ATLANTA, April 28, 2015 /PRNewswire/ -- CryoLife, Inc.
(NYSE: CRY), a leading medical device and tissue processing company
focused on cardiac and vascular surgery, announced today the
enrollment of the first patient in its PerClot Investigational
Device Exemption (IDE) clinical trial, the Company's pivotal
clinical trial to gain approval to commercialize PerClot in the
U.S.
"The first patient enrolled in the PerClot IDE clinical trial is
a positive milestone for the Company and our strategy to expand
indications for our products," stated Pat
Mackin, CryoLife Chairman, President, and Chief Executive
Officer. "We will be working to bring other trial sites
online in the coming months, positioning us to complete enrollment
in the trial in the first half of 2016. With a three-month
follow-up period, we would anticipate obtaining FDA approval for
PerClot in the second half of 2017."
"As surgeons, we are continually confronted with controlling
surgical bleeding," stated Arthur
Coffey, MD, Cardiac Surgeon and PI for the PerClot IDE at
Indiana University Health. "We
are excited to have the opportunity to evaluate this innovative
technology, using a validated bleeding scale, for its ability to
control bleeding during cardiac and general surgery."
Michael House, MD, General Surgeon
at Indiana University Health commented
that "this trial is the first of its kind and represents the future
for evaluating hemostatic devices desiring market approval.
We are excited to announce enrollment of the first patient into
this important clinical trial to evaluate PerClot in the U.S."
The PerClot IDE is a multicenter, multidisciplinary, controlled
clinical investigation. The study will include 324 patients
across cardiac, general, and urological surgical specialties.
The primary objective of this investigation will be to collect
clinical data concerning the safety and efficacy of PerClot versus
C.R. Bard's Arista™ MPH Hemostat in multiple surgical
disciplines when used as an adjunct to conventional means of
achieving hemostasis such as pressure or ligature. The
primary efficacy endpoint of this investigation will be achievement
of hemostasis at the site of application at seven minutes following
application of the prescribed hemostatic agent. The secondary
efficacy endpoint for this investigation will be hemostasis at the
site of application evaluated at five minutes. Safety
endpoints will include, but are not limited to, the incidence of
reoperation due to bleeding, total hospitalization and procedure
time, and the incidence of procedure complications and/or adverse
events through final patient follow-up at three months.
About PerClot
PerClot is a medical device composed of polysaccharide granules
and delivery applicators. The granules are biocompatible,
non-pyrogenic and derived from purified plant starch. The
granules do not contain any human or animal components.
PerClot granules are hydrophilic, allowing PerClot to rapidly
absorb water, forming a gelled adhesive matrix that provides a
mechanical barrier to further bleeding and results in the
accumulation of platelets, red blood cells and coagulation proteins
(thrombin, fibrinogen, etc.) at the site of application.
PerClot is intended for use in clean surgical procedures as an
adjunctive hemostatic device when control of capillary, venular,
and arteriolar bleeding by pressure, ligature and other
conventional procedures is ineffective or impractical.
PerClot is ready to use, requiring no mixing and/or other
components and does not need special handling or storage
conditions. Preclinical evaluations, clinical studies, and
surgical use have shown the efficacy of PerClot to be comparable to
the current selection of popular surgical hemostatic materials.
PerClot has CE Mark designation, and CryoLife began
distributing PerClot in several international markets in the fourth
quarter of 2010.
About CryoLife, Inc.
Headquartered in suburban Atlanta,
Georgia, CryoLife is a leader in the manufacturing,
processing, and distribution of implantable living tissues and
medical devices used in cardiac and vascular surgical
procedures. CryoLife markets and sells products in more than
75 countries worldwide. For additional information about
CryoLife, visit our website, www.cryolife.com.
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. Such
forward-looking statements reflect the views of management at the
time such statements are made and are subject to a number of risks,
uncertainties, estimates, and assumptions that may cause actual
results to differ materially from current
expectations. These statements include those regarding
the anticipated timing and benefits of the PerClot IDE clinical
trial and our strategy to gain new indications and regulatory
approvals for our products. The risks and uncertainties affecting
these statements include that: there is no guarantee that the FDA
will approve the surgical version of PerClot for distribution in
the U.S. in accordance with our expected timeframe, or at all;
clinical trials are subject to a number of risks, including
unanticipated reactions or results, delays, and cost overages, and
we may ultimately be unsuccessful in our clinical trial; as
part of our patent litigation against Medafor, Inc. regarding
PerClot (the "Medafor Litigation"), we have been enjoined from
selling, marketing, and distributing PerClot in the U.S.; there is
no guarantee that we will ultimately prevail in the Medafor
Litigation, and if we do not prevail, we will continue to be
prohibited from selling PerClot in the U.S., or we may have to pay
substantial royalties to sell PerClot in the U.S., until Medafor's
patent expires. These risks and uncertainties include the risk
factors detailed in our Securities and Exchange Commission filings,
including our Form 10-K for the year ended December 31, 2014 and our subsequent filings
with the SEC. CryoLife does not undertake to update its
forward-looking statements.
Contacts:
|
|
CryoLife
D. Ashley
Lee
Executive Vice
President, Chief Financial Officer
and Chief Operating Officer
Phone: 770-419-3355
|
The Ruth
Group
Nick Laudico / Zack
Kubow
646-536-7030 /
7020
nlaudico@theruthgroup.com
zkubow@theruthgroup.com
|
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SOURCE CryoLife, Inc.