AI heart tests drive Cardio Diagnostics (NASDAQ: CDIO) 2026 investor update
Rhea-AI Filing Summary
Cardio Diagnostics Holdings is hosting an investor call to review its current status, recent developments, and strategic priorities, supported by an investor presentation. The company focuses on precision cardiovascular medicine using epigenetics and artificial intelligence to prevent and detect heart disease earlier and more accurately.
The presentation highlights two AI-powered blood tests: Epi+Gen CHD, which estimates three-year coronary heart disease risk and has an estimated U.S. market of about $125 billion with 146 million eligible Americans, and PrecisionCHD, a diagnostic aid with an estimated $51 billion U.S. market and 60 million eligible Americans, both tied to a final CMS payment rate of $854 per test. Management emphasizes growing clinical validation, cost-effectiveness studies, and international partnerships, including a recently launched internal CLIA lab that has reduced initial lab cost of goods by roughly 30% and targets test turnaround times of about 7–10 business days.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
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Item 7.01. Regulation FD Disclosure.
On February 19, 2026, Cardio Diagnostics Holdings, Inc. (the “Company”) is holding an investor conference call (the “Investor Call”) at 3 p.m. Central Standard Time to discuss the Company’s current status, recent developments, and ongoing strategic priorities.
During the Investor Call, members of the Company’s management are discussing, among other things:
| · | Corporate updates and recent developments; |
| · | Recent clinical data; |
| · | Reimbursement progress; and |
| · | Strategic initiatives and long-term objectives. |
A copy of the presentation materials being used in connection with the Investor Call is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. A replay of the Investor Call will be made available on the Company’s investor relations website at https://www.cstproxy.com/cardiodiagnosticsinc/investorday/2026 for a limited period of time.
The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
The presentation materials and remarks being made during the Investor Call contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, those described in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”), and other filings the Company makes with the SEC. The Company undertakes no obligation to update any forward-looking statements except as required by law.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description of Exhibit | |
| 99.1 | Investor Presentation dated February 19, 2026 | |
| 104 | Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: February 19, 2026 | CARDIO DIAGNOSTICS HOLDINGS, INC. | |
| By: | /s/ Elisa Luqman | |
| Elisa Luqman Chief Financial Officer |
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Exhibit 99.1
Leading the Next Frontier in Precision Cardiovascular Medicine 2026 NASDAQ: CDIO 1
Certain statements and information included in this presentation constitute "forward - looking statements" within the meaning of the Private Securities Litigation Act of 1995 . When used in this presentation, the words or phrases “will”, "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," “goal,” or similar expressions are intended to identify "forward - looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 . Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of Cardio Diagnostics Holdings, Inc . (the “Company”) . Such uncertainties and risks include, but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company’s ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing . Actual results and events may differ significantly from results and events discussed in forward - looking statements . An extensive list of factors that can affect future results are discussed in the Current Report on Form 10 - K for the period ended December 31 , 2024 , under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission . Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this presentation . The Company is not making any projections, nor providing any guidance, with regard to its future consolidated results of operations or financial condition . Any prior projections, however communicated, that may have been made in the past bear no relationship to the Company’s current consolidated results and financial condition, nor the underlying facts and circumstances related thereto, and should not be relied upon for any purpose . Disclaimer 2
Risk Assessment Early Diagnosis Risk Management Medical Management & Lifestyle Modifications Monitor Effectiveness Ongoing Evaluation Our Vision: Our Mission is to Make Cardiovascular Disease Prevention and Early Detection More Accessible, Personalized and Precise We envision a future where precision cardiovascular medicine, powered by epigenetics and artificial intelligence, transforms the prevention and early detection of cardiovascular disease, enables targeted interventions, improves patient outcomes, and reduces costs, ultimately alleviating the global burden of heart disease. 3
To our knowledge, we have developed the first and only commercial solutions leveraging epigenetics and AI for cardiovascular disease prevention and early detection Over $176B TAM across Epi+Gen CHD and PrecisionCHD ⁽ ¹ ⁾ Commercially available, clinically validated tests, with growing adoption Strong and growing pipeline supported by ongoing studies and new product development Robust IP portfolio Diversified US and international commercialization strategy Meaningful reimbursement milestones and progress Experienced leadership team with expertise across diagnostics, AI and commercialization Significant opportunity to scale operations Corporate Highlights 4 ⁽ ¹ ⁾ Internal estimate TAM was calculated by multiplying the CMS final gapfill rate with the estimated Americans eligible for the test. Price for te st can vary for patients and organizations.
Chairman President, Nutex Health, Inc. (NUTX) Co - founder of Astrana Health (ASTH) Director and former CEO of Clinigence Holdings (CLNH) MD from Georgetown University School of Medicine Warren Hosseinion, MD Leadership CEO & Director Co - founder of Cardio Diagnostics Co - inventor of the AI - Driven Multi - Omics Engine 16+ years bridging engineering, AI and medicine PhD in Biomedical Engineering from the University of Iowa Meesha Dogan, PhD CMO & Director Co - founder of Cardio Diagnostics Co - inventor of the AI - Driven Multi - Omics Engine NIH - trained molecular biologist MD & PhD in Neuroscience from the University of Iowa Robert Philibert, MD PhD CFO Chief Legal Officer (SEC), Nutex Health, Inc. (NUTX) Co - founder of bigVault Storage Technologies (acquired) JD & MBA in Finance from Hofstra University Licensed in NY/NJ and FL Corp Counsel Elisa Luqman, JD MBA CTO Founding engineer of Cardio Diagnostics Co - inventor of the AI - Driven Multi - Omics Engine 16+ years in AI and high performance computing systems PhD in Mechanical Engineering from the University of Iowa Tim Dogan, PhD 5
⁽ ¹ ⁾ World Health Organization ⁽ ² ⁾ American Heart Association ⁽ ³ ⁾ CDC $2T #1 Cardiovascular disease (CVD) is the leading cause of death globally, accounting for over 19 million deaths in 2022, or about 32% of all global deaths ⁽ ¹ ⁾ Following a healthy lifestyle may prevent ~80% of cardiovascular disease events such as a heart attack ⁽ ¹ ⁾ In the US alone, cardiovascular disease costs the healthcare system $233 billion annually in direct medical costs and an additional $185 billion in lost productivity, with total costs projected to approach $2 trillion by 2050 ⁽ ³ ⁾ 80% 1 in 2 By 2035, approximately 45% of the US population (or over 131 million people) is projected to have some form of cardiovascular disease, bringing the rate close to 1 in 2 ⁽ ² ⁾ Cardiovascular Disease Remains the Leading Cause of Death Globally Despite Largely Preventable 6
⁽ ¹ ⁾ CDC ⁽ ² ⁾ Haidar, A et al., The American Journal of Cardiology Jan 2025, /doi.org/10.1016/j.amjcard.2024.10.003 ⁽ ³ ⁾ American Heart Association Employers Patients In the US, he art disease is responsible for approximately 920,000 deaths in 2023, which equates to 1 in every 3 deaths ⁽ ¹ ⁾ Cardi ovascular disease is one of the largest cost centers in healthcare, accounting for approximately $233 billion annually in direct medical spending in the US ⁽ ¹ ⁾ In addition to increasing premiums and direct medical costs, heart disease leads to an average of 13 lost workdays per year per patient ⁽ ³ ⁾ Payers Physicians & Health Systems In 2021 alone, there were approximately 4.7 million cardiovascular - related hospitalizations, representing one of the largest drivers of acute care volume nationwide ⁽ ² ⁾ The Burden of Cardiovascular Disease is Immense and Growing 7
Epigenetics + Genetics = An Individual’s Unique Molecular Fingerprint We pioneered this approach to measure and quantify an individual’s unique molecular fingerprint to enable more precise clinical care EPIGENETICS (DNA METHYLATION) • Influenced by lifestyle & environment • Larger driver of risk for cardiovascular disease as compared to genetics • Largely confounded by genetics • Changes over time (i.e., dynamic, modifiable - similar to HbA1c) GENETICS (SINGLE NUCLEOTIDE POLYMORPHISMS) • Inherited from parents • <20% of risk for cardiovascular disease is driven by genetics ⁽ ¹ ⁾ • Does not change over time (i.e., not dynamic, non - modifiable) ⁽ ¹ ⁾ Sum heritability from Hou, K et al., Nature Genetics Aug 2019, /doi.org/10.1038/S41588 - 019 - 0465 - 0 8
Our AI - Dr iven Multi - Omics Engine Turns Molecular Biology Into Actionable Clinical Tests LARGE DATA • High quality clinical and molecular samples and database • Ongoing studies for interventions and new modalities DNA Bank & Databank Trade Secrets AI PLATFORM • Non - linear biomarker mining • Multi - modal modeling (genetics, epigenetics, imaging) • Assay development modeling • Custom, proprietary assays • Utilizing cutting edge lab measurement systems Trade Secrets LAB TECHNOLOGY • Lab testing of biomarkers using assays • AI model interpret biomarkers and provide patient - specific insights Copyright, Proprietary & Patented ⁽ ¹ ⁾ PRODUCT Identification of Robust Biomarkers Development of Clinical Tests Our Engine, designed and built over 14+ years, provides a scalable foundation for sustained product expansion, clinical impact, and long - term value creation ⁽ ¹ ⁾ Multiple granted US and international patents ; Other patents pending 9
Cardio D iagnostics’ AI - Powered Clinical Tests Risk Stratification ⁽ ¹ ⁾ Diagnostic Aid ⁽ ² ⁾ To our knowledge, Epi+Gen CHD is the first and only commercially available blood test capable of assessing the three - year risk of a coronary heart disease event, including a heart attack To our knowledge, PrecisionCHD is the first and only commercially available blood test capable of detecting obstructive and non - obstructive coronary heart disease Coupled to our Actionable Clinical Intelligence platform that provides patient - specific insights into the molecular drivers of disease No Fasting Radiation Free Easy to Access (remote/onsite) ⁽ ¹ ⁾ Dogan et al., 2021 Epigenomics ⁽ ² ⁾ Philibert R et al., 2023, Journal of American Heart Association 10
Epi+Gen CHD R isk Stratification Clinical Test cost savings per quality adjusted life year (QALY) ⁽ ³ ⁾ Up to $42K ⁽ ¹ ⁾ Internal estimate ⁽ ² ⁾ Dogan et al., 2021 Epigenomics ⁽ ³ ⁾ Jung Y et al., 2021, Epigenomics - cost savings were not calculated for a specific payer compared to the average sensitivity of the Framingham Risk Score and the ASCVD Pooled Cohort Equation, the two common risk calculators used by clinicians ⁽ ² ⁾ 2.4x more sensitive for women 1.7x more sensitive for men Intended for those between 35 - 75 years old with no history of CHD Americans estimated to be eligible for the test ⁽ ¹ ⁾ 146M Risk category and percentage results Easy to Interpret 11
PrecisionCHD D iagnostic Aid Clinical Test cost savings in the first year if PrecisionCHD used as the primary method of initial CHD assessment for one million lives ⁽ ³ ⁾ ~$113M ⁽ ¹ ⁾ Internal estimate ⁽ ² ⁾ Dogan et al., 2021 Epigenomics ⁽ ³ ⁾ Frisvold D et al., 2024, Advances in Therapy - cost savings were not calculated for a specific payer compared to the average sensitivity of a stress ECG ⁽ ² ⁾ 1.3x more sensitive for women 1.4x more sensitive for men Intended for those between 35 - 80 years old presenting to be evaluated for CHD Americans estimated to be eligible for the test ⁽ ¹ ⁾ 60M S ignal detected or not detected result Easy to Interpret 12
The use of Epi+Gen CHD and PrecisionCHD could save lives and reduce costs associated with cardiovascular disease Our Tests Offer a Scalable, Novel Approach for Cardiovascular Disease Prevention and Detection Not one and done Fast and convenient First - of - its - kind No exposure to ionizing radiation 13
• Up to ~70% of patients referred for coronary angiography due to angina and evidence of ischemia have no obstructive coronary arteries, and many have INOCA ⁽ ¹ ⁾ • Prevalence is particularly high in women ⁽ ¹ ⁾ What is INOCA ? • Ischemia with No Obstructive Coronary Arteries (INOCA) refers to patients who have objective evidence of myocardial ischemia despite having no obstructive coronary artery disease ⁽ ¹ ⁾ • Often driven by coronary microvascular dysfunction or vasospasm, and not by large blockages visible on standard imaging Prevalence ⁽ ¹ ⁾ Expert Consensus on Ischemia with Nonobstructive Coronary Arteries, American College of Cardiology, 2020 Data on INOCA for PrecisionCHD Presented at the American Heart Association Conference 14
• Standard imaging tests detect large - vessel blockages • Therefore, arteries often appear “normal,” leading to underdiagnosis Dangers of INOCA • Not a benign condition • Patients with INOCA have a comparable burden of symptoms: ⁽ ¹ ⁾ ⚬ reduced quality of life ⚬ high risk of adverse cardiovascular outcomes (including recurrent angina, hospitalizations, and longer - term events) Why standard imaging tests miss INOCA? Data on INOCA for PrecisionCHD Presented at the American Heart Association Conference ⁽ ¹ ⁾ Expert Consensus on Ischemia with Nonobstructive Coronary Arteries, American College of Cardiology, 2020 15
The Leverage plots from a Least Squares analysis of the relationship of PrecisionCHD methylation assessments, age and sex var iab les to Duke’s Jeopardy Scores in 267 subjects admitted to the University of Iowa for the care of Acute Coronary Syndrome. Data on INOCA for PrecisionCHD Presented at the American Heart Association Conference 16
• Acute Coronary Syndrome (ACS) is a sudden drop in blood flow to the heart that can cause a heart attack • ~1.4 million Americans are hospitalized with ACS each year ⁽ ¹ ⁾ • ACS patients have higher mortality than matched controls (47% vs. 39%) over a 12 year period of time ⁽ ² ⁾ PrecisionCHD and PrecisionCHD + imaging can better predict mortality in ACS patients than imaging alone • Duke Jeopardy Scores or DJS (an angiographic measure of coronary artery obstruction) AUC=0.647 • PrecisionCHD’s methylation - sensitive digital PCR (MSdPCR) AUC=0.701 • MSdPCR + DJS AUC= 0.729 ACS and Mortality Data on ACS Patient Mortality Presented at the American College of Cardiology Conference 17 ⁽ ¹ ⁾ Kumar et al., 2009 Mayo Clinic Proceedings ⁽ ² ⁾ Ellis et al., 2019 Heart, Lung and Circulations
• DJS was better at predicting nearer - term (<8 months) mortality Time Dependent AUC of Mortality for ACS Patients ACS Mortality is a Multi - Scale Problem Data on ACS Patient Mortality Presented at the American College of Cardiology Conference • MSdPCR was better at predicting longer - term (>8 months) mortality • Combining both provides superior coverage across various time horizons Time (Days) AUC Routine integration of epigenetic testing such as PrecisionCHD into standard ACS workup could refine personalization of post - discharge care 18
Robust and Growing Evidence Base for Epi+Gen CHD and PrecisionCHD Rigorous clinical validation s in partnership leading health systems Economic evidence demonstrating cost effectiveness and cost savings Evidence demonstrating the utility of the tests to monitor treatment effectiveness Expand evidence on the utility of the PrecisionCHD test to detect both obstructive and non - obstructive coronary heart disease (INOCA) - preliminary data presented at AHA conference Multi - modal, multi - time scale study demonstrating the ability of PrecisionCHD to detect coronary heart disease earlier than imaging and predict mortality risk - preliminary data presented at ACC conference Use of PrecisionCHD to inform treatment for inflammatory coronary heart disease with LODOCO and monitor treatment effectiveness - partnership with Agepha Pharma 19
2a 2b 1a 1b REMOTE Telemedicine provider orders test for patient At - home lancet sample collection kit shipped to patient A Highly Scalable Testing and Reporting Process PROVIDER SETTINGS Lancet and/or vacutainer sample collection kits shipped to provider/healthcare organization Provider/healthcare organization orders tests 3 Blood sample collected 4 Sample shipped to Cardio Diagnostics lab 5 Lab performs testing 6 Patient report generated 7 Patient report shared with ordering provider 20
Survey on Feb 10, 2026 found no deficiencies CLIA conditions met For DNA methylation assessments with high precision Utilize digital PCR with proprietary assays Space to increase infrastructure and automation to increase capacity Increased testing capacity Initial lab COGS reduction by ~30% with additional reduction expected with scale ~30% reduction in cost Internal CLIA Lab was Recently Launched to Lower Costs and Increase Testing Capacity Turn around time (TAT) from sample receipt ~7 - 10 business days TAT 21
Ep i+Gen CHD and PrecisionCHD U.S. Market Opportunity 40 - 60% target gross margin at scale $854 final CMS payment rate ~125B total addressable U.S. market ⁽ ¹ ⁾ 146M estimated eligible Americans ⁽ ¹ ⁾ $854 final CMS payment rate ~51B total addressable U.S. market ⁽ ¹ ⁾ 60 M estimated eligible Americans ⁽ ¹ ⁾ 22 ⁽ ¹ ⁾ Internal estimate TAM was calculated by multiplying the CMS final gapfill rate with the estimated Americans eligible for the test. Price for te st can vary for patients and organizations.
Commercial Targets in the U.S. Employers/Unions Offering remote and heart health fair options to drive engagement and utilization among employees Providers and Health Systems Telemedicine and onsite options primarily with internists, PCPs and preventive cardiologists Channel Partners Strat egic partnerships focused on increasing awareness, education and access 23
Opportunistic Global Expansion Through Partnerships Announced Partnership in India with Aimil Ltd and Dr. Lal PathLabs • Aimil to introduce PrecisionCHD to their extensive healthcare network • Dr. Lal PathLabs will be offering PrecisionCHD and has 290+ clinical labs and 300+ MD pathologists in their internal network • Exploring other partner - led international expansion opportunities in Asia, Middle East and Africa • Significant global addressable market opportunity • Opportunity to diversify revenue beyond the U.S. market 24
Major Reimbursement Milestones Achieved and Underway for Both Tests 0439U CPT PLA code $854 final CMS payment rate 0440U CPT PLA code $854 final CMS payment rate • Medicare cover age process is ongoing (final required step for Medicare) • Establishing out - of - network billing capability (expected in Q2 2026) • Engaging commercial payers for pilot programs 25
For more information, please email: investors@cdio.ai 26
FAQ
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Filing Exhibits & Attachments
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