Pulse Biosciences Inc filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

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Date of Report (Date of Earliest Event Reported): December 18, 2025

 

 

 

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 December 18, 2025, Pulse Biosciences, Inc. (the “Company”) issued a press release announcing the approval of its Investigational Device Exemption (IDE) submission by the U.S. Food and Drug Administration, allowing the Company to proceed with the initiation of its NANOPULSE-AF clinical study for the treatment of paroxysmal atrial fibrillation. The single-arm, multicenter, prospective, NANOPULSE-AF study is designed to demonstrate primary safety and effectiveness of the nPulse Cardiac Catheter System for the treatment of recurrent, drug-resistant, symptomatic, paroxysmal atrial fibrillation. Up to 30 sites, including three sites outside the United States, are planned to enroll up to 145 patients.

 

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

 

 

 

 

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.