HeartSciences Reports Third Quarter Fiscal 2024 Financial Results

Southlake, TX, March 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, today reported financial results for the third quarter fiscal 2024 ended January 31, 2024 and provided a business update.

Q3 FY2024 and Recent Accomplishments

HeartSciences has seen a fundamental change in its business opportunity since the end of the second fiscal quarter, with material improvements to its financial position and outlook. A summary of the main changes and business highlights during Q3 FY2024 and to date include:

• Strategic shift from a Company with a single-device, single-algorithm to one with a broad portfolio of AI-ECG cardiovascular algorithms to be delivered via a cloud-based hardware agnostic platform.
  • Enables the Company to provide AI-ECG solutions in any care setting worldwide in a manner that best suits different providers, either via one of the millions of ECG’s currently in clinical use or via our proprietary MyoVista wavECG device;  
• Secured a robust AI-ECG pipeline through the acquisition of licenses for an industry leading portfolio of AI-ECG algorithms, technologies and patent rights from Icahn School of Medicine at Mount Sinai, New York (Mount Sinai).
  • Mount Sinai became the Company’s largest shareholder as a result of the acquisition;
• FDA pathway for the MyoVista device changed to 510(k). Now expect that the 510(k) pathway and use of retrospective data will apply to the cloud-platform and Mount Sinai AI-ECG algorithms, which will facilitate a quicker and more cost-effective regulatory path to commercialization;
• Significantly strengthened both the employee base and broader team to provide for more rapid and effective operational execution:
  • Recruited a new VP of Clinical and Regulatory and engaged a new FDA advisory firm, with specific experience delivering a 510(k) cleared AI-ECG algorithm;
  • Recruited a senior software project director and engaged a leading software developer to develop the AI-ECG cloud-platform, on which work has already started;
  • Strengthened our scientific advisory board with the addition of data scientists and cardiologists and broadened our overall scientific and clinical relationships;
• Diligent, methodical progress towards FDA submission of the MyoVista and incorporated AI-ECG algorithm:
  • Patient recruitment and core-lab work for the MyoVista validation study has been completed;
  • Following the FDA’s agreement for HeartSciences to adjust the echocardiographic measurement thresholds for older patients of the first MyoVista AI-ECG algorithm (to increase clinical value), the Company is updating the algorithm to the modified thresholds in collaboration with Mount Sinai. Once complete, clinical validation is expected to take place relatively quickly, ahead of the overall MyoVista FDA submission.
  • The Company continues to target FDA clearance for the MyoVista around calendar year end 2024; 
• Further clinical validation of MyoVista technology from a peer-reviewed publication with data demonstrating that screening for heart disease in diabetic patients using a MyoVista AI-ECG model significantly outperformed conventional screening standards of care. Diabetes represents a major risk factor for heart disease and affects approximately 500 million people worldwide;
• Significantly improved financial position. The Q3 FY2024 shareholders’ equity was $8.6 million, compared to a $1.6 million deficit in Q2 FY2024, and cash was $7.1 million, compared to $0.1 million in 2Q FY2024, providing a longer cash runway to make material business progress.

Management Commentary