CryoLife Announces Agreement with Cleveland Clinic to Develop Innovative Heart Valve for High Risk Patients
January 10 2007 - 8:45AM
PR Newswire (US)
ATLANTA, Jan. 10 /PRNewswire-FirstCall/ -- CryoLife, Inc.
(NYSE:CRY), a biomaterials, medical device and tissue processing
company, announced today an agreement with Cleveland Clinic to
develop an innovative allograft, or human tissue, heart valve for
patients suffering from serious heart infections. Under terms of
the agreement, the Company will work with Cleveland Clinic to
develop a combination aortic-mitral allograft heart valve for
patients with infective endocarditis, a condition in which the
structures of the heart, particularly the heart valves, are
infected. Under terms of the agreement, Dr. Jose Navia, a cardiac
surgeon with the Heart and Vascular Institute at Cleveland Clinic,
will work with CryoLife to develop the methods necessary to process
the valve. Dr. Navia has filed U.S. patent applications for the
tissue preparation method and valve implantation techniques.
"Patients who develop infective endocarditis of both the native
mitral and aortic valves are at particularly high risk for
morbidity and death stemming from this infection," notes Dr. Navia.
"Current heart valve replacements for these patients include a high
percentage of synthetic materials, which are more prone to
harboring infection. The combination aortic-mitral allograft heart
valve may potentially provide a more infection-resistant treatment
option." "We are pleased to be collaborating with the Cleveland
Clinic to develop this new combination valve from donated human
tissue," said Steven G. Anderson, CryoLife president and chief
executive officer. "This agreement further underscores CryoLife's
commitment to advancing technology for the treatment of patients
suffering from complex cardiac disease who require sophisticated
cardiac reconstruction procedures." About Infective Endocarditis
Infective endocarditis is a condition in which the structures of
the heart, particularly the heart valves, contain some type of
infection. This infection can be localized within the heart, or
generalized throughout the body. Blood clots can form as a result
of this infection. Valve dysfunction is common and can involve the
aortic, mitral or tricuspid valves. In patients with endocarditis,
abscesses may also form in areas surrounding the valves and between
the mitral and aortic valve. Surgical treatment of this condition
involves removal of infected and dead tissue, drainage and closure
of any abscesses, and repair, or more frequently, replacement of
the affected valves. About the Cleveland Clinic Cleveland Clinic,
located in Cleveland, Ohio, is a not-for-profit multispecialty
academic medical center that integrates clinical and hospital care
with research and education. Cleveland Clinic was founded in 1921
by four renowned physicians with a vision of providing outstanding
patient care based upon the principles of cooperation, compassion
and innovation. U.S. News & World Report consistently names
Cleveland Clinic as one of the nation's best hospitals in its
annual "America's Best Hospitals" survey. Approximately 1,500
full-time salaried physicians at Cleveland Clinic and Cleveland
Clinic Florida represent more than 100 medical specialties and
subspecialties. In 2005, there were 2.9 million outpatient visits
to Cleveland Clinic. Patients came for treatment from every state
and from more than 80 countries. There were nearly 54,000 hospital
admissions to Cleveland Clinic in 2005. Cleveland Clinic's Web site
address is http://www.clevelandclinic.org/. Dr. Navia is a paid
consultant for CryoLife. About CryoLife, Inc. Founded in 1984,
CryoLife, Inc. is a leader in the processing and distribution of
implantable living human tissues for use in cardiac and vascular
surgeries throughout the United States and Canada. The Company's
BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to
sutures and staples for use in adult patients in open surgical
repair of large vessels. BioGlue is also CE marked in the European
Community and approved in Canada and Australia for use in soft
tissue repair. The Company also distributes the CryoLife-O'Brien(R)
stentless porcine heart valve and the SG Model 100 vascular graft,
which are CE marked for distribution within the European Community.
For additional information about CryoLife, please visit
http://www.cryolife.com/. CryoLife Media Contacts: D. Ashley Lee
Executive Vice President, Chief Operating Officer and Chief
Financial Officer CryoLife, Inc. Phone: 770-419-3355 Katie Brazel
Fleishman Hillard Phone: 404-739-0150 The Statements made in this
press release that look forward in time or that express
management's beliefs, expectations or hopes, including statements
regarding the potential benefits of a combination aortic-mitral
allograft heart valve, are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These future events may not occur as and when expected, if at all,
and, together with the Company's business, are subject to various
risks and uncertainties. These risks and uncertainties include the
risk that the valve that is the subject of the collaboration may
not be able to be developed cost effectively, if at all, and that
the valve's resistance to infection may not meet expectations. The
Company's business is also subject to a number of risks, including
that the Company's implementation of its strategic plan may not
proceed as expected due to a number of factors outside the
Company's control, including that the Company may be unable to
acquire complementary products or businesses, continue to
successfully license Company technology, or sell underperforming
assets, and that even if the Company is able to successfully pursue
its strategic directives, it may be unable to materially increase
revenues or earnings. In addition, the Company's efforts to
continue to increase revenue may not be effective, since their
effectiveness is subject to such factors as competitive pressures
and tissue availability, that the Company's efforts to develop and
introduce new products outside the U.S. may be unsuccessful, that
the Company's efforts to improve procurement and tissue processing
yields may not continue to prove effective, the possibility that
the FDA could impose additional restrictions on the Company's
operations, require a recall, or prevent the Company from
processing and distributing tissues or manufacturing and
distributing other products, that products and services under
development, including BioDisc, may not be commercially feasible,
the Company's SynerGraft products may not receive FDA approval when
anticipated or at all, that the Company may not have sufficient
borrowing or other capital availability to fund its business, that
pending litigation cannot be settled on terms acceptable to the
Company, that the Company may not have sufficient resources to pay
punitive damages (which are not covered by insurance) or other
liabilities in excess of available insurance, the possibility of
decreases in the Company's working capital if cash flow does not
continue to improve, that to the extent the Company does not have
sufficient resources to pay the claims against it, it may be forced
to cease operations or seek protection under applicable bankruptcy
laws, changes in laws and regulations applicable to CryoLife,
efforts by existing stockholders or others to gain influence or
control over CryoLife may divert management's attention from the
Company's operational recovery or otherwise be detrimental to the
interests of the other stockholders, existing or other potential
litigation initiated by stockholders or others; possible litigation
by CryoLife if stockholders or others make proposals or statements
which CryoLife does not believe to be fair or accurate or in the
best interests of its other shareholders and other risk factors
detailed in CryoLife's Securities and Exchange Commission filings,
including CryoLife's Form 10-K filing for the year ended December
31, 2005, its most recent Form 10-Q, and the Company's other SEC
filings. The Company does not undertake to update its
forward-looking statements. DATASOURCE: CryoLife, Inc. CONTACT: D.
Ashley Lee, Executive Vice President, Chief Operating Officer and
Chief Financial Officer of CryoLife, Inc., +1-770-419-3355, or
Katie Brazel of Fleishman Hillard, +1-404-739-0150 Web site:
http://www.cryolife.com/
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