false 0001625101 0001625101 2026-02-05 2026-02-05

 

 

 

 

Date of Report (Date of Earliest Event Reported): February 5, 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 February 5, 2026, Pulse Biosciences, Inc. (the “Company”) issued a press release announcing 6- and 12-month data from its nPulse^TM Cardiac Catheter first-in-human feasibility study (the “Study”). These data were presented by Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital in New York, at the 31st Annual AF Symposium 2026 meeting in Boston. 

 

The Study has been assessing the initial safety and effectiveness of the Company's nPulse Cardiac Catheter System for the treatment of atrial fibrillation, a form of heart arrhythmia. The Company's endocardial catheter ablation device has been uniquely designed to provide a circumferential, or circular, ablation in a single treatment cycle using proprietary nanosecond PFA energy. To date, in the Study, a total of 165 patients have been treated by nine investigators in Europe, including clinicians at the Na Homolce Hospital in Prague. The initial cohort of 150 treated patients has been evaluated by remapping at approximately 3 months and for rhythm control completed at 6 and 12 months post ablation procedure.

 

Key findings from the Study reported by the Company include:

 

 

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.