Pulse Biosciences (PLSE) Q4 2025 earnings summary

Executive summary

• Advanced nanosecond pulsed field ablation (nsPFA) platform targets disruption in soft tissue ablation markets with high precision, speed, and safety advantages over thermal modalities.

• Achieved 100% procedural success at 6 months and 96% at one year in a feasibility study for paroxysmal AF using the nPulse Cardiac Catheter System.

• Received FDA approval to commence pivotal IDE studies for both endocardial and surgical AF ablation devices.

• Achieved significant progress in 2025, including IDE approvals for cardiac catheter and surgical clamp programs, and expanded European feasibility studies.

• Maintained disciplined expense management and exited 2025 with a strong balance sheet, supporting clinical priorities for 2026.

Financial highlights

• Q4 2025 revenue was $264,000, up from $86,000 in Q3, and full year 2025 revenue totaled $350,000, driven by both capital and disposable device sales.

• Cost of product revenue for Q4 was $260,000; Q4 2025 gross margin was 1.5%.

• Q4 GAAP net loss was $17.4 million, improved from $19.4 million in the prior year; non-GAAP net loss was $12.2 million, up from $10.4 million.

• Full year GAAP net loss was $72.8 million vs. $53.6 million in 2024; non-GAAP net loss was $50.8 million vs. $36.9 million prior year.

• Cash and cash equivalents at year-end were $80.7 million, down from $118 million a year prior; filed a $200 million shelf registration for financial flexibility.

Outlook and guidance

• Focus for 2026 is on clinical and market development execution, including pivotal trial enrollment and CE Mark submissions for cardiac catheter and clamp systems.

• First patient enrollment in pivotal IDE study for paroxysmal AF expected in the next few months, with last patient by Q4 2026.

• Anticipates completing enrollment in key studies and expanding commercial utilization of the Vibrance system.

• Expects FDA therapeutic clearances for additional indications to be essential for significant revenue growth.