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Founded in 1984, CryoLife was the first biomedical company in the world to commercialize the low temperature preservation of human implantable tissues for complex cardiac and vascular reconstruction. Today, in addition to our ongoing advancements in tissue preservation, the company pioneers research in the development of implantable biological devices, surgical adhesives, hemostatic agents and biomaterials for use in cardiac, vascular and general surgery.
The company’s corporate headquarters is in suburban Atlanta, Georgia, where its 200,000 square foot, 21 acre, corporate campus is home to the company’s tissue preservation laboratory and surgical adhesive manufacturing facility. The corporate headquarters features a 3,600 square foot auditorium as well as “wet lab” facilities for hands-on surgical training for physicians. Since the company’s inception, cardiac tissues it has preserved have been used to reconstruct hearts in about 60,000 patients; more than half of those patients have been children. The company believes that more than 30,000 people have received preserved human vascular grafts for limb-saving peripheral vascular reconstruction. The company also sells BioGlue® Surgical Adhesive. Since BioGlue’s successful introduction into European markets in 1998 and then into the U.S. in 2001, this product has been used in more than 550,000 surgical procedures worldwide. In February 2008, the company received FDA clearance to market CryoValve® SG, a human pulmonary heart valve, used for RVOT (right ventricular outflow tract) reconstruction and the Ross Procedure, that is processed using CryoLife’s proprietary SynerGraft® technology. The SynerGraft technology, developed and patented by CryoLife, is designed to remove cells and cellular remnants from tissues without compromising the integrity of the underlying collagen matrix. The CryoValve SG is the first decellularized human cardiac tissue to be cleared by the FDA. In July 2009, the company received a CE Mark approval for BioFoam® Surgical Matrix. BioFoam Surgical Matrix is for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) where conventional hemostatic methods have proven to be ineffective or impractical. BioFoam, a protein hydrogel biomaterial, is the second product in this technology platform to receive a CE Mark (the first was BioGlue). BioFoam contains an expansion agent mixed with a material that creates a mechanical barrier to decrease blood flow resulting in a porous matrix that allows blood to enter, leading to cellular aggregation and enhanced hemostasis. In August 2009, the company received 510(k) clearance from the FDA to market its CryoPatch® SG pulmonary human cardiac patch throughout the United States. The CryoPatch SG is processed with the Company’s proprietary SynerGraft technology designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix. This preserved tissue is indicated for the repair or reconstruction of the right ventricular outflow tract (RVOT) which is a surgery commonly performed in children with congenital heart defects. I feel that the introduction of CryoPatch SG represents another step in the broadening applications of the SynerGraft technology to additional human tissues and cells. CryoPatch SG may offer an attractive tissue reconstruction option for many children born with heart defects. Calendar year 2009 proved to be a very good year for CryoLife. Revenues for the year set an all time record of $111.7 million, an increase of 6% over the same period in 2008. The fourth quarter of 2009 was a very strong quarter with revenues increasing 12% over the same period of 2008 to a record of $28.6 million. Another sign of the Company’s ability to thrive in a very difficult economic situation was that we generated over $16.5 million in operating cash flow for the year giving CryoLife $35.1 million in cash, cash equivalents and restricted securities at year end. Net income for the year was $8.7 million or $0.31 per basic and fully diluted common share. The fourth quarter of 2009 was the Company’s 12th consecutive quarter of profitability.
During feasibility animal testing of BioFoam it was found that it was effective in controlling bleeding at systemic cardiovascular blood pressures. Following additional preclinical testing we expect to submit a CE Mark application for this expanded clinical indication of BioFoam in cardiovascular surgery to our European notified body in the fourth quarter of 2010. Using BioFoam for cardiovascular indications has various advantages for both the patient and the doctor. First of all, BioFoam is more viscous as compared to other products and tends to stay where it is placed on the tissue. Second, you can see where it is in the wound. Third, and most importantly, it is biodegradable in about 6 months whereas some other products may take up to 2 years to biodegrade.
For a more detailed discussion of the company’s history, products and services you may view and request a copy of the 25th anniversary booklet that features a few of the patients and their doctors who have had their lives enhanced with CryoLife preserved tissues and in some cases our biological adhesives and glues. Steven G. Anderson |
During December we completed the initial phase of our prospective European study for BioFoam when used to seal parenchymal tissues such as liver and spleen. The total enrollment for this study when complete will consist of about 70 patients from four clinics in France, Germany and the UK. BioFoam was commercially launched in the European community in January 2010 at the company’s yearly sales kickoff meeting. BioFoam has proven itself to be a highly effective hemostatic agent .
We continue to move forward with our United States regulatory application (IDE) for BioFoam’s use in liver resection surgery. We expect to start our patient enrollment in the 2nd quarter of 2010. The Department of Defense has funded this project for about $5.4 million over the past three years of development and we anticipate applying for additional funding of about $800,000. We expect that DOD grants will support about 90% of the IDE approval process. We expect to submit an IDE for the use of BioFoam in cardiovascular procedures during the first quarter of 2011. This timetable should enable us to receive FDA approval and then launch BioFoam for cardiovascular procedures. BioGlue, BioFoam and Hemostase® will form the basis of a technology platform for hemostatic agents that will provide the company with potential markets that approach $900 million. This hemostatic product portfolio should provide CryoLife with a significant growth engine going forward.