MyoVista® wavECG™
Search documents
HeartSciences Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update
Globenewswire· 2025-12-15 21:15
Core Viewpoint - HeartSciences Inc. is advancing its MyoVista Insights™ healthcare IT platform and has submitted its MyoVista® wavECG™ device for FDA clearance, marking significant progress in the commercialization of its ECG technology [1][2][5]. Group 1: Business Developments - The Company has made substantial advancements in the commercialization of its MyoVista Insights™ platform and has submitted the MyoVista® wavECG™ device to the FDA for 510(k) premarket clearance [2][5]. - MyoVista Insights is classified as a Medical Device Data System (MDDS), which allows for a faster and less costly commercial rollout compared to regulated medical devices [7]. - The platform has received strong validation from early adopters and is currently in commercial discussions with several healthcare institutions, with expectations to announce key customer wins soon [5][7]. Group 2: Financial Results - HeartSciences reported no meaningful revenue for the fiscal second quarter ended October 31, 2025, and had approximately $2.0 million in cash and cash equivalents, along with $4.2 million in shareholders' equity [8]. Group 3: Market Opportunity - The MyoVista Insights platform is designed to host third-party AI-ECG algorithms, positioning the Company to capture a multibillion-dollar market opportunity while reducing costs and time for algorithm development and regulatory clearance [7]. - The Company plans to host an investor call early in the new year to demonstrate the MyoVista Insights software and discuss its commercialization strategy and market opportunity [7].
HeartSciences Announces Conference Participation and Investor Webinar
Globenewswire· 2025-08-15 13:00
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]
HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis
Globenewswire· 2025-06-04 13:00
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]
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
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].
HeartSciences Adds Prominent Key Advisors to its Scientific Advisory Board
Globenewswire· 2025-05-07 13:00
Core Viewpoint - HeartSciences Inc. has appointed three distinguished experts to its Scientific Advisory Board, enhancing its commitment to advancing AI-driven ECG technology for early heart disease detection [1][2]. Group 1: Appointments and Expertise - Dr. Girish Nadkarni, Dr. Joshua Lampert, and Dr. Akhil Vaid have been appointed to the Scientific Advisory Board, bringing extensive expertise in cardiology, AI, and data-driven healthcare [1][2]. - Dr. Nadkarni is a physician-scientist with significant contributions to AI and precision medicine, holding over 375 peer-reviewed publications and an h-index of 90, and has secured approximately $40 million in research funding [3][4]. - Dr. Lampert specializes in cardiac electrophysiology and machine learning, focusing on improving patient care through novel diagnostic tools and has received multiple awards for his contributions to patient care [5][6][8]. - Dr. Vaid is involved in applying machine learning in cardiology, with a focus on developing AI models for cardiac dysfunction detection and ensuring practical implementation of AI solutions in clinical settings [9][10][11]. Group 2: Company Overview and Objectives - HeartSciences is dedicated to enhancing the clinical utility of ECGs through innovative AI technology, aiming to improve cardiac screening, particularly in frontline clinical settings [12]. - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these solutions via a cloud-based platform alongside a low-cost ECG hardware option [12]. - HeartSciences' first product candidate, the MyoVista® wavECG™, aims to provide diagnostic information related to cardiac dysfunction, traditionally available only through cardiac imaging, while also delivering conventional ECG data [12].