CryoLife's BioGlue Surgical Adhesive Featured At European Association for Cardiothoracic Surgery
The study involved 24 sheep, which were divided into a control
group and an experimental group. The control group had a bronchial
attachment done in the conventional manner, with sutures only. The
experimental group of sheep included a bronchial attachment with just
two or three approximating sutures and a lung defect repair using
BioGlue surgical adhesive as a sealant. After the surgical procedures,
the sheep were studied at two-, four- and twelve-week intervals.
Histologically, there were no signs of mucosal damage in any group.
Dr. Hasse stated, "Until recently, tissue adhesives available in
Europe had been unsatisfactory for use in pulmonary applications and
had adverse side effects. However, our animal studies with CryoLife's
BioGlue revealed that the use of BioGlue in sheep allowed a tight air
seal with less potential damage to the underlying tissue at the repair
sites. The results of this study lead me to believe that BioGlue can
effectively treat many of the problems we experience in the estimated
250,000 pulmonary surgical procedures done annually in Europe."
Steven G. Anderson, President and Chief Executive Officer of
CryoLife, said, "We are very pleased with the results of this study by
Dr. Hasse. CryoLife received "CE" (product certification) mark
approval for the distribution in the European Union of its BioGlue
surgical adhesive for pulmonary applications in March of this year,
and we believe these animal studies validate our confidence in
BioGlue."
Founded in 1984, CryoLife, Inc. is the leader in the development
and commercialization of living human tissue implantable devices 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 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
BioGlue will not perform as expected in pulmonary and bronchial
surgical procedures performed on humans, physicians will not find
BioGlue to be acceptable for use in pulmonary applications, or even if
they do, that they will not increase their usage of BioGlue, 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 web site is: http://www.cryolife.com
CONTACT: CryoLife Inc., Atlanta
Edwin B. Cordell Jr., 800/438-8285