[8-K] PULSE BIOSCIENCES, INC. Reports Material Event

Rhea-AI Filing Summary

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.

Insights

Medical device and regulatory specialist

FDA IDE approval lets Pulse Biosciences begin a key atrial fibrillation trial.

The company received U.S. FDA approval of its Investigational Device Exemption submission, which permits initiation of the NANOPULSE-AF clinical study. This trial will test the nPulse Cardiac Catheter System in patients with recurrent, drug‑resistant, symptomatic paroxysmal atrial fibrillation, focusing on primary safety and effectiveness.

The study is structured as a single-arm, multicenter, prospective trial, with plans for up to 145 patients at as many as 30 sites, including three outside the United States. This design can generate real‑world clinical data across diverse centers, but all outcomes will depend on future enrollment, follow‑up, and measured endpoints described in the protocol.

The press release attached as Exhibit 99.1 is incorporated by reference, indicating that further details on endpoints, timelines, and procedural aspects are contained there. Subsequent disclosures as the NANOPULSE-AF study progresses will clarify how the device performs against its safety and effectiveness goals.

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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): December 18, 2025

Pulse Biosciences, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware	001-37744	46-5696597
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
601 Brickell Key Drive, Suite 1080
Miami, Florida 33131
(Address of Principal Executive Offices) (Zip Code)
510-906-4600
(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, If Changed Since Last Report)

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:

Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
Common stock, $0.001 par value per share	PLSE	The Nasdaq Stock Market

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. ☐

Item 8.01 Other Events.

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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Press Release issued by Pulse Biosciences, Inc. dated December 18, 2025 - Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

	PULSE BIOSCIENCES, INC.
Date: December 18, 2025	By:	/s/ Paul A. LaViolette
		Paul LaViolette
		Chief Executive Officer (Principal Executive Officer)