IRVINE, Calif., July 10, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that it has agreed to acquire CardiAQ Valve Technologies, Inc., a
privately held company and developer of a transcatheter mitral
valve replacement system.
"Edwards' primary strategy is to create valuable therapies that
transform patient care. We believe the acquisition and integration
of CardiAQ will advance our development of a transformational
therapy for patients with mitral valve disease who aren't
well-served today," said Michael A.
Mussallem, Edwards' chairman and CEO. "While still
early in the development of this therapy, the progress of the team
of employees and clinicians working on our FORTIS mitral
replacement system has reinforced our confidence in a
catheter-based approach. We believe the experiences and
technologies of FORTIS and CardiAQ are complementary and that this
combination will enable important advancements for patients."
CardiAQ has received a U.S. Food and Drug Administration (FDA)
Investigational Device Exemption (IDE) approval to conduct an early
feasibility study of up to 20 patients, and also plans to initiate
a CE Mark study in Europe.
"CardiAQ is proud of our pioneering efforts in the early
development of this transcatheter mitral valve therapy conceived by
cardiac surgeon Arshad Quadri, M.D.
We believe our technology, which incorporates multiple delivery
approaches with a single valve, shows great promise for patients,"
said Rob Michiels, chief executive
officer of CardiAQ.
"We look forward to joining Edwards, whose experience and
leadership as a developer of breakthrough therapies for heart valve
disease will advance our work," said J.
Brent Ratz, co-founder, president and chief operating
officer of CardiAQ.
The purchase price is up to $400
million, including $350
million in cash at closing, and the remainder payable upon
achievement of a European regulatory milestone. The transaction
remains subject to customary closing conditions. Edwards
expects that this acquisition will be slightly dilutive to 2015
earnings per share. The company will provide updated financial
guidance for 2015 when second quarter earnings are released on
July 28.
As an update to the temporary pause in the FORTIS program,
working closely with its global clinical investigators, Edwards
recently completed its review and has reached agreement on protocol
revisions to re-start enrollment.
The CardiAQ and FORTIS valve systems are not approved for sale
in any country.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of
heart valves and hemodynamic monitoring. Driven by a passion to
help patients, the company partners with clinicians to develop
innovative technologies in the areas of structural heart disease
and critical care monitoring, enabling them to save and enhance
lives. Additional company information can be found at
www.edwards.com.
About CardiAQ Valve Technologies
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary
transcatheter mitral valve (TMV) implant that can be delivered
through multiple delivery systems. Through its unique anchoring
mechanism that engages and utilizes the patient's native mitral
valve anatomy, physicians will be able to implant a new mitral
valve within a beating heart without circulatory support, thus
avoiding open-heart surgery. OrbiMed led the series B financing and
is CardiAQ's largest shareholder. Other venture investors
include Broadview, Advent and Versant.
This news release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. These
forward-looking statements include, but are not limited to,
statements by Michael Mussallem,
Rob Michiels and J. Brent Ratz regarding the timing and status of
the transaction, and the timing, impact and success of clinical
development of mitral valve replacement technologies.
Forward-looking statements are based on estimates and assumptions
made by management of the company and are believed to be
reasonable, though they are inherently uncertain and difficult to
predict. Our forward-looking statements speak only as of the
date on which they are made and we do not undertake any obligation
to update any forward-looking statement to reflect events or
circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by the forward-looking statements based on a
number of factors including but not limited to unexpected
impediments or delays in closing the transaction, unexpected
outcomes after more expanded clinical experience with the devices,
unexpected changes or delays related to product supply, potentials
for unexpected regulatory or quality developments, competitive
dynamics, global economic conditions and customer acceptance.
These factors are detailed in the company's filings with the
Securities and Exchange Commission including its Annual Report on
Form 10-K for the year ended December 31,
2014.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
FORTIS and FORTIS are trademarks of Edwards Lifesciences
Corporation. All other trademarks are the property of their
respective owners.
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SOURCE Edwards Lifesciences Corporation