ATLANTA, Nov. 6, 2017 /PRNewswire/ -- CryoLife,
Inc. (NYSE: CRY), a leading medical device and tissue
processing company focused on cardiac and vascular surgery,
announced today that enrollment has started in the Company's
BioGlue clinical trial in China. The results from the trial
will serve as the basis of the Company's regulatory submission to
the Chinese Food and Drug Administration (CFDA) to gain approval to
commercialize BioGlue in China.
Patients are currently being enrolled at multiple heart
centers in China.
"The initiation of patient enrollment in our BioGlue China
clinical trial is a positive milestone that supports our effort to
expand our global presence in key markets," stated Pat Mackin, CryoLife Chairman, President, and
Chief Executive Officer. "We estimate there are more than
40,000 aortic surgeries in China
each year, which represents a significant growth opportunity for
BioGlue. We anticipate trial enrollment and follow up will
take about one year, which would put us on track for potential CFDA
approval of BioGlue by the end of 2019."
Li-Zhong Sun, MD, Cardiac Surgeon
at Anzhen Hospital in Beijing and
primary investigator for the BioGlue clinical trial in China, said, "BioGlue has been used for many
years in the U.S., Europe and
other Asian countries to successfully treat patients with aortic
dissections and in other cardiac surgery procedures. We are
pleased to begin the BioGlue clinical trial in China in order to bring this important product
to Chinese patients."
The BioGlue clinical trial in China is a prospective, multicenter,
randomized, controlled clinical investigation. The study will
enroll 195 patients across seven sites. The trial will
assess treatment of Chinese patients with acute type A aortic
dissections with standard-of-care procedures with and without
BioGlue as an adjunct for structural repair and hemostasis.
The primary efficacy endpoint of the study will be successful
closure of the false lumen as determined by intraoperative
transesophageal echocardiography (TEE). The closure will also
be measured at the time of patient discharge by computed tomography
angiography (CTA).
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.
Headquartered in suburban Atlanta,
Georgia, CryoLife is a leader in the manufacturing,
processing, and distribution of medical devices and implantable
living tissues used in cardiac and vascular surgical procedures.
CryoLife markets and sells products in more than 80 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 our estimates of the number of aortic surgeries
in China each year, that such
surgeries represent a significant growth opportunity for BioGlue,
the anticipated pace of and timing for enrollment and follow up in
our China BioGlue clinical trial, and the timing of potential
approval by CFDA of BioGlue. These risks and uncertainties
affecting these statements include that: our estimates of the
number of aortic surgeries in China each year and our belief that they
represent a significant growth opportunity for BioGlue may be
incorrect, CFDA clinical trials are subject to a number of risks
and uncertainties, including unanticipated reactions or results,
delays, including in enrollment and follow up, and cost overages,
we may be unsuccessful in our clinical trial and there is no
guarantee that the CFDA will approve BioGlue for distribution in
China in our expected timeframe or
at all. 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, 2016, and our subsequent filings
with the SEC. CryoLife does not undertake to update its
forward-looking statements.
Contacts:
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|
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CryoLife
D. Ashley
Lee
Executive Vice
President, Chief Financial Officer
and Chief Operating Officer
Phone: 770-419-3355
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The Ruth
Group
Zack Kubow
646-536-7020
zkubow@theruthgroup.com
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SOURCE CryoLife, Inc.