Artivion formerly CryoLife Inc.
CryoLife’s mission is to restore patients’ health and quality of life by delivering innovative technologies. CryoLife is one of the world’s leading contemporary medical device companies, providing preserved human tissues for cardiac and vascular surgeries, mechanical heart valves for aortic or mitral valve replacement, surgical adhesives and sealants, cardiac lasers for treatment of refractory angina, and state-of-the-art technology and surgical training in adult and pediatric cardiovascular surgery. CryoLife distributes internationally through a direct sales force in the UK, Ireland, Germany and Austria, and through a global network of professional distributors.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
About Us
Since the company’s inception in 1984, it is estimated that CryoLife’s products and tissues have been implanted in over 1 million patients worldwide.
CryoLife is headquartered in Kennesaw, Georgia, 20 miles northwest of Atlanta, with offices in Austin, Texas and Guildford, Surrey, UK, as well as sales and marketing centers in Germany and Singapore, and representation in over 85 countries worldwide.
The firm’s 700 employees hail from 11 countries and speak 17 languages. CryoLife’s staff includes four full-time physicians and seven Ph.D.s, with disciplines in chemical engineering, biomedical engineering, biochemistry, protein chemistry and organic chemistry.
CryoLife is a public company and is traded on the New York Stock Exchange under the symbol CRY.
Core Behaviors
The achievement of excellence is the foundation of CryoLife’s Core Behaviors. The Company has consistently maintained a corporate commitment to support the following behaviors:
Results Driven
Proceeding or arising as a consequence, effect, or conclusion of meaningful work that motivates to deliver results.
Inspires Others
Leaning in and bringing out the best in others.
Customer Focused
Putting the customer first in all that we do.
Integrity
Maintaining the highest legal, moral, and ethical standards, while doing the right thing even when no one is watching.
Transparency
Exchanging complete and truthful information upfront and visible, in a timely manner.
Collaboration
Working together as a global company to deliver for our clients, shareholders, and each other.
CryoLife Benefits
Our employees enjoy being part of an organization that stretches their potential and that allows them to help others. A key part of job satisfaction is the work environment, as well. Our Kennesaw, Georgia headquarters’ facilities are pristine and are nestled in an idyllic area that is just minutes away from excellent restaurants, bountiful shopping options and major interstates. These factors and more make CryoLife an interesting and convenient place to come to work. We also provide attractive compensation and an excellent benefits package (some highlights listed below) that includes ongoing training and career development opportunities.
- Competitive Paid Time Off
- Education Reimbursement
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Accounts
- Flexible Spending Accounts
- Employee Assistance Program
- Employee Referral Program
- Wellness Program
- 401(k) Plan with company matching benefit
- Discounted Employee Stock Purchase Plan
- Life Insurance
Part Time Employees who meet certain criteria are eligible to participate in:
- 401(k) Plan with company matching benefit
- Discounted Employee Stock Purchase Plan
- Wellness Program
History & Profile
Founded in 1984, CryoLife was the first biomedical company to specialize in the low temperature preservation of human heart valves used for complex cardiac reconstruction primarily in children born with heart defects. Since those initial efforts, CryoLife’s preservation technology has expanded to include cardiac patches, saphenous veins, femoral arteries and veins as well as aorto-illiac vessels for use in central and peripheral vascular reconstruction. CryoLife’s proprietary processes for preserving these cardiovascular tissues have dramatically improved and enhanced the lives of hundreds of thousands of patients.
With studies beginning in 1991, Steven Goldstein, Ph.D., CryoLife’s Senior Director of Tissue Technologies, pushed the company into the forefront of a new approach in implantable tissue-based devices with the development of a decellularization technology that became known as the SynerGraft® process The SynerGraft process is designed to remove cells and antigens from the implantable tissues while preserving the integrity of the tissues’ collagen matrix. SynerGraft processed human pulmonary heart valves were cleared by the FDA in May of 2008 and SynerGraft processed pulmonary cardiac patch tissue was cleared by the FDA in August 2009. SynerGraft processed cardiac patches and valves are used by surgeons for complex cardiac reconstruction and valve replacement procedures.
In 1996, the Company acquired the initial patents and technology for a surgical adhesive, BioGlue®, a protein hydrogel polymer, from its inventor Nicholas Kowanko, Ph.D. After three years of product development and clinical testing, it received a CE Mark approval for all countries in the European community. In 2001, BioGlue received FDA approval for distribution in the U.S. In early 2011, BioGlue was approved in Japan, the world’s second largest surgical adhesive market after the U.S. Since its U.S. and international approvals, it is estimated that BioGlue has been used in over 1 million surgical procedures worldwide.
The company’s protein hydrogel technology platform was expanded in 2009 with the CE Mark approval of BioFoam® Surgical Matrix. BioFoam contains an expansion agent that causes the material to expand its volume by a factor of four or five times and is intended for use as an adjunct in the sealing of abdominal parenchymal tissues such as liver and spleen. CryoLife recently received a CE Mark application for the use of BioFoam in cardiac and vascular reconstruction procedures. BioFoam’s development was funded with grants from the Department of Defense for approximately $5.5 million.
In September of 2010, CryoLife signed an exclusive worldwide manufacturing and distribution agreement with Starch Medical of San Jose, California, for a powdered hemostatic agent, PerClot®. PerClot is CE Marked and is available in certain international markets at this time. CryoLife has received a conditional approval for an Investigational Device Exemption to begin clinical testing of the product in the United States, subject to the Company making certain revisions and refiling the IDE. Manufacturing operations for PerClot began in the third quarter of 2013 at our corporate headquarters facility, focusing on supplying PerClot for the U.S. human clinical trials and, pending regulatory approvals, to support the Canadian and Brazilian markets. International sales of PerClot increased 30% in the first nine months of 2013 over the first nine months of 2012, to $2.7 million.
In May of 2011, the Company completed the acquisition of CardioGenesis Corporation. CardioGenesis is a pioneer in the development and use of laser technology for transmyocardial revascularization (TMR) in patients with severe angina. The CardioGenesis system is approved by the FDA and is CE Marked in Europe. TMR is accepted as a meaningful therapy and treatment for refractive angina by the American College of Cardiology, The American Heart Association, and the Society of Thoracic Surgeons. Revascularization technologies in the first nine months of 2013 were $6.8 million, an 11% increase over the first nine months of 2012.
In January 2016, CryoLife completed acquisition of On-X Life Technologies Holdings, Inc., the leading manufacturer of artificial heart valve replacement and repair products. This acquisition has provided CryoLife access to the $220 million mechanical valve market with a highly advanced portfolio of products. On-X valves have been implanted in over 200,000 patients, and On-X has achieved a 13% revenue CAGR over the past four years with modest sales and marketing support. The On-X aortic valve is the only mechanical valve to receive FDA labeling requiring an INR (international normalized ratio) level of only 1.5-2.0, providing a distinct competitive advantage.
Since its early beginnings with six employees in a 2,400 sq. ft. laboratory near Hartsfield airport in Atlanta, Georgia, CryoLife has grown into a multi-national company with over 600 employees and sales representation in over 85 countries. The Company now occupies a 200,000 sq. ft. corporate headquarters on a 21-acre campus in Kennesaw, Georgia, northwest of Atlanta. Its wholly owned subsidiary, CryoLife Europa Ltd., is located near Heathrow Airport outside of London, England, and serves as a European and Mediterranean distribution center for CryoLife’s implantable medical devices. In February 2014, a new sales and marketing center was opened in Singapore, supporting all of the Company’s business in the Pacific Rim countries; Japan, China, South East Asia, Australia, Malaysia and Indonesia.
Quality and Safety
CryoLife’s comprehensive Quality System is designed to achieve high quality standards through strict levels of quality control. CryoLife’s achievement of quality is indicative of the importance placed on meeting patients’ and customers’ needs and is exemplified by the high quality products being offered.
Collectively, our CryoLife team owns Quality. Our goal is that each team member uniquely applies personal accountability in all areas of our business to those we are entrusted to serve. We accomplish this goal by complying with applicable regulatory and customer requirements and by maintaining the effectiveness of the Quality Management System, and through the establishment and review of quality objectives.
CryoLife’s Quality Management System is in accordance with 21 CFR Part 820 – Medical Devices, Quality System Regulation, 21 CFR Part 1270 – Human Tissue Intended for Transplantation, and 21 CFR Part 1271 – Human Cells Tissues and Cellular and Tissue Based Products. CryoLife’s Quality Management System also incorporates the requirements of applicable ISO Standards, as well as European Medical Device Directives, Australian Medical Device Requirements, Health Canada Medical Device Regulations, and Health Canada Tissue Regulations.
CryoLife emphasizes a total quality assurance approach to all aspects of business. Awareness of Quality Systems and procedures is maintained through employee training and is practiced company-wide.
The CryoLife Quality Management System provides the organizational structure to ensure that products are processed, manufactured, controlled, and distributed according to the appropriate regulatory requirements and corporate policies/procedures. Continuous quality improvement is the basis for the Quality Management System. The periodic reviews of the system identify the strategic plans required to develop, implement, and modify the Quality Management System and identify the processes, controls, equipment, fixtures, resources, and skills necessary to meet ongoing quality requirements.
CryoLife, Inc. is a U.S. FDA-registered medical device establishment (Registration # 1063481) and human cells, tissues, and cellular and tissue-based product establishment (#3001451326). In addition, CryoLife is licensed or registered by the States of Georgia, New York, Florida, California, Maryland, Pennsylvania, Illinois, and Delaware. CryoLife is certified to the international quality standards (ISO 13485:2016) for the design, manufacture, and distribution of tissues and medical devices. CryoLife’s Microbiology Laboratory is a State of Georgia licensed Clinical Laboratory, is a federally licensed CLIA Laboratory, and participates annually in the College of American Pathologists (CAP) Performance Surveys.
