Heart Test Laboratories, Inc. (NASDAQ: HSCS), operating under the trade name HeartSciences, experienced a notable rebound on the U.S. stock market. Following a regular-session loss of 4.61%, where shares closed at $2.90, the stock rose 8.62% after-hours, reaching $3.15. This fluctuation is attributed to HeartSciences’ recent financial developments and strategic advancements.
Financial Advances and Extended Capital Runway
Recent non-dilutive financing arrangements were completed by Heart Test Laboratories, which raised $1.9 million in net funds via an 18-month unsecured loan note. The recent extension of a $500,000 loan note to September 2025 is being followed by this additional funding.
Since late August, Heart Test has increased its capital runway by $2.4 million through such non-dilutive measures, positioning itself favorably for impending FDA submissions and commercial objectives.
Progress in AI-ECG Solutions and Upcoming FDA Submissions
HeartSciences is advancing in the development of both cloud and device-based AI-ECG technologies. These innovations are designed to enhance heart disease detection across various healthcare settings, from large hospitals to mobile testing services managed by nurses.
Heart Test reported holding $4.3 million in cash and cash equivalents and $5.9 million in shareholders’ equity. Following the recent financing, HSCS balance sheet has been further bolstered, extending its financial runway. The MyoVista Insights AI-ECG cloud platform is progressing towards the completion of its Phase 1 version by the end of 2024.
Pre-validation efforts for the low ejection fraction (LVEF ≤ 40) algorithm, licensed from the Icahn School of Medicine at Mount Sinai, are set to commence shortly. Successful pre-validation will pave the way for FDA validation studies using retrospective data, with regulatory submission anticipated in the latter half of 2025.
FDA Submission Timelines and Device Developments
The MyoVista wavECG device is on track for its FDA 510(k) submission in the first quarter of 2025. Heart Test (NASDAQ: HSCS) has resolved previous hardware and software issues, and work on the updated age-adjusted algorithm is nearing completion. A final pre-submission meeting with the FDA will finalize the validation study reporting processes.
Patient recruitment and core-lab work for the MyoVista validation study have been completed, and, contingent on a satisfactory pre-submission meeting, the final validation process is expected to proceed promptly.
