CryoLife, Inc. Purchases Acreage Designated For Future Growth and Expansion of Company Operations
ATLANTA, June 29 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), the leader in the development and commercialization of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves and surgical adhesives, today announced that it had acquired a six-acre parcel of land adjacent to its headquarters and main laboratory facilities in Kennesaw, Georgia. The purchase brings CryoLife, Inc.'s total corporate headquarters campus to 21 acres.
Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., noted that, "The additional acreage will provide the Company with the necessary property to accommodate Phase III of our growth and expansion plans. Currently, in our Phase II expansion program, we have under construction a new two-story, 100,000 square foot building that will be joined to our existing headquarters building. When completed in mid 2001, CryoLife will have over 200,000 square feet of expanded headquarters, laboratories, and manufacturing facilities. The Phase II addition will accommodate the expansion, development, and commercial roll-out of our BioGlue(R) surgical adhesive and the SynerGraft(R) family of tissue-engineered products for both domestic and international markets."
BioGlue was introduced in Europe in April 1998, under a "CE" product certification mark and is currently in commercial distribution in 35 countries worldwide for approved applications in vascular and pulmonary repair. Domestically, BioGlue was approved by the Food and Drug Administration (FDA) for distribution in the U.S. in December 1999 under a Humanitarian Device Exemption (HDE) as an adjunct for repair of acute thoracic aortic dissections. In March 2000, the FDA approved an expansion of the BioGlue human clinical trial for use in all vascular and cardiac repairs.
The Company's SynerGraft program is being directed toward the development of a series of living biological cardiovascular, vascular, and orthopaedic implantable devices, utilizing a technology that removes the cells from animal tissues forming a collagen matrix that can be repopulated with human cells. The SynerGraft program has resulted in the creation of the world's first tissue-engineered heart valve that has been successfully implanted in humans in Australia.
"We are now in the process of applying for a CE mark that would open up SynerGraft heart valves for distribution to the US$400 million European heart valve replacement market. We also plan to file an IDE with the FDA for the human testing of SynerGraft in July of 2000," Anderson added.
Founded in 1984, CryoLife, Inc. is the leader in the development and commercialization of implantable living human tissues for use in cardiovascular, vascular, and orthopaedic surgeries throughout the United States and Canada. The Company's BioGlue(R) surgical adhesive, CE marked in the European Union for use in vascular and pulmonary sealing and repair, is distributed throughout Europe. The Company also manufactures CryoLife- O'Brien(R) and CryoLife-Ross(R) stentless porcine heart valves, which are distributed within the European Community.
Statements made in this presentation that look forward in time or that express management's beliefs, expectations or hopes regarding future occurrences are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These occurrences may not happen when expected, if at all, and are subject to various risks and uncertainties. Such risks and uncertainties include the possibility that SynerGraft valves will not repopulate with human recipient cells, that future clinical SynerGraft test results will prove less encouraging, that SynerGraft regulatory submissions will not be ready when planned or that anticipated regulatory approvals will not be obtained on a timely basis, if at all, the timing of the completion of the Phase II expansion program, and possible changes in growth and expansion plans that could require the acquisition of additional property or work space.
For additional information about the company, visit CryoLife's web site: http://www.cryolife.com
SOURCE CryoLife, Inc.
CONTACT: Ashley Lee, Vice President and Chief Financial Officer of CryoLife, Inc., 800-438-8285/