Mana Capital Acquisition Corp. Enters Combination Agreement With Cardio Diagnostics; Combined Co. Expected To Have An Approximate Post-Transaction Equity Market Capitalization Of $175M
- Cardio Diagnostics, Inc. has pioneered a proprietary artificial intelligence-driven Integrated Genetic-Epigenetic Engine™ that enables improved diagnosis and prevention of cardiovascular disease
- The Company's flagship product, Epi+Gen CHD™, is a highly sensitive and accessible clinical test that assesses the 3-year risk for coronary heart disease, which is the most common type of heart disease and the major cause of heart attacks(1)
- Cardio Diagnostics' cash on the balance sheet prior to closing is expected to fund the combined company's operations through the end of 2023
- The combined company's Chairman will be Warren Hosseinion, MD, current President of Nasdaq-listed Nutex Health, Inc. and co-founder and former CEO of Nasdaq-listed Apollo Medical Holdings, Inc.
- The Board of Directors will include Brandon Sim, co-CEO of Apollo Medical Holdings, Inc. and Dr. Stanley Lau, Founder and Medical Director of Southern California Heart Centers (a wholly-owned subsidiary of Apollo Medical Holdings, Inc.)
Cardio Diagnostics, Inc. ("Cardio Diagnostics" or the "Company"), a pioneering precision cardiovascular medicine company, and Mana Capital Acquisition Corp. (NASDAQ:MAAQU, MAAQ, MAAQW, MAAQR))))) ("Mana"), a special purpose acquisition company ("SPAC"), today announced that they have entered into a definitive business combination agreement that will result in Cardio Diagnostics becoming a publicly listed company.
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Upon closing of the transaction, Mana will be renamed Cardio Diagnostics Holdings, Inc. (the "Combined Company") and it expects to remain listed on the Nasdaq Global Market under a new ticker symbol "CDIO".
Founded in 2017, Cardio Diagnostics' mission is to help physicians better detect and treat cardiovascular disease, the leading cause of death in the United States. At the core of the Company's cardiovascular solutions is a proprietary Integrated Genetic-Epigenetic Engine™ created at the University of Iowa by company founders Meesha Dogan, Ph.D., and Rob Philibert, MD, Ph.D. This technology enables the development of a series of tests for precision prevention, early detection, and assists in personalized treatment of major types of cardiovascular diseases and associated co-morbidities. Drs. Dogan and Philbert will remain with the Combined Company as its CEO and Chief Medical Officer, respectively.
Cardio Diagnostics' flagship product, Epi+Gen CHD™, is a clinical test that was recently commercialized to assess the 3-year risk for coronary heart disease, the most common type of heart disease and the primary cause of heart attacks. This highly sensitive and accessible test that profiles a panel of genetic and epigenetic biomarkers is radiation-free, does not require fasting and is associated with cost savings per quality-adjusted life year and improved survival.(2)
Cardio Diagnostics Investment Highlights
Substantial Addressable Market Opportunity
Cardio Diagnostics believes that adults between the ages of 35 and 75 could benefit from its current and future diagnostic products for cardiovascular disease and associated co-morbidities. The Company believes that its Epi+Gen CHD test could benefit adults ages 35-75 who have not been diagnosed with coronary heart disease, which is approximately 146 million adults and a $51 billion total addressable market in the United States, based on one test per adult.
Epigenetics Testing Expected to Grow
According to Reports and Data, a market research and consulting company, the epigenetic diagnostics market will surpass $19 billion by 2026, growing at a CAGR of more than 13%. The Company expects this market opportunity to further grow with the expansion of epigenetics-based testing and AI in healthcare, a known priority for the Company's target market. A 2021 survey conducted by Optum showed that 98% of healthcare organizations polled either have an AI strategy in place or plan to have one.
Peer-Reviewed Studies Demonstrate the Increased Sensitivity of Epi+Gen CHD Compared to Current Clinical Risk Calculators
In a peer-reviewed study done in collaboration with Intermountain Healthcare and published in Epigenomicsin June 2021(1), Epi+Gen CHD demonstrated a 76% and 78% sensitivity for men and women, respectively, for 3-year coronary heart disease risk. This means that for every 100 men and 100 women deemed "at-risk" for a coronary heart disease event, the test correctly identifies 76 men and 78 women. In comparison, the average sensitivity of the Framingham Risk Score and the ASCVD Pooled Cohort Equation was found to be 44% and 32% for men and women, respectively.
(1) Dogan, Meeshanthini & Knight, Stacey & Dogan, Timur & Knowlton, Kirk & Philibert, Robert. (2021). External validation of integrated genetic-epigenetic biomarkers for predicting incident coronary heart disease. Epigenomics. 13. 10.2217/epi-2021-0123.
(2) Jung, Younsoo, Firsvold, David, Dogan, Timur, Dogan, Meeshanthini & Philibert, Robert. (2021). Cost–utility analysis of an integrated genetic/epigenetic test for assessing risk for coronary heart disease. Epigenomics. 10.2217/epi-2021-0021.
Award-Winning Technology
Epi+Gen CHD was awarded "Clinical Diagnostics Solution of the Year" from BioTech Breakthrough in 2021, and Cardio Diagnostics was recognized as "One to Watch" in Spinoff Prize, organized by Nature Research and Merck KGaA in 2020.
Go-To-Market Strategy and Use of Proceeds
Cardio Diagnostics' Epi+Gen CHD (blood-based) test is currently offered via telemedicine with ongoing expansion to concierge practices and innovative providers. Supported by cash on its balance sheet and the funds raised in connection with the proposed business combination, the Company intends to:
- Develop blood-based and saliva-based products for stroke, congestive heart failure, and diabetes;
- Build out clinical and health economics evidence to obtain payer reimbursement;
- Expand its testing process outside of a single high complexity CLIA lab to multiple labs, including hospital laboratories;
- Introduce the test across several key channels including health systems and self-insured employers; and
- Pursue the potential acquisition of one or more labs and/or synergistic companies in the telemedicine, AI or remote patient monitoring space.
Experienced Management
Cardio Diagnostics is led by a seasoned team of healthcare professionals and executives, including Meeshanthini (Meesha) Dogan, Ph.D., Co-Founder, Chief Executive Officer, and Director, Robert Philibert MD, Ph.D., Co-Founder, Chief Medical Officer, and Director, Elisa Luqman, Chief Financial Officer, and Warren Hosseinion, MD, Chairman, and Co-Founder and former CEO of Apollo Medical Holdings, Inc. and current President of Nutex Health, Inc.
Management Commentary
"According to the U.S. Centers for Disease Control and Prevention ("CDC"), heart disease is the leading cause of death worldwide. Moreover, 8 out of 10 heart attacks and cardiac deaths can be prevented, yet they are not. The human toll from these conditions is incalculable; however, the associated cost per day to our nation's healthcare system is $216 billion, and lost job productivity is $147 billion(3)", stated Meesha Dogan, Ph.D., CEO of Cardio Diagnostics, Inc. "At Cardio Diagnostics, our team has built an Integrated Genetic-Epigenetic Engine™ powered by artificial intelligence. With this engine and our team's deep domain expertise in biology, high-performance computing, and machine learning, we can quickly build and deploy new tests addressing cardiovascular disease. We believe our technology will transform the clinical approach to cardiovascular disease – fundamentally shift it from reactive to proactive – and help physicians combat a disease that is predicted by the American Heart Association to affect about 45 percent of Americans by 2035."
Jonathan Intrater, CEO of Mana Capital Acquisition Corp., stated, "We are excited to partner with the team at Cardio Diagnostics and share their belief that early risk assessment for CHD is a proven method to save lives and reduce healthcare costs. Cardio Diagnostics is the first company to develop and commercialize epigenetics-based clinical tests for cardiovascular disease that have clear value for patients, clinicians, hospitals/health systems, and payors. We believe this business combination will allow a well-capitalized platform to grow through market expansion, new product development, as well as select and accretive acquisitions."
Transaction Terms & Financing
The Combined Company is expected to have an approximate post-transaction equity market capitalization of $175 million assuming no redemptions. Cardio Diagnostics is expected to have approximately $10 million in gross proceeds raised in 2022 from common stock equity investors prior to closing. Cardio Diagnostics' cash on the balance sheet prior to closing is expected to fund the Combined Company's operations through the end of 2023; net proceeds raised in conjunction with the transaction will be used to support the growth strategy.
Current Cardio Diagnostics management, employees and existing shareholders will roll 100% of their existing equity holdings into equity of the Combined Company. Depending on levels of redemptions, existing Cardio Diagnostics security holders will receive between 52% and 85% of the pro forma equity as part of the transaction. The business combination has been approved by the boards of directors of both Mana and Cardio Diagnostics, and is expected to close in the second half of 2022, subject to regulatory and stockholder approvals and other customary closing conditions.
For a summary of the material terms of the proposed transaction, please see the Current Report on Form 8-K to be filed with the U.S. Securities and Exchange Commission (the "SEC") and available at www.sec.gov. Additional information about the proposed transaction will be described in Mana's S-4 filing relating to the business combination, which it will file with the SEC.