Acutus Medical Achieves EU MDR Submission Milestone in Sale of Left-Heart Access Portfolio to Medtronic
December 21 2022 - 6:00AM
Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an
arrhythmia management company focused on improving the way cardiac
arrhythmias are diagnosed and treated, today announced that the
Company has achieved the second milestone under the asset purchase
agreement with Medtronic of its left-heart access portfolio with
the submission for CE Mark of this portfolio under European Union
(EU) Medical Device Regulations (MDR). This milestone triggers a
$17 million earnout payment from Medtronic to Acutus.
“We are very pleased to have achieved this important milestone
ahead of schedule. This submission is a critical step in our
partnership with Medtronic, and we are confident that Medtronic
will be able to accelerate adoption and positive impact on patient
care and physician practice,” said David Roman, President & CEO
of Acutus Medical. “In addition to positioning the left-heart
access portfolio for long-term success in Europe, achieving this
key milestone bolsters our financial position and enables Acutus to
continue to focus on our differentiated mapping and therapy
platform.”
Left-Heart Access Portfolio Sale On June 30,
2022, Acutus completed the first closing of its previously
announced sale of the Company’s left-heart access portfolio to
Medtronic, which includes the AcQCross® septal crossing devices,
the AcQGuide® MINI sheath and integrated crossing device, the
AcQGuide® FLEX Steerable Introducer with integrated crossing
device, and the AcQGuide® VUE steerable sheath.
Under the terms of the agreement, at the first closing,
Medtronic paid cash consideration of $50 million to Acutus for,
among other things, intellectual property rights to the Company’s
left-heart access portfolio and certain equipment used in the
manufacturing of these products. On October 31, 2022, Acutus
completed the first major milestone in this transaction with OEM
qualification and has now achieved the second major milestone of EU
MDR filing. Starting January 28, 2023, Acutus will be eligible to
receive four years of revenue-based earnouts.
About Acutus Medical, Inc.Acutus is an
arrhythmia management company focused on improving the way cardiac
arrhythmias are diagnosed and treated. Acutus is committed to
helping physicians achieve better patient outcomes with a unique
array of products and technologies which enable physicians to
diagnose each patient’s unique disease and create an optimized,
personalized treatment strategy. Through internal product
development, acquisitions and global partnerships, Acutus has
established a global sales presence delivering a broad portfolio of
highly differentiated electrophysiology products that provide its
customers with a complete solution for catheter-based treatment of
cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad,
California.
Caution Regarding Forward-Looking
StatementsThis press release includes statements that may
constitute “forward-looking” statements, usually containing the
words “believe,” “estimate,” “project,” “expect” or similar
expressions. Forward-looking statements inherently involve risks
and uncertainties that could cause actual results to differ
materially from the forward-looking statements. Factors that would
cause or contribute to such differences include, but are not
limited to, the Company’s ability to continue to manage expenses
and cash burn rate at sustainable levels, continued acceptance of
its products in the marketplace, the effect of global economic
conditions on the ability and willingness of customers to purchase
the Company’s systems and the timing of such purchases, competitive
factors, changes resulting from healthcare policy in the United
States and globally, including changes in government reimbursement
of procedures, dependence upon third-party vendors and
distributors, timing of regulatory approvals, the impact of the
coronavirus (COVID-19) pandemic and Acutus’ response to it, and
other risks discussed in the Company’s periodic and other filings
with the Securities and Exchange Commission. By making these
forward-looking statements, Acutus undertakes no obligation to
update these statements for revisions or changes after the date of
this release, except as required by law.
Investor
Contact: |
Caroline
Corner |
Westwicke
ICR |
D:
415-202-5678 |
caroline.corner@westwicke.com |
Media
Contact: |
Peter
Neems |
D:
442-232-6094 |
peter.neems@acutus.com |
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