Pulse Biosciences filings document regulatory disclosures for a Delaware medical technology company developing nPulse nanosecond pulsed field ablation technology. Its 8-K reports cover clinical and Regulation FD disclosures for the nPulse Cardiac Catheter System, atrial fibrillation study updates, investor presentation materials, and development priorities in electrophysiology, cardiac surgery, and soft tissue ablation.
The company's SEC record also includes proxy materials on board governance, executive compensation, equity awards, and shareholder voting matters. Other filings address capital structure, common stock financing arrangements, officer appointments, compensatory arrangements, operating and financial results, ownership matters, and risk factors tied to its technology development and clinical regulatory activities.
Pulse Biosciences, Inc. reported that the U.S. Food and Drug Administration has approved its Investigational Device Exemption submission, allowing the company to start its NANOPULSE-AF clinical study for treating paroxysmal atrial fibrillation. This single-arm, multicenter, prospective trial will evaluate the primary safety and effectiveness of the company’s nPulse Cardiac Catheter System in patients with recurrent, drug‑resistant, symptomatic paroxysmal atrial fibrillation.
The study is planned to enroll up to 145 patients across as many as 30 sites, including three sites outside the United States. Pulse Biosciences disclosed this update through a press release that is filed as an exhibit and incorporated by reference.
Pulse Biosciences (PLSE) furnished an updated investor presentation as Exhibit 99.1. The deck highlights recent progress across its nPulse Vybrance Percutaneous Electrode, nPulse Cardiac Clamp, and nPulse Cardiac Catheter programs. The company may use the materials in meetings with investors and analysts.
The presentation is available on the company’s website and is treated as “furnished” under Item 7.01, not “filed,” which limits associated Exchange Act liabilities. It contains forward‑looking statements and reflects information as of November 2025.
Pulse Biosciences (PLSE) reported Q3 2025 results. Product revenue was $86 thousand. Operating expenses totaled $20.5 million, driven by research and development of $11.4 million and selling, general and administrative of $8.8 million. The company recorded a net loss of $19.4 million (basic and diluted net loss per share of $0.29).
Cash and cash equivalents were $95.2 million as of September 30, 2025, compared with $118.0 million at year‑end 2024. Net cash used in operating activities was $39.4 million for the nine months ended September 30, 2025. Financing inflows included $14.1 million from warrant exercises, $2.1 million from option exercises, and $0.6 million from the employee stock purchase plan.
The company began capitalizing inventory for the Vybrance Percutaneous Electrode System after FDA 510(k) clearance and commenced the PRECISE BTN clinical trial in September 2025 to support U.S. commercialization, targeting up to 50 patients across up to four sites, with over twenty patients treated to date. Common shares outstanding were 67,738 thousand as of September 30, 2025, and 67,767,578 as of October 31, 2025.
Pulse Biosciences (PLSE) furnished an 8-K announcing it issued a press release with financial and operational results for the quarter ended September 30, 2025. The press release is attached as Exhibit 99.1 and incorporated by reference. The company states this information is being furnished and shall not be deemed filed under the Exchange Act.
The filing reiterates the company’s common stock trades on Nasdaq under the symbol PLSE. The press release, dated November 5, 2025, provides the detailed business update and quarterly results referenced in this report.
Pulse Biosciences (PLSE) filed its definitive proxy for a virtual annual meeting on December 9, 2025 at 11:00 a.m. ET. Stockholders will vote to elect six directors, ratify Deloitte & Touche LLP as auditor for 2025, approve a non-binding “say-on-pay,” and select the frequency of future say‑on‑pay votes.
The record date is October 22, 2025. 67,757,578 shares were outstanding and entitled to vote as of that date; a majority present constitutes a quorum. The board recommends voting for all director nominees, for auditor ratification, for executive compensation, and for say‑on‑pay frequency of every three years.
The company discloses that since January 9, 2025 its Audit Committee has had two independent members, below Nasdaq’s three‑member requirement; the board is evaluating candidates and intends to appoint a third member within the permitted cure period. Robert W. Duggan beneficially owns 72.1% of common stock as of October 22, 2025. Auditor fees billed by Deloitte for 2024 totaled $1,041,000, including audit, audit‑related, tax, and other fees.
Pulse Biosciences (PLSE) announced first patient enrollment in its NANOCLAMP AF clinical trial, a single-arm, prospective multicenter study evaluating the safety and effectiveness of the nPulse Cardiac Surgical System for treating atrial fibrillation during concomitant surgical procedures.
The company reported that the first procedure was successfully completed at St. Helena Hospital in St. Helena, California. A related press release was furnished as Exhibit 99.1. This update reflects early clinical progress for the cardiac surgical application of the company’s pulsed-field technology.
Pulse Biosciences reported late-breaking first‑in‑human feasibility results for its nPulse™ Cardiac Surgical System. The study has treated 44 patients across three investigators, with an initial cohort of 24 patients evaluated by electroanatomical mapping about ~3 months after ablation. Key clinical outcomes: posterior box isolations were acutely successful in 100% of cases in the high‑dose cohort; pulmonary vein isolation (PVI) success per vein at ~3 months was 94% (63 of 67); average total ablation time was 50 seconds with an average of 13 applications. No esophageal or phrenic nerve damage and no ablation‑related severe or major adverse events were reported. The company attached a press release as Exhibit 99.1 describing presentation of these results at the European Association for Cardio‑Thoracic Surgery annual meeting.
Pulse Biosciences insider transactions on 10/02/2025: The company's Chief Commercial Officer exercised 4,600 stock options at an exercise price of $1.53 and simultaneously sold those 4,600 shares at a weighted average price of $18.53 per share under a Rule 10b5-1 trading plan. After these transactions the reporting person beneficially owned 43,298 shares of common stock and held options to acquire 425,000 shares that expire on 09/23/2032. The Form 4 discloses the 10b5-1 plan adoption date of 05/14/2025 and notes the option grant date of 09/23/2022 with a four-year vesting schedule.
PULSE BIOSCIENCES reported director compensation and a leadership update. The company's board ratified awards granted August 9, 2024, comprising three grants of 200,000 option shares each for a total of 600,000 options. The filing notes 2,753,901 broker non-votes on an item reported as "Against" and includes an entry of "N/A" for related fields. It also states that Mr. LaViolette became President and Chief Executive Officer on January 9, 2025 and remains an ex officio member of the Strategic Advisory Committee.
Pulse Biosciences (PLSE) insider transactions by Kevin Patrick Danahy. The reporting person, the company's Chief Commercial Officer, executed sales and option-related transactions on September 18–19, 2025 under a Rule 10b5-1 trading plan adopted May 14, 2025. On 9/18/2025 he acquired 20,000 shares at $1.53 via option exercise and sold 20,000 shares at a weighted average price of $18.49, leaving 43,298 shares beneficially owned. On 9/19/2025 he exercised 400 shares at $1.53 and sold 400 shares at $18.48; post-transactions his direct beneficial ownership of common stock reported in Table I was 43,298 shares. Options granted 9/23/2022 covering 450,000 shares vest 25% annually; 20,400 options were exercised in these transactions.