Heart Test Laboratories, Inc.
(Note: This IPO is a unit offering. Each unit consists of one share of common stock and one warrant to buy one share of stock. Heart Test Laboratories, Inc. has applied to the NASDAQ to list its stock under the proposed symbol “HSCS” and the warrant under the proposed symbol “HSCSW”. We are doing business under “HeartSciences,” an assumed name.)
We are 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.
Our device is not cleared for marketing by the FDA and our future success is dependent upon receiving FDA De Novo clearance for the MyoVista and raising sufficient funds to finish our pivotal clinical validation study and device testing and development to submit for, and achieve, FDA De Novo clearance. Additional funding would then be required to support the sales launch of the MyoVista into the U.S., provide working capital and support further research and development, or R&D.
We believe that there is currently no low-cost front-line, medical device that is effective at screening for heart disease. As a result, we believe that frontline physicians face a significant challenge in determining if a patient has heart disease. Although many think of the ECG as the frontline heart disease test, in 2012, the United States Preventive Services Task Force, or USPSTF, conducted an evaluation of conventional ECG testing and stated: “There is no good evidence that an ECG helps physicians predict heart risks in people with no symptoms any better than traditional considerations such as current or former smoking, blood pressure and cholesterol levels.”
ECG devices record the electrical signals of a patient’s heart. The ECG is a ubiquitous relatively low-cost, simple and quick test; it is portable and can be performed in a wide range of clinical settings by a non-specialist clinician or clinical aide. There are three basic categories of heart disease: electrical (such as an arrhythmia), structural (such as valvular disease) and ischemic (such as coronary artery disease, or CAD). Conventional resting ECGs have limited sensitivity in detecting structural and ischemic disease and are typically used for diagnosing cardiac rhythm abnormalities, such as atrial fibrillation, also known as Afib, or acute coronary syndrome, such as a myocardial infarction, which is also known as a heart attack. However, traditional ECGs have a limited role in identifying cardiac dysfunction associated with structural and ischemic disease.
HeartSciences has designed the MyoVista to help address these limitations and extend the clinical capability of an ECG in detecting cardiac dysfunction. We apply AI-machine learning to the signal processed electrical signal of the heart. Our first algorithm, which is not yet FDA cleared, is designed to detect cardiac dysfunction caused by heart disease and/or age-related cardiac dysfunction.
**Note: On Jan. 31, 2022, our shareholders granted our Board of Directors the discretion to effect a consolidation, which we refer to as the reverse stock split, of our Common Stock at a rate to be determined by our Board of Directors at a later date. The Board of Directors approved a one (1)-for-thirty-three (33) reverse stock split on June 1, 2022.
(Note: Heart Test Laboratories, Inc. downsized its IPO at pricing on June 14, 2022, to 1.5 million units, down from 1.75 million units, at $4.25, below the bottom of its $4.50-to-$5.50 range, to raise $6.38 million.)
|Industry:||ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES|
|Address||550 Reserve St, Suite 360, Southlake, Texas 76092|
|View Prospectus:||Heart Test Laboratories, Inc.|
|Revenues||$0.03 mil (last 12 months)|
|Net Income||$-2.45 mil (last 12 months)|
|Price range||$4.25 - $4.25|
|Est. $ Volume||$6.4 mil|
|Manager / Joint Managers||The Benchmark Company|
|Expected To Trade:||6/15/2022|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|