Profile: CryoLife Inc (CRY.N)
24 Nov 2017
CryoLife, Inc. (CryoLife), incorporated on January 19, 1984, is a medical device manufacturer and processor, and is engaged in the distribution of medical devices and implantable human tissues used in cardiac surgical procedures. The Company operates through two segments: Medical Devices and Preservation Services. The Medical Devices segment includes medical devices, such as BioGlue Surgical Adhesive (BioGlue), BioFoam Surgical Matrix (BioFoam), On-X Life Technologies Holdings, Inc. (ON-X) valves and surgical products, CardioGenesis cardiac laser therapy product line, PerClot and PhotoFix. The Preservation Services segment includes external services, such as preservation of cardiac and vascular tissues. 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 (CryoPatch SG), both of which are processed using CryoLife's SynerGraft technology.
The Company offers a protein hydrogel technology (PHT) platform, which is based on a bovine protein that mirrors an array of amino acids that perform 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 the surgical sealants BioGlue and BioFoam from its PHT platform.
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 general surgical applications. 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 was pre-filled in two milliliter (ml), five ml and 10 ml volumes, as of December 31, 2016. Its applicator tips were available in standard sizes, 12 millimeter (mm) and 16 mm spreader tips; 10 centimeter (cm) and 27 cm flexible extender tips, and 10 cm, 27 cm and 35 cm delivery tip extenders, as of December 31, 2016.
BioFoam is a protein hydrogel biomaterial with an expansion agent, which generates a mixed-cell foam. BioFoam seals organs, such as the liver, for use in cardiovascular surgeries, and may provide hemostasis in penetrating wounds and trauma. The Company distributed BioFoam in approximately 45 countries, primarily in Europe, as of December 31, 2016.
Cardiac Repair and Reconstruction
The Company markets the On-X aortic and mitral mechanical heart valves for valve replacement procedures and PhotoFix for cardiac repair. CryoLife also 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.
The On-X catalogue of products includes the On-X prosthetic aortic and mitral heart valve, and the On-X ascending aortic prosthesis (AAP). CryoLife also distributes CarbonAid CO2 diffusion catheters, manufactures Chord-X expanded polytetrafluoroethylene (ePTFE) sutures for mitral chordal replacement and offers pyrolytic carbon coating services to other medical device manufacturers as part of the On-X family of products. Its On-X heart valve is a bileaflet mechanical valve composed of a graphite substrate coated with On-X's pyrolytic carbon coating. PhotoFix is a pericardial patch stabilized using a dye-mediated photo-fixation process that requires no glutaraldehyde.
CryoLife's cardiac preservation process involves dissection, processing, preservation and storage of tissues until the tissues are shipped to an implanting physician. The cardiac tissues preserved by the Company include aortic and pulmonary heart valves, and cardiac patches in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.
Vascular Repair and Reconstruction
CryoLife markets its vascular preservation services, including its CryoVein and CryoArtery tissues for vascular reconstruction surgeries. The vascular tissues preserved by the Company include saphenous veins, aortoilliac arteries, and femoral veins and arteries. CryoLife's vascular tissues have been used to treat various vascular reconstructions, such as peripheral bypass, hemodialysis access and aortic infections.
CryoLife 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. CryoLife's SolarGen 2100s Console uses the solid-state technology of the Holmium: YAG laser system to provide an energy platform that is designed to deliver precise energy output. The Console had an electronic and cooling system technology, which allowed for a smaller and lighter system, and the Console provided 115-volt power capability, as of December 31, 2016. It distributes the SoloGrip III disposable handpieces, which consist of multiple, fine fiber-optic strands in a one millimeter diameter bundle and are designed to work with the Console.
CryoLife is marketing its hemostatic agent PerClot. PerClot is an absorbable powdered hemostat, consisting of plant starch modified into ultra-hydrophilic, adhesive-forming hemostatic polymers. PerClot granules have a molecular structure that absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to any further bleeding and results in the accumulation of platelets, red blood cells and coagulation proteins at the site of application. PerClot was available in one gram, three gram, and five gram configurations with a 100 mm or 200 mm applicator tip for certain sizes, as of December 31, 2016. PerClot Laparoscopic was available in a three gram configuration with a 380 mm applicator tip, as of December 31, 2016. PerClot is indicated for use in surgical procedures, including cardiac; vascular, orthopaedic; neurological; gynecological; Ear, Nose and Throat (ENT), and trauma surgery.
CryoLife markets its CryoVein femoral vein and CryoArtery femoral artery vascular preservation services for vascular access. Its CryoVein femoral vein and CryoArtery femoral artery vascular preservation services are for End-stage renal disease (ESRD) patients.
The Company competes with Baxter International, Inc., Johnson & Johnson, Integra LifeSciences Holdings Corporation, C.R. Bard, Inc., Mallinckrodt PLC., Pfizer, Inc., Orthovita, Inc., Abbott Laboratories, Medtronic, Inc., LivaNova PLC, LifeNet Health, Inc., Edwards Life Sciences, Inc., CorMatrix Cardiovascular, Inc., Admedus, Inc., Synovis Surgical Innovations, LifeNet Health, Inc., LeMaitre Vascular, Inc., Vascular Transplant Services, Artegraft, Inc., Maquet, Inc., Novadaq Technologies, Inc., Mallinckrodt PLC, BioCer Entwicklungs-GmbH, Polyganics B.V. and Hemostasis, LLC.
1655 Roberts Blvd NW
KENNESAW GA 30144-3632