CryoLife, Inc. Receives Approval by 83 Hospitals for Use of BioGlue In Acute Thoracic Aortic Dissections.Business Editors/Health and Medical Writers ATLANTA--(BW HealthWire)--Feb. 22, 2000 CryoLife, Inc. (NYSE NYSE See: New York Stock Exchange :CRY), the leader in the development and commercialization of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves Heart valves Valves that regulate blood flow into and out of the heart chambers. Mentioned in: Heart Failure and surgical adhesives, today announced that it has received approval from the Institutional Review Boards (IRB IRB See: Industrial Revenue Bond ) at 83 hospitals in the United States Lists of hospitals for each U.S. state:
The approval by the IRB follows the action by the Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in granting Humanitarian Device Exemption (HDE HDE Hauptverband des Deutschen Einzelhandels (Central Association of German Retail Trade) HDE Humanitarian Device Exemption HDE Heavy-Duty Engine HDE Holdrege, Nebraska (airport code) ) status for BioGlue in the treatment and repair of acute thoracic aortic dissections, recognized as one of the most life-threatening clinical conditions of the thoracic aorta. Steven G. Anderson, President and Chief Executive Officer of CryoLife, Inc., noted, "Over 450 hospitals nationwide routinely repair about 4,000 acute thoracic aortic dissections each year. These aortic dissections represent an estimated market for BioGlue of about $12 million per year. We are very pleased with the acceptance BioGlue has gained among cardiovascular and thoracic surgeons. With these results, we are very close to achieving our six-month objective of 100 IRB approvals within the first two months of the year. Further, nearly half of the IRB-approved hospitals have already placed orders and received BioGlue." In January 2000, CryoLife, Inc. submitted an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) supplement with the FDA for an expanded clinical study of its BioGlue to include use in vascular and certain cardiac repairs. BioGlue surgical adhesive is "CE" (product certification) marked in Europe for vascular sealing and pulmonary repair, including air leaks in lungs. BioGlue is currently in distribution in over 34 countries for use in vascular and pulmonary repairs addressing a significant portion of the $2 billion USD USD In currencies, this is the abbreviation for the U.S. Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. worldwide market for surgical adhesives and sealants. 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 is approved as an adjunct for acute thoracic aortic dissections under HDE regulations in the United States and is CE marked in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community for use in vascular and pulmonary repair. The Company also manufactures CryoLife-O'Brien(R) and CryoLife-Ross(R) Stentless porcine porcine /por·cine/ (por´sin) pertaining to swine. porcine pertaining to pig. See also hog (1), swine. porcine circovirus 1 a nonpathogenic virus. heart valves which are distributed only within the European Community. Statements made in this press release that look forward in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Such risks and uncertainties include the possibility that the demand for BioGlue surgical adhesive will not continue to increase because (i) surgeons may choose not to utilize BioGlue surgical adhesive, (ii) BioGlue surgical adhesive could have currently unforeseen side effects which could render it undesirable for use in vascular and pulmonary applications, (iii) because future human clinical results with respect to BioGlue could prove less encouraging or (iv) BioGlue surgical adhesive could possibly be found not to be effective in reducing bleeding in humans. Additional risks and uncertainties that could affect the forward-looking statements contained herein include 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). For additional information about the Company, visit CryoLife's web site: http://www.cryolife.com |
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