LONDON--(BUSINESS WIRE)--May 2, 2017--
LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a
market-leading medical technology company, today announced it has
acquired the remaining outstanding interests in Caisson Interventional,
LLC (“Caisson”), in support of LivaNova’s strategic growth initiatives.
Based in Maple Grove, Minn., Caisson is a privately held clinical-stage
medical device company focused on the design, development and clinical
evaluation of a novel transcatheter mitral valve replacement (TMVR)
implant with a fully transvenous delivery system.
“We recognized the potential of the talented Caisson team and its
technology several years ago. This team will now be the cornerstone for
our planned entry into the TMVR space, which has the potential to be an
important growth platform for us in the future,” said LivaNova’s CEO
Damien McDonald. “We intend to invest in the clinical studies,
regulatory approvals, product enhancements and other steps needed to
launch this mitral valve replacement system commercially. We expect it
will become a strategic complement to our heart valve portfolio for
heart team physicians, allowing us to offer patients the most advanced,
minimally invasive mitral valve replacement option.”
Caisson’s device is unique, being the only TMVR product designed solely
for trans-septal approach and delivered through a single venous access.
The system is also designed for the implant to be fully retrieved
following functional evaluation, but prior to final release – a safety
feature important to physicians.
“We created this percutaneous mitral valve replacement implant,
procedure and delivery system to offer a significant new therapy to
patients with severe mitral regurgitation,” said Caisson COO and
Co-founder Todd Mortier.
Caisson initiated its clinical trials through the U.S. FDA Early
Feasibility Study program, and will add clinical sites in Europe and
Canada.
“We look forward to joining LivaNova to combine our efforts in bringing
a superior technology to market,” added Caisson CEO and Co-founder C.J.
Schweich, Jr., M.D.
LivaNova has been an investor in Caisson since 2012 and has agreed to
pay up to $72 million, net of $6 million of debt forgiveness, to acquire
the remaining 51 percent of the company. The first payment of $18
million was made at closing with the balance paid on a schedule driven
primarily by regulatory approvals and sales earn outs. As a result of
the acquisition, LivaNova expects to recognize a pre-tax non-cash gain
during the second quarter on the $15 million book value of its existing
investment in Caisson. The acquisition will be dilutive to earnings for
several years, but LivaNova fully anticipates this transaction will meet
all long-term financial metrics and internal standards. 2017 guidance
will be updated to include the estimated impact of the acquisition
during LivaNova’s first quarter earnings call tomorrow morning.
The Caisson TMVR system is not approved for sale in any country.
About LivaNova
LivaNova PLC is a global medical technology company built on nearly five
decades of experience and a relentless commitment to improve the lives
of patients around the world. LivaNova’s advanced technologies and
breakthrough treatments provide meaningful solutions for the benefit of
patients, healthcare professionals and healthcare systems. Headquartered
in London and with a presence in more than 100 countries worldwide, the
company employs more than 4,500 employees. LivaNova operates as three
business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm
Management, with operating headquarters in Mirandola
(Italy), Houston (U.S.A.) and Clamart (France), respectively.
Safe Harbor Statement
This press release contains forward-looking statements within the
meaning of Section 27A of the United States Securities Act of 1933, as
amended, and Section 21E of the United States Securities Exchange Act of
1934, as amended. Forward-looking statements are not historical facts
but are based on certain assumptions of management and describe the
Company’s future plans, strategies and expectations. Forward-looking
statements can generally be identified by the use of forward-looking
terminology, including, but not limited to, "may," “could,” “seek,”
“guidance,” “predict,” “potential,” “likely,” "believe," "will,"
"expect," "anticipate," "estimate," "plan," "intend," "forecast," or
variations of these terms and similar expressions, or the negative of
these terms or similar expressions. Forward-looking statements contained
in this press release are based on information presently available to
LivaNova and assumptions that the Company believes to be reasonable, but
are inherently uncertain. As a result, the Company’s actual results,
performance or achievements may differ materially from those expressed
or implied by these forward-looking statements, which are not guarantees
of future performance and involve known and unknown risks, uncertainties
and other factors that are, in some cases, beyond the Company’s control.
Investors are cautioned that all such statements involve risks and
uncertainties, including without limitation, statements concerning entry
into the TMVR space, developing Caisson as an important growth platform,
investing in the clinical studies, regulatory approvals, product
enhancements and other steps needed to launch this mitral valve
replacement system commercially, developing Caisson as a strategic
addition to the Company’s heart valve portfolio, offering patients the
most advanced, minimally invasive mitral valve replacement option,
offering a significant new therapy to patients with severe mitral
regurgitation, adding clinical study sites for Caisson’s TMVR device in
Europe and Canada, bringing a superior technology to market, recognizing
a pre-tax non-cash gain during the second quarter on the $15 million
book value of its existing investment in Caisson, and anticipating that
this transaction will meet all long-term financial metrics and internal
standards. Important factors that may cause actual results to differ
include, but are not limited to: (i) risks that the legacy businesses of
Cyberonics, Inc. and Sorin S.p.A. (together, the “combined companies”)
will not be integrated successfully or that the combined companies will
not realize estimated cost savings, value of certain tax assets,
synergies and growth, or that such benefits may take longer to realize
than expected; (ii) the inability of LivaNova to meet expectations
regarding the timing, completion and accounting of tax treatments; (iii)
risks relating to unanticipated costs of integration, including
operating costs, customer loss or business disruption being greater than
expected; (iv) organizational and governance structure; (v) reductions
in customer spending, a slowdown in customer payments and changes in
customer demand for products and services; (vi) unanticipated changes
relating to competitive factors in the industries in which LivaNova
operates; (vii) the ability to hire and retain key personnel; (viii) the
ability to attract new customers and retain existing customers in the
manner anticipated; (ix) the reliance on and integration of information
technology systems; (x) changes in legislation or governmental
regulations affecting LivaNova; (xi) international, national or local
economic, social or political conditions that could adversely affect
LivaNova, its partners or its customers; (xii) conditions in the credit
markets; (xiii) business and other financial risks inherent to the
industries in which LivaNova operates; (xiv) risks associated with
assumptions made in connection with critical accounting estimates and
legal proceedings; (xv) LivaNova’s international operations, which are
subject to the risks of currency fluctuations and foreign exchange
controls; (xvi) and the potential of international unrest, economic
downturn or effects of currencies, tax assessments, tax adjustments,
anticipated tax rates, raw material costs or availability, benefit or
retirement plan costs, or other regulatory compliance costs. The
foregoing list of factors is not exhaustive. You should carefully
consider the foregoing factors and the other risks and uncertainties
that affect the Company’s business, including those described in the
“Risk Factors” section of Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K, the Registration Statement on
Form S-4 and other documents filed from time to time with the United
States Securities and Exchange Commission by LivaNova. LivaNova does not
give any assurance (1) that LivaNova will achieve its expectations, or
(2) concerning any result or the timing thereof, in each case, with
respect to any regulatory action, administrative proceedings, government
investigations, litigation, warning letters, consent decree, cost
reductions, business strategies, earnings or revenue trends or future
financial results.
All information in this press release is as of the date of its release.
The Company does not undertake or assume any obligation to update
publicly any of the forward-looking statements in this press release to
reflect actual results, new information or future events, changes in
assumptions or changes in other factors affecting forward-looking
statements, except to the extent required by applicable law. If we
update one or more forward-looking statements, no inference should be
drawn that we will make additional updates with respect to those or
other forward-looking statements. We caution you not to place undue
reliance on any forward-looking statements, which are made only as of
the date of this press release.
For more information, please visit www.LivaNova.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170502006845/en/
Source: LivaNova PLC
LivaNova PLC Investor Relations and Media
Karen King, +1-281-228-7262
Vice
President, Investor Relations & Corporate Communications
or
Deanna
Wilke, +1-281-727-2764
Corporate External Communications Manager
Corporate.Communications@LivaNova.com
