Pulse Biosciences closes AF catheter trial enrolment early as cash reaches $189m
The company has recruited all 169 evaluable patients for its US pivotal study roughly a quarter early, while revenue remains minimal and equity sales bolster the balance sheet.
Pulse Biosciences has a $189.2 million cash balance and $0.4 million in quarterly revenue from Vybrance. Its commercial prospects in atrial fibrillation (AF) now rest on a catheter-based device that has just cleared a key trial milestone. The company disclosed the position on 5 November 2026 alongside its third-quarter results.
The milestone is full enrolment in NANOPULSE-AF, the US investigational device exemption (IDE) pivotal study of the nPulse Cardiac Catheter System. Pulse recruited 169 evaluable patients and says it got there about three months sooner than planned. The information available does not say when results will be reported, so the readout date is open.
Regulatory steps are next. Pulse intends to file an IDE submission for persistent AF in the fourth quarter of 2026 and to make a CE Mark submission. It expects approval in the fourth quarter of 2027. That date is the company's own expectation, not a regulator's decision.
The third-quarter GAAP net loss was $23.1 million. The cash position was helped by $95.8 million in net proceeds from the company's at-the-market (ATM) equity programme, so the balance sheet reflects recent capital raising as well as operations. The facts available do not say how long the cash is expected to last.
Why it matters
- Early enrolment of a US pivotal device study shortens the recruitment phase, but no results date has been given, so the data timeline remains unclear.
- Pulse plans a persistent AF IDE submission in Q4 2026 and a CE Mark submission, which would widen the programme's regulatory footprint.
- Revenue of $0.4 million against a $23.1 million quarterly loss shows the company is still funded largely by capital markets, including $95.8 million in net ATM proceeds.
- Treat the Q4 2027 approval target as company guidance, not a confirmed regulatory outcome.
Company's press release (SEC filing): Pulse Biosciences, Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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