Pulse Biosciences Completes First U.S. Procedure with Pulsed Field Ablation Electrode Tech

Pulse Biosciences revealed the first procedure using its CellFx nsPFA (Nanosecond Pulsed Field Ablation) percutaneous electrode system in the U.S. has been completed.
 
This first successful case is the first in the company’s pilot program. It follows the March 2024 U.S. Food and Drug Administration (FDA) 510(k) clearance for soft tissue ablation in percutaneous and intraoperative surgeries with the system.
 
Dr. Ralph P. Tufano, Medical Director, Head and Neck Endocrine Surgery for the Sarasota Memorial Health Care System, reported nsPFA’s cell-specific action allowed him to treat his patient with confidence because collateral damage wouldn’t be caused to acellular structures.
 
“The patient was treated for a large, symptomatic, benign, thyroid nodule in our office with just local lidocaine and tolerated the procedure extremely well, reporting no pain during nsPFA energy delivery, and is doing great,” Dr. Tufano told the press. “Based on the impressive results we have seen come out of Italy, I am confident the outcome of the procedure will be excellent. I am looking forward to continuing my collaboration with Pulse Biosciences to further refine the procedure and offer this life-changing new technology to my patients and to help to train other experts in this exciting new procedure.”
 
“Treating our first patient under our newly FDA-cleared nsPFA percutaneous system is a fundamental and opportune milestone for Pulse Biosciences,” added Mitch Levinson, chief strategy officer of Pulse Biosciences. “It is inspiring to see the difference our physicians can make in their patients’ lives with our unique proprietary technology, giving them the potential to set new standards for safety and efficacy as well as decreased workflow time from patient set-up to procedure finish. The administration of local anesthesia at the treatment site with the patient awake, without the need for general anesthesia, in cases to date, is a noteworthy positive. Team Pulse Biosciences is deeply grateful to Dr. Tufano for his partnership over the past 3 years. We are all looking forward to evolving the standard of medicine as together we optimize and introduce the CellFX nsPFA percutaneous procedure on a controlled and measured basis through the balance of 2024.”

More about CellFX nsPFA technology

The system is comprised of a percutaneous needle electrode used with the proprietary CellFX nsPFA console. The novel electrode harnesses and delivers nsPFA energy for precise, nonthermal cellular tissue removal without damaging noncellular structures or inducing thermal necrosis. The system is meant for non-cardiac applications.
 
30 patients underwent thyroid nodule soft tissue ablations with the CellFX nsPFA percutaneous system in Italy from April 2023 through January 2024. Patient follow-ups were conducted weekly for the first 4 weeks, then at 30-, 90-, 180-, and 360-day timepoints following the procedures. No evidence of scarring or injury to surrounding tissue has been observed, and patient treatments have been judged to be successful.
 
The company is currently pursuing CellFX nsPFA technology to treat atrial fibrillation in a select few other markets.