Pulse Biosciences (PLSE) Announces First Patients Enrolled in PRECISE BTN Study

Pulse Biosciences announced the enrollment of the first patients in a multicenter, IRB-approved study (PRECISE) evaluating its nsPFA™ Percutaneous Electrode System to treat benign thyroid nodules (BTNs).

Rhea-AI Filing Summary

Pulse Biosciences announced the enrollment of the first patients in a multicenter, IRB-approved study (PRECISE) evaluating its nsPFA™ Percutaneous Electrode System to treat benign thyroid nodules (BTNs). The filing states the press release dated September 2, 2025, confirms successful initial procedures and that the release is attached as Exhibit 99.1.

The company describes the study as multicenter and IRB-approved, indicating clinical development progress for its proprietary nsPFA technology in a new indication. No financial results, timelines for completion, patient numbers beyond “first patients,” or efficacy/safety data are included in the filing.

Positive

• First patient enrollments in a multicenter, IRB-approved study for the nsPFA Percutaneous Electrode System
• Clinical program advancement into active procedures for a new indication (benign thyroid nodules)
• Press release attached as Exhibit 99.1 ensures public disclosure and regulatory filing compliance

Negative

• None.

Insights

Clinical Development Specialist

TL;DR: First patient enrollments in an IRB-approved multicenter study mark an important early clinical milestone for nsPFA in benign thyroid nodules.

The filing confirms initial procedures in the PRECISE BTN study using Pulse Biosciences' nsPFA Percutaneous Electrode System. Early enrollments in a multicenter, IRB-approved protocol show the program has moved from planning to active clinical execution, which can de-risk development milestones if subsequent recruitment and safety endpoints proceed as expected. The filing contains no efficacy, safety, enrollment targets, or timeline details, so material impact on commercial prospects cannot be assessed from this disclosure alone.

Corporate Governance Expert

TL;DR: The 8-K provides a routine disclosure of a clinical milestone without operational or financial specifics.

The report complies with Form 8-K Item 8.01 by attaching a press release as Exhibit 99.1. It documents a corporate event (first patient procedures) but omits specifics such as number of patients, sites, protocols, or projected timelines. From a governance and disclosure perspective, the company has met short-form reporting requirements; further material updates would depend on future substantive data or program decisions.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Pulse Biosciences (PLSE) announce in this 8-K?

The company announced first patients were enrolled and initial procedures performed in a multicenter, IRB-approved PRECISE study of its nsPFA Percutaneous Electrode System for benign thyroid nodules.

Does the filing include clinical results or patient counts?

No. The 8-K states only that the first patients were enrolled and initial procedures occurred; it does not provide efficacy, safety data, or specific patient numbers.

Is there a press release attached to the filing?

Yes. The press release dated September 2, 2025 is attached as Exhibit 99.1 and incorporated by reference.

Does the filing disclose financial impact or timelines for the study?

No. The filing does not include any financial figures, study timelines, enrollment targets, or projected milestones.

What device is being studied in the PRECISE BTN study?

Pulse Biosciences' proprietary nsPFA™ Percutaneous Electrode System is the device used in the study.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 09/02/2025 - 09:03 AM EDT Learn about SEC filing dates

false 0001625101 0001625101 2025-09-02 2025-09-02

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): September 2, 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 September 2, 2025, Pulse Biosciences, Inc. issued a press release announcing the first patients enrolled in its multicenter IRB-approved study using its proprietary nsPFA^™ Percutaneous Electrode System for the treatment of benign thyroid nodules (BTNs).

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 September 2, 2025 - Pulse Biosciences Announces First Successful Procedures in PRECISE Benign Thyroid Nodule (BTN) Study
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: September 2, 2025	By:	/s/ Paul A. LaViolette
		Paul LaViolette
		Chief Executive Officer (Principal Executive Officer)