Acquisition to expand Interventional
Cardiology Therapies offerings with ultrasound-based renal
denervation therapy for treatment of hypertension
MARLBOROUGH, Mass., March 3,
2025 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced it has entered into a definitive
agreement to acquire SoniVie Ltd., a privately held medical device
company that has developed the TIVUS™ Intravascular Ultrasound
System. An investigational technology, the TIVUS system is designed
to denervate nerves surrounding blood vessels to treat a variety of
hypertensive disorders, including renal artery denervation (RDN)
for hypertension.
Closely associated with overactivity of the sympathetic nervous
system, hypertension is a leading risk factor for cardiovascular
disease, with treatment shown to reduce cardiovascular mortality
and the risk of serious health issues such as stroke, heart attack
or heart failure.1 However, lifestyle modifications and
anti-hypertensive medications designed to modulate the sympathetic
nervous system – partly through renal nerve activity – are often
inadequate in controlling high blood pressure (BP). The TIVUS
system is designed to perform RDN that can help reduce activity in
the kidney's renal nerves and serve as an alternative or adjunctive
therapy to these medications to help regulate BP. Compared to
radiofrequency energy, ultrasound energy has the potential to
penetrate the tissue more deeply, which may result in faster
procedures with effective nerve ablation.
"Renal denervation for hypertension is an exciting medical
advancement for the millions of patients it may help and is
supported by positive results from contemporary clinical trials and
ongoing research," said Lance Bates,
senior vice president and president, Interventional Cardiology
Therapies, Boston Scientific. "We believe the addition of the
differentiated, ultrasound-based TIVUS system can complement our
expansive interventional portfolio with a minimally invasive
therapy for patients with hypertension and provides opportunity for
future advancements in this space."
The catheter-based TIVUS system generates precise ultrasound
energy that passes through the blood and into renal arteries
supplying blood to the kidneys without anchoring to the artery
wall, which allows for continual blood flow to cool the treatment
area. This energy is designed to heat and ablate the bundles of
nerves outside the arteries, stopping their ability to pass signals
and reducing the sympathetic hormones that are released from the
nerves. As a result, the blood vessels relax and the pressure
within them is reduced. Last year, SoniVie announced positive
efficacy data from an IDE pilot trial of the TIVUS system in the
U.S. and Israel. The company
recently initiated the THRIVE global IDE pivotal trial of the
device.
As a strategic investor in SoniVie, Boston Scientific currently
holds an equity stake of approximately 10 percent. Therefore, the
transaction consists of an upfront payment of approximately
$360 million for the 90 percent stake
not yet owned and up to $180 million
upon achievement of a regulatory milestone.*
Boston Scientific anticipates the transaction to be completed in
the first half of 2025, subject to customary closing conditions. On
an adjusted basis, the company expects the transaction to be
slightly dilutive to adjusted earnings per share (EPS) in 2025, and
to offset this through internal cost efficiencies and trade-offs.
On a GAAP basis, the transaction is expected to be more dilutive
due to amortization expense and acquisition-related charges, except
for a one-time gain to be recognized at closing associated with the
company's previously held equity interest in SoniVie Ltd.
*On a 100% basis before consideration of Boston
Scientific's current equity ownership in SoniVie and other closing
adjustments, the transaction price consists of $400 million up
front, and up to $200 million upon achievement of a regulatory
milestone.
Caution: The TIVUS™ Intravascular Ultrasound System is an
investigational device not yet cleared for commercial distribution
in any country.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
technologies that improve the health of patients around the world.
As a global medical technology leader for more than 45 years, we
advance science for life by providing a broad range of
high-performance solutions that address unmet patient needs and
reduce the cost of health care. Our portfolio of devices and
therapies helps physicians diagnose and treat complex
cardiovascular, respiratory, digestive, oncological, neurological
and urological diseases and conditions. Learn more
at www.bostonscientific.com and connect on
LinkedIn and X, formerly Twitter.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains 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. Forward-looking
statements may be identified by words like "anticipate," "expect,"
"project," "believe," "plan," "estimate," "intend" and similar
words. These forward-looking statements are based on our beliefs,
assumptions and estimates using information available to us at the
time and are not intended to be guarantees of future events or
performance. These forward-looking statements include, among other
things, statements regarding our business plans, the financial and
business impact of the transaction and the anticipated benefits of
the transaction, the closing of the transaction and the timing
thereof, product performance and impact, clinical trials, and new
and anticipated product approvals and launches. If our underlying
assumptions turn out to be incorrect, or if certain risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections expressed or implied by our
forward-looking statements. These factors, in some cases, have
affected and in the future (together with other factors) could
affect our ability to implement our business strategy and may cause
actual results to differ materially from those contemplated by the
statements expressed in this press release. As a result, readers
are cautioned not to place undue reliance on any of our
forward-looking statements.
Factors that may cause such differences include, among other
things: future economic, political, competitive, reimbursement and
regulatory conditions; geopolitical events; manufacturing,
distribution and supply chain disruptions and cost increases;
disruptions caused by cybersecurity events; disruptions caused by
public health emergencies or extreme weather or other climate
change-related events; labor shortages and increases in labor
costs; variations in outcomes of ongoing and future clinical trials
and market studies; new product introductions; expected procedural
volumes; the closing and integration of acquisitions, including our
ability to achieve the anticipated benefits of the proposed
transaction and successfully integrate SoniVie's operations;
business disruptions (including disruptions in relationships with
employees, customers and suppliers) following the announcement
and/or closing of the proposed transaction; demographic trends;
intellectual property; litigation; financial market conditions;
future business decisions made by us and our competitors; the
conditions to the completion of the proposed transaction, including
the receipt of any required regulatory approvals and clearances,
may not be satisfied at all or in a timely manner; and the closing
of the proposed transaction may not occur or may be delayed. All of
these factors are difficult or impossible to predict accurately and
many of them are beyond our control. For a further list and
description of these and other important risks and uncertainties
that may affect our future operations, see Part I, Item 1A – Risk
Factors in our most recent Annual Report on Form 10-K filed with
the Securities and Exchange Commission, which we may update in Part
II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we
have filed or will file hereafter. We disclaim any intention or
obligation to publicly update or revise any forward-looking
statements to reflect any change in our expectations or in events,
conditions or circumstances on which those expectations may be
based, or that may affect the likelihood that actual results will
differ from those contained in the forward-looking statements,
except as required by law. This cautionary statement is applicable
to all forward-looking statements contained in this document.
CONTACTS:
Angela Mineo
Media Relations
+1 (763) 955-8325
Angela.Mineo@bsci.com
Jon Monson
Investor Relations
+1 (508) 683-5450
BSXInvestorRelations@bsci.com
1 Cluett, Jennifer L., et al. Renal Denervation for
the Treatment of Hypertension: A Scientific Statement from the
American Heart Association. Hypertension, Vol. 81, No. 10.
https://doi.org/10.1161/HYP.0000000000000240
View original content to download
multimedia:https://www.prnewswire.com/news-releases/boston-scientific-announces-agreement-to-acquire-sonivie-ltd-302389586.html
SOURCE Boston Scientific Corporation
