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CORRESP
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John H. Sellers

T: +1 650 843 5070

jsellers@cooley.com

December 17, 2024

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Technology

100 F Street, N.E.

Washington, D.C. 20549

    Re:
    EBR Systems, Inc.

    Amendment No. 3 to Registration Statement on Form 10-12G

    Filed November 21, 2024

    File No. 000-56671

Ladies and Gentlemen:

On behalf of EBR Systems Inc. (the “Company”),
we are providing this letter in response to comments (the “Comments”) received from the staff of the U.S. Securities and Exchange
Commission’s Division of Corporation Finance (the “Staff”) by letter dated December 3, 2024 with respect to the Company’s
Amendment No. 3 to Registration Statement on Form 10-12G on November 21, 2024, amending previously filed Amendment No. 2 to Registration
Statement on Form 10-12G that was filed on October 23, 2024.

Set forth below are the Company’s responses
to the Comments. The numbering of the paragraphs below corresponds to the numbering of the Comments, which for your convenience we have
incorporated into this response letter in italics. Page references in the text of the Company’s responses correspond to the page
numbers of the Amended Registration Statement. Capitalized terms used but not otherwise defined in this letter have the meanings assigned
to them in the Amended Registration Statement.

Form 10-12G/A No. 3 filed November 21, 2024

Interim Financial Statements

Pre-launch inventory, page F-37

 1. We note that during the three months ended September 30, 2024 you have begun to capitalize certain pre-launch inventory. Please expand
your disclosure herein, or within your Critical Accounting Estimates on page 75, to provide the following additional disclosures:

 · Specifically identify the point during the FDA approval process that you determined a probable future benefit existed and the status
of the FDA’s consideration of the safety and efficacy of the system and evaluation of the manufacturing process at that point.

Cooley LLP 3175 Hanover Street Palo Alto, CA 94304-1130

t: +1 650 843 5000 f: +1 650 849 7400 cooley.com

    U.S. Securities and Exchange Commission

    December 17, 2024

    Page Two

The Company
acknowledges the Staff's comment and notes that an accounting estimate is deemed critical when the nature of the estimate is material
due to the levels of subjectivity and judgment necessary to account for an item, and the impact of the estimate on our financial statements
is material. We advise the Staff that: (a) the value of pre-launch inventory, entirely comprised of raw materials, is stated at cost and
is therefore not subject to measurement uncertainty or subjectivity; and (b) the amount of the capitalized inventory was not material
as of September 30, 2024. Consequently, pre-launch inventory was not determined to be a critical accounting estimate, and therefore, not
included in the related disclosure. We have a process to continue to monitor the balance of pre-launch inventory and modify our disclosures
if our conclusions change.

The Company
determined that a probable future benefit exists when: a) the primary efficacy and safety endpoints had met the pre-specified stopping
rules and the clinical trial was concluded early for success; and b) module three of the pre-market approval application, which contained
manufacturing information, was closed with no further questions regarding the manufacturing process.

 · Identify the risks and uncertainties surrounding market acceptance of the system once approved and how this will affect the realization
of the asset.

The Company
acknowledges the Staff's comment and advises the Staff to reference the Risk Factor disclosure from Item 1A, pages 35 and 36, of our Registration
Statement on Form 10-12G, amended on November 20, 2024. In particular, we disclosed that:

“We
cannot assure you that our products will achieve broad market acceptance among hospitals and physicians... Any failure of our products
to generate sufficient demand or to achieve meaningful market acceptance and penetration will harm our future prospects and have a material
adverse effect on our business, financial condition, and results of operations… Our future growth and profitability largely depend
on our ability to increase physician awareness of our system and our products and on the willingness of hospitals, physicians, patients,
or payors to adopt them…”.

Cooley LLP 3175 Hanover Street Palo Alto, CA 94304-1130

t: +1 650 843 5000 f: +1 650 849 7400 cooley.com

    U.S. Securities and Exchange Commission

    December 17, 2024

    Page Three

We also noted
that:

“We
cannot provide assurance that our efforts to obtain such approvals or generate adoption will be successful or increase the use of our
products, and if we are not successful, it could have a material adverse effect on our business, financial condition, and results of operations”

Please refer
to the Risk Factor disclosure, as well as the pre-launch inventory disclosure on page F-37 for additional information. The Company believes
these disclosures adequately discuss risks and uncertainties surrounding market acceptance of the product once approved and how this will
affect the realization of the assets.

Please
contact me at (650) 843-5070 with any questions or further comments regarding our responses to the Staff’s comments.

    Sincerely,

    /s/ John H. Sellers

    John H. Sellers

    Cooley LLP

    cc:

    John McCutcheon, EBR Systems, Inc.

Cooley LLP 3175 Hanover Street Palo Alto, CA 94304-1130

t: +1 650 843 5000 f: +1 650 849 7400 cooley.com