Pulse Biosciences (NASDAQ:PLSE) executives highlighted recent clinical results for the company’s nanosecond pulsed field ablation (nsPFA) technology, outlined plans for a U.S. investigational device exemption (IDE) study in atrial fibrillation (AF), and discussed capital allocation priorities during a conversation with Oppenheimer Senior Medical Device Analyst Suraj Kalia.
European feasibility data: high rhythm control rates
CEO Paul LaViolette said the company was “very pleased” with the European feasibility study (EFS) results for its NS 360 catheter that were presented at AF Symposium. He cited the following outcomes:
- 100% rhythm control at six months
- 96% rhythm control at 12 months
- 90% freedom from all atrial arrhythmias at 12 months, which he said included event and intermediate monitoring
Why management believes nsPFA is different
In discussing what may be driving the outcomes, LaViolette emphasized that Pulse’s approach is not simply a different waveform but “an entirely different type of PFA” compared to systems delivering microsecond pulsed field ablation. He argued that Pulse’s energy delivery and catheter design enable a “one-shot solution” that lays down a larger, contiguous ablation footprint in about five seconds.
He contrasted this with other approaches that, in his view, still require multiple applications and rotations—“connecting dots” around the pulmonary veins—which can leave gaps that later reconnect and contribute to long-term failures.
LaViolette also pushed back on the notion that better outcomes are due to delivering more total energy. He said Pulse’s nsPFA delivers lower cumulative energy than microsecond PFA systems—“probably 75% or greater less cumulative energy”—because the pulses are extremely short in duration. While amplitude may be higher, he said the overall energy remains low and is delivered efficiently to create electroporation.
That efficiency, he added, reduces the burden on the catheter and allows for a more flexible design with thin-wire electrodes, which in turn supports what he described as a novel catheter configuration and lesion-making footprint that competitors cannot replicate.
Mapping integration and workflow expectations
Kalia asked about mapping integration, noting comments that mapping was not ideally integrated in the EFS study. LaViolette said Pulse used “base case integration” across multiple mapping systems in the European cases, but more recently has demonstrated a higher degree of integration with both Abbott’s EnSite system and Johnson & Johnson’s CARTO system during live cases at AF Symposium and Heart Rhythm Society meetings.
For the U.S. IDE, he said the company expects to have the higher level of integration available, while physicians will still choose their mapping platforms. He suggested improved integration could enhance procedure efficiency by increasing confidence in catheter placement and potentially reducing the number of lesions delivered per case. While he said outcomes improvements are “to be determined,” he noted it is “difficult to improve upon 96%.”
LaViolette also described an internal view of potential workflow efficiency, suggesting the procedure could require as few as two lesions per vein—roughly eight lesions per case—plus additional lesions as needed, potentially around 10 lesions per case. With each lesion lasting about five seconds, he said the approach could create speed and workflow advantages.
U.S. IDE study: timing and enrollment expectations
LaViolette said Pulse received IDE approval in late December and began work with sites in early January, but had not yet enrolled patients. The company expects first patient in and commencement of enrollment “in a few months,” which he framed as early in Q2.
He described the IDE as a 155-patient, single-arm study targeting paroxysmal AF patients entering their first interventional therapy. LaViolette said the enrollment criteria are “relatively clean,” enabling higher patient flow per center than is typical in some other cardiovascular trials. He expects a wave of sites to open in the first month and suggested sites could schedule multiple study cases on a single day to improve efficiency.
Pulse has “conveyed consistently” that it expects to start the study in Q2 and finish in Q4, while aiming to improve on that timeline. He also said investigator interest is “extremely high,” which he believes bodes well for enrollment.
Partnering strategy and capital allocation
On commercialization strategy, LaViolette said the electrophysiology (EP) market is “extremely attractive,” citing large size and strong procedure growth. He said PFA has disrupted the traditional relationship between mapping and ablation systems, with ablation increasingly driving technology choice. Given that Pulse’s nsPFA is “uniquely held” by the company, he said management expects it can be a leading energy for years and views the company as a “pure play disruptive next generation energy” platform.
However, he said building a full commercial organization and launching independently would be “risky, capital intensive and burdensome,” leading Pulse to decide it will pursue partnering. He did not speculate on the eventual structure, and he declined to comment on whether a distribution arrangement versus an outright sale is more likely, saying the company will “do the right thing for our shareholders” and is focused on execution and delivering milestones to increase its attractiveness to potential partners.
LaViolette also addressed resource prioritization between EP and the company’s surgical AF “nano-clamp” program. He said the company is not “downshifting” surgical AF but is “upshifting EP” due to the market opportunity and the potential returns. He said Pulse remains committed to completing the surgical clamp IDE with no change to enrollment plans, but will defer other investments in that franchise—such as next-generation product development or additional feasibility work—while reallocating resources to EP.
CFO Jon Skinner said Pulse ended 2025 with $80 million in cash. He noted the company has a $60 million at-the-market (ATM) facility and a $200 million shelf registration to opportunistically raise capital, and also pointed to partnering as a potential additional source of funding. Skinner said the company has enough cash to reach clinical milestones in 2026 across the two IDE programs.
On spending, Skinner said Pulse had a $15 million cash burn in Q4 and expects burn to increase during 2026, largely tied to the two IDEs and increased R&D spend. He said the highest burn rate should occur around mid-year as both studies reach peak enrollment velocity, and he expects the company to spend more capital in 2026 than in 2025.
About Pulse Biosciences (NASDAQ:PLSE)
Pulse Biosciences, Inc is a clinical-stage bioelectric medicine company that develops and commercializes medical devices based on its proprietary Tissue NanoPoration (TNP) platform. The company’s core technology, NanoPulse Stimulation (NPS), delivers ultrashort, high-voltage electric pulses to targeted tissue, triggering cellular responses without the thermal damage associated with traditional energy-based devices. Pulse Biosciences focuses on applications in dermatology and aesthetic medicine, where controlled ablation of unwanted lesions is critical.
The company’s flagship product, the CellFX® System, is designed to treat a range of benign and malignant skin lesions, including seborrheic keratosis, non-melanoma skin cancers, and various epidermal and dermal lesions.
