# EDGAR Filing Document

**Accession Number:** 0001468492
**File Stem:** 0000950170-25-081410
**Filing Date:** 2025-6
**Character Count:** 11606
**Document Hash:** edf89d7a5447eb39085203ae307e36f1
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-081410.hdr.sgml**: 20250604

**ACCESSION NUMBER**: 0000950170-25-081410

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20250604

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250604

**DATE AS OF CHANGE**: 20250604

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** HeartSciences Inc.
- **CENTRAL INDEX KEY:** 0001468492
- **STANDARD INDUSTRIAL CLASSIFICATION:** ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 261344466
- **STATE OF INCORPORATION:** TX
- **FISCAL YEAR END:** 0430

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41422
- **FILM NUMBER:** 251022069

**BUSINESS ADDRESS:**
- **STREET 1:** 550 RESERVE ST, SUITE 360
- **CITY:** SOUTHLAKE
- **STATE:** TX
- **ZIP:** 76092
- **BUSINESS PHONE:** 682-237-7781

**MAIL ADDRESS:**
- **STREET 1:** 550 RESERVE ST, SUITE 360
- **CITY:** SOUTHLAKE
- **STATE:** TX
- **ZIP:** 76092

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Heart Test Laboratories, Inc.
- **DATE OF NAME CHANGE:** 20090716

?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):** June 04, 2025<br>

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HEARTSCIENCES INC.

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

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| | | |
|:---|:---|:---|
| Texas | 001-41422 | 26-1344466 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 550 Reserve Street, Suite 360 |  |  |
| Southlake**,** Texas |  | 76092 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 682 237-7781<br>

n/a<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** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock | HSCS | The Nasdaq Stock Market LLC |
| Warrants | HSCSW | The Nasdaq Stock Market LLC |

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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.** 
On June 4, 2025, HeartSciences Inc. (the "Company") issued a press release announcing that the Company had been granted a Breakthrough Device designation from the U.S. Food and Drug Administration for its Aortic Stenosis ECG algorithm. The press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

## **Item 9.01 Financial Statements and Exhibits.** 

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| | |
|:---|:---|
| **Exhibit** <br>**No.** | <br>**Description**  |
| Exhibit 99.1 | [<u>Press Release dated June 4, 2025</u>](hscs-ex99_1.htm) |
| Exhibit 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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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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| | | | |
|:---|:---|:---|:---|
|  |  |  | HEARTSCIENCES INC. |
| Date: | June 4, 2025 | By:  | */s/ Andrew Simpson* |
|  |  |  | Andrew Simpson<br>President, Chief Executive Officer and Chairman of the Board of Directors |

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## Exhibit 99.1

Exhibit 99.1

**HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis**

*Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems.*

Southlake, TX – June 4, 2025 (GLOBE NEWSWIRE) – HeartSciences Inc. **(Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company")**, an artificial intelligence ("AI") powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device designation for its Aortic Stenosis ("AS") ECG algorithm.

Aortic Stenosis is one of the most serious and common heart valve diseases, often progressing silently and leading to severe, life-threatening outcomes if left undetected. Early symptoms are frequently vague or absent, resulting in delayed diagnosis and treatment. If unrecognized, AS can cause irreversible myocardial damage and significant deterioration in cardiac function.

The algorithm would offer a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. Once cleared by the FDA, the algorithm will be accessible through HeartSciences' **MyoVista Insights™** cloud-based platform which would directly integrate with hospital electronic health record ("EHR") systems, requiring no additional hardware or testing. This technology provides several key clinical advantages:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Detection in asymptomatic or under-evaluated patients** who may not yet show signs of AS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Real-time or retrospective analysis** using existing ECG data already captured during routine care.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Expanded access to early diagnosis**, especially in underserved areas lacking specialized cardiac imaging or providers.

The algorithm was developed using advanced convolutional neural network (CNN) deep learning techniques and trained on more than 120,000 ECG records. In performance evaluations, it demonstrated the ability to detect aortic stenosis up to 24 months prior to confirmatory echocardiography, with diagnostic accuracy (AUROC) increasing as the disease progressed.

This breakthrough gives clinicians the ability to identify aortic valve disease earlier in its course, allowing for timely interventions and improved patient outcomes. The AI-ECG algorithm was developed at the Icahn School of Medicine at Mount Sinai by Dr. Akhil Valid.

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*"Receiving FDA Breakthrough Device Designation marks another significant milestone for HeartSciences,"* said Andrew Simpson, CEO of HeartSciences. *"By combining the widespread accessibility of ECGs with the power of deep learning, our aortic stenosis algorithm has the potential to transform how this serious and often silent disease is detected—leading to earlier referrals, better treatment pathways, and ultimately, improved lives."*

**About HeartSciences**

HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve ECG's clinical utility. Millions of ECGs are performed every week and the Company's objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and intends to provide these AI-ECG algorithms on a device agnostic cloud-based solution as well as a low-cost ECG hardware platform. Working with clinical experts, HeartSciences ensures that all solutions are designed to work within existing clinical care pathways, making it easier for clinicians to use AI-ECG technology to improve their patient's care and lead to better outcomes. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test.

For more information, please visit: https://www.heartsciences.com. X: @HeartSciences

**Safe Harbor Statement**

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 29, 2024, HeartSciences' Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2024, filed with the SEC on September 12, 2024, HeartSciences' Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2024, filed with the SEC on December 16, 2024, HeartSciences' Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2025, filed with the SEC on March 13, 2024 and in

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HeartSciences' other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

**Investor Relations:**

***Integrous Communications***

Mark Komonoski

Partner

Phone: 877-255-8483

Email: mkomonoski@integcom.us

***Media Contact:***

***HeartSciences***<br>Gene Gephart<br>Phone: +1-682-244-2578 Ext. 2024<br>Email: info@heartsciences.com

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