PULSE BIOSCIENCES, INC. (0001625101) (Filer)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): October 7, 2026

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

On October 7, 2026, Pulse Biosciences, Inc. (the “Company”) announced that it had achieved its enrollment target of 164 evaluable patients in its NANOPULSE-AF clinical study evaluating the Company’s nPulse™ Cardiac Catheter System for the treatment of atrial fibrillation (the “Study”). The Study is a prospective, multicenter, non-randomized IDE pivotal clinical investigation designed to evaluate the safety and effectiveness of the nPulse Cardiac Catheter System in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. The Study achieved target enrollment of 164 evaluable participants across 15 clinical sites, with the first patients treated in April 2026. The primary safety and effectiveness endpoints of the Study will be assessed at 6 and 12 months post-ablation.

A copy of the press release related to the matters set forth herein is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

(d) Exhibits

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.