vascular reconstructions. The Company also preserves femoral veins and arteries and aortoiliac arteries for bypass, hemodialysis access, or reconstruction within infected surgical areas. As of December 31, 2011, the Company shipped approximately 66,100 human vascular tissues, including approximately 4,500 shipments during 2011.
CryoLife’s product BioGlue, designed for cardiac, vascular, pulmonary, and general surgical applications, is a polymer based on bovine blood protein and an agent for cross-linking proteins. CryoLife distributes BioGlue throughout the United States and approximately 75 other countries. CryoLife distributes BioGlue for repair of soft tissues under conformite Europeene Mark Product Certification (CE Mark). CryoLife distributes BioGlue in Japan for use in the repair of aortic dissections.
CryoLife’s product, BioFoam, is a protein hydrogel biomaterial with an expansion agent, which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and develops pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. CryoLife distributes BioFoam under CE Mark certification.
CryoLife’s product, PerClot, is an absorbable, powdered hemostatic agent used in surgery. PerClot particles have a molecular structure that absorbs water from blood, creating a high concentration of platelets, red blood cells, and coagulation proteins at the bleeding site, which accelerates the physiologic clotting cascade. PerClot is readily dissolved by saline irrigation and is totally absorbed within several days. PerClot is available in one gram, three gram and five gram sizes with a 100 millimeter or 200 millimeter applicator tip. PerClot Laparoscopic is available in one gram and three gram sizes with a 380 millimeter applicator tip.
The Company competes with St. Jude Medical, Inc., Medtronic, Inc., Edwards Life Sciences, Inc., Neovasc, Inc., LifeNet Health, Inc. W.L. Gore & Associates’ Propaten, C.R. Bard, Inc., Hancock Jaffe Laboratories, Inc., Maquet, Inc., CorMatrix Cardiovascular, Inc., Baxter International, Inc., Johnson & Johnson Company, Covidien Ltd, NeoMend, Inc., Pfizer, Inc., Orthovita, Inc., King Pharmaceuticals, Inc., Ethicon, Inc., ZymoGenetics, Inc. and Nycomed.
STE 142, 1655 ROBERTS BOULEVARD
KENNESAW GA 30144