Pulse Biosciences (PLSE) Q4 2025 earnings summary

Executive summary

• Advanced nanosecond pulsed field ablation (nsPFA) platform for precise, non-thermal tissue ablation, targeting atrial fibrillation and soft tissue applications.

• 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.

• Achieved significant clinical and commercial milestones 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 to support 2026 clinical priorities.

• Focused on building robust clinical evidence and market foundation before broad commercialization, especially for the Vibrance system.

Financial highlights

• Q4 2025 revenue was $264,000, up from $86,000 in Q3, with full year 2025 revenue totaling $350,000.

• Cost of product revenue was $260,000 for Q4, slightly lower sequentially.

• GAAP costs and expenses decreased by $1.7 million to $18.5 million year-over-year; non-GAAP costs and expenses increased to $13.3 million due to clinical trial and launch activity.

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

• Cash and equivalents at year-end 2025 totaled $80.7 million, down from $118 million at end of 2024.

Outlook and guidance

• Plans to commence and complete pivotal trial enrollment for nPulse Cardiac Catheter and Cardiac Clamp IDE studies in 2026.

• Preparing for CE Mark submissions for both cardiac platforms by end of 2026, with potential approvals in 2027.

• Vibrance system to complete PRECISE benign thyroid nodule study enrollment soon, with expansion to 100 patients and ongoing commercial utilization in key accounts.

• FDA therapeutic clearances for additional indications expected over the next 4-8 quarters.

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