By Jeremy Golden, Benzinga

Nearly 50% of Americans live with diabetes, obesity, hypertension or another major cardiovascular risk, according to the Centers for Disease Control and Prevention (CDC). For many Americans, the first sign of coronary heart disease (CHD) is a heart attack.

A recent announcement by Cardio Diagnostics (NASDAQ: CDIO) details a bright future for the company’s AI-driven molecular heart disease tests, which evaluate objective epigenetic and genetic biomarkers in patients suspected to be at risk or who may have coronary heart disease.

After securing an Innovation Technology contract with Vizient, Inc. — the nation’s largest provider-driven healthcare performance improvement company — Cardio Diagnostics will have access to a potential customer base that encompasses greater than 60% of hospitals and 97% of academic medical centers in the United States.

On the flip side, Vizient provider customers will have access to Cardio Diagnostics' state-of-the-art tests at negotiated pricing, thereby increasing access to the next generation of cardiovascular disease detection technology.

The contract, effective Nov. 1, signifies to Vizient hospital and health system customers a shift toward unique technology that has the potential to bring improvement and cost savings to the healthcare industry.

Vizient’s diverse customer base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers. The company represents more than $130 billion in annual purchasing volume.

Through its Innovative Technology Program, Vizient works with customer-led councils and task forces to review potentially innovative products.

This new contract with Cardio Diagnostics demonstrates Vizient’s confidence in the company’s Epi+Gen CHD and PrecisionCHD tests, which utilize proprietary laboratory assays and AI-driven algorithms to analyze objective epigenetic and genetic biomarkers from a patient's blood sample.

Scaling The Business

Based in part on the new contract with Vizient and what it believes to be increasing interest in its epigenetic tests, Cardio Diagnostics is preparing to fulfill demand while keeping costs down through the launch of a new facility.

Last month, Cardio Diagnostics announced the launch of a new integrated facility in Iowa City, Iowa, that will house a research laboratory, high-complexity Clinical Laboratory Improvement Amendments (CLIA) laboratory and fulfillment center. The new hub will work as the epicenter for distributing sample collection kits to clients and performing all laboratory research and commercial testing.

With a modular setup, the high-complexity CLIA laboratory will enable Cardio Diagnostics to process up to 10,000 tests per month while reducing laboratory processing costs by up to 60%. Those fees currently account for the largest portion of the cost of goods sold.

Cardio Diagnostics reports that performing kitting and fulfillment of sample collection kits internally further reduces this cost by up to 56%. By integrating operations in-house, Cardio Diagnostics expects to meaningfully improve its gross profit margin while continuing to explore opportunities to further scale capacity and drive down costs.

In addition to its pioneering Epi+Gen CHD and PrecisionCHD tests, Cardio Diagnostics is expanding its diagnostic portfolio, by developing tests for stroke, diabetes and heart failure at this new facility. This horizontal integration approach broadens the company's market reach, catering to a more comprehensive range of cardiovascular diseases across the care continuum. By accelerating the development of its product portfolio, Cardio Diagnostics not only enhances its market positioning but also aligns with the trend towards comprehensive, multi-faceted diagnostic solutions in healthcare.

Initial operations at this facility are expected to commence in Q4 2023, with full operations anticipated in Q1 2024.

"Establishing an internal high-complexity CLIA lab will facilitate the development of a testing process that can be completed in under four hours,” said Robert Philibert, MD Ph.D., Cardio Diagnostics’ Chief Medical Officer. “This time frame fits well with our vision of our heart disease diagnostic tests being eventually offered as essentially point-of-care tests, with a same-day turnaround in almost all medical markets.”

With the Vizient contract in place, demand for Cardio Diagnostics tests will soon be higher than ever before. The launch of Cardio Diagnostics’ operational hub will increase distribution and sample processing capabilities, helping the company fulfill demand while fostering continued innovation and setting new standards to improve patient outcomes globally through low-cost precision cardiovascular diagnostics.

This progress will assist in furthering detection for the many individuals at risk for and impacted by cardiovascular disease.

Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease.

Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, 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 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. 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, 2022 and Form 10-Q for the period ended March 31, 2023, 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 press release.

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