Pulse Biosciences, Inc. (PLSE) presented late-breaking data from its first-in-human feasibility study of the nPulse Cardiac Catheter System, showing high procedural success rates and efficient workflow in the treatment of atrial fibrillation (AF). The findings were unveiled at the 31st Annual AF Symposium 2026 in Boston.
Atrial fibrillation is commonly treated through pulmonary vein isolation (PVI), a procedure that can be time-consuming and technically demanding. Pulse Biosciences' nPulse system uses Nanosecond Pulsed Field Ablation (nsPFA) energy, a non-thermal ablation method designed to selectively clear cardiac cells while sparing surrounding tissue.
In the feasibility study, procedural success reached 100% at six months (75/75 evaluable patients) and 96% at 12 months (45/47). The system demonstrated rapid procedure times, with an average of 16.1 applications per procedure, total procedure time of 65 minutes, and fluoroscopy time of 9.8 minutes. Left atrial dwell time averaged 21 minutes. Only 1.3% (2/150) of subjects experienced a serious adverse event related to the primary safety endpoint.
Investigators highlighted the system's efficiency and workflow advantages. Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Fuster Heart Hospital, noted that the catheter's conformable design, differentiated energy delivery, and zero-rotation workflow produced "highly efficient and effective results" compared to other AF feasibility studies.
The ongoing study has treated 165 patients across nine European centres, with remapping performed at approximately three months and rhythm control assessments at six and twelve months. The data support the system's potential to deliver precise and durable PVI using nsPFA energy.
Commenting on the results, CEO Paul LaViolette said the dataset "marks an important milestone" and validates the safety, effectiveness, lesion quality, and speed benefits of the nPulse system. Chief Medical Officer Dr. David Kenigsberg added that the results exceed expectations in a field where recurrence rates of 20-25% are common, noting the company is preparing to treat additional patients in Europe and the U.S. as it initiates its pivotal IDE study.
PLSE has traded between $12.56 and $22.75 over the past year. The stock closed Friday's trading at $20.75, up 51.57%.
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