Adagio Medical Holdings Inc. is moving closer to commercializing a device to treat one of the most dangerous cardiac arrhythmias.
Last month, the Laguna Hills-based device maker said it submitted a premarket approval (PMA) application to the FDA for its vCLAS Ventricular Ablation System, which is designed to treat ventricular tachycardia, a type of abnormal heart rhythm.
The system uses Adagio’s proprietary catheter ablation technology, capable of reaching temperatures as low as -196 degrees Celsius, to scar heart tissue that causes abnormal electrical signals.
The PMA submission is a “defining moment” for Adagio, according to Chief Executive Todd Usen.
“More importantly, for the hundreds of thousands of patients suffering from ventricular tachycardia who currently have no purpose-built solution,” Usen said in a statement.
Adagio has already received CE Mark approval for the system in the European Union and recently reported positive results from its U.S. investigational device exemption (IDE) trial in April.
Six-Month Trial Data
Adagio’s PMA submission was supported by six-month data from its Fulcrum-VT pivotal IDE trial.
The study, which enrolled 209 patients with structural heart disease, found that 84% of participants avoided shocks from implanted heart devices designed to correct dangerous arrhythmias.
Overall, 59% of study patients were free from any ventricular tachycardia (VT) recurrence.
Fulcrum-VT is the first and only fully enrolled IDE clinical trial for ventricular tachycardia to include patients with both ischemic and nonischemic cardiomyopathy disease, according to Adagio.
Ventricular tachycardia has been the latest focus for Adagio.
It accounts for approximately 300,000 sudden cardiac deaths a year in the U.S., Usen said, referring to VT as “one of the most complex and challenging arrhythmias.”
“VT is difficult to treat, and procedures performed with current devices can be overly complex, with sub-optimal outcomes in both effectiveness and safety,” he said.
Fjord Ventures Portfolio Company
Adagio is a portfolio company of Fjord Ventures, a venture capital firm and startup accelerator.
Other companies in Fjord’ portfolio include Sonendo Inc., a maker of dental equipment. Following a financial restructuring after its 2024 delisting from the New York Stock Exchange, the company said it has narrowed operating losses, reduced cash burn and is on track to reach break-even in the second half of this year.
Fjord was founded by Olav Bergheim, who co-founded Aliso Viejo-based Glaukos Corp. along with UCI ophthalmology professor Dr. Richard Hill. Bergheim’s son, Bjarne, serves as CEO and president of Sonendo.
Bergheim served as Adagio’s CEO and board chair from the company’s founding until 2024, when he stepped down and was succeeded by Usen.
The same year, the company went public via a $128 million SPAC merger with Arya Sciences Acquisition Corp. IV.
Adagio shares are down roughly 85% since going public, trading around 75 cents per share with a $16.7 million market cap at press time (Nasdaq: ADGM).
The company had no commercial revenue for the first quarter due to paused commercial activity in Europe. It reported having cash and cash equivalents of $12.9 million as of March 31.
