Progress in Market Development Programs
Pulse Biosciences is advancing its nsPFA technology in three market development programs, with expanded pilot utilization and positive clinical results in Europe. The company has submitted two IDEs for regulatory goals.
Soft Tissue Ablation Success
The nsPFA percutaneous electrode system is FDA cleared for the ablation of soft tissue, with over 140 patients treated in a pilot program and positive outcomes reported. It offers a minimally invasive alternative to thyroidectomy.
Cardiac Surgical Clamp Advancements
The nsPFA surgical ablation clamp has received Breakthrough Device designation and is in the FDA's TAP program. A pivotal trial is planned with 150 patients, supported by positive clinical outcomes from European studies.
Financial Strength
As of June 30, 2025, cash and cash equivalents totaled $106.3 million, up from $26.2 million a year ago. Expected revenue generation from the percutaneous electrode in the second half of 2025.
Cardiac Catheter Feasibility Study
Over 140 patients treated in Europe with positive outcomes. The 360 cardiac catheter system demonstrates decreased procedure times and compatibility with major mapping systems.