ATLANTA, April 6 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an
implantable biological medical device and tissue processing company, today
announced it has been awarded approximately $1.7 million under the Department
of Defense (DoD) Appropriations Bill to continue further development of
CryoLife's protein hydrogel technology. Preclinical studies of CryoLife's
BioFoam(R) Surgical Matrix, a protein hydrogel product under development for
organ sealing, are nearing completion. This grant will help fund upcoming
clinical studies of BioFoam in the United States.
In December 2008, CryoLife received conditional approval from the FDA to
conduct the feasibility phase of the Company's BioFoam IDE submission for
liver parenchyma sealing. Before beginning the feasibility study, the Company
must receive final approval of the study protocol and related documents from
the FDA and an additional approval of the same from the U.S. Department of
Defense. The Company is in the final review process with the Department of
Defense. The Company also filed a CE Mark submission with its Notified Body
in December 2008 for BioFoam's use as an adjunct in the sealing of abdominal
parenchymal tissues (liver and spleen) when cessation of bleeding by ligature
or other conventional methods is ineffective or impractical. The Company also
continues to conduct preclinical research with BioFoam for use in wound
sealing in trauma surgery.
"Over the past four fiscal years the DoD has allocated a total of
approximately $5.4 million to CryoLife for the development of protein hydrogel
products," said Steven G. Anderson, CryoLife president and chief executive
officer. "We are excited about advancing this product through the clinical
process."
BioFoam, a protein hydrogel biomaterial under development by CryoLife,
contains an expansion agent which generates a mixed-cell foam. The foam
creates a mechanical barrier to decrease blood flow and minimize pores for the
blood to enter, leading to cellular aggregation and enhanced hemostasis. It
is easily applied and could potentially be used intraoperatively to control
internal organ hemorrhage, limit blood loss, and reduce the need for future
operations in liver resections. BioFoam is based on the same technology as
BioGlue(R), a CryoLife product approved by the U. S. Food and Drug
Administration to control bleeding as an adjunct to sutures and staples 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.
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 U.S. and Canada. The Company received FDA
clearance for the CryoValve(R) SG pulmonary human heart valve, processed using
CryoLife's proprietary SynerGraft(R) Technology. 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. CryoLife distributes Hemostase MPH, a hemostatic
agent, in much of the U.S. for use in cardiac and vascular surgery and in the
European Community and Canada for cardiac, vascular, and general surgery,
subject to certain exclusions.
Statements made in this press release that look forward in time or that
express management's beliefs, expectations or hopes are forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements regarding the receipt and application of DOD
funds and potential uses and applications for BioFoam. 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 that the Company may not receive all or any
funds allocated under the DoD Appropriation, that BioFoam may not prove safe
or effective for its intended uses, and that BioFoam development may not
result in a commercial product. For additional risks impacting the Company's
business, see the Risk Factors section of the Company's Annual Report on
Form-10-K for the year ended December 31, 2008. The Company does not
undertake to update its forward-looking statements.
For additional information about the Company, visit CryoLife's Web Site:
http://www.cryolife.com.
Media Contacts:
D. Ashley Lee
Executive Vice President, Chief Financial
Officer and Chief Operating Officer
Phone: 770-419-3355
Katie Brazel
Fleishman Hillard
Phone: 404-739-0150
