Heart Test Laboratories, Inc. (HSCS)
Company Description
Heart Test Laboratories is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG’s clinical usefulness.
Our objective is to make an ECG a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. 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. Our business model, which involves the use of the MyoVista device and consumables for each test, is expected to be “razor-razorblade” as the electrodes used with the MyoVista are proprietary to HeartSciences, and new electrodes are required for every test performed.
We previously submitted an FDA De Novo classification request in December 2019. Based on feedback and communications with the FDA during 2020, we have been making modifications to our device and are partially through a new, pivotal clinical validation study and the device testing and development necessary for a revised FDA De Novo submission, which we expect to take place later in the current fiscal year ending April 30, 2023.
| Country | United States |
| Founded | 2007 |
| IPO Date | Jun 15, 2022 |
| Industry | Medical Devices |
| Sector | Health Care |
| Employees | 13 |
| CEO | Andrew Simpson |
Contact Details
Address:
550 Reserve St, Suite 360 Southlake, TX 76092 United States | |
| Phone | 682-237-7781 |
| Website | heartsciences.com |
Stock Details
| Ticker Symbol | HSCS |
| Exchange | NASDAQ |
| Fiscal Year | May - April |
| Reporting Currency | US Dollars |
| IPO Price | $4.25 |
| CIK Code | 1468492 |
| ISIN Number | US42254E1047 |
| SIC Code | 3842 |
Key Executives
| Name | Position |
|---|---|
| Andrew Simpson | Chief Executive Officer, President and Chairman of Directors |
| Mark T. Hilz | Chief Operating Officer, Secretary and Director |
| Danielle Watson | Chief Financial Officer and Treasurer |
Latest SEC Filings
| Date | Type | Title |
|---|---|---|
| Jun 23, 2022 | 8-K | Current report |
| Jun 17, 2022 | 424B4 | Prospectus [Rule 424(b)(4)] |
| Jun 15, 2022 | 8-K/A | Current report |
| Jun 15, 2022 | 8-K | Current report |
| Jun 15, 2022 | EFFECT | Notice of Effectiveness |
| Jun 14, 2022 | CERT | Certification by an exchange approving securities for listing |
| Jun 14, 2022 | 8-A12B | Registration of securities [Section 12(b)] |
| Jun 13, 2022 | S-1/A | General form for registration of securities under the Securities Act of 1933 |
| Jun 10, 2022 | S-1/A | General form for registration of securities under the Securities Act of 1933 |
| Jun 6, 2022 | FWP | Filing under Securities Act Rules 163/433 of free writing prospectuses |