Pulse Biosciences (PLSE) Q2 2025: R&D Spend to Rise with Two IDE Trials and Commercial Launch
Pulse Biosciences accelerated its clinical and commercial agenda in Q2, pushing forward two pivotal IDE trials and expanding pilot use of its NSPFA platform in soft tissue and cardiac ablation markets. Management confirmed a step-up in R&D and operating cash burn is on deck, as the company enters a critical execution phase with initial commercial revenue and partnership discussions in motion. The next two quarters will test Pulse’s ability to convert clinical momentum into sustainable adoption and validate its differentiated technology in real-world settings.
Summary
- Clinical Expansion Accelerates: Two IDE trials for cardiac ablation devices set to drive R&D and adoption focus.
- Commercialization Begins: Pilot soft tissue ablation program transitions to revenue stage in H2 with ASC/OR focus.
- Execution Risk Rises: Elevated cash burn and operational complexity as Pulse scales trials and commercial infrastructure.
Performance Analysis
Pulse Biosciences’ Q2 was defined by heavy investment in clinical and commercial infrastructure, with total GAAP costs and expenses jumping to $20.3 million, driven by organizational expansion and higher stock-based compensation. Non-GAAP costs and expenses also rose materially, reflecting the company’s transition from R&D phase to a dual-track of clinical trial execution and early commercialization. Operating cash burn increased sequentially, in line with management’s plan to resource two major IDE trials and the pilot launch of the percutaneous electrode system.
Commercial revenue is now in sight, as the percutaneous electrode system for benign thyroid nodule ablation moves from pilot to initial sales, with ASC and OR sites prioritized for optimal reimbursement and patient access. Management emphasized the variability of revenue recognition, given diverse contract structures and evaluation placements typical of early-stage medtech launches. Cash reserves of $106.3 million provide runway, but investors should expect quarterly cash use to rise as trial enrollment and commercial activity ramp through the back half of 2025.
- Cost Structure Shift: Administrative and compensation expenses increased, reflecting headcount and trial infrastructure buildout.
- Revenue Inflection Point: Initial sales from the percutaneous electrode expected in H2, with commercial adoption still nascent.
- Cash Burn Trajectory: Q2 operating cash use of $12.8 million, with further increases anticipated as IDE trials commence.
The company is entering a capital-intensive phase, with financial performance now tightly linked to clinical execution and pace of commercial adoption.
Executive Commentary
"This year we plan to demonstrate the strong product market fit for the NSPFA percutaneous electrode system as a treatment for ablation of soft tissue such as benign thyroid nodules and to develop clinical evidence demonstrating NSPFA may be a better treatment than surgery for many patients suffering with benign thyroid disease."
Paul LaViolette, Co-Chair of the Board and Chief Executive Officer
"We ended the quarter with $106.3 million in cash, which was a decrease of $12.9 million versus Q1 of 2025. Cash use this quarter was a result of disciplined expense management and aligned with the planned cash usage. Looking ahead, as previously stated, we expect quarterly cash use to increase as we invest further in our commercial infrastructure and in our IDE clinical studies for our cardiac devices."
John Skinner, Chief Financial Officer
Strategic Positioning
1. NSPFA Technology Platform: Differentiated Mechanism and Market Scope
Pulse’s core asset is its nanosecond pulse field ablation (NSPFA) technology, which delivers non-thermal, deep tissue ablations with short duration pulses. This platform is positioned as a safer, more precise alternative to radiofrequency ablation, particularly in anatomically challenging or delicate areas like the thyroid and heart. Clinical feedback highlights advantages in speed, safety, and preservation of function, supporting the company’s claim of a fundamentally differentiated ablation modality.
2. Multi-Pronged Market Entry: Soft Tissue and Cardiac Applications
The company is pursuing parallel tracks in soft tissue (benign thyroid nodules) and cardiac ablation (surgical clamp and 360 catheter), each with distinct regulatory and commercial pathways. The thyroid pilot program is transitioning to commercial sales, while two IDE trials for cardiac devices (surgical clamp and 360 catheter) are pending FDA approval and set to begin enrollment in the coming months. Early European feasibility data and FDA breakthrough designation for the clamp device provide credibility and regulatory tailwinds.
3. Commercial Model and Channel Strategy: ASC/OR Focus and Reimbursement
Pilot experience has led Pulse to prioritize ambulatory surgery centers (ASC) and operating rooms (OR) over office settings, citing better patient and surgeon experience and improved reimbursement dynamics. Early insurance claims have been processed successfully, and the company is building a pipeline targeting high-volume thyroidectomy centers and ultrasound-guided procedure specialists. Commercial adoption will be gated by capital equipment sales cycles, which Pulse acknowledges can be lengthy and variable.
4. Data Generation and Clinical Evidence: Central to Adoption and Regulatory Progress
High-quality clinical data remains the linchpin of Pulse’s adoption and regulatory strategy, with ongoing and planned multicenter studies in both the US and Europe. Upcoming presentations at major medical meetings and peer-reviewed publications are expected to provide external validation and visibility, supporting both IDE approvals and commercial traction.
5. Partnership Potential in Electrophysiology: Capital Efficiency and Market Access
Pulse signaled intent to partner with a market leader in electrophysiology for its 360 catheter system, recognizing the capital intensity and competitive dynamics of the EP ablation market. Partnership discussions are underway, with the goal of leveraging external commercial infrastructure and accelerating market access.
Key Considerations
The second half of 2025 will be a pivotal execution window for Pulse Biosciences, as the company shifts from technology validation to clinical and commercial scaling. Investors should weigh the following:
Key Considerations:
- Clinical Adoption Curve: Conversion of pilot sites to commercial customers and expansion of procedure volume will be critical for validating product-market fit.
- Regulatory Milestones: Timely IDE approvals and enrollment pace for both cardiac device trials will dictate the speed of US market entry and eventual PMA submissions.
- Cash Management: Rising R&D and commercial spend will test Pulse’s capital discipline and runway, especially if trial timelines extend or revenue ramp lags expectations.
- Partnership Execution: Success in securing a strategic EP partner could unlock scale and de-risk commercialization of the catheter platform.
- Reimbursement and Channel Penetration: Demonstrating consistent insurance coverage and building a robust ASC/OR customer base will be key to sustainable revenue growth.
Risks
Pulse faces classic medtech risks at this stage: regulatory delays, slower-than-expected commercial adoption, and operational strain as trials and launches scale. Cash burn will rise materially, and the company’s ability to secure a strong EP partnership is not guaranteed. Competitive responses from established ablation players and reimbursement headwinds could further challenge execution.
Forward Outlook
For Q3 and Q4 2025, Pulse guided to:
- Initial commercial revenue from the percutaneous electrode, with cadence dependent on contract structure and site conversion.
- Commencement of IDE trials for both the cardiac surgical clamp and 360 catheter systems, with patient enrollment expected to begin in the coming months.
For full-year 2025, management maintained expectations for:
- Increased R&D and operating cash use as clinical and commercial activity accelerates.
Management highlighted several factors that will influence results:
- Clinical data publication and visibility at major medical meetings.
- Progress in partnership discussions for the EP catheter platform.
Takeaways
Pulse Biosciences is at an inflection point, shifting from platform development to clinical and commercial execution in high-value markets.
- Execution on Multiple Fronts: Success depends on coordinated trial enrollment, commercial site activation, and data generation to drive adoption.
- Financial Discipline Required: Cash burn will escalate, and management must balance investment with proof points on revenue and adoption.
- Watch for Commercial and Regulatory Wins: Key milestones in IDE enrollment, revenue recognition, and partnership formation will determine near-term investor sentiment.
Conclusion
Pulse Biosciences enters a critical phase with dual IDE trials and initial commercial sales, but must now prove its differentiated NSPFA platform can scale clinically and commercially. Rising costs and execution risk are balanced by strong clinical feedback and regulatory momentum, setting up a consequential second half of 2025 for investors to monitor.
Industry Read-Through
Pulse’s progress underscores the medtech trend toward non-thermal, minimally invasive ablation modalities, with both soft tissue and cardiac applications attracting regulatory and clinical interest. Rapid procedure times and ASC/OR adoption are becoming critical differentiators, as providers seek efficiency and improved safety profiles. Incumbent ablation players may face pressure to respond with next-generation platforms, and partnership activity in electrophysiology could signal broader consolidation or collaboration trends in the space. Investors should monitor reimbursement dynamics and the pace of real-world adoption as key indicators for the sector.