Pulse Biosciences (NASDAQ:PLSE) reported second-quarter revenue of $434,000 as it accelerated clinical development of its nanosecond pulsed field ablation, or nsPFA, technology, particularly for atrial fibrillation treatment.
Chief Executive Officer and Co-Chairman Paul LaViolette said the company’s strategic focus remains its nPulse Cardiac Catheter System for atrial fibrillation, while it continues development of its surgical clamp and thyroid-focused Vybrance system. The company added that it has more than 250 issued patents worldwide supporting its nsPFA technology.
AFib pivotal trial advances ahead of schedule
The company increased the study’s enrollment target to 164 patients from 145 patients. The protocol change also broadens eligibility to include patients who have failed any one of four antiarrhythmic drug classes, rather than maintaining prior restrictions. LaViolette said the change was intended to better reflect contemporary clinical practice and expand the pool of qualifying patients.
Management said some sites have reached enrollment caps, which limit a single site to no more than 15% of total study enrollment. The company expects to continue activating additional sites while it works toward completing enrollment.
LaViolette said physicians using the system have reported rapid learning curves and efficient workflows. Multiple sites have performed five to seven cases in a day, while some physicians completed initial cases with ablation times of seven to eight minutes or less, according to the company. He said the study has used Abbott’s EnSite mapping system for all cases to date, though the protocol permits use of other commercial mapping systems.
During the question-and-answer session, LaViolette said the pivotal study’s efficacy endpoint combines six- and 12-month patient follow-up data. He described 12-month follow-up among earlier-enrolled patients as the longer timeline consideration for the program.
European feasibility data and regulatory plans
Pulse reiterated results from its European nPulse Cardiac Catheter feasibility study presented at the Heart Rhythm Society meeting. In the five-second ablation cohort, the company reported 100% freedom from atrial fibrillation at six months by 24-hour Holter monitoring among 95 patients, and 96% at one year among 53 patients.
The company also reported 90% Kaplan-Meier estimated freedom from recurrent atrial fibrillation, flutter or tachycardia at one year, with a serious adverse-event rate of 1.7% across 177 patients. LaViolette said the results support a planned CE mark submission in the second half of 2026, with potential approval around the middle of 2027.
Pulse said it continues discussions with potential commercial partners, focusing on established electrophysiology companies with mapping technologies. The company did not identify prospective partners or provide a timetable for a partnership announcement.
Surgical clamp and thyroid programs continue
Pulse’s surgical clamp program also remains in clinical development. Its European feasibility study has treated more than 70 patients at six sites. The company said three-month electroanatomical mapping results in 34 patients showed 94% pulmonary vein isolation success, unchanged from an October 2025 readout, and average total ablation time of 41 seconds per patient.
The company expects to submit the surgical clamp for CE mark review before the end of 2026. Its U.S. NANOCLAMP AF pivotal study is targeting 136 patients across 20 centers, including three international centers, with enrollment expected to conclude by the end of the first half of 2027.
For its Vybrance percutaneous electrode system for symptomatic benign thyroid nodules, disposable sales rose sequentially to $434,000 in the second quarter from $400,000 in the first quarter. Pulse said it entered a partnership with the Clayman Thyroid Center in Tampa, Florida, to generate registry data and conduct thyroid-disease study protocols.
The company expects its PRECISE-BTN benign thyroid nodule study to complete enrollment in August after expanding the trial to 100 patients from 50. Pulse also said a first-in-human feasibility study of nsPFA for papillary thyroid microcarcinoma, conducted through a research collaboration with The University of Texas MD Anderson Cancer Center, is approximately half enrolled and is expected to complete enrollment by year-end.
Loss widens as clinical spending rises
Chief Financial Officer Jon Skinner said second-quarter GAAP costs and expenses increased $5.4 million year over year to $25.7 million, primarily due to higher clinical-program spending and compensation-related expenses. Non-GAAP costs and expenses rose to $20.5 million from $14.8 million a year earlier.
Pulse reported a GAAP net loss of $24.7 million for the second quarter, compared with a $19.2 million loss in the prior-year period. Its non-GAAP net loss was $19.4 million, compared with $13.7 million a year earlier. Skinner said the company expects quarterly non-GAAP operating expenses to remain in a similar range as it funds clinical programs.
- Cash and cash equivalents totaled $101.6 million as of June 30, up from $68.3 million at March 31.
- Cash used in operating activities was $18.7 million during the quarter, compared with $14.6 million in the first quarter.
- The company raised $57.5 million in net proceeds through its at-the-market program since May, including $46.8 million raised during the second quarter.
- Pulse established a new $75 million at-the-market facility and received $1.8 million in gross proceeds from warrant exercises in July.
Management said the financing extends its operating runway through planned clinical and regulatory milestones, while the company continues to prioritize investment in its cardiac catheter program.
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.
