false 0001625101 0001625101 2026-09-15 2026-09-15

 

 

 

 

Date of Report (Date of Earliest Event Reported): September 15, 2026

 

 

 

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:

 

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.

 

 

(d) Exhibits

 

 

 

 

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.