Department of Defense Awards CryoLife $1.7 million to Develop BioFoam Hemostatic Technology
April 06 2009 - 8:30AM
PR Newswire (US)
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 DATASOURCE: CryoLife, Inc. CONTACT: D.
Ashley Lee, Executive Vice President, Chief Financial Officer and
Chief Operating 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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