Market reaction and study overview
Pulse Biosciences (NASDAQ:PLSE) shares advanced on Friday following the release of late-breaking clinical data from the first-in-human feasibility study of its nPulse Cardiac Catheter System, presented at the AF Symposium. The study results, as presented by the company, reported strong procedural outcomes and a low incidence of serious adverse events tied to the primary safety endpoint.
Key trial outcomes
The company said the study showed 100% procedural success in evaluable patients at 6 months and 96% success at 12 months for the treatment of atrial fibrillation. In the dataset presented, the technology demonstrated effectiveness across 150 patients, with short procedure durations and minimal adverse effects.
Among the specific operational metrics disclosed were an average of 16.1 applications per procedure and a total procedure time of 65 minutes. The safety profile was highlighted by the company, noting that only 1.3% of subjects experienced serious adverse events related to the trial’s primary safety endpoint.
Comments from clinicians and company leadership
"These 6- and 12-month data demonstrate a strong safety profile with highly effective and durable PVI achieved with the nPulse Cardiac Catheter Ablation System, suggesting that this system has the ability to considerably advance the treatment of atrial fibrillation," said Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital.
Pulse Biosciences' chief executive, Paul LaViolette, characterized the findings as "an important milestone" that validates the device’s safety, effectiveness, and speed advantages.
Independent commentary and next steps
Oppenheimer analyst Suraj Kalia described the first-in-human results as encouraging, but cautioned that they will require confirmation in subsequent studies: "We consider these FIH results encouraging to say the least, though they will need to be proven out in further studies."
The nPulse system employs the company’s proprietary Nanosecond Pulsed Field Ablation energy. Pulse Biosciences indicated plans to expand patient treatment both in Europe and the United States as it moves forward with a pivotal IDE study.
Study scope and enrollment
The ongoing feasibility program has treated a total of 165 patients across nine investigators in Europe, according to the company. The presented dataset referenced the system’s performance in 150 patients as part of the late-breaking results on which the market reaction was based.
Summary perspective
The trial report combines high short- and mid-term procedural success rates with operational measures - average applications and procedure duration - and a low serious-adverse-event rate tied to the primary safety endpoint. Company leadership and an outside analyst framed the results as promising but in need of further validation through the planned pivotal study and continued enrollment.