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 in preventing, detecting, and treating cardiovascular disease, leveraging its Artificial Intelligence (AI)-driven Multi-Omics Engine™ ². Cardio believes it is the first company to commercialize epigenetics-based clinical tests for cardiovascular disease, targeting multiple stakeholders including patients, clinicians, hospitals, employers, and payors ³. The company's solutions are designed to shift the approach to cardiovascular disease from reactive to proactive, with the goal of altering the trajectory that nearly one in two Americans are expected to develop some form of cardiovascular disease by 2035 ⁴.

Cardio's core business model revolves around developing and commercializing epigenetics-based clinical tests and related software platforms for cardiovascular disease and associated co-morbidities like stroke, heart failure, and diabetes. The company generates revenue primarily from product test sales to telemedicine providers, provider organizations (including concierge practices), and employer organizations ⁵. Revenue recognition occurs upon the completion of testing patient samples ⁶. The pricing of tests is negotiated based on organization type and testing volume commitment ⁷. The company's technology, the AI-driven Multi-Omics Engine™, identifies integrated genetic-epigenetic biomarkers and translates them into clinical tests, combining laboratory assessments of epigenetic DNA biomarkers and genetic biomarkers (SNPs) with a proprietary interpretive predictive machine learning model to predict risk and provide personalized insights ⁸.

Cardio currently offers two primary clinical products: Epi+Gen CHD™ and PrecisionCHD™. Epi+Gen CHD™ is an epigenetics-based clinical blood test designed to assess the three-year risk for a coronary heart disease (CHD) event, such as a heart attack ⁹. In a peer-reviewed study, this test demonstrated a 76% sensitivity for men and 78% sensitivity for women for three-year CHD risk, significantly outperforming the Framingham Risk Score and ASCVD Pooled Cohort Equation, which had average sensitivities of 44% and 32% for men and women, respectively ¹⁰. The test also showed potential cost savings of up to $42,000 per quality-adjusted life year and improved survival compared to the ASCVD Pooled Cohort Equation ¹¹. Epi+Gen CHD™ received a CPT PLA code, 0439U, and a final CMS gapfill payment rate of $854 in 2025 ¹².

PrecisionCHD™ is an integrated epigenetic-genetic clinical blood test for the detection of coronary heart disease ¹³. A peer-reviewed study indicated an overall average area under the curve, sensitivity, and specificity of 82%, 79%, and 76%, respectively, for detecting CHD across three independent test cohorts ¹⁴. For men and women, the average sensitivity was 80% and 76%, respectively, which is approximately 1.4 times and 1.3 times more sensitive than an exercise ECG, a commonly used test with a sensitivity of 58% ¹⁵. PrecisionCHD™ is coupled with the Actionable Clinical Intelligence (ACI) platform, offering epigenetic and genetic insights to clinicians for personalized patient management ¹⁶. This test also received a CPT PLA code, 0440U, and a final CMS gapfill payment rate of $854 in 2025 ¹⁷. Additionally, Cardio launched CardioInnovate360™ in May 2023 as a research-use-only (RUO) solution for biopharmaceutical discovery and development ¹⁸, and HeartRisk™ in February 2024, a cardiovascular disease risk intelligence platform that combines insights from clinical test data with industry and geographic data for population-level CVD risk insights ¹⁹.

For the fiscal year ended December 31, 2025, Cardio reported total revenue of $14,825 ²⁰, a decrease from $34,890 in the year ended December 31, 2024 ²¹. The net loss for 2025 was $6,498,167 ²², an improvement from a net loss of $8,383,453 in 2024 ²³. Basic and diluted net loss per common share was $(3.71) in 2025 ²⁴, compared to $(9.35) in 2024 ²⁵. Cash and cash equivalents stood at $5,110,630 as of December 31, 2025 ²⁶, down from $7,827,487 at December 31, 2024 ²⁷. Total current liabilities were $604,839 in 2025 ²⁸, compared to $631,695 in 2024 ²⁹. The company's accumulated deficit reached $29,250,000 at December 31, 2025 ³⁰.

The year-over-year comparison shows a significant decrease in revenue by $20,065, primarily due to the conclusion of the Family Medicine Specialists’ Heart Attack Prevention testing initiative ³¹. Operating expenses decreased from $8,400,767 in 2024 to $6,498,903 in 2025 ³². This was driven by a $465,081 decrease in sales and marketing expenses to $766,888 in 2025 ³³, and a $1,895,524 decrease in general and administrative expenses to $5,025,570 in 2025 ³⁴, mainly due to lower stock compensation expenses and director and officer insurance expense ³⁵. Conversely, research and development expenses increased by $413,246 to $641,212 in 2025, due to an increase in research and development personnel ³⁶. Amortization expense also increased to $65,233 in 2025 from $19,738 in 2024 ³⁷.

During the reported period, Cardio made progress in its international expansion, with the first international market being India ³⁸. The company also partnered with channel partners such as YMCA of East Tennessee and Southdale YMCA to offer testing to their members and community ³⁹. Furthermore, Cardio advanced in setting up its laboratory facility as a high complexity testing laboratory in compliance with the Clinical Laboratory Improvement Amendments (CLIA) ⁴⁰. A significant regulatory development was the formal rescission by the FDA on September 19, 2025, of its May 2024 final rule that would have regulated Laboratory Developed Tests (LDTs) as medical devices, following a federal court ruling that the FDA exceeded its authority ⁴¹. This reverts LDT oversight to CLIA ⁴². The company also continued to raise capital through an At-the-Market (ATM) Sales Agreement, selling 292,495 shares for gross proceeds of $3,900,492 in 2025 ⁴³.

Cardio expects sales and partnership cycles to remain long, particularly given the current economic uncertainty. The company's ongoing strategy to expand business operations and increase revenue generation includes leveraging its CPT PLA codes and expanding reimbursement efforts with both government and commercial payors ⁴⁴. Cardio is also focused on developing additional products, specifically clinical tests for stroke, congestive heart failure, and diabetes ⁴⁵. A key part of the strategy is to expand its clinical and health economics evidence portfolio to further demonstrate the value of its products and increase their reach ⁴⁶.

The company plans to offer laboratory services through its CLIA laboratory ⁴⁷ and expand the adoption of its products across key channels, including health systems and self-insured employers ⁴⁸. Domestically, Cardio intends to explore additional market opportunities in the U.S. ⁴⁹. Internationally, the company will explore partner-led expansions, building on its first international expansion into India, and investigate opportunities to grow its presence in India, including with local manufacturing ⁵⁰. Operationally, Cardio aims to scale its internal capabilities with a focus on improving efficiency and reducing its cost of goods sold ⁵¹. The company also intends to pursue potential strategic partnership(s) and/or acquisition(s) of one or more synergistic companies ⁵².

Regarding margin trajectory and cost structure, Cardio foresees potential opportunities to increase the gross margin of its Epi+Gen CHD™ and PrecisionCHD™ tests by processing patient samples in larger batches, shipping sample collection kits in larger batches, and increasing the level of automation to reduce manual processing ⁵³. The company expects its general corporate overhead to remain relatively flat ⁵⁴. However, as a public company, it anticipates incurring annual expenses related to legal and exchange requirements, including SEC regulations and Nasdaq listing requirements, as well as directors' and officers' liability insurance, directors' fees, auditing, and legal fees ⁵⁵.

In terms of supply chain and technology infrastructure, Cardio relies on third-party suppliers for sample collection kit contents, which are commonly used and can be sourced from multiple distributors ⁵⁶. These contents are assembled internally into lancet-based and vacutainer-based kits, and the company intends to maintain at least six months' inventory of fully assembled kits ⁵⁷. Proprietary genetic and DNA methylation components are sourced from large manufacturers under cGMP, with alternative manufacturers available ⁵⁸. Laboratory assays are expected to be available to meet anticipated demand for at least six months ⁵⁹. The company's proprietary algorithms can be scaled and automated to process data from thousands of samples, and laboratory processes can be automated and scaled by adding existing commercial equipment ⁶⁰. Cardio currently has 15 full-time and two part-time employees as of March 13, 2026 ⁶¹, and its human capital objectives include identifying, recruiting, retaining, incentivizing, and integrating employees into a collaborative culture ⁶².

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 ⁶³. The company's primary source of capital since 2024 has been sales of common stock under its At-the-Market (ATM) agreement with Craig-Hallum Capital Group, LLC ⁶⁴. As of March 13, 2026, Cardio has sold 2,251,181 shares of common stock under the Sales Agreement, generating $18,754,735 in net proceeds ⁶⁵, and may sell up to another $5,298,889 of common stock through Craig-Hallum under the agreement ⁶⁶. The company anticipates that its principal sources of liquidity, including existing funds and the ATM offering, will be sufficient to fund activities over the next 12 months ⁶⁷. Beyond this period, additional capital will be needed through equity and/or debt issuance to meet long-term operating requirements and grow the business ⁶⁸.

Management explicitly flagged several structural headwinds and execution risks. The healthcare commercialization process for diagnostic tests is inherently lengthy, spanning multiple years, and in some cases, a decade or more, due to regulatory, reimbursement, evidentiary, and behavioral factors ⁶⁹. Revenue growth is expected to remain negligible until third-party reimbursement is secured, tests are incorporated into broader clinical guidelines, and integrated into medical care workflows ⁷⁰. The market for epigenetic tests is new and unproven, with potential for limited growth, which could adversely affect the realization of the business plan ⁷¹. The company's growth strategy may not prove viable, and expected growth and value may not be realized, particularly concerning strategic channel partnerships ⁷². The process to secure broad payor coverage is expected to take years, constraining meaningful revenue generation ⁷³.

Geographic, regulatory, and macro factors also pose constraints. The company's international expansion, such as into India, involves partner-led efforts and potential local manufacturing, which introduces complexities ⁷⁴. While the FDA formally rescinded its rule regulating LDTs as medical devices, the regulatory landscape remains uncertain, with ongoing debate in Congress (e.g., VALID Act) about future LDT regulation ⁷⁵. If the FDA were to regulate Cardio's tests or software, it could incur substantial costs and delays for premarket authorization and compliance with post-market controls ⁷⁶. Inadequate coverage and reimbursement from third-party payors, including Medicare, could limit access and commercial success, as Medicare generally does not cover screening tests without explicit statutory provision ⁷⁷. The company does not expect Medicare or other third-party coverage or reimbursement for Epi+Gen CHD™ or PrecisionCHD™ in the near term ⁷⁸. Market and economic conditions, including inflation, energy costs, geopolitical issues, and unstable global credit markets, may negatively impact the business, financial condition, and stock price ⁷⁹. Rising costs of goods and services, including raw materials, could adversely affect gross margins and profitability ⁸⁰.

Cardio faces material risks stemming from its limited operating history and unproven business model, having generated only nominal revenue of $14,825 in 2025 ²⁰ and incurring an accumulated deficit of $29,250,000 as of December 31, 2025 ³⁰, with no assurance of achieving or sustaining profitability. The healthcare commercialization process for diagnostic tests is inherently lengthy, often spanning a decade or more, due to regulatory, reimbursement, evidentiary, and behavioral factors, which will likely constrain meaningful revenue growth until broad third-party reimbursement and clinical guideline inclusion are achieved ⁶⁹. The market for epigenetic tests is new and unproven, and its limited growth could adversely affect the company's ability to realize its business plan ⁷¹. Intense competition from larger, well-capitalized technology companies with greater resources could limit market share and necessitate significant sales and marketing expenses ⁸¹. Regulatory risks include potential future FDA regulation of Laboratory Developed Tests (LDTs), despite the recent rescission of a rule, which could impose substantial costs and delays for premarket authorization and compliance ⁷⁵. Inadequate coverage and reimbursement from third-party payors, particularly Medicare, for its Epi+Gen CHD™ and PrecisionCHD™ tests, which are currently not expected to have Medicare coverage in the near term ⁷⁸, will severely limit commercial success and revenue generation. Geopolitical issues, such as the ongoing conflict between Russia and Ukraine and hostilities in Iran, along with broader macroeconomic factors like inflation and volatile credit markets, could negatively impact the business, increase costs, and make future financing more difficult ⁷⁹. Operational risks include potential interruptions or performance problems with its technology and infrastructure, cybersecurity breaches that could compromise customer data and harm reputation, and the challenge of managing growth with a small team of 15 full-time and two part-time employees ⁶¹. The company also has a material weakness in internal control over financial reporting due to inadequate segregation of duties within the financial reporting process ⁸². Furthermore, the company's common stock is subject to volatility, and there is a risk of delisting from Nasdaq if it fails to meet continued listing standards, such as maintaining a market value of listed securities (MVLS) of at least $5.0 million ⁸³, which was $4.76 per share on March 11, 2026 ⁸⁴.

Management's tone emphasizes a long-term growth strategy over short-term profitability, acknowledging the inherently lengthy and complex commercialization lifecycle for diagnostic tests, which can span a decade or more from scientific discovery to widespread utilization and revenue generation. They explicitly state that revenue growth is expected to remain negligible until third-party reimbursement is obtained and tests are incorporated into clinical guidelines and workflows ⁷⁰. The company's strategic priorities include leveraging CPT PLA codes and expanding reimbursement efforts with both government and commercial payors, developing additional clinical tests for stroke, congestive heart failure, and diabetes, and expanding its clinical and health economics evidence portfolio to demonstrate product value and increase reach ⁴⁴. Management also highlights the importance of scaling internal operations to improve efficiency and reduce the cost of goods sold, exploring additional market opportunities in the US, and pursuing partner-led international expansions, such as in India ⁵⁰. They anticipate relying primarily on the ongoing At-the-Market (ATM) Offering for the remainder of 2026, provided market conditions are favorable ⁸⁵.