Pulse Biosciences NASDAQ: PLSE said it is sharpening its focus on its nanosecond pulsed field ablation platform for atrial fibrillation after reporting first-quarter 2026 results and highlighting new clinical data from its cardiac catheter program.
On the company’s earnings call, Co-Chairman and Chief Executive Officer Paul LaViolette described the quarter as an “inflection point,” citing updated feasibility data, a strategic shift toward the company’s nPulse cardiac catheter for atrial fibrillation, and the start of enrollment in its U.S. pivotal study.
The company’s technology is based on nanosecond pulsed field ablation, or nsPFA, which LaViolette said delivers energy in billionths of a second. He said the approach is designed to create deeper and more durable lesions while avoiding measurable temperature rise and minimizing neuromuscular stimulation.
Cardiac Catheter Program Becomes Top Priority
Pulse Biosciences is prioritizing its nPulse cardiac catheter system, which is being developed for ablation of paroxysmal atrial fibrillation. LaViolette said the device is designed as a 360-degree circular catheter intended to provide “single-shot” pulmonary vein ablation with a five-second energy application per target location.
The company said it is shifting more resources to the catheter program, including clinical and research and development support. LaViolette said the realignment is intended to accelerate the company’s pivotal IDE study, additional clinical studies and next-generation catheter development.
As part of that effort, Dr. David Kenigsberg has moved into a full-time chief medical officer role, while Liane Teplitsky has joined as chief operating officer. LaViolette said Teplitsky will oversee clinical, regulatory, quality and commercial functions, with an emphasis on the cardiac catheter program.
Updated Feasibility Data Show Strong Procedure Outcomes
LaViolette highlighted updated data presented by Dr. Vivek Reddy at the Heart Rhythm 2026 meeting. The data came from the company’s first-in-human European feasibility study of the nPulse cardiac catheter system and included six-month follow-up on 95 subjects and 12-month follow-up on 63 subjects in the five-second ablation cohort.
According to the company, key findings included:
- 100% procedure success by 24-hour Holter among evaluable patients at six months, with 95 of 95 patients meeting the endpoint.
- 96% procedure success by 24-hour Holter among evaluable patients at one year.
- 90% Kaplan-Meier estimated freedom from recurrent atrial fibrillation, atrial flutter or atrial tachycardia at one year.
- A primary safety endpoint serious adverse event rate of 1.7% across 177 treated subjects.
LaViolette said the results were achieved without antiarrhythmic drugs and showed consistency across operators and sites. He also said procedural data improved from an earlier presentation at the AF Symposium, including lower atrial dwell time, fewer average applications, and lower procedure and fluoroscopy times.
U.S. Pivotal Trial Enrollment Begins
Pulse Biosciences has begun enrolling patients in its NANOPULSE-AF study, a prospective, multicenter IDE pivotal clinical trial evaluating the nPulse cardiac catheter system for recurrent, drug-resistant symptomatic paroxysmal atrial fibrillation.
The company said the first seven patients were treated in one day at St. Bernards Medical Center in Jonesboro, Arkansas, under Dr. Devi Nair, principal investigator of the Arrhythmia Research Group. LaViolette said Dr. Nair had not previously used the nPulse catheter, and he pointed to the initial cases as evidence of the system’s usability and learning curve.
Pulse Biosciences now expects to complete enrollment in the study in early fourth-quarter 2026, tightening its prior guidance from completion by the end of 2026. LaViolette said the company is also using a Bayesian analysis that will incorporate 12-month outcomes for a subset of patients and six-month outcomes for the remainder, which he said should shorten follow-up time compared with traditional methods.
In Europe, the company expects to use its feasibility study data to finalize a CE mark submission in the second half of 2026, with potential CE mark approval in mid-2027. LaViolette also said discussions with potential strategic partners are ongoing, including mapping providers and electrophysiology market leaders.
During the question-and-answer session, LaViolette said the U.S. pivotal protocol allows up to 30 sites, though the company does not expect to use all of them. He said individual sites are generally capped at about 15% to 20% of total enrollment, or in the low 20s of patients per site. He also said the study protocol calls for general anesthesia, though conscious sedation could be viable over the longer term.
Surgical Clamp and Vybrance Programs Continue
Pulse Biosciences is continuing its NANOCLAMP AF pivotal study for the nPulse cardiac clamp, though LaViolette said the company has moderated near-term development in cardiac surgery as it prioritizes the catheter program. The company now expects to complete enrollment in the surgical clamp IDE study by the end of the first half of 2027.
The surgical clamp study is designed to enroll 136 patients at approximately 20 sites, including two international locations. In Europe, investigators have treated more than 60 patients in a cardiac surgery feasibility study, now expanded to six clinical sites. The company said 34 patients underwent electroanatomical mapping about three months after ablation, with a 94% pulmonary vein isolation success rate and average ablation times of 41 seconds per patient.
For the nPulse Vybrance percutaneous electrode system, which is being evaluated for soft tissue ablation including benign thyroid nodules, the company reported about $400,000 in first-quarter revenue from systems and electrodes. LaViolette said the company is operating the program at an intentionally limited scale while focusing on clinical data, reimbursement and selected hospital accounts.
The PRECISE-BTN benign thyroid nodule study has completed enrollment of its first 50 patients and has been expanded to 100 patients. LaViolette also said the company’s collaboration with the University of Texas MD Anderson Cancer Center has begun first-patient enrollment in a feasibility study for papillary thyroid microcarcinoma, with enrollment expected to complete by the end of 2026.
First-Quarter Financial Results
Chief Financial Officer Jon Skinner said first-quarter revenue totaled $401,000, while cost of product revenue was $370,000. Total GAAP costs and expenses were $19.6 million, up from $18 million in the prior-year period, with the increase primarily driven by investment in clinical programs and partly offset by lower stock-based compensation expense.
Non-GAAP costs and expenses rose to $17.4 million from $12.7 million a year earlier, reflecting increased clinical trial, product development and market development activity. GAAP net loss was $18.6 million, compared with $16.8 million in the prior-year period. Non-GAAP net loss was $16.4 million, compared with $11.4 million a year earlier.
Pulse Biosciences ended the quarter with $68.3 million in cash and cash equivalents, down from $80.7 million at the end of 2025. Cash used in operating activities was $14.6 million. Skinner said the company has a $200 million shelf registration available and an at-the-market program with about $60 million of availability as of March 31, 2026.
Skinner said cash usage is aligned with spending on pivotal trials, device scaling and market development, and that the company believes it has sufficient liquidity to fund operations and clinical programs through major 2026 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.
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