ATLANTA, April 25, 2011 /PRNewswire/ -- CryoLife,
Inc. (NYSE: CRY), an implantable biological medical device and
cardiovascular tissue processing company, today announced that its
BioGlue Surgical Adhesive has launched in Japan and is expected to be available in
hospitals by late May 2011.
BioGlue received Shonin approval from the Japanese Ministry of
Health, Labor and Welfare (MHLW) for use in the repair of aortic
dissections in September 2010.
Prior to distribution, MHLW completed a remote inspection of
CryoLife pursuant to Japanese Quality Management System
requirements and required product reimbursement paperwork for
Japanese authorities.
CryoLife's partner, Century Medical, Inc. (CMI) will distribute
BioGlue in Japan for use in this
subset of cardiac surgery. CryoLife will remain the exclusive
supplier of BioGlue to CMI.
"We are pleased to have received Japanese approval for the use
of BioGlue in the repair of aortic dissections, a potentially
life-threatening condition if not properly repaired," stated Mr.
Akira Hoshino, president and chief
executive officer of CMI. "We believe that BioGlue is a
valuable tool that will address many issues facing cardiac surgeons
in Japan."
"We are pleased that BioGlue is approved for this initial use in
Japan. We estimate
Japan to be the second largest
market in the world for surgical hemostats and sealants," said
Steven G. Anderson, president and
chief executive officer, CryoLife, Inc. "Estimated to have
been used in more than 615,000 procedures worldwide, BioGlue has
proven to be a safe, efficacious product, and we look forward to
continuing to expand both its applications and availability
worldwide."
The company estimates that the annual Japanese market for the
use of surgical adhesives in the repair of aortic dissection is
approximately $10 million, and the
total annual market for the use of adhesives and sealants in
Japan is approximately
$150 million. The initial order
is expected to be shipped in late April or early May and the
Company estimates approximately $600,000 in sales for the first 12 months to CMI,
our exclusive distribution partner in Japan. As a part of its product launch,
CMI and the Company provided an introduction of BioGlue to
approximately 110 physicians during The Japanese Society of
Cardiovascular Surgery conference in Tokyo in February, and
renowned cardiac surgeon, Dr. John W.
Fehrenbacher provided clinical data related to BioGlue usage
at The Japanese Society for Vascular Surgery in Okinawa in April.
About BioGlue
BioGlue is a two-component adhesive that creates a flexible,
mechanical seal, independent of the body's clotting mechanism,
within 20 to 30 seconds, and reaches its maximum bonding strength
in two to three minutes.
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, and is CE-marked in the European
Community. In addition, BioGlue is approved in Canada for use in soft tissue repair and in
Australia for use in vascular and
pulmonary sealing and 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 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 and
was recently approved in Japan for
use in the repair of aortic dissections. 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. In late
September 2010, CryoLife entered into
a distribution agreement for PerClot®, an absorbable powder
hemostat that has CE Mark designation allowing commercial
distribution into the European Community and other markets.
For additional information about the company, visit
CryoLife's Web site: http://www.cryolife.com.
About Century Medical
Century Medical, Inc. (CMI) is one of the largest independent
medical device distributors in Japan. With over 30 years experience
marketing medical devices in Japan, CMI has been a pioneering force
successfully introducing many new technologies to the Japanese
healthcare community. CMI maintains six regional sales
offices and employs over 200 highly trained field sales and
marketing people throughout Japan
providing direct nation-wide sales coverage.
Statements made in this press release that look forward in
time or that express CryoLife's or CMI's management's beliefs,
expectations or hopes are forward-looking statements. These
statements include those regarding the expectation that BioGlue
will be available in hospitals in Japan by late May
2011, the belief that BioGlue will address many issues
facing cardiac surgeons in Japan,
the expectation that CryoLife will continue to expand BioGlue's
applications and availability worldwide, and estimated BioGlue
sales for the first 12 months in Japan. These future events may not occur
as and when expected, if at all, and, together with CryoLife's
business, are subject to various risks and uncertainties.
These risks and uncertainties include that the availability
of BioGlue in hospitals in Japan
by late May 2011 may be delayed by
various factors beyond the control of CryoLife, including
regulatory and logistical issues, the belief that BioGlue will
address many issues facing cardiac surgeons in Japan will ultimately be determined by
surgeons and regulators in Japan,
and approvals for additional uses may not be approved and, even if
approved, Japanese surgeons may choose other methods and products
for meeting the needs of their patients, CryoLife's ability to
expand BioGlue's applications and availability worldwide may be
delayed or prohibited altogether by market forces, including the
development of competing products and the changing demands of
consumers and surgeons, and government regulators in various
jurisdictions, estimated BioGlue sales for the first 12 months in
Japan may be lower than expected,
particularly as sales in a new market are difficult to predict and
will be subject to the ability of CMI and its salespeople to
successfully market the product and compete with competing
products. CryoLife's business is also subject to a number of
risks and uncertainties, including the risk factors detailed in
CryoLife's Securities and Exchange Commission filings, including
its Form 10-K filing for the year ended December 31, 2010, and CryoLife's other SEC
filings. CryoLife does not undertake to update its
forward-looking statements.
Media Contacts:
D. Ashley Lee
Phone: 770-419-3355
Executive Vice President, Chief Financial
Officer and Chief Operating Officer
Dana Hartline
Vice President, Edelman
Phone: 404-262-3000
SOURCE CryoLife, Inc.