CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)

ATLANTA, Oct. 27 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY), an
implantable biological medical device and cardiovascular tissue processing
company, today announced that the U.S. Food and Drug Administration (FDA) has
granted approval for the company's Investigational Device Exemption (IDE) to
conduct a human clinical trial for its BioFoam® Surgical Matrix protein
hydrogel technology. BioFoam will be used to help seal liver parenchymal
tissue when cessation of bleeding by ligature or other conventional methods is
ineffective or impractical.

The approved IDE is for a prospective, multicenter, randomized feasibility
study evaluating safety outcomes of BioFoam as compared to a standard topical
hemostatic agent. The feasibility investigation will be conducted at two
investigational sites and will enroll 20 eligible subjects with 10 subjects in
each treatment group. CryoLife now will seek approval from the U.S.
Department of Defense (DoD), which will be the final step necessary to begin
this trial.

"Following our July 2009 CE Mark approval to distribute BioFoam in the EU, we
now have approval to begin a clinical trial, a critical step forward in the
process to gain FDA approval of BioFoam in the U.S.," said Steven G. Anderson,
CryoLife president and chief executive officer. He added, "We believe that
BioFoam may hold tremendous promise for surgeons around the world and are
excited by the early data published thus far."

CryoLife is currently conducting a 60-patient controlled clinical launch of
BioFoam at up to six centers in the United Kingdom, Germany, France and Italy.
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
worldwide.

Upon successful completion of the feasibility study, and subsequent FDA and
DoD approvals, a follow-on prospective, multicenter, randomized, controlled
pivotal study will be conducted. It is currently anticipated that the pivotal
investigation will enroll a total of 164 eligible subjects, 82 subjects in
each treatment group across a maximum of 10 investigational sites.

The primary objective of the pivotal investigation will be to demonstrate a
decrease in the time to achieve intraoperative hemostasis (a complex process
that causes bleeding to stop) following open liver resection surgery in
subjects receiving an application of BioFoam compared to a standard topical
hemostatic agent. The secondary objectives of this investigation will be to
compare time to hemostasis and the achievement of immediate hemostasis between
the BioFoam group and the control group (a standard topical hemostatic agent)
to demonstrate that BioFoam is at least equivalent in performance to the
control group.

About BioFoam

BioFoam, a protein hydrogel biomaterial developed by CryoLife, contains an
expansion agent that 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 can 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. BioFoam received CE mark approval
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.

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 or prosthetic pulmonary valves. The Company's
CryoPatch® SG pulmonary cardiac patch has FDA 510(k) clearance for the repair
or reconstruction of the right ventricular outflow tract (RVOT), which is a
surgery commonly performed in children with congenital heart defects, such as
Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG
is distributed in three anatomic configurations: pulmonary hemi-artery,
pulmonary trunk and pulmonary branch. 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. The Company's BioFoam® Surgical Matrix is CE marked 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. 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 hopes that BioFoam will reduce the
time required to achieve hemostasis during liver resection surgery and reduce
the number of complications following surgery, potential distribution timing
and uses and applications for BioFoam, timing of enrollment in the feasibility
phase of the Company's BioFoam IDE submission and the ability to conduct and
details of the follow-on study after the feasibility phase has been completed.
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 BioFoam may not
prove safe or effective for its intended uses, that early data regarding
BioFoam may be more positive than final data, that BioFoam may not achieve
hemostasis in liver resections or reduce complications following surgery due
to any number of factors that we will not be able to identify until further
procedures are performed, that BioFoam may not be useful in other future
surgical applications, that the Company may not start feasibility phase
enrollment in a timely fashion or may not be able to conduct the follow-on
study as planned due to any number of factors, including unanticipated delays
or difficulty in obtaining FDA and U.S. Department of Defense approval, and
that BioFoam development may not result in a commercial product on the time
table anticipated, or at all, due to factors beyond our control, including
potential lack of acceptance by the medical community. 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 Dec. 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 Contact:

D. Ashley Lee
Executive Vice President, Chief Financial
Officer and Chief Operating Officer
Phone: 770-419-3355

Jerry Tolk
Senior Vice President, Edelman
Phone: 404-262-3000

SOURCE CryoLife, Inc.

D. Ashley Lee, Executive Vice President, Chief Financial, Officer and Chief
Operating Officer, +1-770-419-3355; or Jerry Tolk, Senior Vice President,
Edelman, +1-404-262-3000