July 22, 2024

Xingjuan (Jane) Chao
Chief Executive Officer
Ceribell, Inc.
360 N. Pastoria Avenue
Sunnyvale, CA 94085

       Re: Ceribell, Inc.
           Draft Registration Statement on Form S-1
           Submitted June 24, 2024
           CIK No. 0001861107
Dear Xingjuan (Jane) Chao:

       We have reviewed your draft registration statement and have the
following comments.

        Please respond to this letter by providing the requested information
and either submitting
an amended draft registration statement or publicly filing your registration
statement on EDGAR.
If you do not believe a comment applies to your facts and circumstances or do
not believe an
amendment is appropriate, please tell us why in your response.

        After reviewing the information you provide in response to this letter
and your amended
draft registration statement or filed registration statement, we may have
additional comments.

Draft Registration Statement on Form S-1 submitted June 24, 2024
Cover Page

1.     We note your disclosure on page 52 that your principal stockholders and
management
       own a significant percentage of your stock and will be able to exert
significant control
       over matters subject to stockholder approval. Please revise your cover
page to note the
       same, and to quantify the percentage of your stock that will be held by
your principal
       stockholders and management upon completion of your offering. In
addition, please tell
       us whether you expect to be deemed to be a "controlled company" under
the relevant
       listing rules. If so, please disclose on you cover page and in your
prospectus summary
       whether you intend to take advantage of the controlled company
exemptions under the
       Nasdaq rules, and provide related risk factor disclosure.
 July 22, 2024
Page 2
Prospectus Summary
Overview, page 2

2.     Where you discuss data or statistics about certain medical conditions
and the medical
       industry in which you operate, please revise to provide the sources for
your disclosures, or
       characterize the same as management's opinions or beliefs. For example,
we note the
       following disclosures:

             "conventional EEG systems, which were designed over 100 years ago
for the
           outpatient setting, are insufficient to meet the needs of critically
ill acute care patients
           as they are unable to provide the speed of diagnosis and continuous
monitoring
           necessary for optimal patient management;"

             EEG technicians "typically work limited hours, are staffed across
multiple
           departments within the hospital, and face a national supply
shortage," and "arrival at
           the bedside . . . is often delayed;"

             "it is estimated that up to 92% of all seizures in the intensive
care unit are non-
           convulsive;"

             "the overall mortality rate for status epilepticus is
approximately 30%, with mortality
           increasing by 13% for each hour that the condition goes untreated;"

             "patient response rates to first-line anti-seizure medication drop
by approximately
           30% for every hour medication is delayed from the onset of
seizures;"

             "episodes of confusion and disorientation affect more than seven
million hospitalized
           patients in the United States annually" (page 86); and

             "there is a nationwide shortage of neurologists, with demand
estimated to exceed
           supply by almost 20% by 2025."

       As a related matter, we note your disclosure on page 59 that "[i]n some
cases, we do not
       expressly refer to the sources from which this data is derived. In that
regard, when we
       refer to one or more sources of this type of data in any paragraph, you
should assume that
       other data of this type appearing in the same paragraph is derived from
sources which we
       paid for, sponsored, or conducted, unless otherwise expressly stated or
the context
       otherwise requires." Please revise your filing throughout to clearly
provide the specific
       sources for relevant data and to clearly indicate when data is derived
from sources which
       you paid for, sponsored, or conducted.
3.     You disclose that "the technological and operational limitations of
conventional EEG
       systems have contributed to significant delays in seizure diagnosis and
suboptimal patient
       care and clinical outcomes." Please clarify how patient care and
clinical outcomes are
       measured, and provide support for your disclosure that current patient
care and clinical
       outcomes are "suboptimal." As a related matter, you disclose that "the
Ceribell System
 July 22, 2024
Page 3

        enables clinicians to more rapidly and accurately diagnose and manage
patients at risk of
        seizure in the acute care setting, resulting in improved patient
outcomes and hospital and
        payer economics." Please disclose how Ceribell measures patient
outcomes, and provide
        data supporting your disclosure that outcomes and hospital and payer
economics are
        "improved."
4.      You disclose here and throughout your filing that you estimate you have
a total annual
        addressable market opportunity of approximately $2 billion in the U.S.
acute care setting.
        Please revise your disclosure to provide the data and sources
underlying your estimate of
        your annual addressable market, including how you arrived at "the
approximately three
        million acute care patients in the United States" who you believe
should be monitored
        with EEG each year due to high risk of seizures, and the average
selling prices of the
        hardware and software components of your solution.
5.      We note your disclosure in your risk factor summary that you have a
limited operating
        history and have experienced periods of significant business changes in
a short time.
        Please revise your overview to briefly discuss the operating history of
the company,
        including details describing the "significant business changes in a
short time."
Risk Factors
Business and Industry Risk Factors
We have a limited operating history . . ., page 12

6.      We note your reference to your "significant growth." Please clarify the
metric by which
        you have experienced this growth. For example, disclose whether you
have experienced
        growth in market shares, sales, revenues, or some other metric or
combination of metrics.
We rely on third parties . . ., page 32

7.      We note your disclosure that you utilize and depend upon independent
investigators and
        collaborators, such as third-party researchers, medical institutions,
and strategic partners,
        to conduct and support portions of your preclinical studies and
clinical trials under
        agreements with you. In an appropriate place in your filing, please
describe the material
        terms of these agreements.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Key Factors Affecting Our Results of Operations and Performance, page 68

8.      We note your disclosure that as you seek to increase your account base,
you expect that
        your revenue will increase due to resulting utilization and
subscription revenue. Please
        clarify what is meant by utilization revenue, including whether product
revenue and
        utilization revenue are interchangeable terms. As a related matter, you
disclose on page 69
        that your revenue will continue to fluctuate from quarter-to-quarter
due to a variety of
        factors, including the potential success of your sales force in
expanding adoption of the
        Ceribell System in new accounts and expanding the utilization of your
system in existing
        accounts. To provide context for investors regarding your statements
about revenue, for
        the periods presented in the filing, please disclose the percentage of
your total revenue
        from new accounts compared to existing accounts.
 July 22, 2024
Page 4
Gross Profit and Gross Margin, page 69

9.     Please revise your disclosure to discuss whether you expect gross margin
to increase,
       decrease, or remain the same over the short-term and to briefly describe
the factors that
       you expect to cause your gross margin to fluctuate.
Results of Operations, page 71

10.    Revise to provide more substantial discussion of the underlying drivers
of the increase in
       revenue from FY22 to FY23. For example, discuss what contributed to the
increase in
       headband sales and quantify the impact that the increase in active
account base and
       increase in adoption had on subscription revenue. See Item 303 of
Regulation S-K and
       SEC Release No. 33-8350.
Business, page 82

11.    We note your disclosure throughout the filing that the Ceribell System
hardware is simple
       to use and can be applied by any non-specialized healthcare
professional, and that EEG
       data captured by the recorder is interpreted by Clarity, which
continuously monitors the
       patient's EEG signal and can support the clinician's real-time
assessment of seizure
       activity. You also disclose that EEG data is interpreted and monitored
by specialized
       neurologists. In an appropriate place in your filing, please clarify
whether the need for a
       neurologist or other clinician to read the results of your Ceribell
System, even in
       conjunction with Clarity, could impact the "real-time" assessment of the
Ceribell System's
       data and the intended benefit of the Ceribell System to decrease delays
in diagnosis and
       monitoring. In your discussion, please address any staffing shortages in
the industry for
       clinicians.
Our Success Factors
Recurring, predictable and scalable revenue model with attractive gross
margins, page 84

12.    You disclose that "[w]e generate revenue primarily from two recurring
sources     the sale
       of our single use, disposable headbands and a monthly subscription fee
for the use of our
       system." Please revise your description of business to more clearly
describe your
       subscription model, including the cadence of subscription fees and the
material terms of
       subscription agreements, including termination provisions. In addition,
please clarify
       whether a customer can purchase your product without a subscription to
your services.
Our Growth Strategies
Increase adoption of the Ceribell System in new accounts., page 85

13.    You disclose that there are approximately 5,800 acute care facilities in
the United States
       that you believe could benefit from your system, and as of March 31,
2024, you have
       successfully deployed your system to more than 450 active accounts. To
provide context
       for investors, please clarify whether an acute care facility has one
active account, or
       whether care facilities have multiple accounts. If the 450 active
accounts are encompassed
       in less than 450 care facilities, please clarify this fact in your
disclosure. In addition,
       please revise to describe the significance of the 5,800 acute care
facilities for your growth
       plans, including how you identified that these facilities could benefit
from your system
       and whether and to what extent you have targeted or plan to target these
facilities to open
       accounts.
 July 22, 2024
Page 5

Drive utilization of the Ceribell System within our existing customer base,
page 85

14.    We note your disclosure that "[a]s we grow our customer base, we plan to
drive utilization
       of our system within existing accounts by leveraging our CAMs to raise
awareness of the
       prevalence of seizures in critically ill patients, train and educate
clinicians and nurses, and
       assist our customers in developing diagnostic protocols consistent with
medical society
       recommendations and guidelines. Since implementing this approach in July
2021, we
       have demonstrated success in meaningfully increasing utilization within
our active
       accounts." Please clarify the significance of utilization to your active
accounts, including a
       more detailed discussion of how an account can be active but
under-utilizing your product
       or services. In addition, please describe how you measure a "meaningful"
increase in
       utilization. Make conforming changes to your brief discussion of active
accounts on page
       68, where you disclose that "[w]e define active accounts as those with
an active
       subscription or recent headband usage, which is typically considered to
be six months."
Invest in further growing our base of clinical evidence., page 85

15.    You disclose that "we are sponsoring and supporting studies to further
validate the impact
       of our system on patient outcomes and to further demonstrate the
reliability and
       diagnostic utility of Clarity, with a focus on studies that validate
speed of EEG setup,
       ease-of-use, diagnostic accuracy, enhanced clinician confidence in
treatment decisions,
       improved patient outcomes, and hospital and payer economics." Please
identify the
       studies, including the parties that will perform the studies, and
clarify that there is no
       guarantee that these studies will be able to demonstrate your intended
outcomes.
Market Overview, page 86

16.    Please provide sources for the data included in your disclosures in this
section, including
       your tables and other graphics. As a related matter, we note your
references to Young, et
       al.; Payne, E.T., et al.; De Marchis, G.M., et al.; and Lowenstein, D.
H., et al. Please
       clarify your references to these sources, including a brief description
of the date,
       substance, and findings of these sources.
Our Addressable Market Opportunities in Seizures, page 89

17.    You disclose that "[b]ased on the experiences of several hospital
customers that have
       studied the impact of the Ceribell System on their institutions, we
believe that adoption of
       the Ceribell System will drive an increase in EEG testing volumes."
Please identify the
       hospitals, the parameters of the referenced studies, and the data
underlying your belief
       that the adoption of the Ceribell System will drive an increase in EEG
testing volumes. In
       addition, please disclose whether you compensated these hospitals for
their studies of the
       Ceribell System.
18.    You disclose that you have received a CE Mark for the Ceribell System in
Europe, and in
       the future you intend to pursue additional regulatory clearances in
Europe and elsewhere
       outside of the United States. Please revise your disclosure to discuss
your intended timing
       for pursuing additional regulatory clearances in Europe and to
commercialize your
       product in Europe. Identify other areas outside of the United States
where you are
       pursuing commercialization of your product, if known.
 July 22, 2024
Page 6

Other Potential Opportunities Beyond Seizures, page 90

19.    You disclose that "[i]n September 2022, we received FDA Breakthrough
Device
       Designation for the detection of delirium," and that you "have also
initiated technical and
       clinical work to develop an algorithm that may allow for earlier triage
of ischemic stroke."
       Please clarify whether and to what extent you have sought FDA approval
for the use of
       your algorithm related to ischemic stroke.
20.    As a related matter, we note your disclosure that based on the
prevalence of delirium and
       ischemic stroke, you believe expansion of your indications could
represent "an
       incremental, multi-billion-dollar market opportunity." Please provide
the basis for
       management's belief that these conditions represent a "multi-billion
dollar market
       opportunity," including further describing "prevalence" as it relates to
this opportunity.
       Please also provide your intended timing for commercialization of your
product and
       services related to these two indications, and the relevant steps you
will need to
       accomplish before commercialization.
Reading Services, page 94

21.    Please address the following issues related to your remote reading
services:

             Please expand your discussion to provide more detail describing
how your remote
           EEG interpretation services function in your business operations.
For example, please
           clarify whether a significant portion of your customer base relies
on these remote
           interpretation services. In this regard, we note your disclosure
that you believe this
           product offering will help service a "subset" of your customer
population where
           neurology infrastructure is insufficient. Please also disclose any
restrictions that
           might impact these remote interpretation services, such as any
hours-of-service
           restrictions or differences in timing of the interpretations as
opposed to non-
           remote interpretations. We note the time restrictions from
conventional EEG
           technicians mentioned on page 1 and throughout the prospectus.

             We note your disclosure that you have entered into agreements with
two
           teleneurology providers to offer remote EEG interpretation services
to customers.
           Please disclose the material terms of the agreements with two
teleneurology
           providers, and file the agreements in accordance with Item
601(b)(10) of Regulation
           S-K or tell us why you believe you are not required to do so
Our Clinical Results and Economic Evidence, page 95

22.    Where you reference studies supporting certain conclusions about
Ceribell here and
       throughout your filing, please identify the specific study supporting
this determination.
       For example only, we note the following disclosures:

             "Studies have demonstrated that the reduced montage in the
Ceribell System
           preserved key features of conventional EEG, and that focal seizures
in the area of the
           brain not covered by the reduced montage are very rare in patients
in the acute care
           setting;"
 July 22, 2024
Page 7


             "One study presented in a peer-reviewed publication and three
abstracts reporting on
           different datasets and different iterations of Clarity have shown
that the algorithm
           detected nonconvulsive status epilepticus with 87% to 100%
sensitivity, 93% to 98%
           specificity, and 99% to 100% negative predictive value;" and

             "Studies reported in publications and abstracts have shown
meaningfully shorter time
           to EEG setup (i.e., time from EEG order to EEG acquisition) and time
to
           interpretation or diagnosis with the Ceribell System. For example, a
multicenter study
           of ICUs in five major U.S. hospitals found that it took a median of
five minutes to set
           up a Ceribell EEG, while conventional EEGs took a median of 239
minutes (nearly 4
           hours) for arrival and set-up time (even with EEG technicians
available 24/7 on site
           or on-call)."

       The list of examples above is not exclusive, and you should make
conforming changes
       throughout your filing including, but not limited to, your prospectus
summary
       and description of your business.
23.    In your table beginning on page 97, please clearly list the parties who
conducted each
       identified study, the number of patients studied, if not already
disclosed, and any adverse
       events. In this regard, we note your disclosure on page 28 that the
Ceribell System has in
       certain instances issued false alarms, i.e., report seizure activity
when there is no seizure,
       and in other instances has failed to report or under-reported seizure
activity when there is
       seizure. In addition, where you note that there were "limitations" to
the study, please
       briefly describe these limitations.
24.    We note references to the DECIDE study in your table on page 97. Please
revise your
       filing to expand your discussion of the details of this study,
including:

             Date(s) of trials and location;

             Identity of trial sponsor(s);

             Trial design;

             The number of patients enrolled and the criteria for participation
in the study;

             Specific clinical endpoints established by the trial protocol;

             Observational metrics utilized and the actual results observed;
and

             Comparisons to standard of care.

       Please include a brief discussion of the importance and use of
statistical significance in
       clinical trial analytics. With respect to any additional "clinical
studies" and "third-party
       initiated trials" referenced throughout your filing, including the
"clinical studies or
 July 22, 2024
Page 8

       investigations on the Ceribell System [that] have produced . . .
negative or inconclusive
       results," please provide the information above, or tell us why you do
not include a
       discussion of the relevant studies in your filing.
Research and Development, page 102

25.    You disclose that "[o]ur delirium and ischemic stroke algorithms remain
under
       development, with ongoing research and active clinical studies." In an
appropriate place in
       your filing, please identify the clinical studies and relevant
parameters.
Manufacturing and Supply, page 103

26.    You disclose that you depend on two key suppliers for the manufacturing,
primary
       assembly, and inspection of your headband. To the extent that you are
dependent on these
       or any other suppliers, provide appropriate summary information about
any agreements
       with such suppliers, and file these agreements as exhibits to your
registration statement.
       See Item 601(b)(10) of S-K. Please also identify these suppliers in your
filing, consistent
       with Item 101(h)(4)(v) of Regulation S-K.
Intellectual Property, page 104

27.    Please revise your intellectual property disclosure to clearly describe,
for each material
       patent or group of patents or pending patent applications: (i) the
specific products, product
       groups, and technologies to which such patents relate, (ii) whether the
patents are owned
       or licensed, (iii) the type of patent protection, (iv) patent expiration
dates, and (v)
       jurisdiction. In this regard, it may be useful to provide this
disclosure in tabular form.
Certain Relationships and Related-party Transactions
Parvizi Consulting Agreement, page 133

28.    Please revise your disclosure to clarify whether the Parvizi Consulting
Agreement will
       survive this offering, and if so, please describe the material terms of
the agreement
       moving forward. Please also file the agreement as an exhibit to your
registration
       statement, or tell us why you believe you are not required to do so.
Principal Stockholders, page 134

29.    Please disclose the natural persons with voting and dispositive control
of Entities
       affiliated with The Rise Fund Clearthought L.P., Entities affiliated
with u.life fund, and
       Optimas Capital Partners Fund LP.
General

30.    Please revise your disclosure to clarify the meaning of any significant
scientific or
       technical terms or acronyms the first time they are used in the
prospectus in order to
       provide context for such terms and better ensure that lay readers will
understand the
       disclosure. For example, please define epileptiform and encephalopathic.
31.    Please supplementally provide us with copies of all written
communications, as defined in
       Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
       present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
       not they retain copies of the communications.
 July 22, 2024
Page 9

       Please contact Kristin Lochhead at 202-551-3664 or Li Xiao at
202-551-4391 if you have
questions regarding comments on the financial statements and related matters.
Please contact
Nicholas O'Leary at 202-551-4451 or Katherine Bagley at 202-551-2545 with any
other
questions.



                                                         Sincerely,

                                                         Division of
Corporation Finance
                                                         Office of Industrial
Applications and
                                                         Services
cc:   Kathleen M. Wells, Esq.