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): January 21, 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. ☐
On January 21, 2025, Pulse Biosciences, Inc. (the “Company”) issued a press release announcing late-breaking data from the Company's first-in-human feasibility study of its Nanosecond PFA 360° Cardiac Catheter System. To date, 77 patients have been treated by six investigators in the study. The initial cohort of the first 30 patients treated have been evaluated by remapping completed at approximately three months post ablation procedure. Initial cohort study results include:
| | ● | All (100%) lesions were acutely successful with conduction block |
| | ● | Success rate of pulmonary vein isolation (PVI) at ~3 months was 92.4% (109/118) |
| | ● | Total PVI ablation time was 11.6 ± 4.5 minutes |
| | ● | Total procedure and fluoroscopy times were 88.3 ± 30.1 and 6.9 ± 2.4 minutes, respectively |
| | ● | Left atrial dwell time was 29.6 ± 15.3 minutes |
| | ● | 1 Primary SAE (cardiac perforation) and 2 AEs including vertigo (n=1; managed conservatively) and creatinine elevation (n=1; treated with IV saline), with all AEs resolved without sequelae |
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
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: January 23, 2025 | By: | /s/ Paul A. LaViolette | |
| | | Paul A. LaViolette | |
| | | Chief Executive Officer | |
