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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 4, 2001
CRYOLIFE, INC.
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(Exact name of registrant as specified in its charter)
Florida
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(State or other jurisdiction of incorporation)
1-13165 59-2417093
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(Commission File Number) (IRS Employer Identification No.)
1655 Roberts Boulevard, N.W., Kennesaw, Georgia 30144
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(Address of principal executive offices, including zip code)
(770) 419-3355
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(Registrant's telephone number, including area code)
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(Former name or former address, if changed since last report)
Item 9. Regulation FD Disclosure.
The results of two separate medical studies featuring CryoLife's patented
SynerGraft(R) technology are expected to be presented on May 5, 2001 by Ronald
C. Elkins, M.D. Chief, Section of Thoracic and Cardiovascular Surgery,
University of Oklahoma, Health Sciences Center, Oklahoma City, Oklahoma, a
director of and a consultant to CryoLife, Inc., at the Fourth Stentless
Bioprostheses (Heart Valve) International Symposium, held in San Diego,
California.
Dr. Elkins is expected to review the clinical results of patients implanted
with human heart valve allografts processed using CryoLife's SynerGraft
tissue-engineering technology. The SynerGraft technology centers around the
removal of antigens from human and animal tissues leaving a collagen matrix that
has the potential to then be repopulated, in vivo, with the patient's own cells.
When applied to a heart valve, this creates a replacement tissue structure
similar to a native human heart valve with the potential to repopulate with the
recipient's own cells. The SynerGraft tissue-engineered human heart valves,
called CryoValve(R)SG, implanted in 63 patients were found to reduce immune
responses associated with rejection that are signaled by PRA (panel reactive
antibodies) and often experienced by the recipients of transplanted tissues.
These valves may therefore be appropriate for patients who have experienced
previous immune response to allograft valve implants and for patients who may
have immunodeficiencies.
In a second presentation before the same group, Dr. Elkins is expected to
review animal studies on the viability of SynerGraft technology-treated sheep
heart valves for cellular remodeling. The initial results indicated that the
valves implanted in sheep were repopulated with the recipients' cells following
implantation.
Statements made herein that look forward in time or that express
management's beliefs, expectations or hopes regarding future occurrences are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These future events may not occur when expected,
if at all, and are subject to various risks and uncertainties. Such risks and
uncertainties include the possibility that SynerGraft-treated heart valves will
not have the expected long-term functionality, repopulate with human recipient
cells or reduce immune response, that future clinical SynerGraft test results
will prove less encouraging than current results, that SynerGraft regulatory
submissions will not be ready when planned or that anticipated regulatory
approvals will not be obtained on a timely basis, if at all, 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, 2000.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CRYOLIFE, INC.
Date: May 4, 2001 By: /s/ Steven G. Anderson
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Name: Steven G. Anderson
Title: President, Chief Executive Officer
and Chairman