Adagio Medical Holdings, Inc. (NASDAQ:ADGM) shares are trending overnight after climbing 21.76% to $0.56 in Monday’s after-hours session after the company announced the first patient was successfully treated with its next-generation vCLAS Ultra ablation system under the Food and Drug Administration’s Expanded Access authorization.

The after-hours gain followed a 21.60% rise during Monday’s regular session, with the stock closing at $0.46.

Adagio Medical develops devices designed to treat dangerous abnormal heart rhythms (cardiac arrhythmias) without open-heart surgery.

First Patient Treated

Adagio said the first patient was treated with its next-generation vCLAS Ultra Ultra-Low Temperature Ablation (ULTA) system at the Hospital of the University of Pennsylvania. The patient had previously undergone unsuccessful radiofrequency and coronary venous alcohol ablation (a procedure that uses alcohol to destroy abnormal heart tissue) for ventricular tachycardia (VT).

The procedure was performed by Dr. Gregory Supple, director of Inpatient EP Services at the hospital and an investigator in Adagio’s FULCRUM-VT pivotal trial.

According to the company, the next-generation system uses a single-freeze design and preclinical data suggest it could reduce ablation time by 50% to 75%, with procedures taking up to 30 minutes less than the first-generation device.

Supple said the patient remained free from ventricular tachycardia recurrence about two months after the procedure and noted the new catheter’s flexibility and single-freeze design helped shorten procedure time.

Separately, Adagio said the FDA has approved expanding its FULCRUM-VT investigational device exemption trial to evaluate the safety and effectiveness of the next-generation vCLAS Ultra system. The company added it expects FDA approval for its first-generation ULTA system in the coming months.

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Trading Metrics

Adagio Medical has a market capitalization of approximately $10.17 million, with a 52-week high of $2.58 and a 52-week low of $0.36.

Over the past 12 months, ADGM shares have declined approximately 66.42%.

Benzinga Edge Stock Rankings show negative price trends across the short-, medium- and long-term time frames.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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