ATLANTA, July 7, 2011 /PRNewswire/ -- CryoLife, Inc.
(NYSE: CRY), a leading tissue processing and medical device Company
focused on cardiac and vascular surgery, announced today a
$3.5 million equity investment in
ValveXchange® Inc. ValveXchange is a private medical device company
that was spun-off out of Cleveland Clinic to develop a lifetime
heart valve replacement technology platform featuring exchangeable
bioprosthetic leaflets.
Under the agreement, CryoLife will receive an approximate 19%
initial equity ownership in ValveXchange as well as the right of
first refusal to acquire ValveXchange during a period that extends
through the completion of initial commercialization milestones, as
well as the right to negotiate with ValveXchange for European
distribution rights. Further, CryoLife will make available up
to $2.0 million to ValveXchange in
additional debt financing through a revolving credit facility.
Steven G. Anderson, Chairman,
President and Chief Executive Officer of CryoLife, said, "We
believe that the ValveXchange technology is an extremely compelling
next generation heart valve approach. Its unique replaceable
bioprosthetic leaflet design has the potential to eliminate repeat
open heart surgeries from the long-term wear complications
associated with current biological valves. We believe that
the system may resolve the long standing compromises between
conventional mechanical and biological heart valves, potentially
making this platform applicable to patients of all ages. This
investment is well in-line with our strategy to focus on innovative
products that could further leverage our direct sales force and
their relationships with cardiac surgeons."
Larry Blankenship, Chairman and
Chief Executive Officer of ValveXchange, said, "We are truly
excited to have CryoLife as an investor in our company. We
believe this investment will enable us to bring our innovative
heart valve technology to market. Our animal study data
demonstrated very encouraging results, with valve leaflet exchanges
and second exchanges going smoothly. This funding will support
first-in-man procedures of our Vitality™ Exchangeable Heart Valve
System, anticipated to occur later this year, followed by a planned
European clinical trial. We look forward to delivering this
innovative solution to physicians and patients worldwide."
The Vitality™ Exchangeable Heart Valve System combines the
safety and longevity associated with the most commonly used
surgical bioprosthetic valves with the ability to provide minimally
invasive access for transapical valve exchange. Vitality™ is a
two-part valve platform for patients of all ages that can
potentially overcome the challenges of long-term leaflet wear and
the requirement for repeat invasive valve replacement surgery. The
healed-in support frame of the valve remains in the heart, while
the worn-out leaflet set is designed to be quickly exchanged
without open-heart surgery or cardiopulmonary bypass. The new
leaflet set then provides the same years of service life as the
original with no reduction in valve function.
ValveXchange's second generation system, the Vanguard™, is
designed to allow both the implantation and valve exchange
procedures to be done transapically, through a small incision
between the ribs and a small hole in the apex of the heart, both of
which heal readily. With ValveXchange technology, off-pump MIS
techniques can be applied to both the initial implant and
subsequent exchanges later in life.
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, www.cryolife.com.
About ValveXchange
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 Coumadin® anticoagulation therapy. By adhering to the
time-proven design tenets of well-established tissue valves,
ValveXchange believes its system will offer the best combination of
least-invasive techniques and greatest valve longevity and
durability. These design features are incorporated into its
Vitality™ surgically implantable valves and are being designed into
its Vanguard™ transcatheter valves and future pediatrics products
as well. By introducing the Vitality™ surgically implantable
product line first, ValveXchange believes it will benefit from a
predictable regulatory pathway for Vitality™ and Vanguard™.
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 over two dozen
products into the marketplace, including heart valves. The
company has 10 issued patents covering various aspects of its heart
valve and related technology, as well as 10 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, the belief that CryoLife's
investment in ValveXchange will enable ValveXchange to bring its
heart valve technology to market, the anticipated timing of First
In Man procedures of the Vitality Exchangeable Heart Valve System
and a planned European clinical trial, the anticipated delivering
of the Vitality Exchangeable Heart Valve System to physicians and
patients worldwide, the permanent nature of the Vitality
Exchangeable Heart Valve System and its potential benefits, the
expected longevity of the leaflet sets with no reduction in valve
function, the belief that ValveXchange will benefit from a
predictable regulatory pathway for Vitality and Vanguard, 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 not yet been tested in human patients
and younger patients in particular may respond differently to the
technology than older patients. The anticipated timing of
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 is making 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, 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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ValveXchange
Larry O. Blankenship
Chairman and CEO
Phone (303) 648-4077
lblankenship@valvexchange.com
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SOURCE CryoLife, Inc.