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Letter Text
Ceribell, Inc.
CIK: 0001861107  ·  File(s): 333-291249  ·  Started: 2025-11-25  ·  Last active: 2025-11-25
Orphan - no UPLOAD in window 1 company response(s) Low - unmatched response
CR Company responded 2025-11-25
Ceribell, Inc.
File Nos in letter: 333-291249
Summary
CORRESP · 2025-11-25
Generating summary...
Ceribell, Inc.
CIK: 0001861107  ·  File(s): 333-281784, 377-07298  ·  Started: 2024-09-11  ·  Last active: 2024-10-09
Response Received 4 company response(s) High - file number match
UL SEC wrote to company 2024-09-11
Ceribell, Inc.
File Nos in letter: 333-281784
Summary
UPLOAD · 2024-09-11
Generating summary...
↓
CR Company responded 2024-09-19
Ceribell, Inc.
File Nos in letter: 333-281784
References: September 11, 2024
Summary
CORRESP · 2024-09-19
Generating summary...
↓
CR Company responded 2024-10-08
Ceribell, Inc.
File Nos in letter: 333-281784
Summary
CORRESP · 2024-10-08
Generating summary...
↓
CR Company responded 2024-10-08
Ceribell, Inc.
File Nos in letter: 333-281784
Summary
CORRESP · 2024-10-08
Generating summary...
↓
CR Company responded 2024-10-09
Ceribell, Inc.
Regulatory Compliance Financial Reporting Business Model Clarity
File Nos in letter: 333-281784
References: October 8, 2024
Ceribell, Inc.
CIK: 0001861107  ·  File(s): 333-281784, 377-07298  ·  Started: 2024-10-08  ·  Last active: 2024-10-08
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2024-10-08
Ceribell, Inc.
File Nos in letter: 333-281784
Summary
UPLOAD · 2024-10-08
Generating summary...
Ceribell, Inc.
CIK: 0001861107  ·  File(s): 377-07298  ·  Started: 2024-08-23  ·  Last active: 2024-08-26
Response Received 1 company response(s) Medium - date proximity
UL SEC wrote to company 2024-08-23
Ceribell, Inc.
Summary
UPLOAD · 2024-08-23
Generating summary...
↓
CR Company responded 2024-08-26
Ceribell, Inc.
References: August 23, 2024
Summary
CORRESP · 2024-08-26
Generating summary...
Ceribell, Inc.
CIK: 0001861107  ·  File(s): 377-07298  ·  Started: 2024-07-22  ·  Last active: 2024-07-22
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2024-07-22
Ceribell, Inc.
DateTypeCompanyLocationFile NoLink
2025-11-25 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-10-09 Company Response Ceribell, Inc. DE N/A
Regulatory Compliance Financial Reporting Business Model Clarity
Read Filing View
2024-10-08 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-10-08 SEC Comment Letter Ceribell, Inc. DE 377-07298 Read Filing View
2024-10-08 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-09-19 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-09-11 SEC Comment Letter Ceribell, Inc. DE 377-07298 Read Filing View
2024-08-26 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-08-23 SEC Comment Letter Ceribell, Inc. DE 377-07298 Read Filing View
2024-07-22 SEC Comment Letter Ceribell, Inc. DE 377-07298 Read Filing View
DateTypeCompanyLocationFile NoLink
2024-10-08 SEC Comment Letter Ceribell, Inc. DE 377-07298 Read Filing View
2024-09-11 SEC Comment Letter Ceribell, Inc. DE 377-07298 Read Filing View
2024-08-23 SEC Comment Letter Ceribell, Inc. DE 377-07298 Read Filing View
2024-07-22 SEC Comment Letter Ceribell, Inc. DE 377-07298 Read Filing View
DateTypeCompanyLocationFile NoLink
2025-11-25 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-10-09 Company Response Ceribell, Inc. DE N/A
Regulatory Compliance Financial Reporting Business Model Clarity
Read Filing View
2024-10-08 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-10-08 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-09-19 Company Response Ceribell, Inc. DE N/A Read Filing View
2024-08-26 Company Response Ceribell, Inc. DE N/A Read Filing View
2025-11-25 - CORRESP - Ceribell, Inc.
CORRESP
1
filename1.htm

  CORRESP

  CeriBell, Inc.

360 N. Pastoria Avenue
Sunnyvale, CA 94085

November 25, 2025

VIA EDGAR

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

Attention: Margaret Sawicki

Re:	CeriBell, Inc.

	Registration Statement on Form S-3 (File No. 333-291249)

Ladies and Gentlemen:

In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration by the Securities and Exchange Commission of the effective date of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”) of CeriBell, Inc. We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on December 1, 2025, or as soon as practicable thereafter.

Thank you for your assistance in this matter.

     Very truly yours,

     CERIBELL, INC.

     By:

     /s/ Scott Blumberg

     Scott Blumberg

     Chief Financial Officer

     cc:

     Louisa Daniels, CeriBell, Inc.

     Yawen Du, CeriBell, Inc.

     Kathleen Wells, Latham & Watkins LLP

     John Williams, Latham & Watkins LLP
2024-10-09 - CORRESP - Ceribell, Inc.
Read Filing Source Filing Referenced dates: October 8, 2024
CORRESP
1
filename1.htm

  CORRESP

    140 Scott Drive

Menlo Park, California  94025

Tel: +1.650.328.4600  Fax: +1.650.463.2600

www.lw.com

    FIRM / AFFILIATE OFFICES

    Austin

    Milan

    Beijing

    Munich

    Boston

    New York

    Brussels

    Orange County

    Century City

    Paris

    October 9, 2024

    Chicago

    Riyadh

    Dubai

    San Diego

    Düsseldorf

    San Francisco

    Frankfurt

    Seoul

    Hamburg

    Silicon Valley

    Hong Kong

    Singapore

    VIA EDGAR

    Houston

    Tel Aviv

    London

    Tokyo

    United States Securities and Exchange Commission
Division of Corporation Finance

100 F Street, N.E.
Washington, D.C. 20549-6010

    Los Angeles

    Washington, D.C.

    Madrid

    Attention:

    Nicholas O’Leary

Katherine Bagley

Kristin Lochhead

Li Xiao

              Re:

    CeriBell, Inc.
Response to Letter dated October 8, 2024

Amendment No. 2 to Registration Statement on Form S-1
Filed October 7, 2024

File No. 333-281784

  To the addressee set forth above:

  CeriBell, Inc. (the “Company”) has filed with the U.S. Securities and Exchange Commission (the “Commission”) on the date hereof Amendment No. 3 to its Registration Statement on Form S-1 (the “Registration Statement”). The Company previously filed with the Commission Amendment No. 2 to Registration Statement on Form S-1 (“Amendment No. 2 to Registration Statement”) on October 7, 2024 (File No. 333-281784). The Registration Statement has been revised to reflect the Company’s responses to the comment letter to Amendment No. 2 to Registration Statement received on October 8, 2024 from the staff of the Commission (the “Staff”), and we are hereby providing the Company’s responses to the Staff’s letter.

  For ease of review, we have set forth below each of the numbered comments of the Staff’s letter in bold type followed by the Company’s responses thereto.

     October 9, 2024

Page 2

  Amendment No. 2 to Registration Statement on Form S-1 filed October 7, 2024

  Prospectus Summary

  Recent Developments

  Preliminary Financial Results as of and for the Three Months Ended September 30, 2024

  1.We note your disclosure that “[s]uch estimated and unaudited data constitute forward-looking statements based solely on information available to us as of the date of this prospectus and may differ materially from actual results,” “[o]nce our quarter-end financial closing process is completed, we may report financial results and other data that could differ, and the differences could be material,” and “[w]hile we believe that such information and estimates are based on reasonable assumptions, our actual results may vary, and such variations may be material.” If you choose to disclose preliminary estimates, you should be able to assert that the actual results are not expected to differ “materially” from those reflected in the preliminary estimates. Please revise or remove these statements accordingly.

  Response: The Company respectfully acknowledges the Staff’s comment and has revised page 6 of the Registration Statement accordingly.

  The Offering, page 9

  2.We note your revised disclosure on page 10 that “[c]ertain of our existing stockholders, including stockholders affiliated with certain of our directors, have indicated an interest in purchasing up to an aggregate of approximately $40 million of shares of our common stock in this offering at the initial public offering price (which would represent approximately 40% of the shares sold in this offering).” Given that this indication of interest represents a significant percentage of your total offering, please revise your cover page to include this disclosure. In addition, please identify the relevant directors that are affiliated with the stockholders who have indicated an interest, and disclose whether any 5% or greater shareholders are included in this indication of interest. Finally, please clarify whether and to what extent this interest, if purchased, would impact any of the controlling shareholder percentages you disclose throughout your filing, including on your cover page. Revise you risk factor at the top of page 53 accordingly.

  Response: The Company respectfully acknowledges the Staff’s comment and has revised the prospectus cover page and pages 10, 52-53 and 157-159 of the Registration Statement accordingly.

  * * *

     October 9, 2024

Page 3

  We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (650) 463-2677 or by email at kathleen.wells@lw.com with any questions or comments regarding this correspondence.

    Very truly yours,

    /s/ Kathleen Wells

    Kathleen Wells, Esq.

of LATHAM & WATKINS LLP

    cc:

    Jane Chao, Ph.D., CeriBell, Inc.

Scott Blumberg, CeriBell, Inc.
Louisa Daniels, CeriBell, Inc.
John Williams, Latham & Watkins LLP

Richard Kim, Latham & Watkins LLP
Ilir Mujalovic, Allen Overy Shearman Sterling US LLP
2024-10-08 - CORRESP - Ceribell, Inc.
CORRESP
1
filename1.htm

  CORRESP

  CeriBell, Inc.

  360 N. Pastoria Avenue

  Sunnyvale, California 94085

  October 8, 2024

  VIA EDGAR

  United States Securities and Exchange Commission
Division of Corporation Finance

  100 F Street, N.E.
Washington, D.C. 20549-6010

    Attention:

    Nicholas O’Leary

    Katherine Bagley

    Kristin Lochhead

    Li Xiao

  Re:	CeriBell, Inc. Registration Statement on Form S-1 (Registration No. 333-281784)

  To the addressee set forth above:

  In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-1 (Registration No. 333-281784) (the “Registration Statement”) of CeriBell, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on October 10, 2024, or as soon as practicable thereafter, or at such other time thereafter as our counsel, Latham & Watkins LLP may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Kathleen Wells at (650) 463-2677 or John Williams at (415) 395-8223.

  Thank you for your assistance in this matter.

    Very truly yours,

    CERIBELL, INC.

    By:

    /s/ Scott Blumberg

    Scott Blumberg

    Chief Financial Officer

    cc:

    Jane Chao, Ph.D., CeriBell, Inc.

    Louisa Daniels, CeriBell, Inc.

    Kathleen Wells, Latham & Watkins LLP

    John Williams, Latham & Watkins LLP

    Richard Kim, Latham & Watkins LLP

    Ilir Mujalovic, Allen Overy Shearman Sterling US LLP
2024-10-08 - UPLOAD - Ceribell, Inc. File: 377-07298
October 8, 2024
Xingjuan (Jane) Chao
Chief Executive Officer
Ceribell, Inc.
360 N. Pastoria Avenue
Sunnyvale, CA 94085
Re:Ceribell, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed October 7, 2024
File No. 333-281784
Dear Xingjuan (Jane) Chao:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing
the requested information. 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 any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our September 11, 2024,
letter.
Amendment No. 2 to Registration Statement on Form S-1 filed October 7, 2024
Prospectus Summary
Recent Developments
Preliminary Financial Results as of and for the Three Months Ended September 30, 2024,
page 6
We note your disclosure that "[s]uch estimated and unaudited data constitute forward-
looking statements based solely on information available to us as of the date of this
prospectus and may differ materially from actual results," "[o]nce our quarter-end
financial closing process is completed, we may report financial results and other data
that could differ, and the differences could be material," and "[w]hile we believe that
such information and estimates are based on reasonable assumptions, our actual 1.

October 8, 2024
Page 2
results may vary, and such variations may be material." If you choose to disclose
preliminary estimates, you should be able to assert that the actual results are not
expected to differ "materially" from those reflected in the preliminary estimates.
Please revise or remove these statements accordingly.
The Offering, page 9
2.We note your revised disclosure on page 10 that "[c]ertain of our existing
stockholders, including stockholders affiliated with certain of our directors, have
indicated an interest in purchasing up to an aggregate of approximately $40 million of
shares of our common stock in this offering at the initial public offering price (which
would represent approximately 40% of the shares sold in this offering)." Given that
this indication of interest represents a significant percentage of your total offering,
please revise your cover page to include this disclosure. In addition, please identify
the relevant directors that are affiliated with the stockholders who have indicated an
interest, and disclose whether any 5% or greater shareholders are included in this
indication of interest. Finally, please clarify whether and to what extent this interest, if
purchased, would impact any of the controlling shareholder percentages you disclose
throughout your filing, including on your cover page. Revise you risk factor at the top
of page 53 accordingly.
            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.
2024-10-08 - CORRESP - Ceribell, Inc.
CORRESP
1
filename1.htm

  CORRESP

  October 8, 2024

  VIA EDGAR

  U.S. Securities and Exchange Commission

  Division of Corporation Finance

  100 F Street N.E.

  Washington, D.C. 20549-6010

    Attn:

    Nicholas O’Leary

Katherine Bagley

Kristin Lochhead

Li Xiao

    Re:

    CeriBell, Inc.

Registration Statement on Form S-1, as amended (File No. 333-281784)

Request for Acceleration of Effective Date

  Ladies and Gentlemen:

  In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we hereby join in the request of CeriBell, Inc. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 4:00 p.m., Washington, D.C. time, on October 10, 2024, or as soon as practicable thereafter.

  Pursuant to Rule 460 under the Act, please be advised that we have distributed approximately 620 copies of the Preliminary Prospectus dated October 7, 2024 (the “Preliminary Prospectus”) through the date hereof, to underwriters, dealers, institutions and others.

  In connection with the Preliminary Prospectus distribution for the above-referenced issue, the prospective underwriters have confirmed that they are complying with the 48-hour requirement in Rule 15c2‑8(b) under the Securities Exchange Act of 1934, as amended.

  Very truly yours,

  BOFA SECURITIES, INC.

  J.P. Morgan Securities LLC

  As Representatives of the several underwriters

  [Signature Pages Follow]

    BOFA SECURITIES, INC.

    By:

     /s/ Milton Hsu

    Name:

    Milton Hsu

    Title:

    Managing Director

    J.P. MORGAN SECURITIES LLC

    By:

     /s/ Benjamin Burdett

    Name:

    Benjamin Burdett

    Title:

    Managing Director, Head of Healthcare ECM

  As representatives of the several underwriters

  cc: Ilir Mujalovic, Allen Overy Shearman Sterling US LLP

  [Signature Page to Acceleration Request Letter]
2024-09-19 - CORRESP - Ceribell, Inc.
Read Filing Source Filing Referenced dates: September 11, 2024
CORRESP
1
filename1.htm

  CORRESP

        FIRM / AFFILIATE OFFICES

        Austin

        Milan

        Beijing

        Munich

        Boston

        New York

        Brussels

        Orange County

        Century City

        Paris

        Chicago

        Riyadh

        Dubai

        San Diego

        Düsseldorf

        San Francisco

        Frankfurt

        Seoul

        Hamburg

        Silicon Valley

        Hong Kong

        Singapore

        Houston

        Tel Aviv

        London

        Tokyo

        Los Angeles

        Washington, D.C.

        Madrid

       140 Scott Drive

Menlo Park, California 94025

Tel: +1.650.328.4600 Fax: +1.650.463.2600

www.lw.com

September 19, 2024

VIA EDGAR

United States Securities and Exchange Commission
Division of Corporation Finance

100 F Street, N.E.
Washington, D.C. 20549-6010

      Attention:

      Nicholas O’Leary

Katherine Bagley

Kristin Lochhead

Li Xiao

      Re:

      CeriBell, Inc.

Response to Letter dated September 11, 2024

Registration Statement on Form S-1
Filed August 26, 2024

File No. 333-281784

To the addressee set forth above:

CeriBell, Inc. (the “Company”) has filed with the U.S. Securities and Exchange Commission (the “Commission”) on the date hereof Amendment No. 1 to its Registration Statement on Form S-1 (the “Registration Statement”). The Company previously filed with the Commission a Registration Statement on Form S-1 (the “Initial Registration Statement”) on August 26, 2024 (File No. 333-281784). The Registration Statement has been revised to reflect the Company’s responses to the comment letter to the Initial Registration Statement received on September 11, 2024 from the staff of the Commission (the “Staff”), and we are hereby providing the Company’s responses to the Staff’s letter.

For ease of review, we have set forth below each of the numbered comments of the Staff’s letter in bold type followed by the Company’s responses thereto.

September 19, 2024

Page 2

Registration Statement on Form S-1 filed August 26, 2024

Cover Page

1.We note that you include prominent images after your prospectus cover page. We do not object to graphics that solely feature your products; however, these images should present balanced information about your business. For example, we note that one of your graphics states: “Ceribell AI-Powered Neurodiagnostics,” without additional context, and you disclose throughout your filing that your AI-powered seizure detection algorithm requires a clinician’s assessment and diagnosis. Please revise or remove accordingly. For guidance, refer to Question 101.02 of Securities Act Forms Compliance and Disclosure Interpretations.

Response: The Company respectfully acknowledges the Staff’s comment and has revised the graphics included after the prospectus cover page of the Registration Statement accordingly.

Risk Factors

We rely on third parties . . ., page 32

2.We note your response to comment 3. Please provide a more detailed legal analysis describing why these collaboration agreements are not material to your business.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the agreements with independent investigators and collaborators were entered into in the ordinary course of the Company’s business in connection with its preclinical studies and clinical trials, that the Company does not make material payments pursuant to these agreements, and that the agreements provide for the Company’s sole ownership of the Company’s background intellectual property. The Company’s business is not substantially dependent on such ordinary course agreements, within the meaning of Item 601(b)(10) of Regulation S-K. The Company will continue to monitor its analysis on a going-forward basis.

Participation in this offering by our existing stockholders . . ., page 52

3.You disclose that “[t]o the extent certain of our existing stockholders and their affiliated entities participate in this offering, such purchases would reduce the non-affiliate public float of our shares, meaning the number of shares of our common stock that are not held by officers, directors, and controlling stockholders.” Please revise your disclosure throughout the filing, including your prospectus summary, to clarify whether and to what extent existing stockholders and their affiliates have indicated an interest in purchasing shares in your offering.

Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 52 of the Registration Statement to clarify that there are no

September 19, 2024

Page 3

assurances that existing stockholders or their affiliated entities will participate in the offering to a material extent. The Company further respectfully advises the Staff that in the event existing stockholders and their affiliated entities indicate an interest in purchasing shares in the offering to a material extent, the Company will revise the disclosure to include language in substantially the form noted below:

Certain of our existing stockholders, including stockholders affiliated with certain of our directors, have indicated an interest in purchasing up to an aggregate of approximately $[__] million of shares of our common stock in this offering at the initial public offering price. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters may determine to sell more, fewer or no shares of our common stock in this offering to these entities, or these entities may determine to purchase more, fewer or no shares of our common stock in this offering. The underwriters will receive the same underwriting discounts and commissions on any shares of our common stock purchased by these entities as they will on any other shares of our common stock sold to the public in this offering.

Use of Proceeds, page 61

4.We note your revised disclosure that you will use a certain portion of the proceeds to “advance our delirium and ischemic stroke indications through completion of clinical studies.” Please revise your disclosure to clarify that “completion” of these studies does not necessarily mean that you will receive FDA approval for these indications. Please also clarify whether and to what extent these studies will relate to your Ceribell headbands, recorder, and portal and your Clarity algorithm.

Response: The Company respectfully acknowledges the Staff’s comment and has revised page 61 of the Registration Statement accordingly.

Other Potential Opportunities Beyond Seizures, page 95

5.We note your revised disclosure in response to prior comment 7, but it was not completely responsive to our comment. Please clarify how you determined, based on the average selling price of your headband, that expansion of your indications could represent an incremental, multi-billion-dollar market opportunity, given that your headbands have not been used for these indications and that you have no timeline for commercialization of your Ceribell System relating to these indications. Alternatively, please remove this disclosure from your filing.

Response: The Company respectfully acknowledges the Staff’s comment and has revised pages 2, 88, 89 and 96 of the Registration Statement accordingly.

September 19, 2024

Page 4

Intellectual Property, page 123

6.We note your revised disclosure in response to prior comment 10. Please revise to include the type of patent protection for each listed patent.

Response: The Company respectfully acknowledges the Staff’s comment and has revised page 123 of the Registration Statement accordingly.

Management, page 135

7.We note your disclosure here and throughout the filing that Dr. Parvizi will resign from your board of directors immediately prior to the effectiveness of this registration statement. Revise your disclosure to discuss the extent to which Dr. Parvizi will be entitled to severance and other benefits upon a change in control. In addition, please clarify whether the Parvizi Consulting Agreement will survive this transaction given Dr. Parvizi’s resignation, and if so, 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.

Response: The Company respectfully acknowledges the Staff’s comment and respectfully advises the Staff that the Company has not yet determined the terms of Dr. Parvizi’s consulting relationship with the Company following the offering, including any benefits, and that it plans to revise the disclosure in response to the Staff’s comment and file the agreement with Dr. Parvizi as an exhibit in a future amendment to the Registration Statement.

General

8.We note references to lock-up and market standoff arrangements or agreements throughout your registration statement. If these will be stand-alone agreements, separate from your underwriting agreement, please revise your exhibit index and file these as exhibits.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the form of lock-up agreement will be included as an exhibit to the underwriting agreement that is filed as an exhibit to the Registration Statement. The Company further advises the Staff that the market standoff provisions that apply to substantially all shares not otherwise subject to the lock-up agreements are included in documents that are already filed as exhibits to the Registration Statement, including the provisions in the form agreements under the Company’s 2014 Stock Incentive Plan and 2024 Equity Incentive Plan, which have been filed as Exhibits 10.11 and 10.13 to the Registration Statement, respectively.

* * *

September 19, 2024

Page 5

We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (650) 463-2677 or by email at kathleen.wells@lw.com with any questions or comments regarding this correspondence.

      Very truly yours,

      /s/ Kathleen Wells

      Kathleen Wells, Esq.

of LATHAM & WATKINS LLP

      cc:

      Jane Chao, Ph.D., CeriBell, Inc.

      Scott Blumberg, CeriBell, Inc.
Louisa Daniels, CeriBell, Inc.
John Williams, Latham & Watkins LLP

      Richard Kim, Latham & Watkins LLP
Ilir Mujalovic, Allen Overy Shearman Sterling US LLP
2024-09-11 - UPLOAD - Ceribell, Inc. File: 377-07298
September 11, 2024
Xingjuan (Jane) Chao
Chief Executive Officer
Ceribell, Inc.
360 N. Pastoria Avenue
Sunnyvale, CA 94085
Re:Ceribell, Inc.
Registration Statement on Form S-1
Filed August 26, 2024
File No. 333-281784
Dear Xingjuan (Jane) Chao:
            We have reviewed your registration statement and have the following comments.
            Please respond to this letter by amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our August 23, 2024, letter.
Registration Statement on Form S-1 filed August 26, 2024
Cover Page
1.We note that you include prominent images after your prospectus cover page. We do not
object to graphics that solely feature your products; however, these images should present
balanced information about your business. For example, we note that one of your graphics
states: "Ceribell AI-Powered Neurodiagnostics," without additional context, and you
disclose throughout your filing that your AI-powered seizure detection algorithm requires
a clinician's assessment and diagnosis. Please revise or remove accordingly. For guidance,
refer to Question 101.02 of Securities Act Forms Compliance and Disclosure
Interpretations.
Risk Factors
We rely on third parties . . ., page 32
We note your response to comment 3. Please provide a more detailed legal analysis 2.

September 11, 2024
Page 2
describing why these collaboration agreements are not material to your business.
Participation in this offering by our existing stockholders . . ., page 52
3.You disclose that "[t]o the extent certain of our existing stockholders and their affiliated
entities participate in this offering, such purchases would reduce the non-affiliate public
float of our shares, meaning the number of shares of our common stock that are not held
by officers, directors, and controlling stockholders." Please revise your disclosure
throughout the filing, including your prospectus summary, to clarify whether and to what
extent existing stockholders and their affiliates have indicated an interest in
purchasing shares in your offering.
Use of Proceeds, page 61
4.We note your revised disclosure that you will use a certain portion of the proceeds to
"advance our delirium and ischemic stroke indications through completion of clinical
studies." Please revise your disclosure to clarify that "completion" of these studies does
not necessarily mean that you will receive FDA approval for these indications. Please also
clarify whether and to what extent these studies will relate to your Ceribell headbands,
recorder, and portal and your Clarity algorithm.
Other Potential Opportunities Beyond Seizures, page 95
5.We note your revised disclosure in response to prior comment 7, but it was not completely
responsive to our comment. Please clarify how you determined, based on the average
selling price of your headband, that expansion of your indications could represent an
incremental, multi-billion-dollar market opportunity, given that your headbands have not
been used for these indications and that you have no timeline for commercialization of
your Ceribell System relating to these indications.  Alternatively, please remove this
disclosure from your filing.
Intellectual Property, page 123
6.We note your revised disclosure in response to prior comment 10. Please revise to include
the type of patent protection for each listed patent.
Management, page 135
7.We note your disclosure here and throughout the filing that Dr. Parvizi will resign from
your board of directors immediately prior to the effectiveness of this registration
statement. Revise your disclosure to discuss the extent to which Dr. Parvizi will be
entitled to severance and other benefits upon a change in control. In addition, please
clarify whether the Parvizi Consulting Agreement will survive this transaction given Dr.
Parvizi's resignation, and if so, 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.
General
We note references to lock-up and market standoff arrangements or agreements
throughout your registration statement. If these will be stand-alone agreements, separate
from your underwriting agreement, please revise your exhibit index and file these as 8.

September 11, 2024
Page 3
exhibits.
            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.
            Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            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.
2024-08-26 - CORRESP - Ceribell, Inc.
Read Filing Source Filing Referenced dates: August 23, 2024
CORRESP
1
filename1.htm

  CORRESP

    140 Scott Drive

    Menlo Park, California  94025

    Tel: +1.650.328.4600  Fax: +1.650.463.2600

    www.lw.com

    FIRM / AFFILIATE OFFICES

August 26, 2024

    Austin

    Milan

    Beijing

    Munich

    Boston

    New York

    Brussels

    Orange County

    Century City

    Paris

    Chicago

    Riyadh

    Dubai

    San Diego

    Düsseldorf

    San Francisco

    Frankfurt

    Seoul

    Hamburg

    Silicon Valley

    Hong Kong

    Singapore

    VIA EDGAR

    Houston

    Tel Aviv

    London

    Tokyo

    Los Angeles

    Washington, D.C.

    United States Securities and Exchange Commission

    Madrid

  Division of Corporation Finance

  100 F Street, N.E.

  Washington, D.C. 20549-6010

    Attention:

    Nicholas O’Leary

    Katherine Bagley

    Kristin Lochhead

    Li Xiao

    Re:

    CeriBell, Inc.

    Response to Letter dated August 23, 2024

    Amendment No. 1 to Draft Registration Statement on Form S-1

    Submitted August 5, 2024

    CIK No. 0001861107

  To the addressee set forth above:

  CeriBell, Inc. (the “Company”) has filed with the U.S. Securities and Exchange Commission (the “Commission”) on the date hereof a Registration Statement on Form S-1 (the “Registration Statement”). The Company previously submitted to the Commission a draft Registration Statement on Form S-1 on a confidential basis pursuant to Title I, Section 106 under the Jumpstart Our Business Startups Act on June 24, 2024, as amended by Amendment No. 1 to the draft Registration Statement submitted on a confidential basis on August 5, 2024 (“Amendment No. 1”). The Registration Statement has been revised to reflect the Company’s responses to the comment letter to Amendment No. 1 received on August 23, 2024 from the staff of the Commission (the “Staff”), and we are hereby providing the Company’s responses to the Staff’s letter.

  For ease of review, we have set forth below each of the numbered comments of the Staff’s letter in bold type followed by the Company’s responses thereto.

     August 26, 2024

     Page 2

  Amendment No. 1 to Draft Registration Statement on Form S-1

  Prospectus Summary

  Overview, page 1

  1.We note your response to comment 3 and your revised disclosure on page 94, but your revisions are not completely responsive to our comment. Please revise your prospectus summary to disclose how patient care and clinical outcomes are measured. Footnote disclosure or cross-references may be appropriate.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 1, 68, 87, and 94 of the Registration Statement accordingly to include additional disclosure regarding how the Company measures patient care and clinical outcomes and to include cross references.

  Market Opportunity, page 3

  2.We note your revisions in response to comment 4, including your amended disclosure on page 95. Please revise your prospectus summary to briefly describe the basis for your estimate of your addressable market opportunity. A cross reference or footnote disclosure may be appropriate. Also, your response indicates that the company does not believe “the average selling prices of the hardware and software components of its solution is information that is material to an understanding of the Company's estimate of its total annual addressable market opportunity, in the context of the other details included in Amendment No. 1. The Company has determined the average selling price for the hardware and software components of its solution in light of the value of its solution, competitive benefits, market dynamics, customer demand, competitive pressures and other relevant factors.” Please further explain why the average selling prices of hardware and software components of the company's product are not material to an understanding of the company's total annual addressable market opportunity, given that the market opportunity of $2 billion appears to be tied to your ability to sell your hardware and software at a certain average price.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 3, 88, and 95-96 of the Registration Statement accordingly to include the list prices of the Company’s headband and monthly subscription to Clarity (before market-based discounts) to provide further information related to the Company’s addressable market calculations.  The Company believes these list prices provide a reasonable basis for its addressable market estimates.

     August 26, 2024

     Page 3

  Risk Factors

  We rely on third parties . . ., page 32

  3.We note your revisions in response to prior comment 7. To the extent that any of these collaboration agreements are material, please identify the relevant agreement and include a description of the material terms of each of these agreements in your filing, including rights and obligations, financial terms including amounts paid to date, aggregate milestone amounts to be paid or received, the royalty range and term, as applicable, term, and termination provisions. Please also file these agreements as exhibits.

  Response:	The Company respectfully advises the Staff that none of the Company’s agreements with investigators or collaborators to conduct or support portions of the Company’s preclinical studies and clinical trials are material from either a quantitative or qualitative perspective. These agreements are immaterial in amount and the Company’s business is not dependent on them.

  Use of Proceeds, page 61

  4.We note your disclosure that you “currently intend to use the net proceeds from this offering to fund sales and marketing efforts, fund research and product development activities, conduct or sponsor clinical studies, and for general corporate purposes, including working capital, operating expenses, and capital expenditures.” Please revise to clarify the approximate amount of your net proceeds for each of the principal purposes listed in your disclosure, if known. Please also clarify the products for which you intend to “conduct or sponsor clinical studies,” and the stage of development you expect to reach with proceeds from the offering.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 8, 51, and 61 of the Registration Statement accordingly.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations

  Liquidity and Capital Resources

  Sources of Liquidity, page 80

  5.Please revise your disclosure in this section to provide additional detail about the material terms of the relevant loans, including, as discussed in your revised disclosure on page F-23, that the SVB Loan carries a variable per-annum interest rate at the Prime Rate subject to the floor of 6.00%, the Horizon Loan carries a variable per-annum interest rate at the Prime Rate plus 2.75%, subject to the floor of 9.25%, and that the Company is also required to pay end-of-term fees of 4.0% per tranche drawn on the Maturity Date or upon repayment of the amounts due to the Lenders under the VLSA. In addition, please disclose that the Revolving Facility includes additional fees of $300,000 million that are payable regardless of whether any amounts are drawn. As a related matter, we note your disclosure on page F-23 that “[u]pon execution of the VLSA, the Company paid to the Lenders $245,000 and issued

     August 26, 2024

     Page 4

  warrants to purchase 106,263 shares of the Company’s Series C-1 Preferred Stock at a price of $4.47 per share (‘Initial Warrants’).” Please revise your disclosure here to include a discussion of these terms.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 80, F-22, and F-23 of the Registration Statement accordingly.

  Business

  Invest in further growing our base of clinical evidence, page 91

  6.We note your revisions and response to prior comment 15, but we are not persuaded by your response. Please revise to identify the studies you are sponsoring and supporting, including the parties that will perform the studies, the trial design, and primary end points of the studies.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 91, and 117-118 of the Registration Statement accordingly.

  Other Potential Opportunities Beyond Seizures, page 95

  7.We note your revised disclosure in response to comments 19, 20, and 25, including that you have not yet applied for marketing authorization from the FDA for the use of the Ceribell System relating to delirium or ischemic stroke, and that prior to commercialization within these indications, you would need to apply for and obtain the required marketing authorizations. Please revise to clearly disclose when you expect to apply for marketing authorizations from the FDA, that you have no intended timeline for commercialization of the services related to these two indications, and that there is no guarantee you will obtain the required authorizations. Please also clarify how you determined, based on the average selling price of your headband, that expansion of your indications could represent an incremental, multi-billion-dollar market opportunity, given that your headbands have not been used for these indications and that you have no timeline for commercialization of your Ceribell System relating to these indications. Finally, provide a brief description of the ongoing research and active clinical studies, if any, related to these two indications. In this regard, we note your disclosure on page 118.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 95-96 of the Registration Statement accordingly.

     August 26, 2024

     Page 5

  Our Addressable Market Opportunity in Seizures, page 95

  8.We note your response to comment 18. Please revise to state, as you do in your response, that you do not have specific, intended timing at this stage of development: (i) for pursuing additional regulatory clearances in Europe, or (ii) to commercialize your product in Europe.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 4, 68, 88, 91, 96, and 101 of the Registration Statement accordingly to include the revised statement and to note that the Company intends to pursue additional clearances in Europe within two to four years of its initial public offering.

  Our Clinical Results and Economic Evidence, page 101

  9.We note your footnote disclosure on page 117 including “Study was supported, sponsored, or funded by Ceribell.” Please clarify the difference between supported, sponsored, or funded, and clarify which of the studies noted in the table are included in each category.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 103-118 of the Registration Statement accordingly.

  Intellectual Property, page 120

  10.We note your revisions in response to prior comment 27; however, these revisions do not appear to be completely responsive to our comment. Please revise your intellectual property disclosure to clearly describe in tabular form, 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.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised pages 123-127 of the Registration Statement accordingly.

  Underwriting

  Directed Share Program, page 165

  11.We note your disclosure here and throughout the prospectus regarding your directed share program. Please revise your prospectus to clarify, where appropriate:

  •whether the participating employees in the directed share program include any directors, officers, business associates, and related persons;

  •the “certain minimum requirements” for the directed share program; and

     August 26, 2024

     Page 6

  •the risks associated with the participants of the directed share program not being subject to a 180-day lock-up restriction.

  In addition, please expand your disclosure to address the process that prospective participants will follow to participate in the program, the manner by which you will communicate with prospective participants about the program, when and how you will determine the allocation for the program, whether such allocation will change depending on the interest level of potential participants, and any other material features of the program.

  Response:	The Company respectfully acknowledges the Staff’s comment and advises the Staff that it no longer intends to implement a directed share program. The Company has revised its disclosure throughout the Registration Statement accordingly.

  Financial Statements

  Note 2. Summary of Significant Accounting Policies, page F-8

  12.You disclose that you provide product warranties at page 117. Please revise to provide all required disclosures under ASC 460-10-50 related to product warranties, where applicable.

  Response:	The Company respectfully acknowledges the Staff’s comment and has revised page 118 of the Registration Statement accordingly to disclose that product warranties are not material. The Company further advises the Staff that the Company’s recorder and headband warranty obligations are not material, and therefore the Company has not included disclosures under ASC 460-10-50 related to product warranties.

  * * *

     August 26, 2024

     Page 7

  We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (650) 463-2677 or by email at kathleen.wells@lw.com with any questions or comments regarding this correspondence.

    Very truly yours,

    /s/ Kathleen Wells

    Kathleen Wells, Esq.

    of LATHAM & WATKINS LLP

    cc:

    Jane Chao, Ph.D., CeriBell, Inc.

    Scott Blumberg, CeriBell, Inc.

    Louisa Daniels, CeriBell, Inc.

    John Williams, Latham & Watkins LLP

    Richard Kim, Latham & Watkins LLP

    Ilir Mujalovic, Allen Overy Shearman Sterling US LLP
2024-08-23 - UPLOAD - Ceribell, Inc. File: 377-07298
August 23, 2024
Xingjuan (Jane) Chao
Chief Executive Officer
Ceribell, Inc.
360 N. Pastoria Avenue
Sunnyvale, CA 94085
Re:Ceribell, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted August 5, 2024
CIK No. 0001861107
Dear Xingjuan (Jane) Chao:
            We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in our
July 22, 2024, letter.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted August 5, 2024
Prospectus Summary
Overview, page 1
1.We note your response to comment 3 and your revised disclosure on page 94, but your
revisions are not completely responsive to our comment. Please revise your prospectus
summary to disclose how patient care and clinical outcomes are measured. Footnote
disclosure or cross-references may be appropriate.
Market Opportunity, page 3
We note your revisions in response to comment 4, including your amended disclosure on
page 95. Please revise your prospectus summary to briefly describe the basis for your 2.

August 23, 2024
Page 2
estimate of your addressable market opportunity. A cross reference or footnote disclosure
may be appropriate. Also, your response indicates that the company does not believe "the
average selling prices of the hardware and software components of its solution is
information that is material to an understanding of the Company's estimate of its total
annual addressable market opportunity, in the context of the other details included in
Amendment No. 1. The Company has determined the average selling price for the
hardware and software components of its solution in light of the value of its solution,
competitive benefits, market dynamics, customer demand, competitive pressures and
other relevant factors." Please further explain why the average selling prices of hardware
and software components of the company's product are not material to an understanding
of the company's total annual addressable market opportunity, given that the market
opportunity of $2 billion appears to be tied to your ability to sell your hardware and
software at a certain average price.
Risk Factors
We rely on third parties . . . , page 32
3.We note your revisions in response to prior comment 7. To the extent that any of these
collaboration agreements are material, please identify the relevant agreement and include
a description of the material terms of each of these agreements in your filing, including
rights and obligations, financial terms including amounts paid to date, aggregate
milestone amounts to be paid or received, the royalty range and term, as applicable, term,
and termination provisions. Please also file these agreements as exhibits.
Use of Proceeds, page 61
4.We note your disclosure that you "currently intend to use the net proceeds from this
offering to fund sales and marketing efforts, fund research and product development
activities, conduct or sponsor clinical studies, and for general corporate purposes,
including working capital, operating expenses, and capital expenditures." Please revise to
clarify the approximate amount of your net proceeds for each of the principal purposes
listed in your disclosure, if known. Please also clarify the products for which you intend
to "conduct or sponsor clinical studies," and the stage of development you expect to reach
with proceeds from the offering.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Liquidity and Capital Resources
Sources of Liquidity, page 80
Please revise your disclosure in this section to provide additional detail about the material
terms of the relevant loans, including, as discussed in your revised disclosure on page F-
23, that the SVB Loan carries a variable per-annum interest rate at the Prime Rate subject
to the floor of 6.00%, the Horizon Loan carries a variable per-annum interest rate at the
Prime Rate plus 2.75%, subject to the floor of 9.25%, and that the Company is also
required to pay end-of-term fees of 4.0% per tranche drawn on the Maturity Date or upon
repayment of the amounts due to the Lenders under the VLSA. In addition, please
disclose that the Revolving Facility includes additional fees of $300,000 million that are
payable regardless of whether any amounts are drawn. As a related matter, we note your
disclosure on page F-23 that "[u]pon execution of the VLSA, the Company paid to the 5.

August 23, 2024
Page 3
Lenders $245,000 and issued warrants to purchase 106,263 shares of the Company’s
Series C-1 Preferred Stock at a price of $4.47 per share ('Initial Warrants')." Please revise
your disclosure here to include a discussion of these terms.
Business
Invest in further growing our base of clinical evidence, page 91
6.We note your revisions and response to prior comment 15, but we are not persuaded by
your response. Please revise to identify the studies you are sponsoring and
supporting, including the parties that will perform the studies, the trial design, and
primary end points of the studies.
Other Potential Opportunities Beyond Seizures, page 95
7.We note your revised disclosure in response to comments 19, 20, and 25, including that
you have not yet applied for marketing authorization from the FDA for the use of the
Ceribell System relating to delirium or ischemic stroke, and that prior to
commercialization within these indications, you would need to apply for and obtain the
required marketing authorizations. Please revise to clearly disclose when you expect to
apply for marketing authorizations from the FDA, that you have no intended timeline for
commercialization of the services related to these two indications, and that there is no
guarantee you will obtain the required authorizations. Please also clarify how you
determined, based on the average selling price of your headband, that expansion of your
indications could represent an incremental, multi-billion-dollar market opportunity, given
that your headbands have not been used for these indications and that you have no
timeline for commercialization of your Ceribell System relating to these indications.
Finally, provide a brief description of the ongoing research and active clinical studies, if
any, related to these two indications. In this regard, we note your disclosure on page 118.
Our Addressable Market Opportunity in Seizures, page 95
8.We note your response to comment 18. Please revise to state, as you do in your response,
that you do not have specific, intended timing at this stage of development: (i) for
pursuing additional regulatory clearances in Europe, or (ii) to commercialize your product
in Europe.
Our Clinical Results and Economic Evidence, page 101
9.We note your footnote disclosure on page 117 including "Study was supported,
sponsored, or funded by Ceribell." Please clarify the difference between supported,
sponsored, or funded, and clarify which of the studies noted in the table are included in
each category.
Intellectual Property, page 120
10.We note your revisions in response to prior comment 27; however, these revisions do not
appear to be completely responsive to our comment. Please revise your intellectual
property disclosure to clearly describe in tabular form, 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.

August 23, 2024
Page 4
Underwriting
Directed Share Program, page 165
11.We note your disclosure here and throughout the prospectus regarding your directed share
program. Please revise your prospectus to clarify, where appropriate:

•whether the participating employees in the directed share program include any
directors, officers, business associates, and related persons;

•the "certain minimum requirements" for the directed share program; and

•the risks associated with the participants of the directed share program not being
subject to a 180-day lock-up restriction.

In addition, please expand your disclosure to address the process that prospective
participants will follow to participate in the program, the manner by which you will
communicate with prospective participants about the program, when and how you will
determine the allocation for the program, whether such allocation will change depending
on the interest level of potential participants, and any other material features of the
program.
Financial Statements
Note 2. Summary of Significant Accounting Policies, page F-8
12.You disclose that you provide product warranties at page 117. Please revise to provide all
required disclosures under ASC 460-10-50 related to product warranties, where
applicable.

            Please contact Li Xiao at 202-551-4391 or Kristin Lochhead at 202-551-3664 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.
2024-07-22 - UPLOAD - Ceribell, Inc. File: 377-07298
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