- For cardiovascular conditions, annual health care costs are forecasted to increase from $393 billion in 2020 to $1.4 trillion by 2050, almost quadrupling in size.
- What makes Cardio Diagnostics’ approach distinct, and what gives the company a defensible clinical position, is its ability to detect coronary heart disease earlier and with high sensitivity.
- The company’s recent commercial and regulatory milestones give additional shape to the investment thesis.
Heart disease has held the grim distinction of being the leading cause of death in the United States for decades, and despite advances in medicine, the problem is getting worse, not better. According to the American Heart Association (“AHA”), cardiovascular disease accounted for more than 940,000 deaths in the United States in 2022, maintaining its position as the nation’s number one killer. Into that persistent and costly healthcare burden steps Cardio Diagnostics Holdings (NASDAQ: CDIO), a Chicago-based precision cardiovascular medicine company that is applying artificial intelligence, epigenetics and genetics to a problem that traditional diagnostic tools have never fully solved: detecting coronary heart disease, including forms that standard methods routinely miss, from a simple blood draw.
The scale of the problem that Cardio Diagnostics is working to address is difficult to overstate. According to the AHA, cardiovascular disease remains the leading cause of death across men, women, and most racial and ethnic groups in the nation, with one person dying every 34 seconds from the disease.
The economic burden is equally staggering. For cardiovascular conditions, annual health care costs are forecasted to increase from $393 billion in 2020 to $1.4 trillion by 2050, almost quadrupling in size. In addition, productivity losses are estimated to increase by 54%, from $234 billion to $361 billion. For investors evaluating the size of the opportunity, that backdrop establishes a market driven not by discretionary healthcare spending but by a chronic, escalating, and unavoidable national health crisis.
What makes Cardio Diagnostics’ approach distinct, and what gives the company a defensible clinical position, is its ability to detect heart attack risk and coronary heart disease earlier and with high sensitivity. The company’s two flagship tests, Epi+Gen CHD and PrecisionCHD, were developed using the company’s proprietary AI-driven Multi-Omics Engine. These tests analyze a combination of DNA methylation biomarkers (epigenetic markers) and genetic markers, called single nucleotide polymorphisms (“SNPs”), from a blood sample. Artificial intelligence is then used to interpret these genetic and epigenetic signals and generate personalized insights related to heart attack risk and coronary heart disease detection.”
Epi+Gen CHD assesses a patient’s three-year risk for a coronary heart disease event, including heart attacks. PrecisionCHD aids in the diagnosis and management of coronary heart disease. Both tests are noninvasive and require no fasting or radiation. They can also be performed in a doctor’s office or from an at-home sample collection kit ordered through a telemedicine platform, a meaningful advantage in terms of patient accessibility and clinician adoption. According to Cardio Diagnostics, PrecisionCHD has a sensitivity of better than 75% for both men and women.
Perhaps the most clinically significant aspect of the PrecisionCHD test is initial data supporting its ability to detect nonobstructive forms of coronary heart disease, specifically ischemia with no obstructive coronary arteries (“INOCA”) and myocardial infarction with no obstructive coronary arteries (“MINOCA”), which standard tools including angiograms typically can miss.
Preliminary clinical data supporting this capability was presented at the American Heart Association Scientific Sessions in November 2025, where a University of Iowa collaboration study of 267 hospitalized acute coronary syndrome patients demonstrated that PrecisionCHD’s methylation indices could detect INOCA. For the millions of patients who present with symptoms but receive a clear angiogram, only to suffer subsequent cardiac events, this is the kind of breakthrough that the clinical community has been seeking.
The company’s recent commercial and regulatory milestones give additional shape to the investment thesis. In late 2024, Cardio Diagnostics received finalized CMS reimbursement rates of $854 for its clinical tests, along with dedicated CPT Proprietary Laboratory Analysis codes from the American Medical Association, both critical steps toward mainstream insurance coverage and broad clinical adoption.
Cardio Diagnostics’ recent commercial and reimbursement milestones have helped strengthen its commercialization strategy. In December 2025, the company announced that the Centers for Medicare & Medicaid Services (“CMS”) finalized a gapfill reimbursement rate of $854 for both its Epi+Gen CHD and PrecisionCHD tests, effective for services provided on or after January 1, 2026.
Earlier, the American Medical Association assigned dedicated CPT Proprietary Laboratory Analysis (“PLA”) codes to both tests: 0439U for Epi+Gen CHD and 0440U for PrecisionCHD. Those codes became effective in April 2024. Dedicated reimbursement codes and established CMS payment rates are important steps that can facilitate payer billing, reimbursement and broader clinical adoption.
In addition, the company expanded its provider network in October 2025, adding 15 new provider organizations across the United States. In January 2026, Cardio Diagnostics announced its first international expansion through a strategic agreement with Aimil Ltd. and Dr. Lal PathLabs to launch the PrecisionCHD test in India, a market where cardiovascular disease carries an enormous and growing burden. Dr. Lal PathLabs operates more than 290 clinical laboratories and a network of 300-plus MD pathologists, providing immediate infrastructure for meaningful scale.
Cardio Diagnostics has also established a multichannel commercialization strategy that extends beyond traditional clinical settings. The company is actively pursuing employer and benefits partnerships, and announced that it will exhibit at four national employee benefits conferences in June 2026, targeting employers, brokers, union trustees and plan administrators for whom cardiovascular disease represents one of the largest drivers of medical claims costs. Community-based programs further extend the company’s reach into patient populations that traditional clinical channels may not efficiently serve.
For investors evaluating the diagnostics landscape, Cardio Diagnostics occupies a position that is both scientifically grounded and commercially actionable: a proprietary, AI-driven platform with reimbursement milestones, growing provider adoption, growing evidence supporting the ability to detect what traditional tools miss, and a multi-channel strategy designed to reach patients through clinical, employer, and community pathways simultaneously.
For more information, visit www.CDIO.ai.
NOTE TO INVESTORS: The latest news and updates relating to CDIO are available in the company’s newsroom at https://ibn.fm/CDIO
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