PLSE announces first enrollment in NANOCLAMP AF surgical study

Rhea-AI Filing Summary

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.

Insights

Medtech clinical/regulatory analyst

Early clinical milestone; value hinges on future outcomes.

Pulse Biosciences reported first-patient enrollment in NANOCLAMP AF, a single-arm, prospective multicenter study of its nPulse Cardiac Surgical System for atrial fibrillation during concomitant surgeries. First procedures demonstrate operational readiness across sites and initiate data collection on safety and effectiveness.

As a single-arm study, results will rely on predefined endpoints and historical or literature comparators rather than a randomized control. Outcomes and any subsequent regulatory interactions will determine commercial relevance.

Key items include procedural success rates, safety events, and effectiveness measures tied to atrial fibrillation treatment. Subsequent filings may provide enrollment progress and endpoint readouts.

false 0001625101 0001625101 2025-10-24 2025-10-24

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 24, 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 October 24, 2025, Pulse Biosciences, Inc. (the “Company”) issued a press release announcing the enrollment of the first patient in its NANOCLAMP AF clinical trial, a single-arm, prospective multicenter study designed to demonstrate the safety and effectiveness of the Company's nPulse™ Cardiac Surgical System for the treatment of atrial fibrillation in concomitant surgical procedures.  The successful first procedure was completed at St. Helena Hospital in St. Helena, California.  

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 October 24, 2025 - Pulse Biosciences Announces First Enrollment in the NANOCLAMP AF 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: October 24, 2025	By:	/s/ Paul A. LaViolette
		Paul LaViolette
		Chief Executive Officer (Principal Executive Officer)

FAQ

What did Pulse Biosciences (PLSE) disclose in the 8-K?

The company announced the first patient enrollment in the NANOCLAMP AF clinical trial and noted a successful first procedure.

What is the NANOCLAMP AF study design for PLSE?

It is a single-arm, prospective multicenter study evaluating safety and effectiveness.

Which device is being evaluated in the NANOCLAMP AF study by PLSE?

The nPulse Cardiac Surgical System for the treatment of atrial fibrillation in concomitant surgical procedures.

Where was the first procedure in the NANOCLAMP AF study performed?

At St. Helena Hospital in St. Helena, California.

Did PLSE include supporting materials with this disclosure?

Yes. A press release was furnished as Exhibit 99.1.