Pulse Biosciences, Inc. (Nasdaq: PLSE), a company pioneering novel bioelectric medicine with its proprietary Nanosecond Pulsed Field Ablation™ (nano-PFA™) technology, announced a new publication in the Journal of Thoracic and Cardiovascular Surgery. The preclinical study demonstrates the advantages of Pulse Biosciences’ nano-PFA Cardiac Surgical System compared to radiofrequency (RF) technology for cardiac tissue ablation.
The study aimed to assess the safety and efficacy of Pulse’s nano-PFA Cardiac Surgical System, particularly its ability to ablate cardiac tissue in various heart chambers. Ablation was performed using Pulse’s new parallel clamp, delivering nanosecond pulsed electrical fields to porcine models. These electrical pulses, lasting 1.25 seconds each, were effective across all heart chambers, independent of the tissue thickness or type. Results from the study showed that all lesions created by nano-PFA resulted in persistent exit block of pulmonary veins, which is consistent with histological findings of reliable, durable, contiguous, and transmural ablations. Importantly, these ablations did not cause damage to adjacent organs.
Dr. Gan Dunnington, Chief Medical Officer of Cardiac Surgery at Pulse Biosciences, expressed pride in the publication, emphasizing the promising results. “This data is compelling because it shows that nano-PFA can deliver consistent, transmural ablations across various tissue thicknesses without harming surrounding tissues. Importantly, the procedure is much faster than RF technology, which offers significant benefits for surgeons aiming to ensure positive patient outcomes,” said Dr. Dunnington.
Dr. Niv Ad, Chief Science Officer of Cardiac Surgery at Pulse, highlighted the non-thermal nature of nano-PFA. Unlike RF, which relies on heat to cause tissue destruction, nano-PFA uses high-amplitude, short-duration energy pulses, making it a non-thermal mechanism of action. This reduces the risk of collateral tissue injury, providing a safer and more effective ablation alternative for treating conditions such as atrial fibrillation (AF). Pulse’s ongoing preclinical work supports these findings, with the company focusing on advancing the surgical treatment of AF.
Pulse’s Cardiac Surgical System, featuring a bipolar clamp, produces durable and continuous transmural ablation lesions during cardiac surgery. One of the significant advantages of this system is the speed of its operation. A single application of less than two seconds generates a consistent, transmural, durable ablation—about 20 times faster than existing thermal ablation technologies. Furthermore, since nano-PFA operates through a non-thermal process, it eliminates the risk of thermal spread, which can cause unintended damage to surrounding tissues, a major drawback of thermal RF ablation.
The nano-PFA Cardiac Surgical System was awarded FDA Breakthrough Device Designation in July 2024 and enrolled in the FDA’s TAP (Translational Accelerator Program). Pulse Biosciences is currently conducting a multi-center, first-in-human feasibility study of the technology for AF treatment in Europe, with three centers in the Netherlands enrolling patients. Preliminary results from the study are expected in late 2025.
Pulse Biosciences is dedicated to improving healthcare outcomes through innovative bioelectric technologies. The company’s CellFX® nsPFA™ technology uses nanosecond pulses to non-thermally ablate cells while preserving surrounding tissues. In addition to AF, Pulse is exploring other potential markets for this transformative technology, with the aim of improving the quality of life for patients and providing valuable solutions for healthcare providers.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA, and the company’s logos are trademarks or registered trademarks of Pulse Biosciences, Inc. in the U.S. and other countries.
