Adagio Medical Announces Strategic Restructuring to Accelerate US Pivotal IDE Trial and Product Innovation
28 Fevereiro 2025 - 10:30AM
Business Wire
Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company”), a
leading innovator in catheter ablation technologies for treatment
of cardiac arrhythmias, today announced a corporate restructuring
and realignment of resources to prioritize its FULCRUM-VT US
pivotal investigational device exemption (“Pivotal IDE”) clinical
trial activities and its new product design optimization program.
“After a comprehensive strategic review, we are doubling down on
the priorities that will drive the most meaningful impact for
physicians, patients, and shareholders,” said Todd Usen, the Chief
Executive Officer of Adagio. “Our resources are now focused on the
completion of the FULCRUM-VT Pivotal IDE trial and subsequent
premarket approval of the VT Cryoablation System with vCLAS™
catheter from the U.S. Food and Drug Administration (“FDA”). With
over 35% enrollment complete, we, along with our physicians, are
very encouraged by the system’s performance and early outcomes. In
addition, we will dedicate the appropriate resources to our product
design optimization program, which allows us to design, iterate and
innovate more efficiently. We believe that this focused approach is
crucial to position Adagio as a leader in ventricular tachycardia
solutions, which has been a historically underserved market.”
The streamlining of the Company operations includes a pause in
the limited European launch of the vCLAS catheter, while the
product design optimization program is instituted. The limited
launch provided valuable insights from European electrophysiology
professionals, including gaining a more in-depth understanding of
the broad applicability and unique clinical benefits of Adagio’s
proprietary ultra-low temperature cryoablation technology.
With a narrower focus on key initiatives, the restructuring
includes a reduction in force, effective February 28, 2025. This is
expected to enable additional investment in the aforementioned
critical priorities.
“The decision to part with valued colleagues is difficult, and
we have deep gratitude for their contributions,” continued Mr.
Usen. “We wish them the very best and will strive to build upon
their efforts. I have tremendous confidence in Adagio’s future, and
believe that our highly differentiated and validated technology
will drive the best clinical results for our physicians and,
ultimately, the best outcomes for ventricular tachycardia
patients.”
About FULCRUM-VT
FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in
Recurring Monomorphic Ventricular Tachycardia, NCT05675865) is a
prospective, multi-center, open-label, single-arm study, enrolling
206 patients with structural heart disease of both ischemic and
non-ischemic cardiomyopathy, indicated for catheter ablation of
drug refractory ventricular tachycardia (“VT”) in accordance with
current treatment guidelines. The results of the study will be used
to obtain premarket approval from the FDA for Adagio’s VT
Cryoablation System with the vCLAS™ cryoablation catheter with
industry’s broadest indication for purely endocardial ablation of
scar-mediated VT.
About Adagio Medical Holdings, Inc.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM) is an early
commercial stage medical device company located in Laguna Hills,
California focused on developing proprietary Ultra-Low Temperature
Cryoablation technology that creates contiguous, transmural lesions
to treat cardiac arrhythmias, with an emphasis on ventricular
tachycardia.
Forward-Looking Statements
Certain statements in this press release (this “Press Release”)
may be considered “forward-looking statements” within the meaning
of the “safe harbor” provisions of the United States Private
Securities Litigation Reform Act of 1995. Forward-looking
statements generally relate to future events or future financial or
operating performance of the Company. For example, any statements
that refer to expectations, projections or other characterizations
of future events or circumstances are forward-looking statements.
In some cases, you can identify forward-looking statements by
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terminology. Such forward-looking statements are subject to risks,
uncertainties, and other factors which may be beyond the control of
the Company and could cause actual results to differ materially
from those expressed or implied by such forward-looking statements.
These forward-looking statements are based upon estimates and
assumptions that, while considered reasonable by the Company and
its management, are inherently uncertain. The Company cautions you
that these statements are based on a combination of facts and
factors currently known and projections of the future, which are
inherently uncertain. There are risks and uncertainties described
in the documents and reports, which was filed by the Company with
the U.S. Securities and Exchange Commission (the “SEC”) and will be
filed by the Company from time to time with the SEC. These filings
may identify and address other important risks and uncertainties
that could cause actual events and results to differ materially
from those contained in the forward-looking statements. The Company
cannot assure you that the forward-looking statements in this
communication will prove to be accurate.
Nothing in this Press Release should be regarded as a
representation or warranty by any person that the forward-looking
statements set forth herein will be achieved or that any of the
contemplated results of such forward-looking statements will be
achieved, in any specified time frame, or at all. You should not
place undue reliance on forward-looking statements, which speak
only as of the date they are made in this Press Release. Subsequent
events and developments may cause those views to change. The
Company does not undertake any duty to update these forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20250228369688/en/
Media Ilya Grigorov VP, Global Marketing and Product
Management of Adagio Medical, Inc. igrigorov@adagiomedical.com
Investor IR@adagiomedical.com
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