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.
SOURCE: CryoLife, Inc.
- 08/04/2009
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
(CRY)
