Pulse Biosciences (Nasdaq: PLSE) reaches NANOPULSE-AF enrollment midpoint

Rhea-AI Filing Summary

Pulse Biosciences announced that the NANOPULSE-AF pivotal IDE clinical study of its nPulse Cardiac Catheter System for treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation has surpassed its enrollment midpoint. The prospective, multicenter investigation began in April 2026 and is expected to enroll patients at up to 30 sites, including locations outside the United States.

The company’s nano-PFA technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue and initiating regulated cell death. Management plans to provide additional commentary on study progress during an earnings conference call on August 6 at 1:30pm PT / 4:30pm ET, available via phone and webcast.

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, and exhibit attachments filed with this report.

Key Figures

Planned study sites: up to 30 sites Study start: April 2026 Earnings call date: August 6 +2 more

5 metrics

Planned study sites up to 30 sites Expected enrollment locations for the NANOPULSE-AF pivotal clinical study

Study start April 2026 Commencement of the NANOPULSE-AF pivotal clinical investigation

Earnings call date August 6 Date of the conference call to discuss study progress

Earnings call time 1:30pm PT / 4:30pm ET Scheduled start time for the August 6 investor call

Conference ID 3486060 Conference ID required to join the August 6 investor call by phone

Key Terms

pivotal, clinical investigation, paroxysmal atrial fibrillation, Nanosecond Pulsed Field Ablation, IDE Pivotal Study, +1 more

5 terms

pivotal, clinical investigation regulatory

"a prospective, multicenter, pivotal, clinical investigation currently evaluating"

paroxysmal atrial fibrillation medical

"for treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation"

A heart rhythm problem in which the heart’s upper chambers suddenly start beating fast and irregularly in episodes that begin and stop on their own, typically lasting minutes to days. Like a car that occasionally skids on a patch of ice before regaining control, these episodes raise risks of stroke, hospital visits and ongoing treatment needs, so they matter to investors because they shape demand for drugs, devices, clinical trials, regulatory decisions and healthcare costs tied to companies in this market.

Nanosecond Pulsed Field Ablation technical

"leveraging its novel and proprietary Nanosecond Pulsed Field Ablation technology"

Nanosecond pulsed field ablation is a medical technique that uses extremely short, high‑voltage electrical pulses—each lasting billionths of a second—to selectively disable small areas of tissue, most often to treat irregular heart rhythms. Like a precise, ultra‑brief electric zap that spares surrounding structures, it matters to investors because it can shorten procedure time, reduce complications and recovery, and therefore reshape demand, pricing and adoption for cardiac ablation devices and related services.

IDE Pivotal Study regulatory

"Pulse Biosciences Surpasses Enrollment Midpoint in NANOPULSE-AF IDE Pivotal Study"

An IDE pivotal study is a large, final clinical trial conducted under an Investigational Device Exemption (IDE) that tests whether a medical device is safe and effective enough for regulatory approval and widespread use. For investors, it matters because the study’s results often determine whether a device can reach the market; think of it as the device’s “road test” or final exam where passing opens commercial revenue and failing can halt or delay value creation.

regulated cell death medical

"to non-thermally clear cells while sparing adjacent non-cellular tissue as well as initiating regulated cell death"

Regulated cell death is the set of biological processes in which cells are driven to die by specific, controllable molecular pathways rather than by accidental injury. Think of it as programmed demolition (apoptosis) or different engineered collapse mechanisms (necroptosis, pyroptosis, ferroptosis) that can be switched on or off by drugs or genetic changes. It matters to investors because these pathways are common targets for therapies and diagnostics, influence safety and efficacy in drug development, and can affect clinical outcomes and market potential for medical products.

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Available on EDGAR 07/29/2026 - 09:02 AM Accepted by SEC EDGAR 07/29/2026 - 09:01 AM Learn about SEC filing dates

FAQ

What milestone did Pulse Biosciences (PLSE) report for the NANOPULSE-AF study?

Pulse Biosciences reported that its NANOPULSE-AF pivotal IDE study has surpassed the enrollment midpoint. The trial evaluates the nPulse Cardiac Catheter System in patients with recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation at multiple sites, including locations outside the United States.

What condition is Pulse Biosciences’ (PLSE) nPulse Cardiac Catheter System targeting?

The nPulse Cardiac Catheter System is being evaluated to treat recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation. The NANOPULSE-AF study is a prospective, multicenter, pivotal clinical investigation designed to assess the safety and effectiveness of this approach in a real-world patient population.

When did the NANOPULSE-AF pivotal study for PLSE begin and how many sites are planned?

The NANOPULSE-AF pivotal clinical study began in April 2026 and is expected to enroll patients at up to 30 sites. These sites include locations outside the United States, reflecting a multicenter, international design for the investigation.

When will Pulse Biosciences (PLSE) discuss NANOPULSE-AF study progress with investors?

Pulse Biosciences plans to discuss study progress on August 6 during its earnings conference call at 1:30pm PT / 4:30pm ET. Investors can listen by dialing the provided U.S. or international numbers or via a webcast on the company’s investor website.

What is Pulse Biosciences’ nano-PFA technology mentioned in this PLSE filing?

The company’s Nanosecond Pulsed Field Ablation (nano-PFA) technology delivers nanosecond electrical pulses to non-thermally clear cells while sparing adjacent non-cellular tissue and initiating regulated cell death. Pulse Biosciences is developing this nPulse platform for atrial fibrillation and other select medical applications.

How can investors access Pulse Biosciences’ (PLSE) August 6 earnings call?

Investors may dial 1-800-715-9871 in the U.S. or 1-646-307-1963 internationally and provide Conference ID 3486060. A live and recorded webcast of the August 6 call will also be available on the Pulse Biosciences investor relations website.

false 0001625101 0001625101 2026-07-29 2026-07-29

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): July 29, 2026

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.)
3957 Point Eden Way
Hayward, California 94545
(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 July 29, 2026, Pulse Biosciences, Inc. (the “Company”) announced surpassing the enrollment midpoint of its NANOPULSE-AF clinical study ("Study"), a prospective, multicenter, pivotal, clinical investigation currently evaluating the Company’s nPulse™ Cardiac Catheter System for treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation. The Study commenced in April 2026 and is expected to enroll patients at up to 30 sites, including sites outside the United States.  

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 July 29, 2026 - Pulse Biosciences Surpasses Enrollment Midpoint in NANOPULSE-AF IDE Private 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: July 29, 2026	By:	/s/ Jon Skinner
		Jon Skinner
		Chief Financial Officer
		(Principal Financial Officer)

Exhibit 99.1

Pulse Biosciences Surpasses Enrollment Midpoint in NANOPULSE-AF IDE Pivotal Study

HAYWARD, California, July 29, 2026 – Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nano-PFA or nsPFA™) technology, today announced that the NANOPULSE-AF Study has surpassed its enrollment midpoint after commencing the study in April 2026.

“We are very pleased by the strong enrollment trajectory in the NANOPULSE-AF study. Reaching this midpoint milestone so quickly reflects the enthusiasm of our investigational sites for this technology and its potential to deliver leading durability in pulmonary vein isolation, procedural efficiency and consistent safe and effective patient outcomes,” David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences. “This momentum is driven first by the technology itself. Second, the protocol represents a real-world example of the type of patients we are seeing in clinical practice, where ablation has become a first-line therapy to address patients suffering from atrial fibrillation. We appreciate our close collaboration with the FDA throughout this process, as we move toward completion of our IDE study.”

“The nPulse System has been a remarkably intuitive platform to work with. The learning curve is minimal, and the workflow integrates seamlessly into our existing ablation practice,” said Frank Cuoco, MD, FACC, FHRS, Director of Cardiac Electrophysiology at HCA Trident Health in Charleston, South Carolina, and a top-enrolling investigator in the NANOPULSE-AF Study. “That ease of use is a meaningful driver of the momentum we're seeing in enrollment, and the nPulse System has already demonstrated the potential to be a safe and durable treatment option for our patients. That combination is what is bringing patients into the study so quickly.”

“Having experience with this catheter during the first-in-human cases in Prague, I was excited to get this IDE study started in the United States,” said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY, and National Principal Investigator of the NANOPULSE-AF Study. “Reaching the halfway mark so rapidly is a true testament to the ease of use of this catheter, and the excitement it engenders in the investigators. Having seen the compelling safety and efficacy data in the first-in-man dataset, I look forward to evaluating the full pivotal dataset with my fellow investigators upon the study's completion.”

The Company will provide additional commentary on the progress of the Study during its upcoming earnings conference call on August 6^th at 1:30pm PT / 4:30pm ET. Investors interested in listening to the conference call may do so by dialing 1-800-715-9871 from the U.S. or 1-646-307-1963 internationally and providing Conference ID 3486060. A live and recorded webcast of the event will be available on the Pulse Biosciences Investors website at http://investors.pulsebiosciences.com/.

About Pulse Biosciences®

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as potential to improve the quality of life for patients. The Company’s proprietary nPulse™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue as well as initiating regulated cell death. The Company is actively pursuing the development of its nPulse technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers.

Pulse Biosciences, nPulse, Vybrance, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nPulse Cardiac Catheter System, Pulse Biosciences’ expectations, whether stated or implied, about whether the Company’s nsPFA technology will become either a disruptive treatment option or a superior option for treating atrial fibrillation or any other medical condition, statements relating to the effectiveness of the Company’s nsPFA technology and nPulse System to non-thermally clear cells while sparing adjacent non-cellular tissue, statements concerning the Company’s expected product development efforts, such as advancement of its nPulse Cardiac Catheter to treat paroxysmal atrial fibrillation, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action and catheter design will deliver fast and precise ablations in cardiac tissue and streamline workflow, statements concerning market opportunities, customer adoption and future use of the nPulse System to address a range of conditions such as atrial fibrillation, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

Investor Contacts:

Pulse Biosciences, Inc.

Jon Skinner, CFO

IR@pulsebiosciences.com

Or

Gilmartin Group

Philip Trip Taylor

415.937.5406

philip@gilmartinir.com

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 PULSE MID POINT ENROLLED 11.8 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.2 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.0 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.3 KB