HeartSciences Inc., a medical technology company focused on enhancing the clinical utility of electrocardiograms (ECGs) through artificial intelligence (AI), reported a significant decline in financial performance for the fiscal year ending April 30, 2025. The company generated revenues of $4,350, a decrease of approximately 77% from $18,600 in the previous fiscal year. This decline is attributed to the ongoing development and regulatory approval processes for its MyoVista wavECG device and associated AI-ECG algorithms, which have not yet received FDA clearance for marketing.

The company's operating expenses increased by 32% to $8.4 million in fiscal 2025, compared to $6.3 million in fiscal 2024. Research and development (R&D) expenses rose by 52% to $4.4 million, driven by consulting costs related to the development of the MyoVista Insights Cloud Platform and increased personnel expenses. Selling, general, and administrative expenses also saw a 15% increase, primarily due to legal and professional fees. As a result, HeartSciences reported a net loss of $8.8 million for the year, up from a net loss of $6.6 million in the prior year.

Strategically, HeartSciences has made significant moves to bolster its product offerings and market position. On September 20, 2023, the company entered into multiple license agreements with the Icahn School of Medicine at Mount Sinai to commercialize a range of AI-ECG algorithms. Additionally, the company received FDA Breakthrough Device designation for its aortic stenosis algorithm in June 2025. These developments are expected to enhance the clinical capabilities of the MyoVista wavECG device, which integrates AI algorithms to detect various heart conditions.

Operationally, HeartSciences is focused on expanding its market presence and product adoption. The company has signed two early adopter customers for its MyoVista Insights Cloud Platform, which is designed to integrate seamlessly into existing clinical workflows. As of April 30, 2025, HeartSciences had 15 full-time employees and 9 independent contractors, reflecting a commitment to building a skilled workforce to support its growth initiatives. The company is also preparing for a 510(k) FDA submission for the MyoVista wavECG device and its low ejection fraction algorithm, with expectations for submission in the first half of 2026.

Looking ahead, HeartSciences faces challenges related to its financial stability and the need for additional funding to support its operations and product launches. As of April 30, 2025, the company had approximately $1.1 million in cash and an accumulated deficit of $76.1 million. The company has indicated that it will need to raise substantial additional capital to fund its future operations, including the sales launch of its products in the U.S. and ongoing R&D efforts. The management's ability to secure this funding will be critical to the company's future success and its capacity to navigate the competitive landscape of the medical device industry.

About HeartSciences Inc.

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