Pulse Biosciences, Inc.

Pulse Biosciences develops and commercializes proprietary Nanosecond Pulsed Field Ablation (nsPFA™) technology for soft tissue ablation applications, primarily in cardiac electrophysiology and thyroid treatment. The company's nPulse™ platform utilizes nsPFA energy—a nonthermal ablation modality—to achieve cellular ablation while sparing noncellular structures, reducing collateral tissue damage compared to conventional thermal approaches (radiofrequency, cryotherapy). Primary product focus includes: • CellFX® nsPFA™ 360 Cardiac Catheter: A percutaneous catheter system for pulmonary vein isolation in atrial fibrillation treatment. First-in-human feasibility data (2024–2026) demonstrates rapid vein isolation, favorable lesion durability at 60 days, and minimal adverse effects across 150+ treated patients. • CellFX® nsPFA™ Cardiac Clamp: A surgical instrument for intraoperative cardiac ablation, producing continuous linear transmural lesions during cardiac surgical procedures with reduced procedure time and collateral injury risk. • nPulse™ Vybrance™ Percutaneous Electrode: A needle-based device for percutaneous ablation of benign thyroid nodules, currently in first-in-human feasibility studies (30+ patients treated). Investigational use only. Pulse Biosciences has submitted 510(k) applications to the FDA for both the cardiac clamp and percutaneous electrode (January 2024); neither has yet received clearance. The company is positioned at the intersection of interventional cardiology and cardiac surgery, with applications potentially extending to additional therapeutic areas requiring nonthermal soft tissue ablation. Regulatory status: Investigational devices under development; 510(k) submissions filed; clinical feasibility data presented at major conferences (AF Symposium 2024–2026, HRS 2023–2025, NASIT 2024).