PLSE: Published Data Show Up to 93% Thyroid Nodule Reduction

Rhea-AI Filing Summary

Pulse Biosciences announced publication of early clinical data from a first-in-human, single-arm feasibility study of its CellFX nsPFA Percutaneous Electrode System to treat benign thyroid nodules. The study, conducted at a single center in Naples, Italy, used ultrasound-guided ablation for tissue-response assessments and therapeutic intent. Follow-up ultrasounds showed no intranodular fibrosis or scarring. Fully treated nodules had an average 86% reduction in size at one year, with individual reductions up to 93%, and patients experienced symptom relief with reductions greater than 48% as early as two weeks. The company attached the related press release as an exhibit.

Positive

• Published peer-reviewed early clinical data demonstrating strong efficacy signals for benign thyroid nodules (average 86% reduction at one year).
• No intranodular fibrosis or scarring observed on follow-up ultrasounds, indicating a favorable safety/cosmetic profile.
• Rapid symptom relief with >48% reduction as early as two weeks, suggesting clinical benefit soon after treatment.
• Up to 93% nodule reduction in fully treated cases, showing potential for durable outcomes.

Negative

• None.

Insights

Clinical Outcomes Analyst

TL;DR: Early human feasibility data show strong nodular volume reduction and no scarring, supporting clinical potential for benign thyroid nodules.

The published single-arm First-In-Human feasibility study reports compelling imaging and symptomatic outcomes: mean nodular shrinkage of 86% at one year and up to 93% for fully treated nodules, plus rapid symptom improvement (>48% reduction by two weeks). Absence of intranodular fibrosis or scarring on follow-up ultrasounds is clinically relevant for safety and cosmetic outcomes. As a feasibility study from a single center, findings are preliminary and require confirmation in larger, controlled trials, but results are materially positive for the therapy's clinical profile.

Medical Device Regulatory Specialist

TL;DR: Published first-in-human data strengthen regulatory and clinical evidence but broader data and controlled studies remain necessary.

Publication in a peer-reviewed journal enhances the evidentiary record for the CellFX nsPFA system. Key safety signal—no intranodular fibrosis or scarring—is favorable for regulatory submissions and physician adoption. Reported efficacy (average 86% volume reduction at one year) supports potential therapeutic value for benign thyroid nodules. However, as a single-arm feasibility study, the dataset is limited for definitive regulatory claims; randomized or multicenter studies would better support labeling and broader market uptake.

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, or exhibit attachments filed with this report.

FAQ

What did Pulse Biosciences report about its CellFX nsPFA system (PLSE)?

The company reported publication of early first-in-human feasibility data showing an average 86% nodule size reduction at one year, up to 93% for fully treated nodules, with no intranodular fibrosis or scarring and symptom relief.

Where was the CellFX feasibility study conducted and what was its design?

The study was a single-arm First-In-Human feasibility trial conducted at a center in Naples, Italy, using ultrasound-guided percutaneous ablation in three cohorts for tissue response and therapeutic treatment.

How quickly did patients experience symptom relief in the study?

Patients experienced symptom relief with more than 48% reduction reported as early as two weeks after treatment.

Were there any adverse imaging findings reported in the study?

Follow-up ultrasounds reported no intranodular fibrosis or scarring, indicating no such adverse imaging findings in the published data.

Does the filing include supporting materials for the announcement?

Yes, the press release announcing the publication is attached as Exhibit 99.1 and incorporated by reference.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 08/26/2025 - 09:03 AM Learn about SEC filing dates

false 0001625101 0001625101 2025-08-26 2025-08-26

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): August 26, 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 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
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
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: August 26, 2025	By:	/s/ Jon Skinner
		Jon Skinner
		Chief Financial Officer (Principal Financial Officer)