Cardio Diagnostics Holdings, Inc Launches New Lab and Fulfillment Center, Paving Way for Expanded Testing Capacity, Reduced Costs, Reduced Turnaround Time and Improved Margins

CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc (Nasdaq: CDIO), a pioneer of artificial intelligence-driven precision cardiovascular medicine tests, today announced the launch of the Company’s new integrated facility in Iowa City, Iowa. This facility will house Cardio Diagnostics’ new research laboratory, high-complexity Clinical Laboratory Improvement Amendments (CLIA) laboratory, and fulfillment center, serving as the epicenter for distributing sample collection kits to clients and performing all laboratory research and commercial testing. Initial operations at this facility are expected to commence in Q4 2023, with full operations anticipated in Q1 2024.

“The launch of the new lab and fulfillment facility marks a critical milestone in Cardio Diagnostics’ strategy to vertically integrate operations”

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“The launch of the new lab and fulfillment facility marks a critical milestone in Cardio Diagnostics’ strategy to vertically integrate operations,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. “This facility provides a robust operational hub to accelerate research and development, centralize sample collection kit distribution, scale commercial testing, significantly improve efficiency, and reduce costs. It allows Cardio Diagnostics to reduce reliance on external service providers, enhancing agility as we fulfill demand and scale.”

The modular setup of the high-complexity CLIA laboratory will enable Cardio Diagnostics to process up to 10,000 tests per month while reducing laboratory processing costs, which currently accounts for the largest portion of the cost of goods sold, by up to 60%. Additionally, performing kitting and fulfillment of sample collection kits internally reduces this cost by up to 56%. By integrating operations in-house, Cardio Diagnostics expects to meaningfully improve the gross profit margin and will continue to explore opportunities to further scale capacity and drive down costs.

“Establishing an internal high-complexity CLIA lab will facilitate the development of a testing process that can be completed in under 4 hours. 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,” said Robert Philibert, MD Ph.D., Chief Medical Officer and Co-Founder of Cardio Diagnostics.

The launch of Cardio Diagnostics’ operational hub will foster continued innovation, amplify commercialization opportunities, and set new standards to improve patient outcomes globally through best-in-class, low-cost precision cardiovascular diagnostics.

About Cardio Diagnostics

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. For more information, please visit www.cardiodiagnosticsinc.com.

Forward-Looking Statements

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.