Cardio Diagnostics Holdings, Inc.

Cardio Diagnostics Holdings, Inc. (Cardio) operates in the cardiovascular diagnostic testing market, which is estimated to grow from $8.47 billion in 2022 to $12.41 billion by 2027, representing a Compound Annual Growth Rate (CAGR) of 7.94% ¹. The company aims to become a leading medical technology firm for improved prevention, early detection, and treatment of cardiovascular disease (CVD), leveraging its Artificial Intelligence (AI)-driven Multi-Omics Engine™. The market is driven by factors such as an aging population, rising chronic diseases and associated costs, a shift to value-based care, growth in telemedicine, adoption of AI, and increased patient engagement. The American Heart Association projects that nearly half of Americans will have some form of CVD by 2035 ².

Cardio believes it is the first company to develop and commercialize epigenetics-based clinical tests for cardiovascular disease, offering value propositions for patients, clinicians, hospitals/health systems, employers, and payors. The company's core business model revolves around developing and commercializing clinical tests for major types of cardiovascular disease and associated co-morbidities like coronary heart disease (CHD), stroke, heart failure, and diabetes. Revenue is generated from product test sales, with pricing varying based on organization type and test volume. The company also offers research-use-only solutions and a risk intelligence platform.

Cardio's primary clinical products are Epi+Gen CHD™ and PrecisionCHD™. Epi+Gen CHD™, launched in 2021, is an epigenetics-based clinical blood test for assessing three-year symptomatic CHD risk, including heart attacks. It demonstrated 76% and 78% sensitivity for men and women, respectively, for three-year CHD risk, compared to 44% and 32% for Framingham Risk Score and ASCVD Pooled Cohort Equation ³. This test received a final CMS gapfill payment rate of $854 in 2025 ⁴. PrecisionCHD™, launched in March 2023, is an integrated epigenetic-genetic clinical blood test for the detection of coronary heart disease. It showed an overall average area under the curve, sensitivity, and specificity of 82%, 79%, and 76%, respectively, in three independent test cohorts for detecting CHD ⁵. Its average sensitivity for men and women was 80% and 76%, respectively, outperforming exercise ECG which has a sensitivity of 58% ⁶. PrecisionCHD™ also received a final CMS gapfill payment rate of $854 in 2025 ⁷. Both tests are categorized as laboratory-developed tests (LDTs) and are accompanied by the Actionable Clinical Intelligence (ACI) platform, which provides personalized insights to clinicians.

In May 2023, Cardio launched CardioInnovate360™, a research-use-only (RUO) solution for the discovery, development, and validation of novel biopharmaceuticals for cardiovascular diseases. In February 2024, the company launched HeartRisk™, a cardiovascular disease risk intelligence platform designed to augment its clinical blood tests by combining anonymized and aggregated clinical cardiovascular data with industry and geographic data for real-time population-level CVD risk insights.

For the fiscal year ended December 31, 2025, Cardio reported total revenue of $14,825 ⁸, a decrease from $34,890 ⁹ in 2024. The net loss for 2025 was $6,498,167 ¹⁰, an improvement from a net loss of $8,383,453 ¹¹ in 2024. Basic and diluted net loss per common share for 2025 was $(3.71) ¹², compared to $(9.35) ¹³ in 2024. Cash and cash equivalents totaled $5,110,630 ¹⁴ at December 31, 2025, down from $7,827,487 ¹⁵ at December 31, 2024. Total current liabilities were $604,839 ¹⁶ and total liabilities were $793,061 ¹⁷ at December 31, 2025. The company does not explicitly state total debt or net debt figures, but reports a finance agreement payable of $269,790 ¹⁸ at December 31, 2025.

The decrease in revenue in 2025 was attributed to the conclusion of the Family Medicine Specialists’ Heart Attack Prevention testing initiative ¹⁹, despite new, smaller provider organizations being onboarded. Operating expenses decreased to $6,498,903 ²⁰ in 2025 from $8,400,767 ²¹ in 2024. This was primarily driven by a decrease in General and Administrative expenses to $5,025,570 ²² in 2025 from $6,921,094 ²³ in 2024, mainly due to lower stock compensation expenses. Sales and marketing expenses decreased by $465,081 ²⁴ to $766,888 ²⁵ in 2025, primarily due to a restructuring of sales and marketing personnel. Conversely, research and development expense increased by $413,246 ²⁶ to $641,212 ²⁷ in 2025, due to an increase in research and development personnel. Amortization expense increased to $65,233 ²⁸ in 2025 from $19,738 ²⁹ in 2024, consisting of amortization of intangible assets and patent costs.

During the fiscal year ended December 31, 2025, Cardio focused on driving adoption of its clinical solutions among providers, channel partners, and employers. The company made progress in its international expansion to India and partnered with organizations like YMCA of East Tennessee and Southdale YMCA to offer testing. Cardio also advanced in setting up its laboratory facility as a high complexity testing laboratory in compliance with CLIA. A 1-for-30 reverse stock split was effected on May 12, 2025 ³⁰. The FDA formally rescinded its May 2024 final rule regulating LDTs as medical devices on September 19, 2025, following a federal court ruling ³¹.

Cardio expects sales and partnership cycles to remain long, particularly given current economic uncertainty. The company's ongoing strategy for expanding business operations and increasing revenue generation includes leveraging its CPT PLA codes and expanding reimbursement efforts with both government and commercial payors. Cardio intends to develop additional products, including clinical tests for stroke, congestive heart failure, and diabetes. The company plans to expand its clinical and health economics evidence portfolio to further demonstrate product value and reach, and to offer laboratory services via its CLIA laboratory.

A key growth area involves expanding the adoption of its products across key channels, such as health systems and self-insured employers. Cardio is also exploring additional market opportunities within the U.S. and pursuing partner-led international expansions, with an initial focus on India, including exploring opportunities for local manufacturing. The company aims to scale its internal operations capabilities, focusing on improving efficiency and reducing its cost of goods sold. Furthermore, Cardio plans to pursue potential strategic partnership(s) and/or acquisition(s) of synergistic companies.

Regarding margin trajectory and cost structure, Cardio foresees potential opportunities to increase the gross margin of Epi+Gen CHD™ and PrecisionCHD™ by processing patient samples in larger batches, shipping sample collection kits in larger batches, and increasing the level of automation to reduce manual processing. The company expects its general corporate overhead to remain relatively flat.

In terms of supply chain and manufacturing, Cardio relies on third-party suppliers for sample collection kit contents, which are commonly used and sourced from multiple distributors. These contents are assembled internally into lancet-based and vacutainer-based kits. The company intends to maintain an inventory of fully assembled kits to meet expected demand for at least six months. Proprietary genetic and DNA methylation components are sourced from large manufacturers under cGMP, with alternative manufacturers available. Laboratory assays are also manufactured under cGMP and are expected to be available for at least six months of anticipated demand. The company's clinical blood tests are offered as LDTs through its newly established CLIA-certified laboratory.

For capital allocation, Cardio expects to spend significant amounts to expand existing operations, including geographic expansion, making additional key hires, expanding sales channels, and developing new tests and services. The company's primary cash needs for the remainder of 2026 and the foreseeable future will be for funding day-to-day operations, working capital, its growth strategy, internal laboratory setup expenses, and ongoing FDA submission activities. Cardio expects to rely primarily on its ongoing At-the-Market (ATM) Offering for the remainder of 2026, provided market conditions are favorable. As of March 13, 2026, the company has sold 2,251,181 shares of Common Stock under the Sales Agreement, generating $18,754,735 ³² in net proceeds, and may sell up to another $5,298,889 ³³ of Common Stock through Craig-Hallum under the Sales Agreement. The company does not anticipate paying any cash dividends in the foreseeable future, intending to retain future earnings to finance operations and expansion.

Management explicitly flagged several structural headwinds and execution risks. The commercialization process for diagnostic tests is inherently lengthy, subject to regulatory, reimbursement, evidentiary, and behavioral factors, often spanning a decade or more from initial development to widespread utilization and revenue generation. The market for epigenetic tests is new and unproven, and its growth may be limited, adversely affecting the company's ability to realize its business plan's potential. Estimates of market opportunity and forecasts of market growth may prove inaccurate. The company's ability to generate meaningful revenue will continue to be constrained as securing broad payor coverage is expected to take years. The company also faces intense competition from companies with greater financial and technical resources. The success of its AI/ML technologies depends significantly on retaining key technical personnel.

Cardio faces significant risks due to its limited operating history and unproven business model, having generated only nominal revenue of $14,825 ⁸ in 2025 and incurring an accumulated deficit of $29,250,000 ³⁴ at December 31, 2025. The healthcare commercialization process for diagnostic tests is inherently lengthy, often spanning a decade or more, and securing third-party reimbursement is a challenging, time-consuming, and costly process that may take several years. The market for epigenetic tests is new and unproven, and its growth may be limited, impacting demand for Cardio's solutions. The company operates in a highly competitive and rapidly evolving market, facing larger, well-capitalized technology companies, which could limit its ability to maintain or expand market share. Cybersecurity threats pose a material risk, as unauthorized access to customer data could harm reputation and lead to civil and criminal liability, despite the company's SOC2 and HIPAA governance framework. The company's core technology is licensed from the University of Iowa Research Foundation (UIRF), and this license could be terminated if Cardio breaches its obligations, such as failing to pay applicable license fees or entering liquidation. Furthermore, the non-exclusive license of "technical information" to UIRF could allow unaffiliated third parties to develop competitive products. Intellectual property derived from government funding may be subject to federal regulations under the Bayh-Dole Act, potentially limiting Cardio's exclusive rights or subjecting it to "march-in rights" by the U.S. government. The company's stock price is volatile, and future sales of Common Stock, including through its At-the-Market Issuance Sales Agreement, could cause significant dilution to existing shareholders and depress the market price. The company's ability to maintain its Nasdaq listing is at risk if it fails to meet minimum bid price requirements or the proposed $5 million ³⁵ market value of listed securities (MVLS) threshold, which could lead to delisting and severely impact liquidity and capital raising.

Management's tone emphasizes a long-term growth strategy over short-term profitability, acknowledging that revenue growth will likely remain negligible until broad third-party reimbursement is secured and tests are integrated into clinical guidelines and workflows. They explicitly state that the commercialization lifecycle for diagnostic tests is lengthy, often spanning a decade or more, and that securing broad payor coverage could take years, constraining meaningful revenue generation. Key strategic priorities include leveraging CPT PLA codes and expanding reimbursement efforts with government and commercial payors, developing additional clinical tests for stroke, congestive heart failure, and diabetes, and expanding the clinical and health economics evidence portfolio. Management also prioritizes expanding product adoption across key channels like health systems and self-insured employers, exploring additional U.S. and international market opportunities (starting with India), scaling internal operations for efficiency and reduced cost of goods sold, and pursuing strategic partnerships or acquisitions. The company expects to rely primarily on its ongoing At-the-Market Offering for financing in the near term, with the ability to sell up to another $5,298,889 ³³ of Common Stock through Craig-Hallum under the Sales Agreement.