PULSE BIOSCIENCES, INC. Q2 FY2025 earnings call

Management Statement and Operational Highlights

• Pulse Biosciences has next-generation Nanosecond Pulsed-Field Ablation (nsPFA) technology. Progress on three market development programs: soft tissue ablation, surgical ablation, and 360 catheter system.
• Soft tissue ablation: Pilot program with over 140 patients, transitioning procedures to ASCs/ORs for optimal patient and surgeon experience. Multicenter prospective clinical study to start in Q3 2025.
• Surgical ablation: Cardiac surgical clamp has FDA Breakthrough Device designation, IDE submission under review, feasibility study in Europe with 40 patients treated, showing rapid and consistent ablations.
• 360 catheter system: Feasibility study in Europe with over 140 patients treated, positive outcomes, and IDE study on track to commence in next few months.

Segment Performance

• Soft Tissue Ablation (Percutaneous Electrode): Over 140 patients treated in pilot program for benign thyroid nodules. Market potential in U.S. with ~250,000 annual diagnoses, where current options (thyroidectomy or watchful waiting) are undesirable. Procedures transitioning to ambulatory surgery centers (ASCs) or operating rooms. Multicenter prospective clinical study to commence enrollment in Q3 2025 upon IRB approvals.
• Surgical Ablation (Cardiac Surgical Clamp): FDA Breakthrough Device designation. IDE submission for atrial fibrillation treatment under review. Feasibility study in Europe with 40 patients treated, positive feedback on rapid, consistent ablations.
• 360 Catheter System for AF Ablation: Feasibility study in Europe with over 140 patients treated, positive outcomes. IDE study on track to commence in next few months, with potential strategic partnerships in electrophysiology space.

Guidance

• Quarterly cash use expected to increase for investment in commercial infrastructure and IDE clinical studies for cardiac devices.
• Initial revenue from percutaneous electrode anticipated in second half of 2025, based on contracts with commercial pilot program participants.
• Progress on IDE studies for cardiac devices and continued generation of high-quality clinical data to support regulatory filings and market adoption.

Risks

• Actual results may differ from forward-looking statements due to risks and uncertainties described in press releases and SEC filings.
• Uncertainties related to regulatory approval timelines for IDEs and commercialization of nsPFA technology.
• Dependence on successful clinical trials and market acceptance of the technology among clinicians and customers.

Question and Answer

Q: Share patient baseline characteristics driving pull-through for nsPFA in thyroid ablation?

A: Paul LaViolette explains that patients are symptomatic with benign thyroid nodules, current options include thyroidectomy or watchful waiting, and nsPFA offers a nonthermal, percutaneous alternative preserving thyroid function with symptomatic relief.

Q: Collaboration on cardiac ablation and compatibility with mapping systems?

A: Paul LaViolette discusses strategic partnerships, compatibility with Abbott and Biosense Webster systems, and potential for tighter integration of the nsPFA technology with these mapping systems.

Q: Data from overseas studies for cardiac clamp and catheter?

A: Paul LaViolette mentions that data from European feasibility studies for both cardiac clamp and catheter are included in IDE submissions, with plans to publish data and use it in PMA applications, and modular PMA submissions are beneficial for regulatory processes.