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 significant clinical and commercial milestones in 2025, including IDE approvals for cardiac catheter and clamp programs, expanded European feasibility studies, and 100% procedural success at 6 months and 96% at one year in a feasibility study for paroxysmal AF.

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

• 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, driven by both capital and disposable device sales.

• GAAP costs and expenses for Q4 2025 were $18.5 million, down $1.7 million year-over-year; non-GAAP costs and expenses rose to $13.3 million due to increased clinical and commercial activity.

• Q4 GAAP net loss was $17.4 million (vs. $19.4 million prior year); non-GAAP net loss was $12.2 million (vs. $10.4 million prior year). Full year GAAP net loss was $72.8 million; non-GAAP net loss was $50.8 million.

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

• Filed a $200 million shelf registration to provide financial flexibility for upcoming milestones.

Outlook and guidance

• 2026 focus on clinical and market development execution, including pivotal trial enrollment for cardiac catheter and clamp systems.

• Plan to complete enrollment in key IDE studies and expand European feasibility activities, aiming for CE Mark submissions by end of 2026.

• Vibrance system to complete PRECISE benign thyroid nodule study enrollment and expand to 100 patients, with further data expected in 2026.

• FDA therapeutic clearances for cardiac and soft tissue indications targeted for 2027.

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