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0001625101
0001625101
2026-09-15
2026-09-15
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 15, 2026
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Pulse Biosciences, Inc.
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(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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001-37744
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46-5696597
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(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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| 3957 Point Eden Way |
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Hayward, California 94545
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(Address of Principal Executive Offices) (Zip Code)
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| 510-906-4600 |
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Not Applicable
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(Former Name or Former Address, If Changed Since Last Report)
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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
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Trading Symbol(s)
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Name of Each Exchange on Which Registered
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Common stock, $0.001 par value per share
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PLSE
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The Nasdaq Stock Market
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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. ☐
On September 15, 2026, Pulse Biosciences, Inc. (the “Company”) announced completion of patient enrollment in its PRECISE-BTN clinical study evaluating the Company’s nPulse™ Vybrance™ Percutaneous Electrode System for the treatment of symptomatic benign thyroid nodules (the “Study”). In addition, the Company announced that the first patient enrolled in the Study had completed their final 12-month follow-up visit. Enrollment was completed following an expansion of the Study from its original 50-patient design to 100 patients. All patients were enrolled across three U.S. clinical sites — Sarasota Memorial Health Care System, NYU Langone Health, and Weill Cornell Medicine — within approximately 12 months. The Study protocol specifies follow-up visits at one, three, six, and twelve months post-procedure and endpoints include safety, targeted nodule volume reduction, symptomatic relief, hormone normalization, and improvements in quality of life.
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
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Financial Statements and Exhibits.
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(d) Exhibits
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Exhibit
Number
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Description
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99.1
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Press Release issued by Pulse Biosciences, Inc. dated September 15, 2026 - Pulse Biosciences Completes Enrollment in the PRECISE-BTN Clinical Study.
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104
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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.
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Date: September 15, 2026
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By:
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/s/ Jon Skinner
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Jon Skinner
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Chief Financial Officer
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(Principal Financial Officer) |
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Exhibit 99.1
Pulse Biosciences Completes Enrollment in the PRECISE-BTN Clinical Study Evaluating the nPulse™ Vybrance™ Percutaneous Electrode System for Symptomatic Benign Thyroid Nodules
Completed 100 patient enrollment across three U.S. sites; first patient enrolled completed 12-month follow-up
HAYWARD, California, September 15, 2026 – Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of the novel nPulse™ technology using proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced two milestones in the PRECISE-BTN clinical study evaluating the nPulse™ Vybrance™ Percutaneous Electrode System for the treatment of symptomatic benign thyroid nodules (BTNs). The first patient enrolled in the study completed the final 12-month follow-up visit in August at Sarasota Memorial Health Care System in Sarasota, Florida, under the supervision of Ralph P. Tufano, MD, MBA, FACS. And the 100th patient was enrolled in August completing enrollment in the study.
Enrollment was completed following an expansion of the study from its original 50-patient design to 100 patients. All patients were enrolled across three U.S. clinical sites — Sarasota Memorial Health Care System, NYU Langone Health, and Weill Cornell Medicine in approximately 12 months.
“Completing enrollment in PRECISE-BTN at double the original patient count is a meaningful milestone for the Company and for symptomatic benign thyroid patients,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. “We are grateful to our investigators, coordinators, and patients for making this possible.”
The Company plans to present preliminary data from the PRECISE-BTN study at an upcoming medical society conference, with full data expected upon completion of the study’s 12-month follow-up for all patients.
About the PRECISE-BTN Study
The PRECISE-BTN study is a prospective, single-arm, multicenter clinical investigation designed to evaluate the safety and effectiveness of the nPulse™ Vybrance™ Percutaneous Electrode System using nsPFA energy for the treatment of symptomatic benign thyroid nodules. The study enrolled 100 patients at three clinical sites in the United States, with first procedures performed at Sarasota Memorial Health Care System in Sarasota, Florida, under principal investigator Ralph P. Tufano, MD, MBA, FACS. Participating investigators also include Kepal N. Patel, MD at NYU Langone Health in New York, New York, and Thomas J. Fahey III, MD and Brendan M. Finnerty, MD at Weill Cornell Medicine in New York, New York. Patients are followed at 1, 3, 6, and 12 months post-procedure. Endpoints include safety, targeted nodule volume reduction, symptomatic relief, hormone normalization, and improvements in quality of life.
About Pulse Biosciences®
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 non-cellular 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 concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nPulse™ Vybrance™ Percutaneous Electrode System to treat benign thyroid nodules or any other thyroid disease, statements concerning the Company’s expected clinical and other new product development efforts, including its planned completion of the PRECISE-BTN study and presentation of clinical data, 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.
Investor Contacts:
Pulse Biosciences, Inc.
Jon Skinner, CFO
IR@pulsebiosciences.com
Or
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
