Adagio Medical Provides Business Updates
August 19 2024 - 4:01PM
Business Wire
Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company”), a
leading innovator in catheter ablation technologies for treatment
of cardiac arrhythmias, today provided a business update.
Recent Business Highlights:
- Obtained CE Mark approval and initiated commercial launch of
the vCLAS™ catheter and ultra-low temperature cryoablation (ULTC)
system for treatment of ventricular tachycardia (VT) into select
European markets
- Presented CRYOCURE-VT trial data at European Heart Rhythm
Association and Heart Rhythm Society annual meetings with results
published in EP Europace journal
- Obtained the U.S. Food and Drug Administration (“FDA”) approval
for the FULCRUM-VT Pivotal IDE study
- Closed business combination and PIPE financing and listed the
Company’s common stock on The Nasdaq Capital Market
“For years there has been underinvestment in and pent-up demand
for innovation in ablation catheter technology for patients with
VT,” said Olav Bergheim, Chief Executive Officer of Adagio Medical.
“Adagio’s proprietary ULTC platform holds the promise to solve a
number of unique technical and clinical challenges which make VT
ablations complex and time-consuming, resulting in underutilization
of this potentially life-altering therapeutic procedure. We’ve
received consistent, positive feedback from physicians regarding
our published clinical data, and we are seeing a similar reception
in the initial commercial cases in Europe. Turning to the US
and our FULCRUM-VT Pivotal Study, there has been a strong interest
in study participation among the top VT ablation centers. We expect
patient enrollment to start in September, and look forward to
providing updates on our progress.”
FULCRUM-VT Pivotal IDE Study is a prospective, multi-center,
open label, single-arm study which will evaluate safety and
effectiveness of Adagio Medical VT Cryoablation System in patients
with sustained monomorphic VT due to structural heart disease of
both ischemic and non-ischemic origin. The study will enroll 206
patients at twenty US and Canadian centers, with Roderick Tung
(Banner University Medical Center Phoenix, Phoenix, AZ, USA) and
Atul Verma (McGill University Health Centre, Montreal, Canada)
serving as study co-principal Investigators. The FDA approved the
Pivotal IDE protocol in May 2024. The initial, Early Feasibility
(EFS) stage of FULCRUM-VT has enrolled 20 patients at Banner
University Medical Center Phoenix, Phoenix, AZ, Vanderbilt
University Medical Center Nashville, TN, Mount Sinai Hospital New
York, NY, and University of California in San Francisco, CA.
Business Combination
As previously announced, on July 31, the Company closed its
business combination with ARYA Sciences Acquisition Corp IV
(Nasdaq: ARYD; or “ARYA”), a special purpose acquisition company
sponsored by an affiliate of Perceptive Advisors, LLC. The shares
of common stock of the Company commenced trading under the ticker
symbol “ADGM” on the Nasdaq Capital Market on August 1, 2024.
In conjunction with the consummation of the Business Combination
with ARYA, the combined company raised approximately $84.2 million,
which consisted of funds held in ARYA’s trust account, a concurrent
equity and warrant private placement (including $29.5 million of
bridge financing used by the Company prior to closing and funds
from ARYA’s trust account not redeemed), and a concurrent
convertible security financing (including $7 million of bridge
financing used by the Company prior to closing), offset by
approximately $13.1 million of transaction costs (including
approximately $1 million for the payoff of a term loan with Silicon
Valley Bank) relating to the closing of the Business Combination.
Proforma cash-on-hand after closing was approximately $35
million.
About Adagio Medical
Adagio Medical is an early commercial stage medical device
company located in Laguna Hills, California focusing on developing
innovative cryoablation technologies that create contiguous,
transmural lesions to treat cardiac arrhythmias, including
paroxysmal and persistent atrial fibrillation, atrial flutter, and
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
terminology such as “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “forecast,” “future,” “intend,” “may,”
“might,” “plan,” “possible,” “potential,” “predict,” “project,”
“propose,” “seek,” “should,” “strive,” “will,” or “would” or the
negatives of these terms or variations of them or similar
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 definitive proxy/final prospectus relating to the Business
Combination, which was filed by the Company with the SEC, and
described in other documents 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/20240819719403/en/
Media Ilya Grigorov Vice President, Global Marketing and
Product Management Adagio Medical, Inc.
igrigorov@adagiomedical.com
Investor IR@adagiomedical.com
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