CryoLife Seeks Canadian Marketing Approval for BioGlue Surgical Adhesive; BioGlue Now in Use in 33 Countries
Approval of the Medical Device License Application would make
BioGlue surgical adhesive commercially available to physicians in
Canada. The approval process can take a minimum of 75 days. Under
Canadian regulations, five hospitals have obtained approval under
TPP's Special Access Program (SAP) to use BioGlue surgical adhesive.
Additional hospitals will be able to apply for SAP while CryoLife's
Medical Device License Application is awaiting approval.
Steven G. Anderson, President and Chief Executive Officer of
CryoLife, said, "The filing of this application is another step in
making BioGlue available to physicians around the world. To date,
BioGlue is in use in 33 countries."
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
Therapeutic Products Programme will not approve the Medical Device
Application on a timely basis or at all, or if approved, that Canadian
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:
CONTACT: CryoLife Inc., Atlanta
Roy Vogeltanz, 800/438-8285