On March 14, 2024, Heart Test Laboratories, Inc., doing business as HeartSciences, released its financial and operational results for the third quarter of fiscal year 2024, which ended on January 31, 2024. The company, which specializes in AI-powered medical technology for heart disease detection, announced a strategic shift towards a broad portfolio of AI-ECG cardiovascular algorithms delivered through a cloud-based platform. HeartSciences secured a significant AI-ECG pipeline through licensing agreements with Mount Sinai, which also became the company's largest shareholder. The FDA pathway for HeartSciences' MyoVista device has been changed to 510(k), indicating a more cost-effective and quicker route to commercialization. The company has made progress towards FDA submission of the MyoVista device and incorporated AI-ECG algorithm, with...Show More

On March 14, 2024, Heart Test Laboratories, Inc., doing business as HeartSciences, released its financial and operational results for the third quarter of fiscal year 2024, which ended on January 31, 2024. The company, which specializes in AI-powered medical technology for heart disease detection, announced a strategic shift towards a broad portfolio of AI-ECG cardiovascular algorithms delivered through a cloud-based platform. HeartSciences secured a significant AI-ECG pipeline through licensing agreements with Mount Sinai, which also became the company's largest shareholder. The FDA pathway for HeartSciences' MyoVista device has been changed to 510(k), indicating a more cost-effective and quicker route to commercialization. The company has made progress towards FDA submission of the MyoVista device and incorporated AI-ECG algorithm, with patient recruitment and core-lab work for the MyoVista validation study completed. Clinical validation is expected to proceed swiftly following an agreement with the FDA to adjust echocardiographic measurement thresholds for older patients. HeartSciences aims for FDA clearance for the MyoVista device around the end of calendar year 2024. The company also reported significant improvements in its financial position, with shareholders' equity at $8.6 million and cash at $7.1 million, compared to a deficit and near-zero cash in the previous quarter. The financial uplift was attributed to net proceeds from sales of common stock and conversion of debt to equity. HeartSciences' CEO, Andrew Simpson, emphasized the company's vision to transform cardiovascular medicine with AI-ECG technology and highlighted the operational and financial strides made since the previous quarter. The company's full financial results have been filed with the SEC and are available on its website.