0001437749-25-028093.txt : 20250902 0001437749-25-028093.hdr.sgml : 20250902 20250902090334 ACCESSION NUMBER: 0001437749-25-028093 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20250902 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250902 DATE AS OF CHANGE: 20250902 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: 251283215 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 8-K 1 plse20250829_8k.htm FORM 8-K plse20250829_8k.htm
false 0001625101 0001625101 2025-09-02 2025-09-02
 
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): September 2, 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 September 2, 2025, Pulse Biosciences, Inc. issued a press release announcing the first patients enrolled in its multicenter IRB-approved study using its proprietary nsPFA™ Percutaneous Electrode System for the treatment of benign thyroid nodules (BTNs).
 
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
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: September 2, 2025
By:
/s/ Paul A. LaViolette
  
   
Paul LaViolette
  
   
Chief Executive Officer
(Principal Executive Officer)
  
 
 
 EX-99.1 2 ex_858311.htm PRESS RELEASE ISSUED BY PULSE BIOSCIENCES, INC. DATED SEPTEMBER 2, 2025 ex_858311.htm

Exhibit 99.1

 

Pulse Biosciences Announces First Successful Procedures in PRECISE Benign Thyroid Nodule (BTN) Study

 

HAYWARD, Calif. [Business Wire]– September 2, 2025, Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced the first successful procedures in a multicenter IRB-approved study using Pulse Biosciences’ nsPFA™ Percutaneous Electrode System for the treatment of benign thyroid nodules (BTNs).

 

“Successful procedures for the first enrolled patients in our PRECISE-BTN clinical study for the treatment of benign thyroid nodules (BTNs) marks a significant milestone not only for Pulse Biosciences but also for the broader medical community and patients who stand to benefit from this organ-sparing technology,” said Dr. Ralph P. Tufano, director of Head and Neck Endocrine Surgery at Sarasota Memorial Hospital (SMH) in Sarasota, Florida, and principal investigator for the PRECISE-BTN study conducted through SMH’s Kolschowsky Research and Education Institute and Brian D. Jellison Cancer Institute.. “The objective of this multicenter clinical study is to continue to build clinical evidence in support of this patient-friendly procedure by showing we can safely reduce the debilitating symptoms caused by BTNs, while preserving thyroid function and avoiding complete thyroid removal. Our first two procedures were successful, and we are showing early positive results. We look forward to providing further updates as patients progress.”

 

The PRECISE-BTN study is a prospective, single arm, multicenter, clinical study using the Pulse Biosciences nsPFA™ Percutaneous Electrode System for the treatment of BTNs. Benign thyroid nodule soft tissue ablation procedures will be performed on up to 50 patients with the nsPFA™ Percutaneous Electrode System across four sites. Per study protocols, patients will be observed and evaluated in follow-up visits to assess the procedure at 1, 3, 6 and 12 months post procedure. Study endpoints evaluated during the follow-up timepoints include safety, targeted nodule volume reduction, symptom reduction, and improvements in quality of life and cosmesis.

 

“In addition to the remarkable work done to enroll and treat our first patients in the PRECISE-BTN multicenter clinical study, we continue to successfully treat patients through the pilot phase of our commercial launch,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. “The progression of our clinical studies highlights our commitment to advancing patient treatment and providing valuable insights and outcomes in our field.”

 

About Pulse Biosciences®

 

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, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action will deliver fast and precise ablations or effectiveness as a treatment for BTNs, 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.

 

 

Contacts:

 

Investors:

Pulse Biosciences, Inc.

Jon Skinner, CFO

IR@pulsebiosciences.com

 

Or


Gilmartin Group
Philip Trip Taylor

415.937.5406
philip@gilmartinir.com

 

 
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