Pulse Biosciences Shares Rise 5% in 2 Days Since NANOPULSE-AF Enrollment Completed

Key highlights

• Full enrollment of 164 evaluable patients achieved across 15 clinical sites
• Recruitment completed three months ahead of the original nine-month projection
• Study evaluates the nPulse Cardiac Catheter System using proprietary nano-PFA technology
• Primary safety and effectiveness endpoints will be assessed at 6 and 12 months post-ablation
• Rapid enrollment indicates strong investigator interest within the electrophysiology community

Clinical Milestone and Study Design

Pulse Biosciences announced the completion of patient recruitment for its NANOPULSE-AF IDE pivotal clinical study, which evaluates the nPulse Cardiac Catheter System. This prospective, multicenter, non-randomized investigation is designed to assess the safety and effectiveness of the system in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. The study reached its target of 164 evaluable participants across 15 world-class clinical sites. The accelerated enrollment pace, concluding three months ahead of the expected nine-month timeline, highlights the clinical community's interest in Nanosecond Pulsed Field Ablation technology. Primary endpoints will be monitored at 6 and 12 months post-procedure to support future regulatory submissions.

Operational and Strategic Implications

• The nPulse system utilizes a one-shot approach designed for straightforward procedural workflow
• Successful enrollment follows the completion of the PRECISE-BTN study for the nPulse Vybrance system
• Pulse Biosciences plans to submit for CE mark regulatory approvals in the second half of 2026
• Clinical data from this pivotal study will provide the foundation for broader commercialization efforts
• The rapid learning curve observed by operators suggests potential for seamless clinical integration

Investigator Perspective

“The rapid learning curve, seamless integration into current practice and efficient workflow allowed operators to enroll steadily once they started. This is one of the fastest-enrolling trials I have seen or participated in.”

Financial and Market Context

Pulse Biosciences currently operates as a clinical-stage medical device company, reporting annual revenue of approximately $0.35 million. To support its ongoing clinical development and regulatory pathways, the company recently established an $85 million at-the-market equity distribution agreement with Mizuho Securities in September 2026. While the stock has faced a monthly decline of 9.07%, it has maintained significant momentum over the longer term with a 70.35% gain for the quarter. The company's market capitalization remains near $3.55 billion as it transitions toward expected regulatory submissions and subsequent commercialization phases for its nano-PFA technology platforms.

Down 2.4% since our story on 7 Oct: $49.75 when we broke it → $48.54 at the close on 13 Oct. Daily closing prices. Source: Yahoo Finance.

Show the prices

14 Sep	$54.21
15 Sep	$55.20
16 Sep	$49.61
17 Sep	$50.61
18 Sep	$53.87
21 Sep	$53.31
22 Sep	$52.69
23 Sep	$51.98
24 Sep	$51.83
25 Sep	$51.63
28 Sep	$52.32
29 Sep	$50.89
30 Sep	$49.92
1 Oct	$49.83
2 Oct	$47.90
5 Oct	$50.50
6 Oct	$49.75
7 Oct	$49.09
8 Oct	$49.98
9 Oct	$53.81
12 Oct	$52.45
13 Oct	$48.54

Management commentary

“The enrollment pace reflects the enthusiasm we saw at sites from their first cases- once operators did one or two cases, they were amazed and hooked and eager to do more.”

“In my experience to date, the catheter design and one-shot approach have allowed for a straightforward and efficient procedural workflow.”

PULSE BIOSCIENCES, INC. · financial snapshot

Share price	$49.75
Market cap	$3.5B
Revenue (annual)	$350,000
1-month price change	-9.07%
Sector	HealthcareMedical Instruments & Supplies

Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.