Pulse Biosciences Q2 Earnings Call Highlights

Pulse Biosciences accelerated its atrial fibrillation program: The U.S. NANOPULSE-AF pivotal trial surpassed 82 evaluable patients across 12 sites and is now expected to complete enrollment in early October, ahead of schedule. The enrollment target was increased to 164 patients, with broader eligibility criteria. European feasibility data for the nPulse cardiac catheter showed 96% freedom from atrial fibrillation at one year among 53 patients and a 1.7% serious adverse-event rate across 177 patients. Pulse plans to pursue a CE mark submission in the second half of 2026, potentially leading to approval around mid-2027.

Higher clinical spending widened losses: Second-quarter revenue was $434,000, while the GAAP net loss increased to $24.7 million from $19.2 million a year earlier. The company ended June with $101.6 million in cash after raising $57.5 million through its at-the-market program, extending its runway for planned clinical and regulatory milestones.

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 Pulse said its U.S. NANOPULSE-AF pivotal investigational device exemption, or IDE, study had enrolled more than 82 evaluable patients, excluding roll-in patients, since enrollment began in April. The company has activated 12 investigational sites and expects to complete enrollment in early October, three months earlier than its original target. 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-Meie...