0001193125-26-104080
SEC filingHeartBeam, Inc. reported a net loss of $21.0 million for fiscal year 2025, an 8% increase from a $19.4 million loss in 2024. The company generated no revenue, as its FDA-cleared HeartBeam System for arrhythmia assessment did not generate any revenue in 2025. Total operating expenses were $21.1 million, a 6% increase year-over-year, driven by a 22% rise in research and development spending to $13.4 million, partially offset by a 13% decrease in general and administrative expenses to $7.7 million. The company ended the year with $4.4 million in cash and cash equivalents, a $2.0 million increase from the prior year, primarily due to $16.6 million in net proceeds from the sale of common stock, which offset $14.0 million in net cash used in operating activities. Management has expressed substantial doubt about the company's ability to continue as a going concern, stating existing cash is insufficient to fund operations for the next twelve months.
HeartBeam, Inc. reported a net loss of $21.0 million for the fiscal year ended December 31, 2025, representing an 8% increase from a net loss of $19.4 million in 2024. The company generated no revenue during the period, as its FDA-cleared HeartBeam System for arrhythmia assessment did not produce any sales. Total operating expenses reached $21.1 million, up 6% from $19.9 million in the prior year. This increase was primarily driven by higher research and development spending, which rose 22% to $13.4 million, while general and administrative expenses decreased 13% to $7.7 million. Other income totaled $124,000, consisting mainly of interest income, representing a 72% decrease from the prior year due to lower cash balances.
The company reported no revenue for fiscal year 2025, as stated explicitly in the document: "The HeartBeam System did not generate any revenue in 2025." HeartBeam is a medical technology company in the pre-revenue stage, focused on developing ambulatory cardiac monitoring solutions. The company's initial product, the HeartBeam System, received FDA clearance for arrhythmia assessment in December 2024 (3D ECG technology) and December 2025 (12-lead ECG synthesis software). The company is planning a limited market introduction in early 2026, focusing on select concierge and preventive cardiology groups. No segment revenue breakdown is provided as the company has not yet commenced commercial operations.
With zero revenue, the company reported negative gross and operating margins. The loss from operations was $21.1 million, matching total operating expenses. Research and development expenses increased by $2.4 million or 22% year-over-year, primarily due to higher product development costs for the HeartBeam System ($1.5 million increase), increased headcount-related costs from reallocation into AI and R&D ($1.2 million), and higher stock-based compensation expense ($1.4 million). These increases were partially offset by lower clinical study costs ($0.7 million decrease) and reduced consulting expenses for foundational clearance ($1.0 million decrease). General and administrative expenses decreased by $1.1 million or 13%, primarily due to lower stock-based compensation expense ($0.6 million), reduced consulting costs ($0.4 million), and lower employee costs ($0.3 million), partially offset by higher commercial readiness consulting costs ($0.2 million).
The company ended the year with $4.4 million in cash and cash equivalents, a $2.0 million increase from $2.4 million at the end of 2024. Net cash used in operating activities was $14.0 million, primarily due to the net loss of $21.0 million, partially offset by $5.1 million in stock-based compensation expense, $0.2 million in stock issuance for services, $0.1 million in depreciation expense, and $1.6 million in net changes from operating assets and liabilities. Net cash used in investing activities was $0.6 million for property and equipment purchases. Net cash provided by financing activities was $16.6 million from net proceeds from the sale of common stock. The balance sheet shows total assets of $5.8 million, total liabilities of $3.2 million, and stockholders' equity of $2.6 million. Management has expressed substantial doubt about the company's ability to continue as a going concern, stating that existing cash is insufficient to fund operations for the next twelve months.
The company is focused on several key growth initiatives: a limited market launch in early 2026 for its FDA-cleared HeartBeam System; pursuing FDA clearance for heart attack detection indication; developing an extended wear patch monitor; and advancing AI-based screening and prediction algorithms using longitudinal data. Recent developments include hiring a Chief Commercial Officer in January 2026, announcing its first commercial customer (ClearCardio) on March 4, 2026, enrolling first patients in a heart attack detection pilot study on March 5, 2026, and entering into a strategic AI collaboration with Mount Sinai on March 10, 2026. The company has an At-the-Market offering agreement with Public Ventures, with approximately $8.1 million available for issuance as of March 11, 2026. Key risk factors include the need for additional capital, limited operating history, no revenues to date, regulatory challenges, and intense competition in the medical device industry.