Company will enter obstructive sleep apnea space, enhancing its
portfolio of Neuromodulation treatments and therapies
LONDON--(BUSINESS WIRE)--Dec. 5, 2017--
LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a
market-leading medical technology company, today announced it has
entered into an agreement to acquire the remaining outstanding interests
in ImThera Medical, Inc. (“ImThera”). Headquartered in San Diego,
Calif., ImThera is a privately held company focused on neurostimulation
for the treatment of obstructive sleep apnea (“OSA”). ImThera
manufactures an implantable device that stimulates multiple tongue
muscles via the hypoglossal nerve, which opens the airway while a
patient is sleeping.
“The ImThera device is highly aligned with our existing Neuromodulation
business, and we are extremely excited about the opportunity to optimize
the technology and fold it into our universal platform. In the near
term, we will focus on expanding ImThera’s current commercial presence
in the European market, while advancing enrollment in a U.S. Food and
Drug Administration (FDA) pivotal trial,” said Damien McDonald,
LivaNova’s Chief Executive Officer. “The OSA market is large and
growing, with many unmet needs. With our strong commercial capabilities
and robust manufacturing, we look forward to bringing this innovative
technology to the large patient population that has been unsuccessful
with other treatments, allowing them to improve their quality of life.”
Patients with OSA can experience impaired daytime functionality, along
with severe comorbidities such as heart failure and stroke. ImThera’s
implantable device received CE Mark in 2012 and is indicated for
patients with moderate to severe OSA who are unable or unwilling to use
continuous positive airway pressure (“CPAP”) therapy. For these
patients, the device is designed to reduce or eliminate sleep apnea, as
demonstrated through clinical studies and its initial commercial use in
Europe. Enrollment in a pivotal study is currently under way with the
FDA to obtain premarket approval for the OSA implant.
“Adding ImThera and its obstructive sleep apnea device to our portfolio
will strengthen our position as a leader in the field of
neuromodulation,” said Jason Richey, LivaNova's President of North
America and General Manager of the Neuromodulation business.
LivaNova has been an investor in ImThera since 2011 and has agreed to
pay up to approximately $225 million to acquire the remaining
outstanding interests of ImThera. Up-front costs are approximately $78
million with the balance paid on a schedule driven by regulatory and
sales milestones. The deal is projected to be near-term accretive and is
expected to close in early 2018 (subject to approvals and other
customary closing conditions).
“ImThera Medical shares LivaNova’s mission to help patients live longer,
better lives. We are proud of the accomplishments we have made in
developing an effective CPAP alternative for individuals suffering from
OSA. This acquisition will benefit healthcare providers, shareholders
and most of all, the patients who are at the heart of everything we do,”
said Marcelo Lima, ImThera’s Founder, President and Chief Executive
Officer. “This is the culmination of several years of hard work by our
team of dedicated professionals. We welcome the opportunity to become
part of the LivaNova family and look forward to the continued evolution
of our product.”
About ImThera Medical, Inc.
ImThera Medical is a global leader in neurostimulation for the treatment
of obstructive sleep apnea. Headquartered in San Diego, ImThera was
founded to improve the lives of patients suffering from the debilitating
effects of OSA. ImThera’s sleep therapy product is comprised of an
implanted small generator and multi-channel electrode lead, along with
an external handheld remote control that can start, stop or pause
therapy. ImThera collaborates with the world’s top scientists and
medical experts in sleep medicine, and its product is commercially
available in several countries outside the United States.
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
closing of the proposed acquisition of ImThera, entry into the OSA
space, developing the ImThera device as an important growth platform,
investing in the clinical studies, regulatory approvals, product
enhancements and other steps needed to launch this device commercially
in new markets, developing ImThera as a positive addition to the
Company’s neuromodulation portfolio, offering patients the most advanced
OSA therapy, offering a significant new therapy to patients with OSA,
adding clinical study sites for ImThera’s implantable device, bringing a
superior technology to market and anticipating that this transaction
will meet all LivaNova long-term financial metrics and internal
standards. 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.
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/20171205005619/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
