October 7, 2024

John McCutcheon
Chief Executive Officer
EBR Systems, Inc.
480 Oakmead Parkway
Sunnyvale, CA 94085

       Re: EBR Systems, Inc.
           Amendment No. 1 to Registration Statement on Form 10-12G
           Filed September 18, 2024
           File No. 000-56671
Dear John McCutcheon:

       We have reviewed your filing and have the following comments.

       Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe a
comment applies to your facts and circumstances, please tell us why in your
response.

         After reviewing your response and any amendment you may file in
response to this
letter, we may have additional comments.

Form 10-12G/A filed September 18, 2024
Overview of anticipated commercial pathway for WiSE, page 15

1.     We note your response to prior comment 6 and reissue in part. Refer to
Figure 1.7:
       Anticipated Commercial Pathway for WiSE System. Please revise Figure 1.7
to
       remove any implication and clarify that there is no assurance that your
product will be
       approved by the FDA in the first quarter of 2025, with adoption and
growth to follow
       in 2026. Please revise your disclosures throughout accordingly.
Target markets for WiSE CRT, page 17

2.     We note the disclosure that you believe the addressable market
opportunity to be
       approximately $3.6 billion in the U.S based on the distinct patient
groups, that include
       (i) patients whose existing CRT system leads to the left heart have
either been
       deactivated or become ineffective, due to malfunction and/or failure
(Chronic Lead
       Failure), (ii) where lead placement to pace the LV such as via the
coronary sinus (CS),
       was not achievable due to anatomical or disease-related barriers (Acute
Lead Failure),
 October 7, 2024
Page 2

       (iii) patients with pre-existing pacemaker systems often need upgrades
to biventricular
       pacing as their heart failure progresses (High Risk Upgrade), and (iv)
subset of
       patients using leadless pacemakers that may require biventricular
pacing, which
       traditional systems cannot provide (Leadless Upgrades). On page 37, you
disclose that
       your estimates of the annual total addressable markets for WiSE CRT are
based on
       "internal and third-party estimates, including, the number of patients
with heart failure
       requiring Cardiac Resynchronization Therapy and the assumed prices at
which
       [you] can sell products for markets that have not been definitively
established." Please
       revise your disclosure to more fully describe the material assumptions
used in your
       total addressable market estimate.
Item 1A. Risk Factors, page 43

3.     We note your revisions and response to prior comment 13. You state that
       the Company   s products include components that are manufactured and
supplied by
       third parties, some of which are single-source suppliers. Please explain
to us why
       reliance on single-source suppliers does not pose a material risk to you
or revise your
       disclosure accordingly.

Note 2 - Summary of significant accounting policies
Reclassification, page F-9

4.     We have reviewed your response and revised disclosures in response to
comment 19
       and have the following additional comments:
           Please provide us with sufficiently detailed information to
understand the specific
          nature of work your sales team performed to support and advance the
Company's
          clinical trials and ongoing clinical development and how such work
met the
          definition of research and development as set forth in ASC 730-10-20
as well as
          the guidance in ASC 730-10-55-1; and
           Notwithstanding the above bullet, if your employees performed
research and
          development activities as defined by ASC 730-10-20 during the periods
          presented, but the related expenses were classified and disclosed as
sales and
          marketing expenses in your prior financial statements and notes
thereto, it is not
          clear how those financial statements complied with the disclosure
requirements of
          ASC 730-10-50-1 which requires the disclosure of total research and
development
          costs charged to expense in each period for which an income statement
is
          presented. As such, we reissue our prior comment and ask that you
reassess the
          guidance in ASC 250-10-20 and the definition of an error in
previously issued
          financial statements and provide additional support for your
conclusion that the
          revisions to your expense classifications were not errors.
General

5.     We note your revisions in response to prior comment 22. We reissue in
part. Please
       cite the source for the statistic of 25% of all CRT implants are
classified as upgrades
       from other cardiac pacing devices or clarify if that is also from the
American Heart
       Association Journal and the Heart Rhythm Journal.
 October 7, 2024
Page 3

        We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence
of action by the staff.

       Please contact Tayyaba Shafique at 202-551-2110 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Nicholas O'Leary at 202-551-4451 or Lauren Nguyen at
202-551-
3642 with any other questions.



                                                         Sincerely,

                                                         Division of
Corporation Finance
                                                         Office of Industrial
Applications and
                                                         Services
cc:   John Sellers, Esq.