8-K

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 Exchange Act of 1934

Date of Report (Date of earliest event reported): October 19, 2022

Heart Test Laboratories, Inc

(Exact name of Registrant as Specified in Its Charter)


Texas	001-41422	26-1344466
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

550 Reserve Street, Suite 360
Southlake, Texas		76092
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 682 237-7781

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

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:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	HSCS	The NASDAQ Stock Market LLC
Warrants	HSCSW	The NASDAQ Stock Market LLC

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. ☐

Item 7.01 Regulation FD Disclosure.

On October 19, 2022, Heart Test Laboratories, Inc. (the “Company”) issued a press release announcing that the Company was issued a Current Procedural Terminology code by the American Medical Association for ECG AI Analysis of Cardiac Dysfunction. The press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be incorporated by reference into any filings made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.


Exhibit No.		Description
Exhibit 99.1		Press Release dated October 19, 2022.
Exhibit 104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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.


			HEART TEST LABORATORIES, INC.

Date:	October 19, 2022	By:	/s/ Andrew Simpson
			Andrew Simpson Chief Executive Officer

Exhibit 99.1

HeartSciences Announces Major Milestone with the Issuance of CPT® Codes by the American Medical Association for ECG AI Analysis of Cardiac Dysfunction

Issuance of new reimbursement-related codes expected to accelerate
the use and adoption of ECG-based cardiac dysfunction AI algorithms,
including HeartSciences’ MyoVista

Southlake, Texas, October 19, 2022 - Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), a medical technology company focused on saving lives by making an ECG (also known as an EKG) a far more valuable screening tool through the use of AI, today reports that the American Medical Association (AMA) has issued new industry-first Category III Current Procedural Terminology (CPT®) codes for novel AI assistive algorithmic ECG risk assessment for cardiac dysfunction. These codes are expected to cover the AI cardiac dysfunction algorithm incorporated in the Company’s MyoVista® Wavelet ECG Cardiac Testing Device currently in development for FDA De Novo submission and clearance. The codes are in addition to the long-established CPT codes in place for the conventional ECG.

CPT Category III codes are designed to facilitate the use, adoption, and potential reimbursement of emerging technologies. The new CPT codes go into effect in the CPT codebook on January 1, 2023.

“This is a major milestone for HeartSciences. The issuance of new CPT codes by the AMA acknowledges the importance of AI analysis of cardiac dysfunction using an ECG. It also further validates the commercial opportunity for the MyoVista,” stated Andrew Simpson, Chief Executive Officer of HeartSciences. “One of the most significant needs in healthcare is the ability to detect cardiac dysfunction early. An AI-enabled ECG is a relatively low-cost, simple, and quick way to do that. Millions of ECG tests are performed every week and we believe adding detection of cardiac dysfunction to the ECG would make it a far more valuable heart screening tool.”

About HeartSciences

Heart Test Laboratories, Inc. d/b/a 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 an ECG’s clinical usefulness. Millions of ECGs are performed every week and the Company’s objective is to improve healthcare by making 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. The 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.

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

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and relate 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’ filings with the U.S. Securities and Exchange Commission 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.

For investor and media inquiries, please contact:

Investor Relations:

Crescendo Communications, LLC

Phone: (212) 671-1021

Email: [email protected]

Company:
Gene Gephart
Phone: +1-737-414-9213 (US)
Email: [email protected]