Pulse Biosciences receives FDA Breakthrough Device Designation for nsPFA Cardiac Surgery System for AF treatment

PULSE BIOSCIENCES, INC.

FDA Breakthrough Device Designation for CellFX nsPFA Cardiac Surgery System to treat atrial fibrillation.
Designation provides expedited development and prioritized review; company plans PMA approval pathway.
Preclinical data shows single <2-second application creates transmural ablation, ~20x faster than thermal RF.
First-in-human cases expected in Netherlands soon; pivotal clinical trial planned for 2025.
No risk of thermal spread due to non-thermal nano-PFA mechanism, potentially safer than current options.

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