# EDGAR Filing Document

**Accession Number:** 0001861107
**File Stem:** 0001193125-26-001800
**Filing Date:** 2026-1
**Character Count:** 12897
**Document Hash:** fa2e2098e24a08b0039ece913c1fecec
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-001800.hdr.sgml**: 20260105

**ACCESSION NUMBER**: 0001193125-26-001800

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20260105

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260105

**DATE AS OF CHANGE**: 20260105

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Ceribell, Inc.
- **CENTRAL INDEX KEY:** 0001861107
- **STANDARD INDUSTRIAL CLASSIFICATION:** ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 471785452
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42364
- **FILM NUMBER:** 26504388

**BUSINESS ADDRESS:**
- **STREET 1:** 360 N. PASTORIA AVENUE
- **CITY:** SUNNYVALE
- **STATE:** CA
- **ZIP:** 94085
- **BUSINESS PHONE:** (800) 436-0826

**MAIL ADDRESS:**
- **STREET 1:** 360 N. PASTORIA AVENUE
- **CITY:** SUNNYVALE
- **STATE:** CA
- **ZIP:** 94085

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** January 05, 2026<br>

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CeriBell, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-42364 | 47-1785452 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 360 N. Pastoria Avenue |  |  |
| Sunnyvale**,** California |  | 94085 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 800 436-0826<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | |
|:---|:---|
| **<br>Title of each class** | **<br>Name of each exchange on which registered** |
| Common stock, $0.001 par value per share<br> CBLL | Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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| | |
|:---|:---|
| **Item 8.01** | **Other Events.** |

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On January 5, 2026, CeriBell, Inc. ("Ceribell") issued a press release announcing that the U.S. Food and Drug Administration ("FDA") granted Breakthrough Device Designation for Ceribell's Large Vessel Occlusion (LVO) stroke detection and monitoring solution.

A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference.

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| | | |
|:---|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  | **Financial Statements and Exhibits.**  |
| Exhibit No. |  | Description |
| 99.1 |  | [<u>Press Release dated January 5, 2026.</u>](cbll-ex99_1.htm) |
| 104 |  | Cover Page Interactive Data File, formatted in Inline XBRL.  |

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **CERIBELL, INC.** |
| Date: | January 5, 2026 | By:  | /s/ Scott Blumberg |
|  |  |  | Scott Blumberg<br>Chief Financial Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**Ceribell Receives FDA Breakthrough Device Designation for LVO Stroke Detection and Monitoring Solution**

*Clearance would position the Ceribell System as the first and only point-of-care electroencephalography (EEG) technology to aid in detection and monitoring of Large Vessel Occlusion (LVO) stroke in the hospital setting*

SUNNYVALE, Calif., January 5, 2026 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) ("Ceribell"), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Large Vessel Occlusion (LVO) stroke detection monitor for patients in the hospital setting. This first-in-class LVO stroke detection monitor uses Ceribell's existing hardware and applies an AI-based algorithm to interpret EEG signals for early detection of LVO stroke.

The Breakthrough Device Designation for LVO Stroke represents the latest achievement in Ceribell's continued efforts to extend its point-of-care EEG brain monitoring technology to additional indications, building on recent FDA 510(k) clearances for its next-generation Clarity® algorithm to detect electrographic seizures in neonates (November 2025) and its proprietary delirium screening and monitoring solution (December 2025).

Nearly 800,000 strokes occur annually in the U.S.<sup>1</sup> In particular, LVO strokes are medical emergencies and have disproportionately higher morbidity and mortality compared to non-LVO ischemic stroke, contributing to ~62% of post-stroke dependence and ~96% of post-stroke mortalities.<sup>2</sup> Timely detection and access to treatment of LVO stroke can result in tremendous health benefits over patients' lifetimes, with every minute saved associated with a week of disability-free life.<sup>3</sup>

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Unlike community-onset stroke, which occurs outside the hospital and often triggers immediate emergency response, in-hospital stroke affects patients who are already admitted. Scientific literature shows that stroke detection and treatment in hospitalized patients are often significantly delayed compared to strokes occurring outside of hospitals.<sup>4,5,6</sup> This leads to worse outcomes, as patients face about three times higher rates of mortality, and are half as likely to be discharged home compared to community-onset stroke, even after adjusting for clinical characteristics and comorbidities in hospitalized patients.<sup>7</sup> Out of 800,000 stroke patients, up to 17% are in-hospital-onset stroke.<sup>4,5</sup>

Dr. Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS, Clinical Professor of Neurology and Neurosurgery, notes that: "In-hospital strokes frequently occur in units that aren't specialized in neurology, where bedside teams may not have sufficient training or tools to detect subtle neurological changes concerning a stroke. Many of these patients are recovering from surgery, intubated, ventilated, or on medications that complicate their assessment, making it incredibly difficult to spot the early signs of a stroke. A tool that continuously monitors brain function and alerts the care team the moment something is wrong would allow us to intervene sooner and facilitate achieving better outcomes for patients."

The Breakthrough Device Designation recognizes the potential of Ceribell's LVO stroke detection monitor to enable timely and accurate LVO detection compared to the current standard-of-care, supported by validation through rigorous, prospective, multi-center studies using EEG data and clinical assessments. "Stroke is a devastating condition, but one where quick access to treatment can make a lifetime of a difference," said Jane Chao, Ph.D., co-founder and CEO of Ceribell. "At a time when minutes matter, patients with in-hospital stroke often experience hours of delay. Ceribell is proud that this FDA Breakthrough Device Designation recognizes the potential of the Ceribell System to provide accurate and timely detection of LVO stroke for this vulnerable patient population."

The LVO Breakthrough Device designation is another critical milestone that further reinforces Ceribell's mission to make EEG a new vital sign for better brain care.

**References**

<sup>1</sup> Martin, S. S., et al. (2025). 2025 Heart disease and stroke statistics: A report of US and global data from the American Heart Association. Circulation, 151(8), e41–e660. https://doi.org/10.1161/CIR.0000000000001303

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<sup>2</sup> Malhotra, et al. (2017). Ischemic strokes due to large-vessel occlusions contribute disproportionately to stroke-related dependence and death: A review. Frontiers in Neurology, 8, 651.https://doi.org/10.3389/fneur.2017.00651

<sup>3</sup> Meretoja, A. et al. (2017). Endovascular therapy for ischemic stroke: Save a minute — save a week. Neurology, 88(22), 2123–2127. https://doi.org/10.1212/WNL.0000000000003981

<sup>4</sup> Nouh, A. et al. (2022). Identifying best practices to improve evaluation and management of inhospital stroke: A scientific statement from the American Heart Association. Stroke, 53(4), 165–175. https://doi.org/10.1161/STR.0000000000000402

<sup>5</sup> Cumbler, E. (2015). In-hospital ischemic stroke. The Neurohospitalist, 5(4), 173–181. https://doi.org/10.1177/1941874415588319

<sup>6</sup> Cummings, S. et al. (2022). Delays in the identification and assessment of in-hospital stroke patients. Journal of Stroke and Cerebrovascular Diseases, 31(4), 106327. https://doi.org/10.1016/j.jstrokecerebrovasdis.2022.106327

<sup>7</sup> Cumbler, E. et al. (2014). Quality of care and outcomes for inhospital ischemic stroke: Findings from the National Get With The GuidelinesStroke. Stroke, 45(1), 231–238. https://doi.org/10.1161/STROKEAHA.113.003617

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other statements that are not statements of historical fact. Forward-looking statements can be identified by the use of words such as "will," "may," "could," "likely," "ongoing," "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," "assume," "target," "forecast," "guidance," "goal," "objective," "aim," "seek," "potential," "hope," and other words of similar meaning. These statements are based on management's current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those described. Such risks and uncertainties, including those related to regulatory approvals, clinical use and adoption, market acceptance, competition, and other factors, are described under the "Risk Factors" sections of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other reports filed with the U.S. Securities and Exchange Commission ("SEC"). These filings are available on the SEC's website at https://sec.gov/ and on Ceribell's website at https://investors.ceribell.com/. Ceribell undertakes no obligation to update any forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

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**About CeriBell, Inc.**

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. Ceribell has developed the Ceribell System, a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute-care setting. By combining proprietary, highly portable, and rapidly deployable hardware with sophisticated artificial intelligence ("AI")-powered algorithms, the Ceribell System enables rapid diagnosis and continuous monitoring of patients with neurological conditions. The Ceribell System is FDA-cleared for use in detecting seizure and delirium in intensive care units and emergency rooms across the U.S. Ceribell is headquartered in Sunnyvale, California. For more information, please visit www.ceribell.com or follow the company on LinkedIn.

**Investor Contact**

Brian Johnston or Laine Morgan

Gilmartin Group

Investors@ceribell.com

**Media Contact**

Brian Price

Press@ceribell.com

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