CryoLife Seeks Australian Marketing Approval for BioGlue Surgical Adhesive
ATLANTA--(BW HealthWire)--July 26, 1999--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 has submitted a Therapeutic Device Application to the Australian Therapeutic Good Administration (TGA) 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).
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).
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 in Brisbane, Australia, have used BioGlue in 34 patients with
promising results. Now, with the filing of the Therapeutic Device
Application, the TGA will allow additional surgeons who have made
application for the IPU to use BioGlue surgical adhesive."
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 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 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
surgical adhesive could have currently unforeseen side effects which
could render it undesirable for use in vascular and pulmonary
applications, 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
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:
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CONTACT: CryoLife Inc., Atlanta
Roy Vogeltanz, 800/438-8285
KEYWORD: GEORGIA
INDUSTRY KEYWORD: MEDICINE BIOTECHNOLOGY PRODUCT