ATLANTA, Oct. 25 /PRNewswire/ -- CryoLife, Inc.
(NYSE: CRY), an implantable biological medical device and
cardiovascular tissue processing company, announced today that it
has begun European distribution of PerClot®, a novel polysaccharide
hemostatic agent used to control bleeding during surgical
procedures or following traumatic injuries.
"PerClot is an exciting technology platform that has seen
success in Europe already, and we
are pleased to begin offering this product in France," stated Steven
G. Anderson, CryoLife president and chief executive officer.
"Our international and largely unrestricted distribution
agreement allows us to address a very broad range of medical
specialties in the growing hemostatic agent market. We look
forward to expanding distribution within the European Union and
many other markets around the world in the coming months."
The European hemostatic market is estimated to be $279 million in 2010 growing to approximately
$430 million in 2014.(1)
On September 28, 2010, CryoLife
entered into a worldwide distribution agreement and a manufacturing
agreement with Starch Medical Inc. (SMI) of San Jose, California for PerClot, a unique,
absorbable powder hemostat that has CE Mark designation allowing
commercial distribution into the European Community and other
markets. PerClot is indicated for use in surgical procedures,
including cardiac, vascular, orthopedic, spinal, neurological,
gynecological, ENT and trauma surgery as an adjunct hemostat when
control of bleeding from capillary, venous, or arteriolar vessels
by pressure, ligature, and other conventional means is either
ineffective or impractical.
CryoLife plans to file an Investigational Device Exemption (IDE)
with the United States Food and Drug Administration (FDA) to begin
clinical trials for the purpose of obtaining Pre-Market Approval
(PMA) to distribute PerClot in the U.S.
About PerClot
PerClot is a medical device composed of absorbable modified
polymer (AMP®) particles and delivery applicators. AMP
particles are derived from purified plant starch. PerClot
contains no human or animal components. It is intended for
use as an absorbable hemostatic system to control bleeding during
surgical procedures or following traumatic injuries.
PerClot is ready to use, requiring no mixing and/or other
components and does not need special handling or storage
conditions. Pre-clinical evaluations, clinical studies and
surgical use have shown the efficacy of PerClot to be comparable to
the current popular choice of surgical hemostatic materials while
its unique formulation allows for rapid absorption. PerClot
particles are readily dissolved by saline irrigation and are
degraded rapidly by human enzymes, primarily amylase, within
several days.
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. CryoLife
distributes PerClot®, an absorbable powder hemostat, in the
European Community. CryoLife currently distributes
HemoStase®, a hemostatic agent, in much of the U.S. for use in
cardiac and vascular surgery and in many international markets for
cardiac, vascular, and general surgery, subject to certain
exclusions, although CryoLife has received notice from Medafor,
Inc. that it has terminated its HemoStase distribution agreement
with CryoLife.
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 CryoLife's expanding distribution of
PerClot within the European Union and many other markets around the
world in the coming months, the estimated growth of the European
hemostatic market by 2014, and CryoLife's plans to file an IDE with
the FDA to begin clinical trials for the purpose of obtaining a PMA
to distribute PerClot in the U.S. 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 we may not
ultimately be successful in our attempts to expand our distribution
into other markets or such expansion may take longer than expected.
Depending on the market, we may still need to obtain
regulatory approvals prior to distribution and there is no
guarantee that such approvals and/or market acceptance of PerClot
will be obtained within our expected timeframe, if at all.
Also, some degree of confusion regarding our position in
various markets may exist because of our past difficulties with
Medafor and our distribution of HemoStase, and our ability to
leverage opportunities related to PerClot may take longer than
expected and require more resources from us in order to educate the
market. Given the addition of PerClot to our product mix and
any resultant confusion this may cause, there is no guarantee that
we will not experience short-term difficulties in our efforts to
successfully expand into other markets. The European
hemostatic market may not continue to grow as expected due to any
number of economic or regulatory factors or as the result of the
advantages of or pricing competition from competitive products.
There is no guarantee that the FDA will approve PerClot for
distribution in the U.S. in accordance with our expected timeframe,
if at all. FDA approvals are dependent upon a number of
factors, many of which are outside CryoLife's control, including
successful clinical trial results, and discretionary decisions made
by the FDA personnel. Any number of factors could delay
clinical trial conduct and analysis and result in delays in the
approval process. CryoLife's IDE application could be denied
by the FDA, and if the application is approved, the clinical trials
that follow may not be successful in leading to approval for our
distribution of PerClot in the U.S. CryoLife's business is
also subject to a number of risks and uncertainties, including the
risk factors detailed in our Securities and Exchange Commission
filings, including our Form 10-Q filing for the quarter ended
June 30, 2010, our Form 10-Q filing
for the quarter ended March 31, 2010
and our Form 10-K filing for the year ended December 31, 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: http://www.cryolife.com.
(1) Frost and Sullivan Report – European Tissue Sealants and
Topical Hemostats Market M2F8-54 Oct 2008, Page 45.
Media Contacts:
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D. Ashley Lee
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Executive Vice President, Chief
Financial Officer and
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Chief Operating
Officer
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Phone: 770-419-3355
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Dana Hartline
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Vice President,
Edelman
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Phone: 404-262-3000
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SOURCE CryoLife, Inc.
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