# EDGAR Filing Document

**Accession Number:** 0001779372
**File Stem:** 0001213900-25-113353
**Filing Date:** 2025-11
**Character Count:** 4191
**Document Hash:** af438709667bda0186c98f2d7baca869
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-113353.hdr.sgml**: 20251121

**ACCESSION NUMBER**: 0001213900-25-113353

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20251120

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20251121

**DATE AS OF CHANGE**: 20251121

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** HeartBeam, Inc.
- **CENTRAL INDEX KEY:** 0001779372
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 474881450
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41060
- **FILM NUMBER:** 251505021

**BUSINESS ADDRESS:**
- **STREET 1:** 2118 WALSH AVE., SUITE 210
- **CITY:** SANTA CLARA
- **STATE:** CA
- **ZIP:** 95050
- **BUSINESS PHONE:** 408-899-4443

**MAIL ADDRESS:**
- **STREET 1:** 2118 WALSH AVE., SUITE 210
- **CITY:** SANTA CLARA
- **STATE:** CA
- **ZIP:** 95050

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

CURRENT REPORT

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

**Date of Report (Date of earliest event reported): November 20, 2025**

**<u>HEARTBEAM, INC.</u>**

(Exact name of Registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| Delaware | 001-41060 | 47-4881450 |
| **(State or other jurisdiction<br> of incorporation)** | **(Commission File Number)** | **(IRS Employer<br> Identification No.)** |

---

**<u>2118 Walsh Avenue, Suite 210</u>**

**<u>Santa Clara, CA 95050</u>**

**(Address of principal executive offices, including zip code)**

**<u>(408) 899-4443</u>**

**(Registrant's telephone number, including area code)**

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

☐ Written communication 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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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock | BEAT | NASDAQ |
| Warrant | BEATW | NASDAQ |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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. ☐

**Item 8.01: Other Events**

On November 20, 2025, HeartBeam, Inc. (the "Company") received a Not Substantially Equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) related to the Company's 510(k) application for its 12-Lead Electrocardiogram (ECG) Synthesis Software.

The Company stands behind its clinical data and will be working with the FDA to come to a resolution.

In addition, the Company is evaluating launching its novel 3D ECG system, which received FDA 510(k) clearance in December 2024.

**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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| | | |
|:---|:---|:---|
|  | **<u>HeartBeam, Inc.</u>** | **<u>HeartBeam, Inc.</u>** |
| Date: November 21, 2025 | By: | */s/ Timothy Cruickshank* |
|  | Name: | Timothy Cruickshank |
|  | Title: | Chief Financial Officer |

---