# EDGAR Filing Document

**Accession Number:** 0001625101
**File Stem:** 0001437749-25-030816
**Filing Date:** 2025-10
**Character Count:** 13448
**Document Hash:** 9c6ab64bc14405f5c29b657557ce6b4d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-030816.hdr.sgml**: 20251010

**ACCESSION NUMBER**: 0001437749-25-030816

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251010

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251010

**DATE AS OF CHANGE**: 20251010

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** PULSE BIOSCIENCES, INC.
- **CENTRAL INDEX KEY:** 0001625101
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 465696597
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37744
- **FILM NUMBER:** 251386387

**BUSINESS ADDRESS:**
- **STREET 1:** 3957 POINT EDEN WAY
- **CITY:** HAYWARD
- **STATE:** CA
- **ZIP:** 94545
- **BUSINESS PHONE:** 510-906-4600

**MAIL ADDRESS:**
- **STREET 1:** 3957 POINT EDEN WAY
- **CITY:** HAYWARD
- **STATE:** CA
- **ZIP:** 94545

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Pulse Biosciences, Inc.
- **DATE OF NAME CHANGE:** 20151210

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Electroblate, Inc.
- **DATE OF NAME CHANGE:** 20141113

?xml version='1.0' encoding='ASCII'? plse20251009_8k.htm

**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): **<u>October 10, 2025</u>**

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

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| | | |
|:---|:---|:---|
| 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. ☐

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| | |
|:---|:---|
| **Item 8.01** | **Other Events.**  |

---

On October 10, 2025, Pulse Biosciences, Inc. (the "Company") issued a press release announcing late-breaking clinical study results from its nPulse™ Cardiac Surgical System first-in-human feasibility study. To date, 44 patients have been treated by three investigators in the study. In the initial cohort, twenty-four patients have had the ablation effectiveness and durability evaluated by electroanatomical mapping at approximately three months post the ablation procedure. Initial cohort study results include:

● All (100%) posterior box isolations were acutely successful in the high-dose cohort

● Success rate of PVI (per vein) at ~3 months was 94% (63/67)

● Average total ablation time of 50 seconds with average number of 13 applications

● No reports of esophageal or phrenic nerve damage

● No ablation-related severe or major adverse events

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.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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(d) Exhibits

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| | |
|:---|:---|
| **<u>Exhibit</u>** <br> **<u>Number</u>** | **<u>Description</u>** |
| 99.1 | [Press Release issued by Pulse Biosciences, Inc. dated October 10, 2025 - Pulse Biosciences Announces Presentation of Late-Breaking Data from the nPulse™ Cardiac Surgical System First-In-Human Feasibility Study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting](ex_868565.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

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**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.

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| | | |
|:---|:---|:---|
|  | **PULSE BIOSCIENCES, INC.** | **PULSE BIOSCIENCES, INC.** |
| Date: October 10, 2025 | By: | /s/ Paul A. LaViolette |
|  |  | Paul LaViolette |
|  |  | Chief Executive Officer<br> *(Principal Executive Officer)* |

---

## Exhibit 99.1

**Exhibit 99.1**

**Pulse Biosciences Announces Presentation of Late-Breaking Data from the nPulse**™ **Cardiac Surgical System First-In-Human Feasibility Study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting**

*Successfully treated atrial fibrillation (AF) in initial 30 patients with the nPulse*™ *Cardiac Surgical System*

**HAYWARD, Calif. [Business Wire]**–October 10, 2025 Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced late-breaking clinical study results from the nPulse™ Cardiac Surgical System first-in-human feasibility study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark.

The feasibility study is intended to assess the initial safety and efficacy of the nPulse Cardiac Surgical System for the treatment of Atrial Fibrillation (NCT06355063). To date, 44 patients have been treated by investigators in Europe, including Dr. Bart van Putte in cases performed at St. Antonius Hospital Nieuwegein, Netherlands, Dr. Bart Maesen performing cases at Maastricht UMC+, Maastricht, Netherlands, and Dr. Antoine Driessen performing cases at Amsterdam UMC, Amsterdam, Netherlands. In this initial cohort 24 patients have had the ablation effectiveness and durability evaluated by electroanatomical mapping at approximately three months post the ablation procedure.

"Electroanatomical mapping results for the first 24 patients treated with the nPulse Cardiac Surgical System show durable and consistent pulmonary vein isolation (PVI) and posterior box isolation, achieved safely with rapid ablation times," said Dr. Bart van Putte, Cardiothoracic Surgeon at St. Antonius Hospital Nieuwegein, The Netherlands. "This feasibility study represents the first use of an epicardial PFA surgical technology, and the early results suggest the speed, safety and effectiveness of the nPulse Surgical Cardiac Clamp's efficient workflow has the potential to significantly expand the use of cardiac surgical ablation for patients suffering from atrial fibrillation."

**Initial Cohort Study Results**

&nbsp;&nbsp;&nbsp;&nbsp;**●** All (100%) posterior box isolations were acutely successful in the high-dose cohort

&nbsp;&nbsp;&nbsp;&nbsp;**●** Success rate of PVI (per vein) at ~3 months was 94% (63/67)

&nbsp;&nbsp;&nbsp;&nbsp;**●** Average total ablation time of 50 seconds with average number of 13 applications

&nbsp;&nbsp;&nbsp;&nbsp;**●** No reports of esophageal or phrenic nerve damage

&nbsp;&nbsp;&nbsp;&nbsp;**●** No ablation-related severe or major adverse events

Also, at the EACTS annual meeting, a live-in-a-box case transmission featured the nPulse Cardiac Surgical System in a recorded case performed and presented by Dr. Bart van Putte. The case highlighted the nPulse Cardiac Surgical System's ability to rapidly achieve PVI and posterior box isolation with a fast, efficient procedure workflow.

"Pulse Biosciences is the first company to bring PFA into the cardiac surgical field for the treatment of atrial fibrillation," said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. "We believe our novel and proprietary nonthermal nPulse technology offers significant advantages in safety, as demonstrated across our multiple clinical applications, as well as efficacy, and speed compared to traditional thermal ablation methods like radiofrequency. We remain on track to initiate an IDE study this year to clinically validate the nPulse Cardiac Surgical System, and we look forward to continued collaboration with leading physicians as we work toward commercial approval and broader patient access."

**Note: Dr. Bart van Putte serves as a consultant to Pulse Biosciences**

**About Pulse Biosciences**<sup>®</sup>

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as the 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 noncellular tissue. 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, such as surgical soft tissue ablation.

Pulse Biosciences, nPulse, Vybrance, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA, nanosecond PFA 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 whether the nPulse Surgical Cardiac Clamp can safely and effectively create durable reproducible lesions, statements concerning the potential comparative benefits of nPulse technology, such as whether it may offer significant advantages in safety, efficacy, and speed compared to traditional thermal ablation methods like radiofrequency, statements concerning the Company's future clinical and regulatory initiatives anywhere in the world, 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.

<u>**Contacts:**</u>

**Investors:**

Pulse Biosciences, Inc.

Jon Skinner, CFO

IR@pulsebiosciences.com

**Or**

<br> Gilmartin Group<br> Philip Trip Taylor

415.937.5406<br> philip@gilmartinir.com