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 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): April 13, 2025

 

EBR SYSTEMS, INC.
(Exact Name of Registrant as Specified in its Charter)

 

Delaware   000-56671   57-1164669
(State or Other
Jurisdiction of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

480 Oakmead Parkway

Sunnyvale, CA 94085

(Address of Principal Executive Office) (Zip Code)

 

Registrant's telephone number, including area code: (408) 720-1906

 

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: None

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
None. None. None.

 

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 x

 

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 April 13, 2025, EBR Systems, Inc. (the “Company”) issued a press release announcing that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of its premarket approval application (PMA) for the WiSE CRT System and approved the WiSE CRT System for commercial distribution for adult patients who are at least 22 years of age, are indicated for cardiac resynchronization therapy (CRT), have an existing or are eligible for an implanted right ventricular pacing system, and are in one of the following two categories:

•           Patients in whom previous coronary sinus (CS) lead implantation was unsuccessful, or where an implanted lead has been turned off, referred to as "previously untreatable";

•          Patients with previously implanted pacemakers or Implantable Cardioverter-Defibrillators (ICDs) in whom standard CRT upgrade is not advisable due to known relative contraindications for CS lead or CRT device implantation, referred to as "high risk upgrades".

•            A copy of the press release 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   Press Release dated April 13, 2025.
     
104   Cover Page Interactive Data (embedded within the Inline XBRL document).

 

   
 

 

SIGNATURES

 

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 hereunto duly authorized.

 

Date: April 14, 2025 EBR SYSTEMS, INC.
   
  By: /s/ John McCutcheon
  Name: John McCutcheon
  Title: Chief Executive Officer