Edwards Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix
24 Luglio 2024 - 10:15PM
Business Wire
Edwards Lifesciences (NYSE: EW) today announced investments that
reflect the company’s deep commitment to advancing patient care
through structural heart innovation, addressing large unmet patient
needs and supporting sustainable long-term growth.
Edwards has entered into an agreement to acquire JenaValve
Technology, a pioneer in the transcatheter treatment of aortic
regurgitation (AR), a deadly disease that impacts a significant and
growing population and is largely untreated today. JenaValve
presented positive results of its U.S. pivotal trial for the
treatment of symptomatic, severe AR in high-risk patients late last
year. As the pioneer in valve innovation for more than 60 years,
Edwards believes it is uniquely positioned to lead this next
frontier of aortic valve disease treatment. Edwards anticipates FDA
approval of the JenaValve Trilogy Heart Valve System in late 2025,
which will represent the first approved therapy for patients
suffering from AR.
Building on an investment made in 2016, Edwards has exercised
its option to acquire Endotronix, a leader in heart failure
(HF) management solutions. Many structural heart patients Edwards
serves today also suffer from HF with limited options. This
acquisition will expand Edwards’ structural heart portfolio into a
new therapeutic area to address the large unmet needs of patients
suffering from HF. Last month, Endotronix received FDA approval for
Cordella, an implantable pulmonary artery pressure sensor allowing
early, targeted therapeutic intervention. A CMS national coverage
determination is expected in early 2025.
“These acquisitions expand our opportunities to address the
unmet needs of aortic regurgitation and heart failure patients
around the world,” said Bernard Zovighian, Edwards’ CEO. “We are
pleased to enter these structural heart therapeutic areas with
innovation, world-class science and clinical evidence to provide
access to life-saving technologies for patients around the
world.”
Edwards anticipates these investments will strengthen its
leadership in structural heart innovation and represent long-term
growth opportunities. Edwards expects minimal revenue contribution
from these acquisitions in 2025. The aggregate upfront purchase
price for these strategic investments is approximately $1.2
billion. The acquisitions are subject to the satisfaction of
certain closing conditions, including the receipt of required
antitrust and foreign investment approvals.
About Edwards
Lifesciences
Edwards Lifesciences is the global leader of patient-focused
innovations for structural heart disease and critical care
monitoring. We are driven by a passion for patients, dedicated to
improving and enhancing lives through partnerships with clinicians
and stakeholders across the global healthcare landscape. For more
information, visit www.edwards.com and follow us on Facebook,
Instagram, LinkedIn, X and YouTube.
This news release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
We intend the forward-looking statements contained in this press
release to be covered by the safe harbor provisions of such Acts.
These forward-looking statements can sometimes be identified by the
use of forward-looking words, such as “may,” “might,” “believe,”
“will,” “expect,” “project,” “estimate,” “should,” “anticipate,”
“plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,”
“aspire,” “confident” and other forms of these words and include,
but are not limited to, statements made by Mr. Zovighian and
statements regarding our expected continued performance of Edwards;
performance of the Edwards, JenaValve or Endotronix technologies;
product and therapy benefits; patient access and outcomes; size of
treatable population; leading position; growth opportunities; unmet
needs in structural heart, aortic regurgitation, and heart failure
therapeutic areas; probability of approval by the FDA and in the
anticipating timeline; probability of a positive NCD by the CMS and
in the anticipated timeline; synergies between the technologies,
business, and operations of each of JenaValve and Endotronix and
Edwards’ technologies, products, portfolio, expertise, and
operations; ability to leverage the technology or innovation from
these acquisitions or cause or ensure accelerated access to
life-saving technologies for patients or development of novel
technologies as a result of these acquisitions; commitment to
expand opportunities in structural heart innovation, address large
unmet patient needs, and support sustainable long-term growth;
objective to expand Edwards’ portfolio into new structural heart
therapeutic areas; opportunities and revenue return on these
acquisitions and their contribution to Edwards’ growth and
performance, as well as the expectations on timing of such returns
and contributions; therapy approval pipeline for patients suffering
from AR; probability of the closing of the two acquisitions; other
objectives and expectations; and other statements that are not
historical facts. 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. Investors
are cautioned not to unduly rely on such forward-looking
statements.
Forward-looking statements involve risks and uncertainties that
could cause actual results or experience to differ materially from
that expressed or implied by the forward-looking statements.
Factors that could cause actual results or experience to differ
materially from that expressed or implied by the forward-looking
statements include, but are not limited to: (i) Edwards may be
unable to close the acquisitions of each of JenaValve and
Endotronix, which may materially and adversely affect Edwards’
business and the price of Edwards’ common stock; (ii) the
occurrence of any event, change or other circumstance that could
cause Edwards to abandon the acquisitions of either or both of
JenaValve and Endotronix; (iii) risks related to disruption of
management’s attention from Edwards’ ongoing business operations;
(iv) the effect of the announcement or the pendency of the
acquisitions on Edwards’ relationships with its customers,
operating results and business generally; (v) potential significant
transaction costs associated with either or both acquisitions; (vi)
the outcome of any legal proceedings or regulatory actions to the
extent initiated against Edwards or others related to either or
both acquisitions; (vii) the ability of Edwards to execute on its
strategy and achieve its goals and other expectations after the
closing of either or both acquisitions; (viii) legal, regulatory,
tax and economic developments affecting Edwards’ business; (ix) the
unpredictability and severity of catastrophic events, including,
but not limited to, acts of terrorism, outbreak of war or
hostilities or current or future pandemics or epidemics, as well as
Edwards’ response to any of the aforementioned factors; and (x)
other risks detailed in Edwards’ filings with the SEC, which may be
found at edwards.com.
Edwards, Edwards Lifesciences, and the stylized E logo are
trademarks of Edwards Lifesciences Corporation or its affiliates.
All other trademarks are the property of their respective
owners.
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Media Contact: Amy Hytowitz, 949-250-4009 Investor
Contact: Mark Wilterding, 949-250-6826
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