Acquisition to expand cardiovascular portfolio
with complementary and differentiated calcium modification
platform, furthering company's strategy to address coronary
and peripheral disease
MARLBOROUGH, Mass., Jan. 8, 2025
/PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today
announced it has entered into a definitive agreement to acquire
Bolt Medical, Inc., the developer of an intravascular lithotripsy
(IVL) advanced laser-based platform for the treatment of coronary
and peripheral artery disease.
"Representing one of the fastest growing medical device
segments, intravascular lithotripsy therapy addresses a significant
unmet need for patients with complex calcified arterial disease
through a minimally invasive approach," said Lance Bates, senior vice president and
president, Interventional Cardiology Therapies, Boston Scientific.
"Bolt Medical is developing a next-generation technology that is
highly complementary to our existing portfolio. The addition of
this system to our offerings can help us better serve physicians
and their patients and provides a platform for future
innovation."
Cardiovascular diseases are the leading cause of death
globallyi and are commonly due to narrowing of
coronary and peripheral arteries, which can restrict blood flow.
These narrowed arteries are often created by cholesterol
deposits and may also have buildup of calcium that can increase the
complexity of potential treatments. Lithotripsy is a procedure in
which a physician breaks up hardened masses such as calcium to help
restore blood flow. The Bolt IVL™ system is designed with a novel
application of lithotripsy to fracture calcium by creating acoustic
pressure waves inside of a balloon catheter. The system also
includes visible, directional emitters for consistent energy
delivery in the treatment of the calcified lesions.
Boston Scientific initially developed the concept for the Bolt
IVL system which helped establish Bolt Medical in 2019. As a
strategic investor in Bolt Medical, Boston Scientific has an equity
stake of approximately 26 percent. As a result, the transaction
consists of an upfront payment of approximately $443
million for the 74 percent stake not yet owned and up
to $221 million upon achievement of certain regulatory
milestones.+
Bolt Medical recently announced the completion and results of
the RESTORE ATK and RESTORE BTK pivotal clinical trials
investigating the Bolt IVL™ Above the Knee (ATK)
and Below the Knee (BTK) systems for the treatment of peripheral
artery disease in patients with moderate to severely calcified
lesions. The data from both studies will be used to support U.S.
Food and Drug Administration (FDA) and CE Mark regulatory
submissions for the devices. In December
2024, Bolt Medical received FDA approval to commence the
global FRACTURE IDE clinical trial in the U.S., which is
investigating the use of the Bolt IVL™ Coronary System for the
treatment of coronary arterial disease with severely calcified
lesions.
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 via 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 Bolt
Medical.
+On a 100% basis before consideration of Boston
Scientific's current equity ownership in Bolt Medical, debt and
other closing adjustments, the transaction price consists of
$600 million up front, and up to
$300 million upon achievement of
certain regulatory milestones.
Caution: The Bolt IVL™ system is an
investigational device, which is 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, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. 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, and product performance and
impact. 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 forward-looking 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; market competition for our products;
expected procedural volumes; new product introductions; demographic
trends; the closing and integration of acquisitions, including our
ability to achieve the anticipated benefits of the proposed
transaction and successfully integrate Bolt Medical's operations;
business disruptions (including disruptions in relationships with
employees, customers and suppliers) following the announcement
and/or closing of the proposed transaction; 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 press release.
CONTACTS:
Laura Aumann
Media Relations
(651) 582-4251
laura.aumann@bsci.com
Jon Monson
Investor Relations
+1 (508) 683-5450
BSXInvestorRelations@bsci.com
i Cardiovascular diseases (CVDs) (who.int)
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SOURCE Boston Scientific Corporation
