Clinical trialsCompany release

Pulse Biosciences completes enrolment in US pivotal AF ablation trial ahead of schedule

🇺🇸 Pulse Biosciences, Inc. (PLSE) · Thu 05 Nov 2026

The company finished enrolling 169 evaluable patients in NANOPULSE-AF about three months early and reported Q3 2026 cash of $189.2 million.

Pulse Biosciences has finished enrolment in NANOPULSE-AF, the US investigational device exemption (IDE) pivotal study of its nPulse Cardiac Catheter System for atrial fibrillation (AF). The company announced the milestone with its third-quarter 2026 results on 5 November 2026.

The study enrolled 169 evaluable patients, and Pulse says it reached this point about three months ahead of schedule.

The company plans to file an IDE submission for persistent AF in the fourth quarter of 2026. It also intends to make a CE Mark submission, and anticipates approval in the fourth quarter of 2027.

On financials, Pulse reported $0.4 million in revenue from Vybrance and a GAAP net loss of $23.1 million for the quarter. Cash stood at $189.2 million, helped by $95.8 million in net proceeds from its at-the-market (ATM) equity programme.

What it means for your team

  • Regulatory teams tracking cardiac ablation devices should note the planned Q4 2026 persistent AF IDE submission and the CE Mark filing, with approval targeted for Q4 2027.
  • Completed enrolment in the pivotal study means the company's attention shifts to follow-up and data analysis; the timing of results has not been stated in the information available.
  • Market-access planners should treat the Q4 2027 approval date as a company expectation, not a regulatory decision.

Company's press release (SEC filing): Pulse Biosciences, Inc. ↗

Article written by VigiEye from the official source (Pulse Biosciences, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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