Profile: CryoLife Inc (CRY.N)
21 Oct 2016
CryoLife, Inc. (CryoLife), incorporated on January 19, 1984, is engaged in medical device manufacturing and distribution, and in the processing and distribution of implantable human tissues for cardiac and vascular surgeries. The Company operates in two segments: Medical Devices and Preservation Services. The Medical Devices segment includes external revenues from product sales of BioGlue, BioFoam, PerClot, CardioGenesis cardiac laser therapy, Hemodialysis Reliable Outflow (HeRO) Graft, and ProCol Vascular Bioprosthesis (ProCol). The Preservation Services segment includes external services revenues from the preservation of cardiac and vascular tissues.
The Company's surgical sealants and hemostats include BioGlue Surgical Adhesive (BioGlue), BioFoam Surgical Matrix (BioFoam), and PerClot, an absorbable powdered hemostat, which the Company distributes internationally for Starch Medical, Inc. (SMI). The Company's CardioGenesis cardiac laser therapy product line, which includes a laser console system and single-use, fiber-optic handpieces, is used for the treatment of coronary artery disease in patients with severe angina. The Company markets the HeRO Graft and distributes ProCol, which are solutions for end-stage renal disease (ESRD) in certain hemodialysis patients. CryoLife is the distributor of PhotoFix for Genesee Biomedical, Inc. (GBI). PhotoFix is a bovine pericardial patch stabilized using a dye-mediated photo-fixation process that requires no glutaraldehyde. 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 of which are processed using CryoLife's SynerGraft technology.
The Company offers protein hydrogel technology (PHT) platform, which is based on a bovine protein that mirrors a range of amino acids that perform complex functions in the human body. Together with a cross-linker, the protein forms a hydrogel, a water-based biomaterial somewhat similar to human tissue. CryoLife offers surgical sealants BioGlue and BioFoam from its PHT platform. The Company's product, BioGlue, is a polymer consisting of bovine blood protein and an agent for cross-linking proteins, which are developed for use in cardiac, vascular, pulmonary, and surgical applications. Its BioGlue is dispensed by a controlled delivery system that consists of a disposable syringe, which may be used with, or without, a multi-use delivery device, and various applicator tips. BioGlue is pre-filled in approximately two milliliter (ml), five ml and 10 ml volumes. Applicator tips are available in standard size, over 12 millimeter (mm) and 16 mm spreader tips, over 10 centimeters (cm) and 27 cm flexible extender tips, and over 10 cm, 27 cm, and 35 cm delivery tip extenders. The Company's product, BioFoam, is a protein hydrogel biomaterial with an expansion agent, which generates 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. BioFoam is used to seal organs, such as the liver. BioFoam is also used in cardiovascular surgeries and to provide hemostasis in penetrating wounds and trauma. It is used intra-operatively to control internal organ hemorrhage, limit blood loss and reduce the need for future re-operations in liver resections. CryoLife distributes BioFoam in Europe as adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) and as an adjunct to hemostasis in cardiovascular surgery when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.
CryoLife markets the hemostatic agent PerClot. The Company's PerClot is an absorbable powdered hemostat, consisting of plant starch modified into ultra-hydrophilic, adhesive-forming hemostatic polymers. PerClot granules are biocompatible, absorbable polysaccharides containing no animal or human components. PerClot granules have a molecular structure that absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to further bleeding and results in the accumulation of platelets, red blood cells, and coagulation proteins (thrombin and fibrinogen) at the site of application. PerClot is dissolved by saline irrigation and is absorbed by the body within several days. PerClot is available in approximately one gram, three gram, and five gram configurations with a 100 mm or 200 mm applicator tip for certain sizes. PerClot Laparoscopic is available in a three gram configuration with a 380 mm applicator tip. PerClot is indicated for use in surgical procedures, including cardiac, vascular, orthopedic, neurological, gynecological, Ear-Nose-Throat (ENT) and trauma surgery as an adjunct hemostat when control of bleeding from capillary, venular, or arteriolar vessels by pressure and ligature. The Company distributes PerClot in Europe and other international countries.
The Company's CardioGenesis cardiac laser therapy product line consists of Holmium: yttrium aluminum garnet (YAG) laser consoles, related service and maintenance, and single-use, fiber-optic handpieces, which are used in Transmyocardial Revascularization (TMR) to treat patients with severe angina resulting from diffuse coronary artery disease. Its SolarGen 2100s Console (Console) has an advanced electronic and cooling system technology, which allows for a smaller system, while providing over 115-volt power capability. The Company distributes the SoloGrip III, and the Port Enabled Angina Relief with Laser (PEARL) 5.0 disposable handpieces, which consist of multiple, fine fiber-optic strands in a one-millimeter diameter bundle and are designed to work with the Console. The SoloGrip III handpiece is used to provide access for treating all regions of the left ventricle. The PEARL 5.0 handpiece is used with Intuitive Surgical's da Vinci Surgical System for use in minimally invasive surgeries.
The Company's ProCol is a biological graft derived from a bovine mesenteric vein that provides vascular access for ESRD hemodialysis patients. ProCol provides vascular access for ESRD patients in an earlier stage of the treatment protocol than the HeRO Graft. The HeRO Graft is a graft-based solution for ESRD hemodialysis patients with limited access options and central venous stenosis (narrowing of the venous system).
Cardiac and Vascular Repair and Reconstruction
CryoLife markets its cardiac preservation services, including its CryoValve and CryoValve SG tissues for heart valve replacement surgeries and its CryoPatch and CryoPatch SG tissues for cardiac repair procedures. CryoLife markets its vascular preservation services, including its CryoVein and CryoArtery tissues for vascular reconstruction surgeries. CryoLife distributes PhotoFix for cardiac and vascular repair. PhotoFix is a bovine pericardial patch stabilized using a dye-mediated photo-fixation process that requires no glutaraldehyde. The Company's preservation process involves dissection, processing, preservation, and storage of tissues by the Company, until they are shipped to an implanting physician. The tissues preserved by the Company include aortic and pulmonary heart valves; cardiac patches in over three anatomic configurations, including pulmonary hemi-artery, pulmonary trunk and pulmonary branch, and vascular tissues, including, saphenous veins, aortoilliac arteries and femoral veins and arteries. The Company's cardiac tissues are used in a range of valve replacement and cardiac reconstruction surgeries. The Company's vascular tissues are used to treat vascular reconstructions, such as peripheral bypass, hemodialysis access and aortic infections. The Company's cardiac tissues include the CryoValve SGPV and the CryoPatch SG, both processed with the Company's SynerGraft decellularization technology. CryoLife uses the SynerGraft technology for a significant portion of its pulmonary valve and pulmonary cardiac patch tissue processing.
The Company competes with Baxter International, Inc., Johnson & Johnson, Integra LifeSciences Holdings Corporation, C.R. Bard, Inc. (Bard), Mallinckrodt PLC, Orthovita, Inc., Pfizer, Inc., BioCer Entwicklungs-GmbH, LifeNet Health, Inc., Novadaq Technologies, Inc., Boston Scientific Corp., Medtronic, Inc., Edwards Life Sciences, Inc. LivaNova, St. Jude Medical, Inc., CorMatrix Cardiovascular, Inc., Admedus, Inc., Synovis Surgical Innovations, W.L. Gore & Associates, Artegraft, Inc., Bard and Boston Scientific Corp. and Maquet, Inc.
1655 Roberts Blvd NW
KENNESAW GA 30144-3632