Positive Data Presented for Pulse Biosciences’ nano-PFA Tech

Pulse Biosciences Inc.’s proprietary Nanosecond Pulsed Field Ablation (nano-PFA or nsPFA) technology is showing promise in treating benign thyroid nodules.

Preliminary results from a first-in-human feasibility study demonstrate that nano-PFA pulses delivered by the company’s Percutaneous Electrode System reduced nodule sizes on average by more than 50% without residual fibrosis or scarring, and provided symptomatic relief within the first month of treatment. The nonthermal and minimally invasive nature of nano-PFA energy can potentially mitigate the risk of complications from thermal ablation procedures or the surgical removal of benign thyroid nodules.

“I am proud to report that in the treated nodules, we observed significant nodule volume reductions which led to great improvements in symptoms for the patients in our study. We are excited to finish the long-term follow-up, complete the study, and continue the utilization of nano-PFA to advance the standard of care for patients with benign thyroid nodules,” said Dr. Stefano Spiezia, chief of Endocrine Surgery Division at Napoli Ospedale del Mare (Naples, Italy) and principal investigator of the study and founder of “Save Your Thyroid” institute.

Enrollment in the study evaluating Pulse Biosciences’ nsPFA Percutaneous Electrode System has been completed. The trial will support the initial safety and effectiveness profile of the nsPFA electrode or needle in treating and reducing benign thyroid nodule volumes.

“These results suggest nano-PFA energy can provide symptomatic relief to patients with benign thyroid nodules across the first month after the treatment,” Pulse Biosciences President/CEO Burke T. Barrett stated. “We would like to thank Dr. Spiezia and his team for all the clinical work they continue to do with the System. This feasibility study and our ongoing U.S. pilot program will inform the design of the pivotal trial we intend to commence mid-2025. The study will be designed to support a specific labeling indication to commercialize the system in the United States as a treatment for benign thyroid nodules.”

The Percutaneous Electrode System consists of a percutaneous needle electrode used with the proprietary nano-PFA Console. The electrode is designed to harness and deliver key advantages of nano-PFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system has received U.S. Food and Drug Administration 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. This proprietary system is designed for non-cardiac applications.

Pulse Biosciences is a bioelectric medicine company committed to health innovation that can potentially improve patients’ quality of life. Its CellFX nsPFA technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The company is actively developing its CellFX nsPFA technology for use in treating atrial fibrillation and in a select few other markets where it could have a profound impact on healthcare. Pulse Biosciences is headquartered in Miami, Fla., and maintains an office in Hayward, Calif.