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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):
August 20, 2026
| 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 5.02. Departure of Directors or Certain Officers; Election
of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Transition of Chief Commercial Officer
On August 21, 2026, EBR Systems, Inc. (the “Company”)
announced the impending departure of Erik Strandberg, Chief Commercial Officer, who will be leaving the Company in the coming months,
which final date has yet to be determined. Mr. Strandberg’s departure is not the result of any dispute or disagreement with the
Company on any matter relating to the Company’s operations, policies or practices.
John McCutcheon, the Company’s President
and Chief Executive Officer, will assume responsibility for the Company’s commercial organization while the Company conducts a search
to identify a successor Chief Commercial Officer.
The Company expects to enter into an agreement
with Mr. Strandberg at a later date relating to his departure and will disclose the material terms of any such agreement by an amendment
to this Current Report on Form 8-K.
Item 8.01. Other Events.
On August 21, 2026, the Company issued a press
release announcing the departure of Mr. Strandberg as the Company’s Chief Commercial Officer. A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 8.01, including
the related information set forth in the press release attached hereto as Exhibit 99.1, is being “furnished” and shall not
be deemed “filed” with the Securities and Exchange Commission for the purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section and is not incorporated by
reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after
the date hereof, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release of EBR Systems, Inc. issued on August 20, 2026 (furnished herewith) |
| |
|
|
| 104 |
|
Cover Page Interactive Data File (formatted as inline XBRL) |
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: August 24, 2026 |
EBR SYSTEMS, INC. |
| |
|
| |
By: |
/s/ John McCutcheon |
| |
Name: |
John McCutcheon |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1

| ASX ANNOUNCEMENT |
21 August 2026 |
EBR announces transition of Chief Commercial Officer
Santa Clara, California; 21 August 2026: EBR Systems, Inc. (ASX:
“EBR”, “EBR Systems”, or the “Company”), developer of the world’s only
wireless cardiac pacing device for heart failure, today announced the impending departure of Erik Strandberg, Chief Commercial Officer,
who will be leaving the Company in the coming months. During Mr. Strandberg’s transition out, President and CEO John McCutcheon
will assume responsibility for the commercial organization as a search is conducted to identify a replacement Chief Commercial Officer.
The Company does not expect any negative impact on US commercial adoption because of this change. During this period the Company will
focus on accelerating outstanding training requirements in the field team to ensure there is capacity to support ongoing and increasing
clinical demand for WiSE.
|
John McCutcheon, EBR Systems’ President & Chief Executive
Officer said:
“We thank Erik for his significant contributions to EBR, particularly his efforts to build a best-in-class commercial organization
in preparation for the launch of the WiSE® System. We will continue to build the capabilities of our exceptional commercial
team as we execute our strategy of selective expansion of hospitals and increased utilisation of WiSE within existing accounts. Our
field sales and clinical organization will continue to provide nothing but the most exemplary patient care and physician training.”
|
ENDS
This announcement has been authorised for release by the EBR
Systems General Disclosure Committee, a Committee of the Board of Directors.
For more information, please contact:
| Company |
Investor Relations |
| Andrew Shute |
Gabriella Hold |
| Chief Corporate Development Officer |
The Capital Network |
| P: +44 7730 691421 |
P: +61 2 7257 7338 |
| E: investors@ebrwise.com |
E: gaby@thecapitalnetwork.com.au |
| |
|
| |
Julia Maguire |
| |
The Capital Network |
| |
P: +61 2 7257 7338 |
| |
E: julia@thecapitalnetwork.com.au |
About EBR Systems
Silicon Valley-based EBR Systems (ASX:EBR) is
dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac
pacing. The patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac
pacing leads, historically the major source of complications, effectiveness and reliability issues in cardiac rhythm disease management.
The initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients
requiring Cardiac Resynchronisation Therapy (CRT). Future products potentially address wireless endocardial stimulation for bradycardia
and other non-cardiac indications.
EBR SYSTEMS, INC. (ARBN
654 147 127)
4600 Patrick Henry Drive, Santa Clara CA 95054
USA T: +1 408 720 1906 W: https://ebrsystemsinc.com/
EBR Systems’ WiSE Technology
EBR Systems’ WiSE technology is the world’s
only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart’s left ventricle. This has
long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is thought to be a potentially superior,
more anatomically correct pacing location. WiSE technology enables cardiac pacing of the left ventricle with a novel cardiac implant that
is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart’s left ventricle – and
the attendant problems – are potentially eliminated. WiSE is an investigational device in most markets and is currently only available
for sale in the US.
Forward-Looking Statements
This announcement contains or may contain forward-looking
statements that are based on management’s beliefs, assumptions, and expectations and on information currently available to management.
Forward-looking statements involve known and unknown risks, uncertainties, contingencies and other factors, many of which are beyond the
Company’s control, subject to change without notice and may involve significant elements of subjective judgment and assumptions
as to future events which may or may not be correct.
All statements that address operating performance,
events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation
our expectations with respect to our ability to commercialize our products and achieve broad market adoption including our estimates of
potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products; our expectations
with respect to our clinical trials, including enrollment in or completion of our clinical trials and our associated regulatory applications
and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. These forward-looking
statements are based on EBR Systems’ current expectations and inherently involve significant risks and uncertainties. EBR Systems’
actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result
of certain risks and uncertainties including those risks described in more detail in its most recently filed Annual Report on Form 10-K,
Quarterly Report on Form 10-Q, and other documents on file with the SEC from time to time and available on the SEC’s website
at www.sec.gov.
Management believes that these forward-looking
statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only
as of the date when made. EBR does not assume any obligation to publicly update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise. EBR may not actually achieve the plans, projections or expectations disclosed in
forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking
statements.
Foreign Ownership Restriction
EBR’s ASX-traded (ASX: EBR) CHESS Depositary
Interests (CDIs) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933
(Securities Act) for offers or sales which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under
the Securities Act or the laws of any state or other jurisdiction in the US. The holders of EBR’s CDIs are unable to sell the CDIs
into the US or to a US person unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. Hedging
transactions with regard to the CDIs may only be conducted in accordance with the Securities Act.
EBR SYSTEMS, INC. (ARBN
654 147 127)
4600 Patrick Henry Drive, Santa Clara CA 95054
USA T: +1 408 720 1906 W: https://ebrsystemsinc.com/