# EDGAR Filing Document

**Accession Number:** 0001625101
**File Stem:** 0001437749-25-027725
**Filing Date:** 2025-8
**Character Count:** 13132
**Document Hash:** fb7da552d61b8486e99ab128b5b973ae
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-027725.hdr.sgml**: 20250826

**ACCESSION NUMBER**: 0001437749-25-027725

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250826

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250826

**DATE AS OF CHANGE**: 20250826

**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:** 251252797

**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'? plse20250825_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>August 26, 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 August 26, 2025, Pulse Biosciences, Inc. (the "Company") issued a press release announcing the publication of early data from the Company's clinical study of its CellFX nsPFA Percutaneous Electrode System for the treatment of benign thyroid nodules (the "Study") in the journal *Thyroid*. The Study was conducted by Professor Stefano Spiezia as a single-arm First-In-Human feasibility study at the Ospedale del Mare center in Naples, Italy. The CellFX nsPFA Percutaneous Electrode System was used under ultrasound guidance to ablate benign thyroid nodules, as either isolated ablations to assess tissue response (Cohorts 1 & 2) or for full treatment of thyroid nodules with therapeutic intent (Cohort 3). Results showed no intranodular fibrosis or scarring on follow-up ultrasounds and fully treated nodules (Cohort 3) had up to 93% reduction in size at 1 year on ultrasound assessment (average 86% reduction), with symptom relief and >48% reduction as early as 2 weeks.

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 August 26, 2025 - Pulse Biosciences Announces Publication of First-In-Human Data for Treatment of Benign Thyroid Nodules](ex_856819.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: August 26, 2025 | By: | /s/ Jon Skinner |
|  |  | Jon Skinner |
|  |  | Chief Financial Officer<br> *(Principal Financial Officer)* |

---

## Exhibit 99.1

**Exhibit 99.1**

**Pulse Biosciences Announces Publication of First-In-Human Data for Treatment of Benign Thyroid Nodules in the Journal *Thyroid***

*First-in-Human Clinical Feasibility Study Demonstrates Effectiveness of Ablation of Benign Thyroid Nodules Using Nanosecond Pulsed Field Ablation*

HAYWARD, Calif.--(BUSINESS WIRE) August 26, 2025-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced a new publication in the Journal *Thyroid*. The First-in-Human Clinical feasibility study demonstrates the effectiveness of ablation of benign thyroid nodules using nsPFA energy.

The study was designed to assess the ability of nsPFA energy to provide a safe and effective option for the treatment of symptomatic benign thyroid nodules with minimal side effects. The study was conducted by Professor Stefano Spiezia as a single-arm First-In-Human feasibility study at the Ospedale del Mare center in Naples, Italy. The CellFX nsPFA Percutaneous Electrode System was used under ultrasound guidance to ablate benign thyroid nodules, as either isolated ablations to assess tissue response (Cohorts 1 & 2) or for full treatment of thyroid nodules with therapeutic intent (Cohort 3). Results showed no intranodular fibrosis or scarring on follow-up ultrasounds and fully treated nodules (Cohort 3) had up to 93% reduction in size at 1 year on ultrasound assessment (average 86% reduction), with symptom relief and >48% reduction as early as 2 weeks.

"We are very proud to have this data published in a leading scientific journal in the field, the renowned Journal *Thyroid*. The results of this study are extremely compelling and demonstrate nsPFA's ability to offer advantages in treating benign thyroid nodules compared to other methods such as thyroidectomy or thermal ablation. This technology provides a favorable safety profile, rapid symptom reduction, and lack of internodular fibrosis and scarring," said Dr. Stefano Spiezia, Chief of Endocrine Surgery at Ospedale del Mare. "These benefits are very appealing to surgeons who always prioritize generating consistent positive outcomes for their patients with increased safety and effectiveness."

Dr. Ralph Tufano, Pulse Biosciences' Scientific Advisory Board Chair, Head and Neck Surgery, commented, "Unlike RFA, the nonthermal mechanism of nsPFA preserves surrounding nerves and blood vessels, allowing for safe and effective treatment of the entire nodule, even when located in sensitive areas like near the recurrent laryngeal nerve, esophagus, trachea, and critical arteries. Another key advantage of nsPFA over RFA is its significantly faster rate of thyroid nodule volume reduction: nsPFA achieved a 71% reduction within just one month, whereas RFA-treated nodules in four large clinical trials typically required six months to reach comparable shrinkage. The rapid reduction in nodule size combined with the absence of adverse effects supports the feasibility of this new approach and its potential to improve patient outcomes."

A Late-Breaking Abstract of this work was presented at the 2024 American Thyroid Association meeting.

**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 CellFX® nsPFA™ 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 CellFX nsPFA 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, 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 relating to the effectiveness of the Company's CellFX nsPFA Percutaneous Electrode System to safely and effectively treat benign thyroid nodules or cause significant nodule volume reductions, whether within a month or otherwise, statements concerning whether any clinical study will show that the Company's novel nsPFA mechanism of action will deliver fast and precise ablations, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nsPFA Percutaneous Electrode System, and Pulse Biosciences' expectations, whether stated or implied, regarding whether the Company's CellFX nsPFA technology will become a disruptive, superior and durable treatment option for treating benign thyroid nodules or any other medical condition or otherwise advance current medical standards of care, 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