ATLANTA, Aug. 12 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an
implantable biological medical device and cardiovascular tissue processing
company, today announced that it has received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) for its CryoPatch SG pulmonary human
cardiac patch. CryoPatch SG is processed with the Company's proprietary
SynerGraft technology designed to remove allogeneic donor cells and cellular
remnants from tissue without compromising the integrity of the underlying
collagen matrix.
CryoPatch SG is indicated 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.
Implantation of the CryoPatch SG reduces the risk for induction of HLA
class I and class II alloantibodies, based on Panel Reactive Antibody (PRA)
measured at up to one year, compared to standard processed pulmonary cardiac
tissues. Data have not been provided to evaluate the effect of reduced
alloantibodies on the long-term durability, or long-term resistance to
rejection by the patient, of the CryoPatch SG.
Avoiding elevated PRA is important for patients receiving CryoPatch SG as
some may ultimately require a heart transplant. While the link between immune
response and allograft tissue performance is still being debated, there is
evidence that an elevated PRA poses a significant risk to future organ
transplant patients. In these patients, an increased PRA can decrease the
number of possible donors for subsequent organ transplants, and increase time
on transplant waiting lists.
"The introduction of CryoPatch SG represents another step in the
broadening applications of the SynerGraft technology to patients and
surgeons," said Steven G. Anderson, CryoLife's president and chief executive
officer. "CryoPatch SG may offer an attractive tissue reconstruction option
for many children born with heart defects."
Management estimates that the U.S. market for CryoPatch SG and other
tissues and products for the indications listed above is $15 million.
CryoLife anticipates that the first CryoPatch SG will be available for
shipment late in the third quarter of 2009.
In February 2008, the Company received a 510(k) clearance from the FDA for
its CryoValve SG pulmonary human heart valve. CryoValve SG is indicated for
the replacement of diseased, damaged, malformed, or malfunctioning native or
prosthetic pulmonary valves. The valve can be used in conjunction with right
ventricular outflow tract reconstruction procedures (RVOT), commonly performed
in children with congenital heart defects. In addition, the valve can be used
for pulmonary valve replacement during the Ross Procedure, an operation in
which a patient's defective aortic valve is removed and replaced with his own
pulmonary valve. The CryoValve SG is then surgically implanted in place of
the removed native pulmonary valve.
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 human 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 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. 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. 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. These statements include those regarding anticipated effectiveness,
benefits and indications for use of CryoPatch SG and the anticipated U.S.
market it would address, as well as the timing of use of the SynerGraft
technology. 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 CryoPatch SG
may not perform as well as expected or provide all of the benefits
anticipated, nor may the first shipments of CryoPatch SG occur as expected,
that the CryoPatch SG has a one year shelf life, and other risk factors
detailed in CryoLife's Securities and Exchange Commission filings, including
CryoLife's Form 10-K filing for the year ended December 31, 2008, our Form
10-Q for the quarter ended March 31, 2009, our Form 10-Q for the quarter ended
June 30, 2009, and the Company's other SEC filings. The Company does not
undertake to update its forward-looking statements.
For additional information about the company, visit CryoLife's Web site:
SOURCE: CryoLife, Inc.
- 08/12/2009
CONTACT:
D. Ashley Lee, Executive Vice President, Chief Financial
Officer and Chief Operating Officer,
+1-770-419-3355;
Katie Brazel, Fleishman
Hillard, +1-404-739-0150
Web Site: http://www.cryolife.com
(CRY)
