Adagio Medical Provides Clinical and Business Updates

Rhea-AI Summary

Adagio Medical Holdings (NASDAQ: ADGM) provided updates on its focus on ventricular tachycardia (VT) solutions. The company announced its participation in the 2025 European Heart Rhythm Association Annual Meeting, where two medical experts will present on the company's ultra-low temperature cryoablation (ULTC) technology.

The FULCRUM-VT IDE Pivotal Study has reached 40% enrollment, targeting 206 patients with structural heart disease for catheter ablation of drug refractory ventricular tachycardia. The study aims to support US premarket approval of the VT Cryoablation System with vCLAS™ catheter, with full enrollment expected in H2 2025.

The company also announced CFO John Dahldorf's departure, effective March 21, 2025, to be replaced by a transitional CFO. CEO Todd Usen expressed confidence in the company's financial resources and corporate structure to achieve their goals.

Positive

• FULCRUM-VT IDE Pivotal Study reached 40% enrollment milestone
• Study on track for completion of full patient enrollment in H2 2025
• Expanded use of vCLAS™ catheter by European medical experts

Negative

• CFO departure and replacement with transitional CFO indicates potential management instability

Insights

Medical Device Specialist

Adagio Medical's clinical update shows promising progress in their specialized cardiac ablation technology path. The 40% enrollment milestone in their FULCRUM-VT IDE Pivotal Study represents significant advancement toward potential FDA approval of their VT Cryoablation System. With full enrollment targeted for H2 2025, this 206-patient trial studying both ischemic and non-ischemic cardiomyopathy patients establishes a clear regulatory timeline.

The company's ultra-low temperature cryoablation (ULTC) technology is particularly notable for its expanding applications. Beyond scar-related monomorphic ventricular tachycardia, Adagio is now demonstrating ULTC's application for premature ventricular complexes (PVCs), which constitute over 50% of current VT ablation cases. This represents a substantial market expansion opportunity as the technology addresses specific procedural challenges in these treatments.

While the clinical progress is encouraging, the CFO transition comes at a critical juncture in the company's development. The announcement of a "transitional CFO" rather than naming a permanent replacement could raise questions about long-term financial leadership during this pivotal clinical development phase. For a company with Adagio's relatively modest market capitalization ($17M), maintaining financial stability while advancing toward regulatory approval is particularly crucial.

Financial Analyst

This update from Adagio Medical provides mixed signals for investors. On the positive side, the FULCRUM-VT trial's 40% enrollment progress indicates the company is maintaining momentum on its regulatory pathway for the VT Cryoablation System. Meeting clinical timelines reduces regulatory uncertainty and keeps potential commercialization on track for this micro-cap medical device player.

However, the departure of CFO John Dahldorf and replacement with an unnamed "transitional CFO" raises governance questions. While presented as aligning with the company's streamlined focus, executive transitions during critical clinical development phases typically warrant scrutiny. The lack of specific financial metrics in this update is also notable - no cash position details, burn rate information, or commercialization timeline projections are provided.

The expansion of their technology application to PVCs could represent market opportunity diversification, potentially broadening revenue streams if approved. However, with a market cap of just $17M and ongoing clinical trial expenses, investors should carefully monitor cash runway and financing needs. While the CEO expresses confidence in financial resources, the actual financial position remains unquantified in this announcement. The company appears to be prioritizing clinical development over near-term commercialization, suggesting revenue generation remains a future prospect.

LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company”), a leading innovator in catheter ablation technologies, provided updates today on the progress in its streamlined focus on leadership in ventricular tachycardia (“VT”) solutions.

Recent Business Highlights:

• The Company will participate in the scientific program of the 2025 European Heart Rhythm Association (the “Association”) Annual Meeting to be held from March 30 through April 1 in Vienna, Austria.
  • At the Association’s Ablation Innovation Summit, Dr. Tom De Potter, MD, PhD Associate Director, Cardiovascular Center at AZORG hospital in Aalst, Belgium will deliver a lecture on the use of the Company’s proprietary ultra-low temperature cryoablation (“ULTC”) technology for treatment of scar-related monomorphic ventricular tachycardia.
  • In addition, Professor Mark Gallagher, MD from St. George’s University Hospital in London, UK, will present a first-in-human case series using ULTC for ablation of premature ventricular complexes (“PVC”). The ablations of idiopathic PVCs constitute over half of current VT ablation cases. ULTC uniquely addresses some of the procedural challenges associated with these ablations.
• The Company announced that the FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia, NCT05675865) IDE Pivotal Study is over 40% enrolled. The trial, designed to support US premarket approval of the VT Cryoablation System with the vCLAS™ catheter is on track for completion of full patient enrollment in the second half of 2025. FULCRUM-VT 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 in accordance with current treatment guidelines.
• In alignment with its key initiatives, prioritizing the FULCRUM VT US pivotal trial and product design optimization, the Company announced that John Dahldorf, the Company’s CFO, has decided to leave the Company, effective March 21, 2025. Mr. Dahldorf will be replaced by a transitional CFO.

“I’m extremely pleased with the FULCRUM-VT enrollment progress and the expanded use of the vCLAS™ catheter by European thought leaders. This speaks to how effectively our Company’s products address a universally recognized market need for purpose-built VT ablation technology,” said Todd Usen, Chief Executive Officer (“CEO”) of the Company. “I’d also like to thank John for his support as I took over the CEO position at the Company, and I sincerely wish him the best. We are confident we have the financial resources and the corporate structure to achieve our goals and drive the most meaningful impact for physicians, patients, and shareholders.”

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 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250317840136/en/

Media Contact

Ilya Grigorov

VP, Global Marketing and Product Management of Adagio Medical Holdings, Inc.

igrigorov@adagiomedical.com



Investor Contact

IR@adagiomedical.com

Source: Adagio Medical Holdings, Inc.

FAQ

What is the current enrollment status of Adagio Medical's FULCRUM-VT trial (ADGM)?

The FULCRUM-VT IDE Pivotal Study is over 40% enrolled, with full enrollment of 206 patients expected in the second half of 2025.

What technology will be presented at the 2025 European Heart Rhythm Association Meeting for ADGM?

Adagio Medical's ultra-low temperature cryoablation (ULTC) technology for treating scar-related monomorphic ventricular tachycardia and premature ventricular complexes.

How many patients is ADGM's FULCRUM-VT study targeting?

The study is enrolling 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy.

When is Adagio Medical's CFO John Dahldorf leaving the company (ADGM)?

John Dahldorf will leave the company effective March 21, 2025, to be replaced by a transitional CFO.