CryoLife Receives Approval for Clinical Testing of BioGlue in Japan
ATLANTA--(BW HealthWire)--July 7, 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 its Japanese distributor, Century Medical Inc., has received approval for clinical trials of CryoLife's BioGlue(R) surgical adhesive to begin in Japan. The Japanese Ministry of Health and Welfare's approval includes trials for vascular and pulmonary repair applications at eight hospitals for a total of 75-90 patients. The clinical trial process will begin later this year, and it is anticipated that the trial period will be completed in 2000.
Steven G. Anderson, president and chief executive officer of
CryoLife, said, "These clinical trials represent our initial entry
into Asia. If these trials prove to be successful and BioGlue is
approved for commercial distribution in Japan, this could
substantially expand our market for surgical adhesives and related
products. CryoLife's BioGlue surgical adhesive began commercial
distribution in Europe in 1998 and is currently in clinical trials in
the United States. BioGlue is an animal protein-based surgical
adhesive with the potential to replace sutures and staples in many
surgical procedures. We expect to receive additional clinical trial
approvals for BioGlue in other countries later this year."
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
Japanese BioGlue trials will not begin or be completed in the time
frame anticipated, the possibility that the Japanese BioGlue trials
will not be successful and that the Japanese Ministry of Health and
Welfare will not approve BioGlue surgical adhesive for commercial
distribution in Japan, or if approved, that Japanese 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: http://www.cryolife.com
--30--SL/na*
CONTACT: CryoLife Inc.
Roy Vogeltanz, 800/438-8285
KEYWORD: GEORGIA INTERNATIONAL ASIA PACIFIC EUROPE CANADA
INTERNATIONAL KEYWORD: MEDICINE BIOTECHNOLOGY