Core Insights - HeartSciences Inc. is focused on transforming ECG technology through AI to enhance early detection of heart disease and has reported significant progress in its business and technology developments for Q2 FY2025 [1][2] Business Highlights - HeartSciences is the only company developing next-generation ECG device hardware, cloud-native software, and AI-ECG algorithms, aiming to modernize the ECG industry which relies on outdated technology [2][11] - The MyoVista Insights platform is nearing completion of Phase 1, with a focus on creating a cloud-native ECG reporting system on AWS, expected to be implemented in test sites in the first half of 2025 [3][4] - Phase 2 will introduce AI-ECG reporting and operate like an app store for AI-ECG algorithms, reducing costs and regulatory burdens [4][5] - Phase 3 aims to establish an ECG management system, targeting a multi-billion dollar market, with a focus on lower costs and improved interoperability [5] Product Development - Progress on the MyoVista® wavECG device is on track for FDA submission by the end of Q1 2025, with a pre-submission meeting planned to finalize the validation study [7] - The first cloud-based AI-ECG algorithm, focusing on low ejection fraction, is in pre-validation, with FDA validation studies anticipated to follow [6] Regulatory and Market Position - HeartSciences' AI-ECG algorithms have been included in the CMS 2025 OPPS final rule, allowing for immediate reimbursement upon commercial launch, marking a significant milestone for AI-ECG adoption [8] - The company aims to provide a versatile AI-ECG solution suitable for various healthcare settings, enhancing access to cardiac screening tools [11][13] Financial Overview - For Q2 FY2025, HeartSciences reported no revenues, with cash and cash equivalents at approximately $4.1 million and shareholders' equity at approximately $4.0 million [12]

Southlake, TX, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, announced today that Company CEO Andrew Simpson has been invited to participate in the 2024 Maxim Healthcare Virtual Summit, presented by Maxim Group LLC and hosted by M-Vest, from Tuesday October ...

Core Viewpoint - Heart Test Laboratories, Inc. (HeartSciences) is making significant advancements in AI-powered ECG technology aimed at improving heart disease detection and is on track for regulatory submissions in 2025 [1][10]. Financial Overview - For Q1 FY2025, HeartSciences reported no revenues, with cash and cash equivalents at approximately $4.3 million and shareholders' equity at approximately $5.9 million [11]. - The company strengthened its balance sheet post-quarter by securing $1.9 million in non-dilutive financing and extending a $500,000 loan note to September 2025 [3][11]. Product Development - The MyoVista Insights AI-ECG algorithm cloud-platform is progressing, with Phase 1 completion expected by the end of 2024, and prevalidation work on a low ejection fraction algorithm set to begin soon [4][5]. - The FDA 510(k) submission for the MyoVista® wavECG™ device is on track for Q1 2025, with hardware and software issues resolved and final validation studies anticipated to follow a successful pre-submission meeting [6]. Innovation and Market Position - HeartSciences is developing both cloud and device-based AI-ECG solutions, which will enhance heart disease detection across various healthcare settings [2]. - The company has received positive feedback on its MyoVista Insights platform and is actively engaging with key opinion leaders to bolster commercialization efforts [10]. Intellectual Property and Recognition - HeartSciences has expanded its intellectual property portfolio with new patents, including a notice of allowance for detecting left and right ventricular dysfunction using deep learning [9]. - The MyoVista® wavECG™ device was selected for demonstration at the United Nations General Assembly Digital Health Symposium, highlighting its potential to transform healthcare [8].

AI Technology Development - The company is focused on developing AI-based ECG technology to enhance cardiac screening capabilities [106]. - The MyoVista wavECG device is a proprietary 12-lead ECG that integrates AI-ECG algorithms for improved diagnostic information [106]. - The company entered into License Agreements with Mount Sinai to commercialize AI-ECG algorithms for various cardiovascular conditions [108]. - The FDA has cleared an algorithm for low ejection fraction (less than 40%) under the 510(k) pathway, with a submission for the MyoVista wavECG device planned for Q1 2025 [115]. - The company has received a patent for MyoVista wavelet technology from the Indian Patent Office in May 2024 [122]. Financial Performance - The company incurred approximately $300,000 in accrued interest to FRV as part of a debt extension agreement [122]. - The Streeterville Note issued to the company amounts to $2,510,000, with an interest rate of 8.5% per annum and a maturity of 18 months [123]. - Operating expenses primarily consist of research and development and selling, general, and administrative expenses [125]. - Research and development expenses include costs related to clinical trials, regulatory compliance, and personnel-related costs [126]. - Research and development expenses increased to $1.2 million for the three months ended July 31, 2024, up by $659,000 or 117% compared to the same period in 2023, primarily due to consulting costs for the MyoVista Insights Cloud Platform [129]. - Selling, general, and administrative expenses were approximately $0.9 million for the three months ended July 31, 2024, an increase of $86,000 or 11% compared to the same period in 2023, mainly due to payroll and professional expenses related to the reverse stock split [129]. - Total operating expenses reached $2.1 million for the three months ended July 31, 2024, reflecting a $745,000 or 56% increase from $1.3 million in the same period of 2023 [128]. - The net loss for the period ended July 31, 2024, was $2.1 million, a $685,000 or 50% increase compared to a net loss of $1.4 million in the same period of 2023 [128]. - As of July 31, 2024, the company had an accumulated deficit of $69.4 million and stockholder's equity of $5.9 million, with working capital of $4.7 million [131]. - The company incurred net cash used in operating activities of $2.0 million for the three months ended July 31, 2024, compared to $1.4 million for the same period in 2023 [137]. Capital Raising Activities - The company raised approximately $1.6 million from the sale of Common Stock under the Lincoln Park Purchase Agreement as of the date of the Quarterly Report [132]. - The company received approximately $9.8 million in net proceeds from the sale of Common Stock under the amended EDA as of the date of the Quarterly Report [133]. - The company entered into a Note Purchase Agreement with Streeterville for an unsecured promissory note of $2.51 million, resulting in approximately $1.9 million in net cash proceeds [134]. - The company reported a decrease in cash and cash equivalents to approximately $4.3 million as of July 31, 2024, down from $5.8 million as of April 30, 2024 [135].

Southlake, TX, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced the close of a non-dilutive financing, with $1.9 million in net proceeds. The unsecured loan note has an 18-month maturity date and follows the recent 12-month extension of a $500 ...

HeartSciences Provides Business Update and Reports Fiscal 2024 Financial Results Southlake, TX, July 29, 2024 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today reported financial results for the fiscal year 2024 ended April 30, 2024 and provided a business update. Fisc ...

Core Viewpoint - Heart Test Laboratories, Inc. (d/b/a HeartSciences) is advancing its AI-powered medical technology for ECGs/EKGs, aiming to enhance early detection of heart disease and improve healthcare outcomes through innovative solutions [1][36]. Business Developments - The company has fundamentally transformed its business model, positioning itself to offer both cloud-based and device-based AI-ECG solutions across various healthcare settings [3][34]. - The MyoVista Insights cloud-platform is being developed with a phased rollout plan, targeting FDA clearance alongside its first cloud-based AI-ECG algorithm [4][19]. - The company is finalizing adjustments to its device-based AI-ECG algorithm, leveraging extensive patient data from Mount Sinai to enhance its clinical utility [7][12]. Financial Overview - As of April 30, 2024, the company reported cash and cash equivalents of approximately $5.8 million and shareholders' equity of about $7.3 million, indicating a strong balance sheet [10][29]. - During fiscal year 2024, the company raised $10.3 million in net proceeds from common stock sales and converted $1.1 million of debt to equity [29]. Regulatory and Clinical Progress - The company is preparing for an FDA validation study for the LVEF algorithm, utilizing retrospective data to streamline costs and timelines [5][23]. - The MyoVista wavECG device is on track for FDA submission in early 2025, with final system testing underway [15][22]. - The company has established a robust patent portfolio, including new patents for AI-ECG applications in assessing heart function [9][28]. Market Position and Future Outlook - HeartSciences aims to capitalize on a projected $25 billion annual market for AI-ECG solutions, focusing on bridging the diagnostic gap for early heart disease detection [33]. - The MyoVista Insights platform is designed to be device agnostic, facilitating a marketplace for AI-ECG algorithms and enhancing clinical access to these technologies [11][34]. - The company has received positive feedback from early clinical use of its devices in Europe and has been selected to showcase its technology at significant health symposiums [26][34].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of Registrant as specified in its Charter) TEXAS 26-1344466 (State or other jurisdiction of incorporation or organization) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended April 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-4142 ...

Duncan Sleeman, UWE – Senior Lecturer (Cardiac Physiology) / Programme Lead (PGCert Echocardiography), an author of the abstract, stated, "The introduction of the MyoVista wavECG device could revolutionize our approach to managing the LV function query echo referral waitlist. By pre-screening inhospital patients with this AI-powered ECG device, we could identify those who do not require further cardiology intervention, thereby reducing unnecessary referrals and enabling quicker access to care for those in n ...

Southlake, TX, July 26, 2024 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ:HSCS, HSCSW))) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced an analysis published by the Innovation Value Institute (IVI) titled "Introduction of AI assisted Digital Health Technology to Improve Cardiovascular Pathway Efficiency" focused o ...