Pulse Biosciences Q1 2025: Navigating Contradictions in Product Progress, Regulatory Pathways, and Financial Outlook

Commercialization progress of soft tissue ablation device, product development and commercialization progress, clinical study regulatory pathway, and financial outlook and revenue expectations are the key contradictions discussed in Pulse Biosciences' latest 2025Q1 earnings call.



Soft Tissue Ablation Device Commercialization:
- Pulse Biosciences has made progress in commercializing its soft tissue ablation device, with over 90 patients treated in a pilot program using the percutaneous electrode for benign thyroid nodule treatment.
- The company aims to initiate IDE pivotal studies for its Cardiac 360 catheter and cardiac surgical clamp, indicating a commitment to further validate and expand its technology's applications.

Financial Performance and Stock-Based Compensation:
- Total GAAP costs and expenses increased to $18 million in Q1 2025, up from $10.6 million in the prior year period.
- The increase was primarily driven by a significant rise in noncash stock-based compensation, which was $5.7 million in Q1 2025 compared to $1.8 million in the prior year period.

Cardiac Clamp Feasibility Study:
- Pulse Biosciences is progressing with its first-in-human feasibility study for treating AF with its surgical cardiac clamp, having already treated 30 patients with plans to enroll up to 60 patients.
- The company expects to share preliminary results of this trial in late 2025, aiming to address an unmet need in cardiac surgery procedures.

nsPFA 360 Catheter Clinical Evidence:
- The company presented clinical data on its nsPFA 360 catheter at the HRS 2025 Annual Meeting, demonstrating procedural efficiency and positive patient outcomes, such as 100% acute successful electrical isolation in 86 of 86 pulmonary veins.
- This data supports the potential of the nsPFA 360 catheter to advance the treatment of AF and positions the company favorably for FDA approval.