UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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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 |