CryoLife, Inc. Announces Expansion Of Production Capacity For BioGlue And Porcine Heart Valves
On January 6, 1998, BioGlue was awarded the European CE (product certification) mark, allowing unrestricted commercial distribution of BioGlue for vascular sealing and reconstruction surgeries within the European Community.
On June 9, 1998, the Company announced that the Food and Drug Administration (FDA) had approved the Company's investigational device exemption (IDE) to conduct human trials of BioGlue in the repair of acute aortic dissections. The trials are expected to be conducted at up to 20 investigational sites, involving some 300 patients in the United States. To accommodate international sales and the domestic human trials program, CryoLife has begun the build-out of a new 13,000 square foot BioGlue production facility at the Company's headquarters and main laboratory facilities in suburban Atlanta. The new production facility is expected to be completed in October 1998. When completed it will provide capacity for 300,000 units in five-cc and ten-cc sizes of BioGlue at an average selling price of $300.00 (USD) per unit.
Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., noted, ``The expanded BioGlue production capacity will also allow CryoLife to seek additional CE marks for other medical applications of BioGlue. We plan to submit a CE mark application for the use of BioGlue in the prevention of air leaks in lung reduction surgeries for emphysema patients in the fourth quarter 1998.''
CryoLife also announced that it had begun expansion of its porcine heart valve production facility in Marietta, Georgia. The build-out, to total 20,000 square feet, follows the award of the European CE mark for the CryoLife-Ross(TM) porcine heart valves allowing commercial distribution in Europe. The CryoLife-Ross pulmonary valve is an advanced design stentless porcine heart valve for use in cardiac reconstruction surgeries in children and adults.
The Company's porcine heart valve manufacturing facility also produces the CryoLife-O'Brien(R) aortic stentless porcine heart valve that was introduced into the European market in 1996, following the award of the CE mark.
Anderson also noted, ``The expanded porcine heart valve facility provides production capacity for up to 5,000 heart valve units annually, and we believe that it will strengthen our position in the $75 million (USD) European tissue heart valve market by providing valves that address both pediatric and adult cardiac reconstruction surgeries.''
Founded in 1984, CryoLife, Inc. is a leader in the development and commercialization of technology for ultra-low temperature preservation (``cryopreservation'') of viable human tissues for use in cardiovascular, vascular, and orthopaedic surgeries throughout the United States and Canada. The Company's BioGlue surgical adhesive, CE marked in the European Union for use in vascular sealing and repair, is distributed throughout Europe. Through its wholly-owned subsidiary, Ideas for Medicine(R), Inc., CryoLife is the manufacturer and distributor of an extensive line of single-use medical devices used primarily in vascular and cardiovascular surgery. The Company also manufactures stentless porcine heart valves which are distributed within the European Community.
Note: Statements made in this release which look forward in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such risks and uncertainties include the ability of the Company to complete its investigational device exemption trials on schedule, the timing of the completion of the Company's new BioGlue production facility, the timing of the submission of additional CE mark application for BioGlue, the effect of the Company's increased porcine heart valve production capacity on its position in the European tissue heart valve market, the ability of the Company to successfully implement its operating strategy, changes in economic cycles, competition from other companies, changes in laws and governmental regulations applicable to the Company and other risk factors detailed in the Company's Securities and Exchange Commission filings, including the Company's Prospectus dated March 30, 1998 contained in its Registration Statement on Form S-3 (No. 333-46545).
The Company's Internet address: http://www.cryolife.com