- 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 Epigenomics in 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.”
(3)https://www.cdc.gov/chronicdisease/about/costs/index.htm#:~:text=More%20than%20877%2C500%20Americans%20die,lost%20productivity%20on%20the%20job
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.
Advisors
The Benchmark Company LLC is serving as the financial advisor to
Mana; Becker & Poliakoff LLP is serving as legal advisor to
Mana. Shartsis Friese LLP is serving as legal advisor to Cardio
Diagnostics.
About Mana Capital Acquisition
Corp
Mana Capital Acquisition Corp. is a newly incorporated blank
check company formed for the purpose of engaging in a merger, stock
exchange, asset acquisition, stock purchase, recapitalization,
reorganization or other similar business combination with one or
more businesses or entities. Its efforts to identify a prospective
target business will not be limited to a particular industry or
geographic region, although it intends to focus its search on
target businesses operating in North America, Europe and Asia in
the healthcare, technology, green economy, and consumer products
sectors.
About Cardio Diagnostics
Cardio Diagnostics is a biotechnology company that makes
cardiovascular disease prevention and early detection more
accessible, personalized, and precise. The Company was formed to
further develop and commercialize a proprietary Artificial
Intelligence (AI)-driven Integrated Genetic-Epigenetic EngineTM
(“Core Technology”) for cardiovascular disease to become one of the
leading medical technology companies for enabling improved
prevention, early detection, and assists in treatment of
cardiovascular disease.
Additional Information and Where to
Find It
In connection with the proposed Business Combination, Mana will
file a registration statement on Form S-4 containing proxy
materials in the form of a proxy statement with the SEC. The Form
S-4 will include a proxy statement to be distributed to holders of
Mana’s common stock in connection with Mana’s solicitation of
proxies for the vote by Mana’s shareholders with respect to the
proposed Business Combination and other matters as described in the
Form S-4, as well as the prospectus relating to the offer of
securities to be issued to Cardio’s stockholders in connection with
the proposed Business Combination. After the Form S-4 has been
filed and declared effective, Mana will mail a definitive proxy
statement, when available, to its stockholders. Investors and
security holders and other interested parties are urged to read the
Form S-4, any amendments thereto and any other documents filed with
the SEC carefully and in their entirety when they become available
because they will contain important information about Mana, Cardio
and the proposed Business Combination. Additionally, Mana will file
other relevant materials with the SEC in connection with the
Business Combination. Copies may be obtained free of charge at the
SEC’s web site at www.sec.gov. Securityholders of Mana are urged to
read the Form S-4 and the other relevant materials when they become
available before making any voting decision with respect to the
proposed Business Combination because they will contain important
information about the Business Combination and the parties to the
Business Combination.
Participants in
Solicitation
Mana and Cardio and their respective directors and executive
officers may be considered participants in the solicitation of
proxies with respect to the proposed Business Combination under the
rules of the SEC. Security holders may obtain more detailed
information regarding the names, affiliations, and interests of
certain of Mana’s executive officers and directors in the
solicitation by reading Mana’s Form S-4 and other relevant
materials filed with the SEC in connection with the Business
Combination when they become available. Information about the
directors and executive officers of Mana is set forth in Mana’s
annual report for the year ended December 31, 2021 on Form 10-K
(the “Form 10-K”), which was filed
with the SEC on March 31, 2022. Information regarding the persons
who may, under the rules of the SEC, be deemed participants in the
solicitation of the stockholders in connection with the proposed
Business Combination will be set forth in the Form S-4 when it is
filed with the SEC. These documents can be obtained free of charge
at www.sec.gov.
Cardio and its directors and executive officers may also be
deemed to be participants in the solicitation of proxies from the
stockholders of Mana in connection with the proposed Business
Combination. A list of the names of such directors and executive
officers and information regarding their interests in the proposed
Business Combination will be included in Form S-4 filed in
connection with the proposed Business Combination.
No Offer or Solicitation
This press release is not a proxy statement or solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed Business Combination and shall not
constitute an offer to sell or a solicitation of an offer to buy
the securities of Mana or Cardio, nor shall there be any sale of
any such securities in any state or jurisdiction in which such
offer, solicitation, or sale would be unlawful prior to
registration or qualification under the securities laws of such
state or jurisdiction. No offering of securities shall be made
except by means of a prospectus meeting the requirements of Section
10 of the Securities Act of 1933, as amended, or an exemption
therefrom.
Forward-Looking
Statements
This press release includes “forward-looking statements” within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. Mana and Cardio’s actual
results may differ from their expectations, estimates and
projections and consequently, you should not rely on these
forward-looking statements as predictions of future events. Words
such as “expect,” “estimate,” “project,” “budget,” “forecast,”
“anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,”
“believes,” “predicts,” “potential,” “continue,” and similar
expressions are intended to identify such forward-looking
statements. These forward-looking statements include, without
limitation, Mana’s and Cardio’s expectations with respect to future
performance and anticipated financial impacts of the Business
Combination, the satisfaction of the closing conditions to the
Business Combination and the timing of the completion of the
Business Combination. These forward-looking statements involve
significant risks and uncertainties that could cause the actual
results to differ materially from the expected results. Most of
these factors are outside Mana’s and Cardio’s control and are
difficult to predict. Factors that may cause such differences
include, but are not limited to: (1) the occurrence of any event,
change or other circumstances that could give rise to the
termination of the Merger Agreement or could otherwise cause the
Business Combination to fail to close; (2) the outcome of any legal
proceedings that may be instituted against Mana or Cardio following
the announcement of the Merger Agreement and the Business
Combination; (3) the inability to complete the Business
Combination, including due to failure to obtain approval of the
stockholders of Mana or other conditions to closing in the Merger
Agreement; (4) the receipt of an unsolicited offer from another
party for an alternative business transaction that could interfere
with the Business Combination; (5) the inability to obtain the
listing of the common stock of the post-acquisition company on the
Nasdaq Stock Market or any alternative national securities exchange
following the Business Combination; (6) the risk that the
announcement and consummation of the Business Combination disrupts
current plans and operations; (7) the ability to recognize the
anticipated benefits of the Business Combination, which may be
affected by, among other things, competition, the ability of the
combined company to grow and manage growth profitably and retain
its key employees; (8) costs related to the Business Combination;
(9) changes in applicable laws or regulations; (10) the possibility
that Cardio may be adversely affected by other economic, business,
and/or competitive factors; (11) the impact of COVID-19 on the
combined company’s business; and (12) other risks and uncertainties
indicated from time to time in the proxy statement to be filed
relating to the Business Combination, including those under “Risk
Factors” therein, and in Mana’s other filings with the SEC. Some of
these risks and uncertainties may in the future be amplified by the
COVID-19 outbreak and there may be additional risks that Mana
considers immaterial or that are unknown. Mana cautions that the
foregoing list of factors is not exclusive. Mana further cautions
readers not to place undue reliance upon any forward-looking
statements, which speak only as of the date made. Mana does not
undertake or accept any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
to reflect any change in its expectations or any change in events,
conditions or circumstances on which any such statement is
based.
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Cardio Diagnostics, Inc. Meesha Dogan, Ph.D., CEO 855-226-9991
investors@cardiodiagnosticsinc.com
Mana Capital Acquisition Corp. Jonathan Intrater, CEO (413)
519-3764
Mana Capital Acquisition (NASDAQ:MAAQ)
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