MARLBOROUGH, Mass.,
July 5, 2018 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) today announced a
definitive agreement to acquire Cryterion Medical, Inc., a
privately-held company developing a single-shot cryoablation
platform for the treatment of atrial fibrillation (AF). The
addition of this cryoballoon platform positions the company as the
first to have both cryothermal and radiofrequency (RF) single-shot,
balloon-based ablation therapies in its portfolio. Boston
Scientific has been an investor in Cryterion since its inception in
2016 and the transaction price for the approximately 65 percent
remaining stake not already owned by Boston Scientific consists of
$202 million in up-front
cash.
The quickly expanding global electrophysiology (EP) market is
estimated to reach $5 billion in
2018. Additionally, single-shot ablation therapies are believed to
be the fastest growing sub-segment within the EP market, with rates
well into in the double digits, and trending toward more than
$1 billion over the next few
years.
Patients with AF – a common heart rhythm disorder – are often
treated with anti-arrhythmic drugs as well as cardiac ablation.
Ablation therapy is the process of delivering RF (heating) or
cryothermal (cooling) energy to the areas of the heart muscle
responsible for the abnormal heart rhythm. Both types of energy can
be used to isolate pulmonary veins, which are often the source of
AF.
The Cryterion Medical cryoablation platform uses cryothermal
energy to interrupt the irregular electrical signals that can cause
AF. Developed with a next-generation balloon catheter, advanced
mapping catheter, steerable sheath and enhanced console, the system
is designed to streamline overall procedural workflow, enhance
maneuverability and improve positioning in challenging anatomy.
"Initial clinical study results demonstrate that our system has
a promising safety profile as well as acute efficacy," said
Keegan Harper, president and chief
executive officer, Cryterion Medical, Inc. "We look forward to
bringing this advanced cryoablation system to market with the
support of Boston Scientific."
Performance of the cryoablation system from Cryterion Medical is
being investigated in a clinical study in Europe. Clinical evidence from this study will
be included in a regulatory submission for CE Mark, expected in
early 2019. The company will also pursue regulatory approval in the
U.S. and plans to submit an investigational device
exemption (IDE) application to the U.S. Food and Drug
Administration, with patient enrollment expected to begin in
2019.
"The acquisition of Cryterion Medical enhances our AF ablation
procedure offerings, allowing physicians to select a therapeutic
option based on clinical preference and specific patient needs,"
said Kenneth Stein, M.D., senior
vice president and chief medical officer, Rhythm Management and
Global Health Policy, Boston Scientific. "We are committed to
providing physicians with a comprehensive suite of therapies that
lead the way for clinical advancements and address the needs of the
increasing population of patients with AF."
Boston Scientific offers an innovative portfolio of EP products
and services for the diagnosis and management of cardiac rhythm
disorders. The company continues to expand its EP offerings
through internal investments and acquisitions.
Cryterion is headquartered in Carlsbad, California, with offices in
Montreal, Canada and Wexford,
Ireland.
Boston Scientific expects the transaction to be immaterial on an
adjusted earnings per share basis through 2020, and accretive
thereafter. On a GAAP basis for 2019 and subsequent years, the
transaction is expected to be less accretive, or more dilutive as
the case may be, due to amortization expense and
acquisition-related net charges. For 2018 on a GAAP basis, the
transaction is expected to be accretive due to a one-time gain on
prior investment.
*The Cryterion cryoablation system is not available
for sale.
About Boston Scientific
Boston Scientific
transforms lives through innovative medical solutions that improve
the health of patients around the world. As a global medical
technology leader for more than 35 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 healthcare. For
more information,
visit www.bostonscientific.com and connect
on Twitter and Facebook.
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
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include, among other things, statements regarding the acquisition,
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Please refer to Part II, Item 7 - Management's Discussion and
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The GAAP financial measures most directly comparable to adjusted
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CONTACTS:
Trish Backes
Media Relations
(651) 582-5887 (office)
Trish.Backes@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
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SOURCE Boston Scientific Corporation