HeartSciences Inc.

HeartSciences Inc.

At a glance

• Name: HeartSciences Inc. (operating as HeartSciences; product brand MyoVista)
• Location: Southlake, Texas (principal office: 550 Reserve Street, Suite 360, Southlake, TX 76092)
• Corporate status: Texas corporation; public company with common stock listed on Nasdaq; also issues IPO warrants and various preferred shares
• Focus: healthcare information technology advancing electrocardiography (ECG) with artificial intelligence
• Mission: modernize ECG workflows and enable scalable deployment of AI-ECG capabilities across healthcare systems

What the company sells and does

MyoVista Insights™ platform

• Cloud-native, vendor- and device-agnostic ECG management platform
• Centralizes ECG storage and management, waveform visualization, reporting, workflow optimization, and interoperability with EMRs and ECG devices
• Designed to host AI-ECG algorithms from multiple vendors (an AI-ECG marketplace) and integrate them into clinical workflows
• Marketed as an AI-ECG orchestration platform to deploy and manage multiple algorithms within a single clinical environment
• Business model: installation fees, SaaS usage fees, and fees from AI-ECG marketplace hosting/licensing
• Classification: Medical Device Data System (MDDS), exempt from FDA 510(k) premarket clearance

MyoVista wavECG™ device

• 12-lead ECG device designed to complement the MyoVista Insights™ platform and host embedded AI-ECG algorithms
• Includes Glasgow-based ECG interpretation software licensed as part of device software
• FDA submission: 510(k) premarket clearance submitted December 2025; currently under FDA review
• Future plans: integrate an impaired cardiac relaxation (e’) AI-ECG algorithm under development and align with updated ASE LVDD guidelines; separate FDA submissions planned for device and algorithm where required

AI-ECG marketplace

• Platform designed to host third-party AI-ECG algorithms and manage licensing/hosting arrangements
• Licensed algorithms include those from Mount Sinai; Mount Sinai’s portfolio includes an aortic stenosis algorithm with FDA Breakthrough Device Designation (2025)

Key product and commercial developments (timeline)

• Early adopter phase launched in 2025
• March 2026: major version upgrade of MyoVista Insights™ for broader deployment (mobile access, enhanced reporting, expanded interoperability)
• March 2026: Epic Toolbox designation for the ECG Management System category from Epic Systems Corporation
• March 2026: plan to scale across cardiology and enterprise healthcare IT environments

Intellectual property and collaborations

Patents and registrations

• 9 U.S. utility patents and 1 U.S. design patent issued
• 1 U.S. utility patent allowance licensed to the company
• U.S. patent family expirations: March 2031 to August 2040
• 14 international design registrations and 25 international utility patents granted (expirations 2036–2040)
• 1 patent allowance in Europe

Licenses and agreements

• wavECG inventions and rights licensed via:
  • January 2014: invention assignment transferring wavECG technology to the company
  • December 2015: University of Glasgow Licensing Agreement (Android platform software modules for resting 12‑lead ECG analysis)
• Mount Sinai licenses (2023): cover AI-ECG algorithms hosted on MyoVista Insights™; ongoing royalties and milestones tied to net sales and sublicensing revenue; integration and updates planned for the platform

Other collaborations

• Rutgers, The State University of New Jersey: multi-year collaboration to research and develop additional AI-ECG algorithms (entered November 29, 2022)

Regulatory status

United States

• MyoVista Insights™: classified as MDDS and exempt from FDA 510(k)
• MyoVista wavECG™: Class II device; 510(k) submitted December 2025 and under FDA review
• Regulatory path includes separate considerations for device and AI‑ECG algorithm submissions where clinical guidelines are updated

EU and other jurisdictions

• CE Mark under the EU Medical Devices Directive (MDD) achieved February 2017; MDD CE mark lapsed February 2022
• EU MDR compliance and updated CE marking not yet established
• EU AI Act (Regulation 2024/1689) introduces high-risk AI obligations; compliance activities underway for AI-based medical devices

Data and privacy

• GDPR implications for cross-border data transfers and data protection; HIPAA considerations for U.S. healthcare data
• Ongoing oversight regarding privacy, security, and cross-border data transfers

Commercial and market status

• Deployments: implemented in several healthcare settings during early adopter phase; focus on establishing key commercial reference sites and revenue-generating installations
• Commercial activity: announced customer engagements for MyoVista Insights™ and ongoing discussions for additional engagements
• Revenue model: installation fees, SaaS usage fees, and AI-ECG marketplace fees for third-party algorithms
• Revenue performance: limited revenue to date from MyoVista wavECG™ device sales; MyoVista Insights™ in development with no reported platform revenue during that stage
• Target markets: primary care through large health systems and international markets, including India and other developing healthcare systems

Financial snapshot (as reported, as of July 20, 2026 and April 30, 2026 where noted)

• Employees and contractors:
  • 14 full-time employees (as of July 20, 2026)
  • 9 independent contractors
• Capital structure (as of July 20, 2026):
  • Common stock outstanding: 3,899,491 shares
  • Series C Preferred: 380,440 shares outstanding (convertible into 295,011 common shares)
  • Series D Preferred: 425,836 shares outstanding (convertible into 425,836 common shares)
  • Options and warrants exercisable for: 3,605,453 common shares
• Profitability and solvency:
  • Net loss for fiscal 2026: approximately $9.1 million
  • Net loss for fiscal 2025: approximately $8.8 million
  • Accumulated deficit: approximately $85.3 million (as of April 30, 2026)
  • Stockholders’ equity: approximately $0.2 million (as of April 30, 2026)
  • Company reports ongoing operating losses and substantial doubt about the ability to continue as a going concern
• Operations and facilities:
  • Headquarters/office: 4,634 square foot suite leased in Southlake, TX (lease through May 31, 2028)
• Market status:
  • Nasdaq-listed with ongoing risk of delisting if listing criteria are not met
  • No declared cash dividends; equity financing contemplated for growth and working capital

Core value proposition

• Platform-centric ECG technology stack intended to modernize ECG workflow, enable scalable AI-ECG deployment, and support a multi-vendor AI-ECG ecosystem
• Combines cloud-native infrastructure, device-agnostic interoperability, and a marketplace for AI algorithms
• Aims to broaden AI-enabled interpretation beyond traditional human-read ECGs and support earlier detection across care settings
• Strategic partnerships and licensing (Mount Sinai, Rutgers, Glasgow) to build AI-ECG algorithm offerings and pipeline