Financial Performance - Revenues for the three months ended July 31, 2025, were $2,000, with a cost of sales of $1,000, resulting in a gross margin of $1,000 [193]. - The Company incurred a net loss of $2.1 million for the period ended July 31, 2025, with an accumulated deficit of $78.2 million [198]. - Cash and cash equivalents increased to approximately $2.8 million as of July 31, 2025, up from $1.1 million as of April 30, 2025 [205]. - Net cash used in operating activities was $1.9 million during the three months ended July 31, 2025, primarily due to the net loss [207]. - Net cash provided by financing activities was $3.6 million during the three months ended July 31, 2025, primarily from the issuance of Series D Preferred Stock and warrants [209]. Research and Development - The company is focused on developing AI and innovative software technology to enhance the clinical usefulness of ECGs, aiming to provide modernized ECG solutions for a broader range of heart disease detection [155]. - Phase 1 of the MyoVista Insights Cloud Platform has been launched, with expected revenue from installation fees and SaaS-based usage fees, adopting a recurring subscription revenue model for AI-ECG algorithms [157]. - The company has been granted a foundational patent covering the estimation of echocardiography parameters indicative of heart function using an ECG in June 2025 [175]. - Research and development expenses decreased by $228,000, or 19%, to $997,000 for the three months ended July 31, 2025, primarily due to reduced cloud consulting costs [194]. Regulatory and Compliance - The company received FDA "Breakthrough Device" designation for its aortic stenosis ECG algorithm in June 2025 [176]. - The company plans to submit the MyoVista wavECG device for FDA clearance under the 510(k) pathway in calendar 2025 [170]. - The company aims for an FDA submission of a low-ejection fraction algorithm during the first half of calendar 2026 [170]. Capital and Financing - The company has entered into a Series D Preferred Stock offering with a maximum amount of $15.0 million, priced at $3.50 per unit [178]. - The Company issued 1,556,409 Units consisting of Series D Preferred Stock and Warrants for gross proceeds of approximately $5.4 million as of the date of the Quarterly Report [181]. - The Company expects to continue raising capital through the sale of additional equity securities, debt, or strategic partnerships to fund ongoing operations [204]. Operational Challenges - The company has experienced recurring losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern [172]. - As of January 31, 2025, the company's stockholders' equity was reported at $1,786,689, below the Nasdaq minimum requirement of $2.5 million [173]. - Selling, general, and administrative expenses increased by $27,000, or 3%, to approximately $878,000 for the three months ended July 31, 2025, mainly due to increased stock compensation expense [195]. - Interest expense rose to $184,000 for the three months ended July 31, 2025, an increase of $161,000 or 715% compared to the same period in 2024 [196]. Accounting and Reporting - No material changes to critical accounting policies and estimates from the 2025 Annual Report on Form 10-K [211]. - Smaller reporting company is not required to provide quantitative and qualitative disclosures about market risk [212].

Core Viewpoint - HeartSciences Inc. is actively engaging with investors through multiple virtual events in August 2025 to showcase its AI-powered ECG technology aimed at early heart disease detection [1][2][3] Group 1: Upcoming Events - The company will host an Investor Webinar on August 20, 2025, at 2:00 PM Eastern Time, providing an overview of its mission, market opportunity, and recent progress [2] - HeartSciences will also present at the Emerging Growth Conference 85 on the same day at 3:10 PM Eastern Time, allowing real-time interaction with investors [3] - Archived webcasts of these events will be available for those unable to attend live [4] Group 2: Company Overview - HeartSciences focuses on enhancing the clinical utility of ECGs through innovative AI technology, aiming to improve cardiac screening, especially in frontline clinical settings [5] - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these through a cloud-based solution and a low-cost ECG hardware platform [5] - The MyoVista® wavECG™, the company's first product candidate for FDA clearance, is designed to provide diagnostic information related to cardiac dysfunction alongside conventional ECG data [5]

[Form 8-K Current Report: HeartSciences Inc.](index=1&type=section&id=Form%208-K%20Current%20Report%3A%20HeartSciences%20Inc.) [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) HeartSciences Inc. announced its fiscal year 2025 financial and operating results on July 24, 2025, via a press release furnished as Exhibit 99.1, which is not considered 'filed' for regulatory liability purposes - The company issued a press release on July 24, 2025, to provide financial and operating results for the fiscal year ended April 30, 2025[7](index=7&type=chunk) - The press release is attached as Exhibit 99.1 and is incorporated by reference into this report[7](index=7&type=chunk) - Information in this item and the attached exhibit is not considered "filed" for Section 18 of the Securities Exchange Act of 1934 liability purposes[8](index=8&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits accompanying the Current Report, primarily the July 24, 2025 press release (99.1) and an Interactive Data File (104) Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1* | Press Release dated July 24, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

Core Viewpoint - HeartSciences Inc. is advancing its AI-powered ECG technology to enhance heart disease detection and aims for commercialization in 2026, pending regulatory approvals [1][6]. Fiscal 2025 and Business Highlights - The company made significant strategic advancements in fiscal year 2025, focusing on enhancing the clinical value of ECGs through AI and cloud technologies applicable in various healthcare settings [2]. - HeartSciences launched the MyoVista Insights software platform, designed to modernize ECG management and integrate with existing hospital systems, facilitating access to AI-ECG algorithms [6][7]. MyoVista Insights™ Software Platform - MyoVista Insights aims to become the first cloud-native ECG management software, targeting a multibillion-dollar market by replacing outdated systems [6]. - The platform began rollout in May 2025, with plans for a second phase alongside the FDA submission of a cloud-based algorithm for detecting reduced ejection fraction in 2026 [6]. MyoVista® wavECG™ Device - The company is nearing FDA submission for the MyoVista wavECG device, with final testing nearly complete [6]. - The device incorporates an algorithm for impaired cardiac relaxation that aligns with updated guidelines from the American Society of Echocardiography [6]. Financial Results - HeartSciences reported no significant revenue for fiscal year 2025, with approximately $1.1 million in cash and $0.2 million in shareholders' equity as of April 30, 2025 [8]. - The company raised $3.1 million in gross proceeds through a Reg A+ offering and converted $0.9 million of debt into equity, strengthening its balance sheet [11]. Regulatory and Market Developments - The Centers for Medicare & Medicaid Services approved reimbursement for AI-ECG algorithms at $128 per test, in addition to standard ECG reimbursement [6]. - The FDA granted "Breakthrough Device" designation for HeartSciences' aortic stenosis ECG algorithm, indicating significant potential in the market [6]. Intellectual Property and Partnerships - HeartSciences expanded its intellectual property portfolio, holding 44 granted patents worldwide, including a key patent for estimating echocardiographic parameters via ECG [6]. - The company is growing its institutional clinical partnerships and Scientific Advisory Board to support clinical adoption and development [6].

AI and Product Development - The company is focused on developing AI-based ECG algorithms to enhance the clinical utility of ECGs for detecting a broader range of heart diseases [19]. - The MyoVista wavECG device is a proprietary 12-lead ECG that integrates AI-ECG algorithms to provide diagnostic information related to cardiac dysfunction [19]. - The company entered into license agreements with Icahn School of Medicine at Mount Sinai to commercialize AI-ECG algorithms for various cardiovascular conditions [21]. - The company received Breakthrough Device designation from the FDA for the aortic stenosis algorithm licensed from Mount Sinai in June 2025 [21]. - The company aims to submit the MyoVista Insights Cloud Platform and low ejection fraction algorithm for FDA clearance in the first half of calendar year 2026 [32]. - The MyoVista Insights Cloud Platform is being developed to provide efficient ECG management, hosting multiple AI-ECG algorithms, and aims to create an AI-ECG marketplace [40]. - The first AI-ECG cloud-based algorithm is expected to be a low ejection fraction algorithm licensed from Mount Sinai, developed using over 100,000 patient records, with a regulatory pathway anticipated to be 510(k) [44]. - The MyoVista wavECG device incorporates a cardiac dysfunction algorithm and features a 12-lead resting ECG capability, designed to detect diastolic dysfunction [48]. - The company is preparing for a 510(k) FDA submission for the MyoVista wavECG device in calendar 2025, following the FDA's new product code for cardiovascular machine learning-based notification software [31]. - The company anticipates expanding its pipeline of AI-ECG algorithms following regulatory clearance of the first algorithm, leveraging relationships with clinical institutions for further development [47]. Market Potential and Financials - Heart disease is the leading cause of death globally, with an estimated 17.9 million deaths from cardiovascular diseases in 2019, representing 32% of all global deaths [33]. - The cost of heart disease in the U.S. was approximately $240 billion annually in 2018 and 2019, including healthcare services, medications, and lost productivity [35]. - The global ECG market is projected to grow from $10.93 billion in 2023 to $30.87 billion by 2034, indicating significant market potential for MyoVista's products [60]. - Approximately 48% of Medicare beneficiaries are enrolled in Medicare Advantage plans, creating a target market for MyoVista's cloud-based and hardware platforms [65]. - The initial revenue model for the MyoVista wavECG device is expected to follow a "razor-razorblade" model, with proprietary electrodes required for each test performed [20]. - The initial revenue model for the MyoVista wavECG device includes capital sales and recurring revenue from proprietary supplies, with a focus on device-agnostic AI-ECG algorithm delivery [67]. - The MyoVista wavECG device is expected to qualify for Medicare reimbursement for existing ECG testing procedures, with interpretation and report ranges from approximately $17 to $55 depending on the healthcare facility type [72]. Regulatory and Compliance Challenges - The company is preparing for a 510(k) FDA submission in calendar 2025 for the MyoVista wavECG device, following a De Novo clearance granted in August 2023 [169]. - The FDA's 510(k) clearance process for medical devices typically takes from three to twelve months, but often takes longer [94]. - The company must comply with stringent QSR requirements during the design and manufacturing process of medical devices [108]. - The FDA has broad regulatory compliance powers, including the ability to impose sanctions such as recalls or fines for non-compliance [110]. - The company previously achieved a CE Mark under the EU Medical Devices Directive in February 2017, which has since lapsed and must now comply with the EU MDR [115]. - The updated CE mark certificate under EU MDR is necessary for the company to market the MyoVista wavECG in the European Economic Area [115]. - The company is subject to extensive government regulation, and failure to comply could harm its business and lead to enforcement actions [132]. - The company faces significant challenges in obtaining regulatory approval for its MyoVista wavECG hardware and associated platforms, which are critical for its business plan [149]. Financial Performance and Risks - The company has incurred significant operating losses, reporting net losses of approximately $8.8 million and $6.6 million for Fiscal 2025 and Fiscal 2024, respectively, with an accumulated deficit of approximately $76.1 million as of April 30, 2025 [136]. - The company anticipates continued significant operating losses for the foreseeable future due to the uncertainties associated with developing medical devices [138]. - There is substantial doubt about the company's ability to continue as a going concern due to recurring losses and limited capital resources, which may adversely affect its share price and ability to raise new capital [164]. - The company may need to raise additional funding, which may not be available on acceptable terms, potentially impacting its development efforts [128]. - Material weaknesses in internal controls over financial reporting have been identified, which could impact the accuracy of financial statements and compliance with stock exchange requirements [157][161]. Competition and Market Dynamics - The company faces intense competition from established players like GE Healthcare, Philips, and Baxter, which have greater brand recognition and resources [191]. - The medical device market, particularly in ECG technologies, is highly competitive, leading to potential price reductions and lower product margins [192]. - If competitors offer significant discounts, the company may need to lower its prices, impacting revenue generation [193]. - The company must continuously enhance its products and develop new technologies to remain competitive in a rapidly changing medical device market [189]. Operational and Management Challenges - The company relies heavily on attracting and retaining skilled personnel, with intense competition for qualified employees in the medical device field [194]. - The management team has limited experience in managing a public company, which may affect compliance with regulatory obligations [197]. - As of July 23, 2025, the company had only 15 full-time employees, making it vulnerable to operational risks if key personnel leave [198]. - Future growth may require additional managerial and operational resources, which could disrupt operations if recruitment challenges arise [195]. External Factors and Risks - The company plans to conduct business outside the U.S., exposing it to various regulatory and economic risks [200]. - Changes in global economic conditions, including inflation and geopolitical events, could adversely affect the company's financial condition and liquidity [205]. - The company’s operations may be impacted by health crises, such as pandemics, which could disrupt manufacturing and supply chains [209]. - Regulatory changes may impose restrictions on operations, leading to higher costs or lower sales for approved products [211]. - Clinical studies are necessary for future product submissions, which are lengthy and costly with uncertain outcomes [213]. - Delays in clinical studies can adversely affect costs, timing, and successful completion, impacting regulatory approval [214].

Core Insights - HeartSciences Inc. has received FDA Breakthrough Device designation for its AI-driven ECG algorithm designed to detect Aortic Stenosis, a serious heart valve disease [1][5] Company Overview - HeartSciences is focused on advancing ECG technology using AI to enhance early detection of heart diseases, aiming to improve healthcare outcomes [5] - The company has developed one of the largest libraries of AI-ECG algorithms and plans to offer these solutions through a cloud-based platform that integrates with existing hospital EHR systems [5] Technology and Innovation - The AI-ECG algorithm can detect moderate-to-severe Aortic Stenosis up to 24 months before confirmatory echocardiography, utilizing advanced convolutional neural network techniques trained on over 120,000 ECG records [3][4] - The algorithm is designed for seamless integration with hospital systems, requiring no additional hardware or testing, thus enhancing clinical utility [3] Clinical Impact - Early detection of Aortic Stenosis through this algorithm allows for timely interventions, potentially improving patient outcomes and reducing the risk of irreversible myocardial damage [2][4] - The technology aims to expand access to early diagnosis, particularly in underserved areas lacking specialized cardiac imaging [7]

Core Insights - HeartSciences Inc. has been granted a foundational patent by the USPTO for estimating echocardiography parameters using an ECG, enhancing its intellectual property portfolio [1] - The company has a total of 44 granted patents, including 10 US patents and 34 international patents across key markets [2] - The CEO of HeartSciences emphasized the strength of their AI-ECG algorithm patent portfolio, positioning the company as a significant player in the AI-ECG field [3] Company Overview - HeartSciences is focused on applying AI technology to ECGs to improve their clinical utility, aiming to enhance cardiac screening, especially in frontline clinical settings [5] - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these algorithms through a cloud-based solution and a low-cost ECG hardware platform [5] - The MyoVista® wavECG™, the company's first product candidate for FDA clearance, is designed to provide diagnostic information related to cardiac dysfunction alongside conventional ECG data [5]

Core Insights - HeartSciences Inc. has signed its first commercial customer, Westcliffe Health Innovations, for its MyoVista Insights™ platform, marking a significant milestone in its commercial journey [1][7] - The MyoVista Insights platform aims to enhance ECG management and improve clinical decision-making through AI technology, positioning itself as a vendor- and device-agnostic solution [4][8] Company Overview - HeartSciences is focused on applying AI technology to ECGs to improve their clinical utility, particularly in frontline healthcare settings [8] - The company has developed a large library of AI-ECG algorithms and aims to provide these through a cloud-based solution alongside low-cost ECG hardware [8] Product Details - MyoVista Insights is a cloud-native ECG management system designed to streamline workflows and reduce operational costs for healthcare providers [4] - The platform is intended to facilitate easy access to ECGs and expert interpretation, particularly in areas with socio-economic challenges [6] Partnership Significance - The partnership with Westcliffe Health Innovations is expected to establish it as a key reference site for HeartSciences in the UK market [3] - Dr. Matthew Fay, a prominent figure in UK cardiology, emphasizes the importance of easy access to ECGs in addressing cardiovascular disease in the community [5][6]

Core Insights - HeartSciences Inc. is focused on transforming ECGs/EKGs through AI technology to enhance early detection of heart disease [1][4] - The company will present at the Emerging Growth Conference 82, providing insights into its mission and market opportunities [2] - HeartSciences is offering a Regulation A investment opportunity for qualified investors, allowing access to investment terms typically unavailable in public markets [2] Company Overview - HeartSciences utilizes innovative AI-based technology to improve the clinical utility of ECGs, aiming to enhance cardiac screening, especially in frontline clinical settings [4] - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these algorithms through a cloud-based solution and a low-cost ECG hardware platform [4] - The MyoVista® wavECG™, the company's first product candidate for FDA clearance, provides diagnostic information related to cardiac dysfunction alongside conventional ECG data [4]

Core Viewpoint - HeartSciences Inc. is leveraging AI technology to enhance ECG diagnostics, aiming to improve early detection of heart disease and save lives [1][3]. Group 1: Company Overview - HeartSciences is focused on transforming ECGs/EKGs through AI to enhance their clinical utility, particularly in frontline clinical settings [3]. - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these algorithms via a cloud-based solution and a low-cost ECG hardware platform [3]. - The first product candidate, MyoVista® wavECG™, is a resting 12-lead ECG that provides diagnostic information related to cardiac dysfunction, traditionally available only through cardiac imaging [3]. Group 2: Market Opportunity - The AI-ECG platform is designed to significantly improve the diagnostic capabilities of standard ECGs, enabling faster and earlier detection of heart disease at the point of care [2]. - The upcoming investor webinar on May 14, 2025, will provide insights into HeartSciences' mission and market opportunities, along with a discussion on the current Regulation A investment opportunity [2]. Group 3: Investment Information - HeartSciences is offering securities under Tier II of Regulation A, providing qualified investors access to investment opportunities typically unavailable in public markets [2][5].