HeartSciences Inc.

HeartSciences Inc. operates in the healthcare information technology industry, focused on advancing electrocardiography through the integration of artificial intelligence. The company addresses a diagnostic gap where heart disease often remains asymptomatic until advanced stages, contributing to high rates of undiagnosed disease. The global ECG market is projected to grow significantly, driven by increased demand and technological advancements. The World Health Organization estimates that approximately 19.8 million people died from cardiovascular diseases in 2022, representing 32% of all global deaths. The company believes that improving how ECG data is managed, analyzed, and integrated into clinical workflows can increase its overall clinical and operational value.

The medical device industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products. Competitors include traditional ECG manufacturers such as GE Healthcare Technologies, Inc., Koninklijke Philips N.V., Baxter International, Inc., and Nihon Kohden Corporation, as well as new commercial entrants to the AI-ECG market such as Anumana, Inc., Tempus Labs, Inc., or VIZ.ai. The company believes its competitive strengths derive from its platform-centric approach, which focuses on simplifying existing ECG workflows while enabling scalable integration of AI-ECG capabilities. The USPTO has issued nine utility patents and one design patent to the company, and a patent allowance for a utility patent exclusively licensed to the company, with patent expiration dates ranging from March 2031 to August 2040.

The company generates revenue from installation fees, software-as-a-service usage fees, and fees associated with AI-ECG algorithms made available through the platform's AI-ECG marketplace, including third-party algorithms. The primary customer segments include healthcare providers across cardiology and healthcare IT environments. The platform is designed as a cloud-native, software-as-a-service solution, aligning with healthcare providers' increasing preference for scalable, subscription-based solutions that reduce capital expenditures and internal IT complexity.

The company's first commercial product is MyoVista Insights, a cloud-native, vendor- and device-agnostic ECG management platform designed to modernize ECG workflows and enable scalable deployment of AI-ECG capabilities across healthcare systems. MyoVista Insights is classified as a Medical Device Data System and is exempt from FDA 510(k) requirements. The platform is designed to host AI-ECG algorithms from multiple vendors and integrate them directly into clinical workflows. In March 2026, MyoVista Insights received Epic Toolbox designation for the ECG Management System category from Epic Systems Corporation. The company also holds multiple license agreements entered into in 2023 with the Icahn School of Medicine at Mount Sinai covering a range of AI-ECG algorithms, including an aortic stenosis algorithm that received FDA Breakthrough Device Designation in 2025.

The company has developed the MyoVista wavECG device, which provides conventional ECG functionality and is designed to host embedded AI-ECG algorithms. The company submitted the MyoVista wavECG device to the FDA for 510(k) premarket clearance in December 2025, and the submission remains under FDA review. Following updated American Society of Echocardiography guidelines for the assessment of Left Ventricular Diastolic Dysfunction, including revised age-based thresholds for cardiac relaxation (e'), the company elected to separate the FDA submissions for the device and the impaired cardiac relaxation algorithm. Additional development and validation will be required to align the algorithm with the updated clinical standards.

In March 2026, the company released a significant version upgrade of MyoVista Insights for broader deployment across cardiology and healthcare IT environments, including mobile device access, enhanced reporting capabilities, and expanded interoperability. The company deployed MyoVista Insights into several healthcare settings during its early adopter phase and recently announced commercial customer engagements. The company entered into a multi-year collaboration agreement with Rutgers, The State University of New Jersey on November 29, 2022, to research and develop additional AI-ECG algorithms. As of July 20, 2026, the company had 14 employees and 9 independent contractors.

The company has a limited operating history and has incurred significant operating losses since its inception, anticipating continued losses for the foreseeable future. The company will require additional funding to support working capital, continued development and commercialization of MyoVista Insights, and regulatory clearance of the MyoVista wavECG device and associated AI-ECG algorithms. There is substantial doubt about the company's ability to continue as a going concern. The aggregate market value of voting stock held by non-affiliates as of October 31, 2025 was approximately $10.4 million, based on a closing price of $3.05.

The company's primary growth vector is the MyoVista Insights platform, designed as a cloud-native ECG management and AI orchestration platform. The company believes that a SaaS-based model, combined with device-agnostic deployment, enables access to underpenetrated markets and may support broader adoption across a wider range of healthcare providers. The company is in discussion with several third-party AI-ECG algorithm development companies regarding hosting and commercialization arrangements on the platform, including for algorithms that have received FDA or other regulatory clearance. The company expects to enter into one or more such arrangements as the marketplace develops.

The company's second growth vector is the MyoVista wavECG device, which is designed to complement the MyoVista Insights platform by enabling integrated ECG acquisition and analysis at the point of care. The company submitted the device to the FDA for 510(k) premarket clearance in December 2025, and the submission remains under FDA review. The future success of the MyoVista wavECG device is dependent on obtaining FDA clearance and the integration of an impaired cardiac relaxation (e') AI-ECG algorithm under development. The company also intends to bring forward selected licensed algorithms from Mount Sinai based on commercial viability and regulatory pathway.

The filing does not discuss specific margin or cost outlook targets.

The company's R&D staff designs its hardware, software and internally developed AI-ECG algorithms. The company currently employs five full-time R&D staff. Hardware development assistance is provided by outside consulting firms, and the company internally develops software for the device along with the assistance of multiple software development contractors. The data science work necessary to build the AI-ECG algorithms is performed both internally and externally using outside data science experts.

The filing does not specify R&D spending levels, capital expenditure plans, share repurchase authorization amounts, or dividend policy with exact figures.

The company faces structural headwinds including the need to raise additional funding, which may not be available on acceptable terms or at all. Failure to obtain funding on acceptable terms and on a timely basis may require the company to curtail, delay or discontinue its development efforts and other operations. The company's future operating results are dependent on receiving regulatory approval for the MyoVista wavECG and associated AI-ECG algorithms from the FDA, which the company has not received as of the date of filing of the Annual Report on Form 10-K.

The company identified weaknesses in its internal controls and cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in the future. All of the company's assets are subject to security interests.

The company has a limited operating history and has incurred significant operating losses since its inception, anticipating continued losses for the foreseeable future. There is substantial doubt about the company's ability to continue as a going concern, which could prevent it from obtaining new financing on reasonable terms or at all. The company's future success depends on obtaining FDA clearance for the MyoVista wavECG device, submitted in December 2025 and still under review, and the integration of an impaired cardiac relaxation algorithm requiring additional development and validation. The company will need to raise additional funding, which may not be available on acceptable terms, and failure to obtain funding may require curtailment or discontinuation of development efforts. All of the company's assets are subject to security interests, and the company has identified weaknesses in its internal controls that may not be effectively remediated.

Management's message emphasizes the company's platform-centric strategy focused on workflow enablement through MyoVista Insights as a cloud-based ECG management and AI orchestration platform. The strategic priorities include simplifying and improving processes that are already widely performed within healthcare systems, including ECG acquisition, storage, interpretation, and reporting. Management believes that by improving workflow efficiency, reducing system fragmentation, and simplifying data management, MyoVista Insights can deliver operational and economic benefits independent of AI-ECG adoption. The company is focused on establishing key commercial reference sites and revenue generating installations, having recently announced commercial customer engagements for MyoVista Insights and being in active discussions regarding additional customer engagements.