Pulse Biosciences Advances Cardiac Ablation Trials with FDA Approvals — Pulse Biosciences, Inc.

Event summary

Pulse Biosciences reported 100% procedural success at 6 months and 96% at one year in its first-in-human feasibility study for the nPulse Cardiac Catheter System.
Received FDA approval to commence a pivotal IDE study for treating paroxysmal atrial fibrillation with the nPulse Cardiac Catheter System in Q4 2025.
Generated $264 thousand in revenue from a highly controlled commercial launch of soft tissue ablation products.
Full year 2025 revenue was $350 thousand, with GAAP net loss of ($72.8) million.

The big picture

Pulse Biosciences is making significant strides in the cardiac ablation space, leveraging its proprietary nsPFA technology to treat atrial fibrillation. The FDA approvals for pivotal studies mark a critical milestone, positioning the company to compete in a growing market for minimally invasive cardiac treatments. However, the path to commercial success hinges on successful clinical trial execution and managing financial resources amid high operational costs.

What we're watching

Clinical Trial Execution: The pace at which Pulse Biosciences can complete pivotal enrollment in both cardiac programs will determine the timeline for potential FDA approval.
Revenue Diversification: Whether the company can sustain revenue growth from its soft tissue ablation products while advancing its cardiac ablation trials.
Cash Burn Rate: How Pulse Biosciences manages its cash burn rate, with $80.7 million in cash as of December 31, 2025, down from $118.0 million a year earlier.