SecProbe.io

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.
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 3.

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