CryoLife Seeks Australian Marketing Approval for BioGlue Surgical Adhesive.ATLANTA--(BW HealthWire)--July 26, 1999-- 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 submitted a Therapeutic Device Application to the Australian Therapeutic Good Administration (TGA See TARGA. TGA - Targa Graphics Adaptor ) for the use of BioGlue(R) surgical adhesive in vascular and pulmonary sealing and repair. The TGA is comparable to the United States' 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. ). Approval of the Therapeutic Device Application would make BioGlue surgical adhesive commercially available to physicians in Australia. The approval process, even if successful, can take up to nine months. However, while the submission is under review, TGA has agreed to permit physicians to use BioGlue if they apply for an Individual Patient Use (IPU IPU Inter-Parliamentary Union IPU Indraprastha University IPU Invisible Pink Unicorns :-) IPU Image Processing Unit IPU Instruction Processing Unit IPU Intelligent Processing Unit IPU Integrated Power Unit IPU Integer Processing Unit ). Steven G. Anderson, President and Chief Executive Officer of CryoLife, said, "The filing of this application is another step in our mission to enable BioGlue to be used by physicians around the world. Through application and granting of IPUs, surgeons at Prince Charles Hospital An NHS district hospital in Merthyr Tydfil, South Wales. It opened in 1978. External links
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(TM) 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 within the European Community. Statements made in this press 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 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 TGA will not approve the Therapeutic Device Application on a timely basis or at all, or if approved, that Australian surgeons may choose not to utilize BioGlue surgical adhesive, the possibility that BioGlue ings, including the Company's Form 10-K for the year ended December 31, 1998. Editor's Note: CryoLife Customer Service may be accessed by telephone: 1-800-438-8285 (U.S. and Canada) 1-770-419-3355 (International) 1-770-590-3753 (International fax) E-mail: customerservice@cryolife.com For additional information about the Company, visit CryoLife's web site: http://www.cryolife.com |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion