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Heart Test Laboratories(HSCS) - 2025 Q4 - Annual Results
2025-07-24 20:17
[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) |
HeartSciences Provides Business Update and Reports Fiscal 2025 Financial Results
Globenewswire· 2025-07-24 20:15
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aims to become the first cloud-native ECG management software, targeting a multibillion-dollar market by replacing outdated systems [6].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].
Heart Test Laboratories(HSCS) - 2025 Q4 - Annual Report
2025-07-24 20:05
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended April 30, 2025 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 001-41422 HEARTSCIENCES INC. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorp ...
HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis
Globenewswire· 2025-06-04 13:00
Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR SystemsSouthlake, TX, June 04, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”) powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, today announced that the U.S. Food and Drug Admin ...
Foundational US Patent Granted for ECG Assessment of Heart Function, Further Expands HeartSciences’ Patent Portfolio and IP Value
Globenewswire· 2025-06-03 13:00
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]
HeartSciences Signs First MyoVista Insights™ Platform Customer, Marking Major Commercial Milestone
GlobeNewswire News Room· 2025-05-29 13:00
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]
HeartSciences’ CEO Andrew Simpson to Present at Emerging Growth Conference 82 on Wednesday, May 21, 2025
Globenewswire· 2025-05-20 13:00
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]
HeartSciences to Host Investor Webinar and Q&A on Wednesday May 14, 2025 - Featuring CEO Andrew Simpson
Globenewswire· 2025-05-08 13:00
Southlake, TX, May 08, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq:HSCS) ("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 that it will host a live investor webinar on Wednesday, May 14, 2025, at 2:00 p.m. EDT | 11:00 a.m. PDT, featuring a presentation and Q&A session with CEO Andrew Simpson. Register Now To attend the webinar and participat ...
HeartSciences Adds Prominent Key Advisors to its Scientific Advisory Board
Globenewswire· 2025-05-07 13:00
Southlake, TX, May 07, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq:HSCS) ("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 appointment of Dr. Girish Nadkarni, MD, Dr. Joshua Lampert, MD, and Dr. Akhil Vaid, MBBS, to its Scientific Advisory Board. These appointments underscore HeartSciences' commitment to advancing and transforming data-d ...
HeartSciences Announces Launch of MyoVista Insights™ Platform and Related Early Adopter Program
Globenewswire· 2025-05-01 13:00
Southlake, TX, May 01, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (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 it has launched the MyoVista InsightsTM platform and related early adopter program for select reference sites. MyoVista Insights is a cloud-native next-generation ECG Management System designed to enhance ...