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. The editorial comment associated with the study titled “Prediction of Abnormal Myocardial Relaxation from Signal Processed Surface ECG” presented below discusses recent applications of machine learning to data derived from surface 12-lead ECGs in relation to cardiac dysfunction: “These are some of the most significant advances in electrocardiography since its inception, which has historically had a limited, if any, role in the evaluation of cardiac dysfunction. In the past, our cardiovascular community was resigned to the fact that surface ECGs are poor indicators for cardiac dysfunction.” Khurram Nasir, MD, MPH, MSC, Department of Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, et. al.,Journal of American College of Cardiology Editorial Comment Volume 76 Number 8 2020. Almost all forms of heart disease, including CAD and structural disease, affect heart muscle, or cardiac, function prior to symptoms. Impaired cardiac function is first observed as impaired cardiac relaxation which is an early indicator of diastolic dysfunction and usually continues to increase in severity as heart disease progresses. The diastolic phase of the cardiac cycle occurs when the heart muscle relaxes (following contraction). Diastolic dysfunction may also be related to age-related cardiac dysfunction. If we receive FDA clearance for the MyoVista, our main target markets would be frontline healthcare environments in the U.S., such as primary care, to assist physician decision making in the cardiology referral process. Currently, cardiology referral decisions are often based on a patient’s risk factors and/or a conventional ECG test. Accordingly, many patients with heart disease are left undetected while no treatment or intervention is required for most patients referred for cardiac imaging. We believe that adding the capability to detect cardiac dysfunction to a standard 12-lead resting ECG could help improve cardiac referral pathways and be valuable for patients, physicians, health systems and third-party payors. 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. We require the funding from this offering to continue our work towards FDA resubmission and clearance. Although the net proceeds of this offering are anticipated to be sufficient to achieve FDA clearance, which would allow us to market the MyoVista in the U.S., there is no assurance that this would be the case. Additional funding would be required to support the sales launch of the MyoVista into the U.S., provide working capital and support further R&D. Our auditors’ report on our audited financial statements for Fiscal 2021 contains an explanatory paragraph regarding substantial doubts about our ability to continue as a going concern because we have experienced recurring losses, negative cash flows from operations, limited capital resources, a net shareholders’ deficit, as well as significant debt obligations. These events and conditions, along with other matters, indicate that a material uncertainty exists that may cast significant doubt on our ability to continue as a going concern. If we are unable to continue as a going concern, we may have to liquidate our assets, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. We are a Texas corporation based in Southlake, Texas and were incorporated in Texas in August 2007. Our principal executive offices are located at 550 Reserve Street, Suite 360, Southlake TX.
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1. Exact Sciences for heart disease diagnostics, focusing on advanced ECG analysis for earlier detection.
2. A specialized GE Healthcare, dedicated to making standard ECG machines significantly smarter for detecting heart disease.
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- MyoVista® ECG Device: A medical device that utilizes proprietary Wavelet Signal Processing™ technology to provide advanced detection and assessment of myocardial dysfunction.
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HeartSciences (symbol: HSCS) primarily sells its MyoVista wavECG™ device to other companies, operating on a Business-to-Business (B2B) model.
Based on their latest public filings, such as the 10-K for the fiscal year ended December 31, 2022, HeartSciences has explicitly stated that no single customer accounted for 10% or more of its revenue during that period. Consequently, HeartSciences does not have specific, publicly disclosed "major customers" by name, as its sales are distributed across a network of purchasers rather than concentrated with a few large entities.
Their customer base primarily consists of the following categories of organizations:
- Healthcare Providers: This category includes hospitals, cardiology clinics, physician offices, and other medical facilities that acquire and utilize the MyoVista wavECG™ device for the diagnostic assessment of heart disease in their patients.
- Medical Device Distributors: HeartSciences partners with a network of medical device distributors. These companies purchase the MyoVista wavECG™ devices from HeartSciences and then resell them to the various healthcare providers mentioned above, both domestically and internationally.
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Andrew Simpson, Chairman and Chief Executive Officer
Andrew Simpson has almost 30 years' experience across a wide variety of business sectors and sizes, from small entrepreneurial ventures to large corporate and public companies. He served as Group CEO of the Peel Group, a large private company in the U.K. with approximately $8 billion of business assets, from 2006 to 2010. During his tenure, he led a strategic restructuring, strengthened and created key divisional teams, introduced key partners into several divisions (including the sale of stakes in its £1.6 billion ports business and £200 million airport business), materially increased liquid assets by approximately £500 million, divested non-core assets, and managed £3 billion of debt funding across multiple facilities. From 2003 to 2006, he was a main board director of Speedy Hire plc. (a FTSE 250 company), where he was responsible for its development and expansion, which included seventeen acquisitions and several non-core divestments that saw the share price quadruple in value. Andrew qualified as a Chartered Accountant with Price Waterhouse and spent eight years in investment banking at Rothschild, advising on a wide variety of M&A transactions, debt and equity fundraisings, IPOs, and shareholder value issues. He was appointed CEO of HeartSciences in March 2022.
Danielle Watson, Chief Financial Officer
Danielle Watson is a CPA with over 15 years of financial experience. She has served as HeartSciences' Financial Controller since November 2021. Before joining HeartSciences, Ms. Watson held senior leadership roles at Moss Adams, LLP from November 2007 to November 2021, where she provided audit and assurance services to both public and privately held companies, with an emphasis on financial reporting, consolidations, strategic planning, purchase price accounting, and SEC reporting.
Mark Hilz, Chief Operating Officer
Mark Hilz brings over 30 years of experience as a President/CEO of multiple successful startup companies. He previously served as CEO of INX, a technology infrastructure consulting company he was asked to start as a subsidiary for a public company. Founded in 2000, INX grew to $400 million in revenue with 15 offices, 2,000 customers, and 500 employees, was traded on NASDAQ, completed multiple offerings, and was successfully sold to private equity in December 2011. Prior to that, Mr. Hilz founded and ran PC Service Source, a technology logistics outsourcing firm, as CEO. This company grew to over $160 million in revenue with 1,100 employees within an 8-year span. Mr. Hilz raised startup capital from traditional venture capital sources and, after four years of operations, successfully took the company public in an IPO on NASDAQ, followed by a successful public offering. His experience includes raising venture capital, multiple successful public offerings, and numerous M&A transactions as both a buyer and a seller.
Aaron Peterson, VP Research and Development
Aaron Peterson serves as the Vice President of Research and Development for HeartSciences.
Isabella Schmitt, VP Clinical and Regulatory Affairs
Isabella Schmitt possesses a diverse background encompassing regulatory affairs, clinical trial design and management, product management, and quality assurance. She has guided regulatory, quality, and clinical initiatives for over 100 successful regulatory filings and FDA interactions. Additionally, she has authored articles for multiple publications, participated in numerous podcasts, and engaged in speaking opportunities covering regulatory affairs submissions and interactions for medical devices and AI/ML in healthcare.
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The clear emerging threat for HeartSciences is the rapid advancement and increasing clinical adoption of artificial intelligence (AI) and machine learning algorithms for the interpretation of standard 12-lead electrocardiograms (ECGs). These AI solutions are demonstrating growing capabilities in detecting a wide range of cardiac conditions, including myocardial ischemia, often with accuracy comparable to, or even exceeding, human interpretation or specialized signal processing technologies. If these AI algorithms become ubiquitous and highly accurate in extracting diagnostic information from any standard ECG machine, they could diminish the unique value proposition of HeartSciences' MyoVista® wavECG™ device, which relies on its proprietary signal processing to identify similar conditions. This threat is analogous to how new software platforms and algorithms can disrupt specialized hardware or fixed proprietary solutions by leveraging more accessible data and general-purpose computing power.
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HeartSciences (symbol: HSCS) operates within the global Artificial Intelligence-enhanced Electrocardiography (AI-ECG) market. The company's main products and services, including its MyoVista wavECG device and MyoVista Insights software platform, target this market.
The addressable market for HeartSciences' products and services is the global ECG market, which is projected to grow from $10.9 billion in 2023 to $25.1 billion by 2032. HeartSciences is positioned to capture market share in this high-growth global market following regulatory clearances.
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HeartSciences (HSCS) anticipates several key drivers for future revenue growth over the next 2-3 years, primarily centered around its AI-powered electrocardiogram (ECG) technology and associated platforms:
- Commercialization and Adoption of MyoVista Insights™ Software Platform: HeartSciences successfully launched MyoVista Insights, a cloud-native software platform designed to modernize legacy ECG management systems and serve as a marketplace for AI-ECG algorithms. The platform began a phased rollout in May 2025 at early adopter reference sites. Its ability to integrate with existing ECG devices and hospital EHR systems without requiring new hardware makes adoption seamless and cost-efficient. The company aims for MyoVista Insights to become the first cloud-native ECG management software stack in a multi-billion dollar market.
- Launch and FDA Clearance of New AI-ECG Algorithms: HeartSciences is developing and seeking regulatory clearance for additional AI-ECG algorithms. Specifically, the company targets FDA submission in the first half of calendar year 2026 for its first cloud-based algorithm for detecting reduced ejection fraction, with potential clearance later that year. Furthermore, HeartSciences has already received FDA Breakthrough Device Designation for its aortic stenosis ECG algorithm. These new diagnostic algorithms, when cleared, are expected to expand the clinical utility and market penetration of the MyoVista Insights platform.
- FDA Clearance and Commercialization of MyoVista® wavECG™ Device: The MyoVista® wavECG™ device is HeartSciences' first product candidate for FDA clearance, a resting 12-lead ECG designed to provide diagnostic information related to cardiac dysfunction, traditionally only available through cardiac imaging, alongside conventional ECG information. The company is preparing for FDA 510(k) submission for this device. Obtaining FDA approval and subsequently commercializing the MyoVista wavECG device is a significant expected revenue driver.
- Favorable Reimbursement Landscape for AI-ECG: The Centers for Medicare & Medicaid Services (CMS) have approved CPT reimbursement codes for AI-ECG, covering algorithms provided by MyoVista Insights at $128 per test, using any compatible ECG device. This enhanced reimbursement framework is expected to support AI-ECG adoption across the healthcare system by benefiting key stakeholders and is a crucial factor for future revenue growth.
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Share Issuance
- HeartSciences raised $3.1 million through a Regulation A+ offering and converted $0.9 million of debt to equity in fiscal year 2025.
- An offering statement was filed in May 2025 for up to 4,285,714 units of Series D Convertible Preferred Stock at $3.50 per unit, representing a maximum offering amount of $15,000,000.
- The net common equity issued was $10 million in 2024 and $7 million in 2023.
Inbound Investments
- The company raised $3.1 million through a Regulation A+ offering in fiscal year 2025.
- A $15 million offering of Series D Convertible Preferred Stock was approved in May 2025.
Capital Expenditures
- HeartSciences reported significant capital expenditures of $125.27 million in 2022.
- Capital expenditures also included $30.19 million in 2021 and $27.01 million in 2020.
- These expenditures are focused on the advancement of AI-based technology for ECGs, specifically the MyoVista wavECG device and the MyoVista Insights™ cloud-native software platform.
