# EDGAR Filing Document

**Accession Number:** 0001625101
**File Stem:** 0001437749-25-038213
**Filing Date:** 2025-12
**Character Count:** 13726
**Document Hash:** 869837018d4ed1e14b2e8e6e916d62be
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-038213.hdr.sgml**: 20251218

**ACCESSION NUMBER**: 0001437749-25-038213

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251218

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251218

**DATE AS OF CHANGE**: 20251218

**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:** 251581443

**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'? plse20251218_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>December 18, 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.**  |

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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.

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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 December 18, 2025 - Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation](ex_900505.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: December 18, 2025 | By: | /s/ Paul A. LaViolette |
|  |  | Paul LaViolette |
|  |  | Chief Executive Officer<br> *(Principal Executive Officer)* |

---

## Exhibit 99.1

**Exhibit 99.1**

**Pulse Biosciences Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation**

**HAYWARD, Calif. [Business Wire]**–December 18, 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 that the U.S. Food and Drug Administration (FDA) has granted approval for the Company's Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the initiation of its nPulse Cardiac Catheter Ablation System Study, (NANOPULSE-AF) for the treatment of paroxysmal atrial fibrillation (PAF).

This single-arm, multicenter, prospective study is designed to demonstrate primary safety and effectiveness of the nsPFA Cardiac Cather System for the treatment of recurrent drug-resistant symptomatic paroxysmal AF. Up to 30 sites, including three sites outside the United States, are planned to enroll up to 145 patients. Additional details of the study are available on clinicaltrials.gov (NCT07018596).

"Pulsed field ablation has already reshaped how we treat atrial fibrillation, but its full potential is just emerging. This IDE represents a critical next step—evaluating nanosecond pulsed field ablation across leading U.S. centers and select European sites to further improve safety and durable freedom from atrial arrhythmias," said Dr. David Kenigsberg, Chief Medical Officer, Electrophysiology at Pulse Biosciences. "Unlike existing systems, which rely on microsecond energy delivery, our nanosecond PFA platform is designed to deliver meaningfully lower total energy with the potential to further reduce collateral injury to surrounding structures. Specifically designed for pulmonary vein isolation, the nPulse Cardiac Catheter has the potential to set a new standard for AF ablation."

The nPulse Cardiac Catheter is designed to deliver a complete circumferential lesion in a single, brief energy application without the need to stack lesions, and eliminating the need to stop, rotate and reposition the catheter. The Company's ongoing feasibility study in Europe with the nPulse Cardiac Catheter has now enrolled 150 patients by leading investigators with subject follow-up ongoing. Positive initial clinical outcomes support a strong foundation of real-world evidence to support broader global adoption of nsPFA treatments.

"This novel technology offers a highly intuitive and user-friendly experience, with a pliable catheter designed for precise positioning and consistent energy delivery to achieve durable, transmural pulmonary vein isolation," said Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY, and principal investigator of the study. "Based on my extensive hands-on experience with the nPulse Cardiac Catheter, the combination of a differentiated nanosecond pulsed-field energy source and thoughtful catheter design has the potential to deliver effective lesion formation with a favorable safety profile, while simplifying workflow in the EP lab. We look forward to the results of this IDE as the clinical data continue to evolve."

"This FDA IDE approval is a major milestone for Pulse Biosciences and is a testament to the strength of our preclinical and human clinical data," said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences. "With the support of leading electrophysiologists, we believe our proprietary nanosecond PFA represents a next-generation energy modality with the potential to improve the safety, effectiveness, and efficiency of AF ablation through a simpler, clinician-friendly procedure. We look forward to sharing follow-up data in 2026."

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

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 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 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 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 360 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, statements concerning early clinical successes and whether they are predictive of the safety and efficacy of any medical device such as the nPulse 360 Cardiac Catheter, Pulse Biosciences' expectations, whether stated or implied, regarding 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, 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.<br> Paul LaViolette, Co-Chairman and CEO

IR@pulsebiosciences.com

**Or**

<br> Gilmartin Group<br> Philip Trip Taylor

415.937.5406<br> philip@gilmartinir.com