Pulse Biosciences announces ‘positive’ clinical data presented at meeting

Pulse Biosciences (PLSE) announced “positive preliminary results” from its first-in-human feasibility study using Nanosecond Pulsed Field Ablation for the treatment of benign thyroid nodules at the 2024 American Thyroid Association Annual Meeting. “The preliminary data demonstrate that nano-PFA pulses effectively delivered by the Company’s Percutaneous Electrode System reduced nodule sizes on average by over 50%, without evidence of residual fibrosis or scarring, and provided symptomatic relief within the first month of treatment. The nonthermal and minimally invasive nature of nano-PFA energy has shown potential to mitigate the risk of complications from thermal ablation procedures or surgical removal of benign thyroid nodules,” the company stated. “These groundbreaking results suggest nano-PFA energy can provide symptomatic relief to patients with benign thyroid nodules across the first month after the treatment. 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,” said Burke Barrett, Pulse Biosciences President and Chief Executive Officer.