CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology
August 04 2009 - 8:30AM
PR Newswire (US)
ATLANTA, Aug. 4 /PRNewswire-FirstCall/ -- CryoLife, Inc.,
(NYSE:CRY) an implantable biological medical device and
cardiovascular tissue processing company, today announced it has
received CE mark approval for its BioFoam Surgical Matrix
(BioFoam). The CE mark allows immediate, unrestricted commercial
distribution of BioFoam in the European Community for 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. BioFoam is the
second product from the Company's protein hydrogel technology
platform to receive a CE mark. CryoLife plans a controlled clinical
launch of BioFoam at up to six centers in the United Kingdom,
Germany, France and Italy to support its initial marketing efforts.
Based on the number of liver and spleen procedures performed
annually in the European Community, CryoLife estimates the annual
European market opportunity for BioFoam to be approximately $30
million and more than $100 million on a worldwide basis. "We are
excited about securing our first approval for the use of BioFoam in
organ resection surgery and look forward to continuing our
development efforts to bring BioFoam into the U.S. market," said
Steven G. Anderson, CryoLife president and chief executive officer.
"Over the past four fiscal years, the U.S. Department of Defense
has allocated approximately $5.4 million to CryoLife for the
development of products containing a protein hydrogel, which is the
primary component of BioFoam." In December 2008, CryoLife received
conditional approval from the FDA to conduct the feasibility phase
of the company's BioFoam IDE submission for liver parenchymal
sealing. The feasibility phase will enroll a total of 20 subjects
at two investigational sites in the U.S. Before beginning this
phase, the Company must receive final approval of the study
protocol and related documents from the FDA and an additional
approval of the study from the U.S. Department of Defense. CryoLife
is in the final stages of this approval process. About BioFoam
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 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 reoperations in
liver resections. BioFoam is based on the same protein hydrogel
technology platform from which BioGlue Surgical Adhesive was
developed. BioGlue is 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's CryoValve SG pulmonary heart valve, processed using
CryoLife's proprietary SynerGraft technology, has FDA 510(k)
clearance for the replacement of diseased, damaged, malformed, or
malfunctioning native pulmonary valves. The Company's BioGlue
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.
BIOGLUE Aesthetic(TM) Medical Adhesive is CE marked in the European
Community for periosteal fixation following endoscopic browplasty
(brow lift) in reconstructive plastic surgery and is distributed by
a third party for this indication. CryoLife distributes
HemoStase(TM), 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 distribution timing and 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 on the time table anticipated,
or at all. 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 and the Company's
subsequent Form 10-Q filings. 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 Katie
Brazel Executive Vice President, Fleishman Hillard Chief Financial
Officer and Phone: 404-739-0150 Chief Operating Officer Phone:
770-419-3355 DATASOURCE: CryoLife, Inc. CONTACT: D. Ashley Lee,
Executive Vice President, Chief Financial Officer and Chief
Operating Officer, +1-770-419-3355; or Katie Brazel, Fleishman
Hillard, +1-404-739-0150 Web Site: http://www.cryolife.com/
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