Pulse Biosciences (NASDAQ:PLSE) used its fourth-quarter and full-year 2025 earnings call to outline progress across its nanosecond pulsed field ablation (nsPFA) platform, including advancing two atrial fibrillation (AF) programs toward pivotal-stage development and continuing a controlled early commercial rollout of its Vibrance soft-tissue ablation system.
2025 milestones and 2026 priorities
Chief Executive Officer Paul LaViolette said the company’s top objective remains advancing its nsPFA platform into late-stage clinical development for AF in both electrophysiology and cardiac surgery. He added that Pulse is also exploring the feasibility of launching its soft tissue ablation system ahead of a specific therapeutic claim, using Category III reimbursement.
Looking to 2026, LaViolette said Pulse plans to execute on clinical and market development priorities across three areas:
- Electrophysiology: commence and complete enrollment in the nPulse Cardiac Catheter IDE study in 2026, while continuing European treatments to support a CE Mark submission.
- Cardiac surgery: expand and accelerate IDE site activation and complete enrollment in 2026, while continuing European feasibility activity and preparing for a CE Mark submission by the end of 2026.
- Soft tissue ablation: complete enrollment in the PRECISE benign thyroid nodule study, deepen utilization in key accounts, and continue demonstrating clinical advantages of Vibrance nsPFA.
Electrophysiology: nPulse “one-shot” catheter and European outcomes
LaViolette described Pulse’s nPulse cardiac catheter as a “one-shot” solution intended to deliver circumferential pulmonary vein isolation (PVI) with a single five-second energy burst. He said the rapid delivery results in minimal cumulative energy to tissue, with “no measurable tissue temperature elevation” and “low neuromuscular stimulation,” which management believes supports shorter procedure times and potentially reduced anesthesia needs.
On clinical data, LaViolette highlighted outcomes presented at the AF Symposium on Feb. 5, 2026 from European studies. He said the lead investigator reported:
- 100% procedural success or freedom from AF at six months (for evaluable patients, as described on the call)
- 96% procedural success at one year (for evaluable patients)
- 90% freedom from atrial arrhythmia at 12 months on a Kaplan-Meier curve
Management also emphasized procedural efficiency, saying physicians are “routinely” finishing ablations in about 6–8 minutes or faster. LaViolette contrasted nsPFA with microsecond PFA by noting nsPFA’s fast delivery allows physicians to proceed without delays between dose deliveries, while microsecond PFA requires prolonged recharging times.
In Q&A, LaViolette said reception to the AF Symposium data was “exceptionally positive,” and reiterated plans to start IDE enrollment in the next 1–2 months and complete enrollment in 2026. He cited physician interest, workflow, and protocol design as key drivers of enrollment velocity.
Mapping partnerships and integration plans
LaViolette said Pulse is actively pursuing strategic partnerships with mapping providers and electrophysiology market leaders to accelerate global commercialization, describing a potential “win-win” from integrating nsPFA with an established mapping ecosystem.
Responding to a question about mapping integration, LaViolette said the company expects improved software integration in the IDE study. He referenced a live case from Prague shown at the AF Symposium that demonstrated more complete integration and catheter rendering compared with earlier feasibility cases.
He also discussed a next-generation nPulse concept that would combine a “regional footprint” device with a focal or larger-footprint focal capability in the same product, allowing PVI and left atrial ablation without exchanging devices, but he said it remains in development and the company is not providing timelines.
Cardiac surgery: NanoClamp-AF pivotal study
Pulse’s nPulse Cardiac Clamp is in an FDA-approved IDE pivotal study, NanoClamp-AF, which management described as the first pivotal IDE study for a surgical device that delivers PFA. LaViolette said the device is designed to deliver fast, contiguous, transmural ablation lines during open-heart procedures for patients with AF.
He said enrollment is underway and expected to conclude during 2026. The company plans to enroll 136 patients across about 20 sites, including two international locations. Management also pointed to European experience presented at EACTS, emphasizing fast ablation times and reproducible workflow, and said the program remains on track for a CE Mark filing by the end of 2026.
Vibrance rollout, thyroid studies, and MD Anderson collaboration
For soft tissue ablation, LaViolette said the nPulse Vibrance percutaneous electrode system is initially being used to treat symptomatic benign thyroid nodules. He cited 250,000 new annual U.S. diagnoses and said this corresponds to 150,000 total or partial thyroid removal surgeries each year, which Pulse views as an opportunity for a minimally invasive alternative.
Pulse reported fourth-quarter revenue of $264,000 from Vibrance systems and electrodes, up from $86,000 in the third quarter. LaViolette said the company is taking a disciplined approach in a limited number of centers, monitoring procedural volumes, outcomes, reimbursement, and business factors. In Q&A, he said the product remains in “market development mode,” with an emphasis on building a foundation around data quality and reimbursement before pushing broader commercialization.
On the PRECISE benign thyroid nodule study, management said enrollment of 50 patients is expected to complete in the next few months, with plans to expand to 100 patients over the ensuing two quarters. LaViolette also noted that data from Dr. Stefanos Viasia in Naples, Italy was accepted for a podium presentation at NASIT in March.
Pulse also announced a research collaboration with the University of Texas MD Anderson Cancer Center to evaluate nsPFA for benign and malignant thyroid tumors. LaViolette said an FDA-approved IDE study is evaluating nsPFA for papillary thyroid microcarcinoma, with enrollment expected to complete by year-end 2026, and that preclinical work is underway in anaplastic thyroid carcinoma.
Chief Financial Officer Jon Skinner said Pulse ended 2025 with $80.7 million in cash and cash equivalents, down from $118 million at the end of 2024. Fourth-quarter cash used in operating activities was $14.8 million. Skinner also noted the company filed a $200 million shelf registration, which he said provides flexibility to support the balance sheet as the company pursues upcoming clinical milestones.
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.
