ATLANTA, Oct. 13, 2011 /PRNewswire/ -- CryoLife, Inc.
(NYSE: CRY), a leading tissue processing and medical device company
focused on cardiac and vascular surgery, announced today that
ValveXchange, Inc., a company in which CryoLife owns a minority
interest, has completed the first three human implants with its
novel Vitality™ two-part heart valve system.
The surgeries were performed in Asuncion, Paraguay and took place on
Sept. 26 and 27, 2011. Three men aged
49, 62 and 72 received the Vitality™ heart valves. All have been
discharged and are recovering normally.
The mission of ValveXchange is to bring the full, active
lifestyle advantages of tissue heart valves to patients of all
ages. Currently, bioprosthetic tissue valves are recommended only
for older patients because the leaflet sets wear out every 10-15
years, requiring repeated open-heart surgeries. Younger patients
today receive mechanical heart valves that do not wear out, but
require lifelong doses of anticoagulation drugs that force a
sedentary lifestyle with serious side effects.
The ValveXchange concept is a two-part valve with a permanently
implanted base and an easily replaceable leaflet set. The leaflet
set is designed to be replaced transapically (through the apex of
the heart), accessed by a small incision between the ribs and not
requiring any future open-heart surgeries. ValveXchange is
currently developing the tool set for the transapical leaflet
replacement procedure. Leaflets can also be replaced using standard
and minimally invasive surgical techniques that are faster and
simpler than traditional valve replacement surgeries.
Steven G. Anderson, Chairman,
President and Chief Executive Officer of CryoLife, said, "We are
pleased that ValveXchange has successfully completed their
First-in-Man procedures with the Vitality system. The unique
bioprosthetic leaflet set design has the potential to bring the
benefits of tissue valves to patients and eliminate the need for
repeat open heart surgeries. This significant milestone reaffirms
our belief in ValveXchange as an emerging cardiovascular technology
company."
CryoLife acquired a 19 percent equity ownership in ValveXchange
in July, as well as the right of first refusal to acquire
ValveXchange during a period that extends through the completion of
initial commercialization milestones and the right to negotiate
with ValveXchange for European distribution rights.
About CryoLife
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.
CryoLife'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. CryoLife'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. CryoLife'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. CryoLife'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,
through its subsidiary Cardiogenesis Corporation, specializes in
the treatment of cardiovascular disease and devices that treat
severe angina. Its market leading FDA-approved Holmium: YAG laser
system and single use fiber-optic delivery systems are used to
perform a surgical procedure known as Transmyocardial
Revascularization (TMR).
For additional information about CryoLife, visit CryoLife's
website, http://www.cryolife.com/.
About ValveXchange, Inc.
ValveXchange, Inc. is an emerging technology company based in
Colorado. Calling itself "The
Lifetime Tissue Valve Company." ValveXchange is developing the
first-of-its-kind "serviceable" bioprosthetic heart valve. By
offering the possibility of periodic, minimally invasive exchange
of the worn-out leaflet set, young and physically active patients
can avoid the use of a mechanical valve and its associated lifetime
of warfarin anticoagulation therapy. These design features are
incorporated into its Vitality™ surgically implantable valves and
are being designed into its Vanguard™ transcatheter valves and
future pediatrics products.
ValveXchange was founded by Dr. Ivan
Vesely, a PhD biophysicist internationally recognized for
his research in the field of bioprosthetic heart valves. Chairman
and CEO Larry Blankenship is a
30-year veteran of the medical device field and serial entrepreneur
who has previously guided more than two dozen products into the
marketplace, including heart valves. The company has ten patents
covering various aspects of its heart valve and related technology,
and ten additional patent applications in process.
Statements made in this press release that look forward in
time or that express CryoLife's or ValveXchange's management's
beliefs, expectations or hopes are forward-looking statements.
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
potential of ValveXchange technology to eliminate repeat open heart
surgeries from the long-term wear complications associated with
current biological valves, the belief that the system may resolve
the long standing compromises between conventional mechanical and
biological heart valves, the potential to make ValveXchange
technology open to patients of all ages, and the implied
expectation that CryoLife will ultimately reap benefits from its
equity investment in ValveXchange. These future events
may not occur as and when expected, if at all, and, together with
CryoLife's and ValveXchange's business, are subject to various
risks and uncertainties. These risks and uncertainties
include that the ValveXchange technology may not be effective in
eliminating repeat open heart surgeries from the long-term wear
complications associated with biological valves and future testing
or use by patients and physicians may prove otherwise, competitors
may develop products that are more effective or better received by
the marketplace, and long-term benefits of any new medical
technology, including the ValveXchange technology and the ability
of the system to resolve long standing compromises between
conventional mechanical and biological heart valves, will not be
able to be fully observed until the technology has been in use for
an extended period of time. The ValveXchange technology may
not be successfully implemented with patients of all ages, as the
technology has only recently been tested in human patients, and
younger patients in particular may respond differently to the
technology than older patients. The initial human tests have
only recently been performed and ultimate results may not meet
expectations. The anticipated timing of additional procedures
and testing related to the Vitality Exchangeable Heart Valve System
may be delayed due to regulatory restraints and business
considerations. The ability of ValveXchange to successfully
distribute the Vitality Exchangeable Heart Valve System worldwide
is dependent upon the technology's acceptance by patients and
physicians and the marketing efforts of ValveXchange employees and
distributors, as well as general global economic conditions.
The benefits of the Vitality Exchangeable Heart Valve System
may not ultimately prove to be permanent and the technology may not
prove to be as beneficial to patients as expected, if at all.
Also, the related leaflet sets may not last as long as
expected and/or they may not retain the expected level of valve
function for the entire life of the leaflet sets. The
investment that CryoLife has made in ValveXchange may not be
successful and it may take longer than expected for ValveXchange's
technology to be accepted in the market and for CryoLife to reap
the benefits of its investment in ValveXchange. Even with
CryoLife's investment in ValveXchange, some or all of its products
and systems may not be brought to market when expected, if at all.
Business considerations, market forces or regulatory issues
may impede distribution efforts. Regulatory approvals, in
particular, are subject to testing results and the discretion of
governmental and administrative agents, and there is no guarantee
that ValveXchange will obtain the requisite approvals for its
products and systems, or that the approval process will not be more
time-consuming and costly than expected. ValveXchange is also
subject to the general risks inherent in the medical device sector,
including regulatory concerns, market acceptance of its products
and technology, reliance on key persons, the possibility of
lawsuits, and the ability to obtain sufficient insurance coverage
and future funding, among other things. 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, its
Form 10-Q filing for the quarter ended March
31, 2011, its Form 10-Q filing for the quarter ended
June 30, 2011, and CryoLife's other
SEC filings. CryoLife and ValveXchange do not undertake to
update their forward-looking statements.
Contacts:
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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
Nick Laudico / Zack
Kubow
646-536-7030 / 7020
nlaudico@theruthgroup.com
zkubow@theruthgroup.com
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SOURCE CryoLife, Inc.