Earnings

Pulse Expands Nanopulse-AF Target After Protocol Change

The Tip Desk · August 6, 2026 · 3 min read

Cash and cash equivalents stood at $101.6 million as of June 30, 2026, after $46.8 million of ATM net proceeds in the quarter.

Pulse Biosciences (PLSE) surpassed the halfway point of enrollment in NANOPULSE-AF, its U.S. IDE pivotal trial of the nPulse Cardiac Catheter System, with more than 82 evaluable patients after the first patients were treated in early April. The company reiterated an enrollment-completion target of early fourth quarter 2026, three months earlier than the original timeline.

The Hayward, California, bioelectric medicine company also amended the trial protocol to drop prior restrictions on the class of anti-arrhythmic drug failure required for qualification. Patients on all four classes of anti-arrhythmic drugs now qualify, reflecting real-world patient management. The change increased the total evaluable patient target by 19 patients to 164 and expanded the pool of qualifying patients, supporting the early fourth-quarter completion expectation. Investigational sites now total 12.

Chief Executive Paul LaViolette said the catheter’s ease of use, workflow integration and demonstrated safety and durability outcomes were driving rapid progress. The company continued to progress toward a CE Mark submission in the second half of 2026, supported by European feasibility data at six months of follow-up, with potential approval anticipated by the middle of 2027.

Surgical atrial fibrillation work advanced in parallel. The first-in-human European feasibility study for the nPulse Cardiac Surgical System had treated over 70 patients to date across six sites, versus over 60 patients across three sites reported in the prior quarter. NANOCLAMP-AF, the U.S. IDE pivotal study for concomitant surgical ablation, remained on a path to complete enrollment by the end of the first half of 2027. The company remains on schedule to file for CE Mark for the surgical system before the end of 2026, with potential approval anticipated by the middle of 2027.

Soft tissue ablation generated $434 thousand of second-quarter revenue, sequential growth over the first quarter’s $0.4 million of nPulse Vybrance capital and disposables sales. Total revenue for the three months ended June 30, 2026, was $0.4 million as the company remained in a controlled commercial launch. PRECISE-Benign Thyroid Nodule enrollment was expected to complete within the month after expansion from a 50-patient design to 100 patients, with trial completion across three sites projected in under one year. A first-in-human feasibility study of nsPFA for papillary thyroid microcarcinoma with MD Anderson Cancer Center was approximately half-enrolled, with completion expected by year-end 2026. The company also announced a partnership with the Clayman Thyroid Center in Tampa to demonstrate Vybrance therapy for symptomatic benign thyroid nodules.

GAAP costs and expenses for the three months ended June 30, 2026, were $25.7 million, an increase of $5.4 million from $20.3 million a year earlier, which was attributed primarily to increased investment in clinical programs and compensation-related spending. GAAP net loss was $24.7 million, or $0.36 a share, compared with $19.2 million, or $0.28 a share, a year earlier. Non-GAAP net loss was $19.4 million. Research and development expense was $17.0 million. Selling, general and administrative expense was $8.5 million.

Cash and cash equivalents totaled $101.6 million as of June 30, 2026, compared with $68.3 million as of March 31, 2026. The sequential increase of $33.3 million reflected net proceeds raised under the company’s at-the-market program during the quarter. Cash used in operating activities in the second quarter of 2026 totaled $18.7 million, compared with $14.6 million used in the first quarter.

During the quarter, the company raised $46.8 million in net proceeds through the ATM, including approximately $13 million from insiders and $33.8 million from outside investors. Subsequent to the close of the quarter, it raised an additional $10.7 million in net proceeds through the ATM and $1.8 million in gross proceeds from warrant exercises. It has since put a new $75 million ATM facility in place and continues to maintain an effective shelf registration statement for up to an additional $125 million, providing financing flexibility through the key clinical and regulatory milestones ahead.

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