ATLANTA, April 4, 2011 /PRNewswire/ -- CryoLife, Inc.
(NYSE: CRY), an implantable biological medical device and
cardiovascular tissue processing company, announced today that it
has filed an 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. to control bleeding during surgical procedures or following
traumatic injuries.
PerClot is a unique, absorbable powder hemostat and is intended
for use in surgical procedures when control of bleeding by
pressure, ligature, and other conventional means is either
ineffective or impractical. The therapeutic areas in which
PerClot will be used consist of cardiac, general, urological,
orthopedic, and neurosurgical procedures. PerClot has CE Mark
designation and CryoLife began distributing PerClot in several
international markets in the fourth quarter of 2010.
"We're pleased to reach this milestone in the commercialization
of PerClot in the U.S.," stated Steven G.
Anderson, CryoLife president and chief executive officer.
"We plan to begin enrollment in the pivotal trial later this
year and hope to have pre-market approval no later than 2013."
The U.S. hemostatic market is estimated to be $732 million in 2010 growing to approximately
$1.1 billion in 2014, while the
European market is estimated to be $279
million in 2010 growing to approximately $430 million in 2014.(1)
CryoLife's proposed IDE study would include a total of
approximately 330 patients in a randomized, prospective,
multicenter trial. The primary objective would be to evaluate
the hemostatic effectiveness of PerClot versus control hemostatic
devices (Gelfoam® and Surgicel®) at 5 minutes. Efficacy would
be assessed by comparing intraoperative time to hemostasis (primary
endpoint). The secondary objectives would be to evaluate the
proportion of subjects with hemostasis at 1, 3, 7, and 10 minutes
after trial treatment. Safety endpoints would include but are
not limited to the incidence of reoperation due to bleeding, total
hospitalization time, and the incidence of procedure complications
and/or adverse events through final patient follow-up.
About PerClot
PerClot is a medical device composed of absorbable
polysaccharide particles and delivery applicators. The
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 superior rapid absorption.
PerClot particles are degraded by human enzymes,
alpha-amylase and glucoamylase, and by macrophages typically 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.
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 U.S. and
European hemostatic market by 2014, and expectations of obtaining
FDA approval no later than 2014. 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.
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. Growth of U.S. and
European hemostatic markets is subject to a number of factors,
including economic conditions, technology advances and competition
from other products. 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-K filing for the year ended December 31, 2010, 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) Millennium Research Group (MRG) Report – US Markets for
Surgical Hemostats, Internal Tissue Sealants and Adhesion Barriers
2009 RPUS20SA08, page 25. Frost and Sullivan Report –
European Tissue Sealants and Topical Hemostats Market M2F8-54 Oct
2008, Page 45.
Media Contact:
D. Ashley Lee
Executive Vice President, Chief Financial Officer and
Chief Operating Officer
Phone: 770-419-3355
SOURCE CryoLife, Inc.