Pulse Biosciences nets FDA breakthrough tag in cardiac pulsed field ablation

After developing its pulsed field ablation technology for use outside cardiology, Pulse Biosciences has now received a boost from the FDA with a breakthrough designation to help adapt its approach to treat irregular heart rhythms. 

Earlier this year, the company’s CellFX hardware collected a 510(k) clearance from the agency for the needle-based, surgical ablation of soft tissues. Like all pulsed field ablation systems, it employs ultra-fast, fluctuating electric fields that can disrupt troublesome cells without generating the heat that can spread to harm adjacent organs.

The breakthrough designation comes just days after the company reported that it raised more than $83 million through a rights offering on the Nasdaq. 

Now, Pulse Biosciences said it plans to pursue a premarket approval for its device in atrial fibrillation, as opposed to a 510(k) green light, with the ability to be used alongside other open heart surgeries and deliver a total application time of under 2 seconds. 

A first-in-human study in the Netherlands is slated for later this year, while a U.S. pivotal trial is set for 2025. The company said its platform was also designed to one day be used with catheter-based therapies.

“The Breakthrough Device Designation granted by the FDA is an exciting milestone for Pulse. It emphasizes the unique potential benefits of nanosecond PFA,” said President and CEO Burke Barrett, who joined Pulse Biosciences as chief in May. Barrett previously spent 18 years at the electrophysiology developer CardioFocus.

“I’ve spent the majority of my career working closely with electrophysiologists and introducing them to novel technologies, and I believe that CellFX nsPFA energy has the potential to advance the standard of care for the treatment of atrial fibrillation and additional disease states,” he said in a statement at the time.

That month also saw the company report its first U.S. procedure with the CellFX percutaneous electrode system, with a benign nodule ablation performed at the Sarasota Memorial Hospital’s Thyroid and Parathyroid Center in Florida.