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CORRESP Filing

Cardio Diagnostics Holdings, Inc.
Date: May 16, 2025 · CIK: 0001870144 · Accession: 0001079973-25-000888

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File numbers found in text: 001-41097

Referenced dates: May 7, 2025

Date
May 16, 2025
Author
Elisa Luqman
Form
CORRESP
Company
Cardio Diagnostics Holdings, Inc.

Letter

Correspondence

Cardio Diagnostics Holdings Inc

311 W Superior St, Ste 444

Chicago, IL 60654

(855) 226 9991

info@cardiodiagnosticsinc.com

www.cardiodiagnosticsinc.com

May 16, 2025

VIA EDGAR

Division of Corporation Finance

Office of Life Sciences

United States Securities and Exchange Commission

Attention: Bonnie Baynes, Angela Connell

Re: Cardio Diagnostics Holdings, Inc. Form 10-K for the Fiscal Year Ended December 31, 2024 File No. 001-41097

Set forth below is the response of Cardio Diagnostics Holdings, Inc. (the " Company ") to the comment received from the staff of the Division of Corporation Finance (the " Staff ") of the U.S. Securities and Exchange Commission (the " Commission ") by letter dated May 7, 2025, with respect to the Company's Form 10-K for the fiscal year ended December 31, 2024 (No. 001-41097), which was filed with the Commission on March 20, 2025 (the " Form 10-K ").

For your convenience, our response is prefaced by the exact text of the Staff's comment in bold, italicized text.

Form 10-K for the Fiscal Year Ended December 31, 2024

Item 8. Financial Statements and Supplemental Data

Note 3 – Summary of Significant Accounting Policies, page F-7

1. We note your response and proposed disclosure to prior comment five and reissue our comment in part. Please confirm that your future filings will include the ASC 280-10-50 disclosure requirements to provide your measure of segment profit/loss, significant segment expense, and other requirements that may be applicable to your single operation segment.

RESPONSE :

The Company filed its Form 10-Q for the quarterly period ended March 31, 2025 on May 15, 2025. The Company included in that filing, and will include in subsequent filings, the segment disclosures required by ASC 280-10-50, as amended by ASU 2023-07. The applicable portion of Note 2 to the Company's Form 10-Q for the quarterly period ended March 31, 2025 reads as follows:

Segments

The Company uses the "management approach" in determining reportable operating segments. The management approach considers the internal organization and reporting used by the Company's chief operating decision maker ("CODM"), who is our chief executive officer, for making operating decisions and assessing performance as the source for determining the Company's reportable segments. Management, including the CODM, reviews operating results solely by monthly revenue and operating results of the Company and, as such, the Company has determined that the Company has one operating segment as defined by ASC Topic 280 "Segment Reporting".

One hundred percent of the Company's revenues are generated from products testing for major types of cardiovascular disease, and therefore the Company has one operating segment for financial reporting purposes. The Company's principal products are its Epi+Gen CHD and PrecisionCHD tests. Epi+Gen CHD assesses the risk for a coronary heart disease event, including a heart attack, in the next three years. PrecisionCHD aids in diagnosing and managing coronary heart disease. The tests can be paid for by provider organizations, patients, and/or employers. Customers are generally charged for tests utilized for the minimum committed test volume and the pricing can vary based on organization type, size and volume.

Reportable segment information is presented below:

March 31, December 31,

Current Segment assets

Cash $ 9,688,719 $ 7,827,487

Accounts receivable 9,552 18,612

Prepaid expenses and other current assets 837,222 944,683

Total current segment assets 10,535,493 8,790,782

Long-term segment assets

Property and equipment, net 640,992 672,861

Right of use assets, net 390,171 432,397

Intangible assets, net 1,333 5,333

Deposits 12,850 12,850

Patent costs, net 701,279 701,089

Total segment assets $ 12,282,118 $ 10,615,312

The accounting policies of the product testing segment are the same as those described in the summary of significant accounting policies. The measure of segment assets is reported on the balance sheet as total consolidated assets.

Reportable segment operating results are presented below:

Three Months Ended March 31,

Revenue

Product Test sales $ 940 $ 15,928

Total Segment Revenue $ 940 $ 15,928

Segment Operating expenses

Payroll and related costs $ 601,046 $ 2,935,775

Rent and facility expense 66,393 41,555

Legal and professional expense 301,520 349,737

Consulting and contractor expense 160,802 222,778

Insurance expense 156,567 181,737

Filing fees expense 20,131 75,153

Transfer agent expense 6,382 13,566

Software and web computing expense 78,591 72,213

Board compensation expense 49,612 50,000

Investor relations expense 3,750 61,095

Other segment items (a) 97,248 120,332

Research and development expense 2,200 10,840

Sales and marketing expense 41,820 34,402

Amortization expense 45,438 4,793

Interest expense, net 4,504 5,536

Total Segment Net Income $ (1,635,064 ) $ (4,163,584 )

(a)

Other segment items included in segment net income include shipping expense, taxes expense, subscription fees expense, bank fees expense and other overhead expense.

The Company will incorporate similar disclosure regarding its single operating segment in its future periodic reports.

On behalf of the Company and its management, I acknowledge that the Company and its management are responsible for the adequacy and accuracy of their disclosures, notwithstanding any review, comments, action or absence of action by the Staff.

Please direct any questions that you may have with respect to the foregoing, or if any additional supplemental information is required by the Staff, please contact Elisa Luqman at eluqman@cdio.ai.

Very truly yours,
CARDIO DIAGNOSTICS HOLDINGS, INC.

Show Raw Text
CORRESP
 1
 filename1.htm

 Correspondence

 Cardio
 Diagnostics Holdings Inc

 311 W Superior St, Ste 444

 Chicago, IL 60654

 (855) 226 9991

 info@cardiodiagnosticsinc.com

 www.cardiodiagnosticsinc.com

 May 16, 2025

 VIA EDGAR

 Division of Corporation Finance

 Office of Life Sciences

 United States Securities and Exchange Commission

 Attention: Bonnie Baynes, Angela Connell

 Re: Cardio Diagnostics Holdings, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2024
File No. 001-41097

 Set forth below is the
response of Cardio Diagnostics Holdings, Inc. (the " Company ") to the comment received from the staff of the Division
of Corporation Finance (the " Staff ") of the U.S. Securities and Exchange Commission (the " Commission ")
by letter dated May 7, 2025, with respect to the Company's Form 10-K for the fiscal year ended December 31, 2024 (No. 001-41097),
which was filed with the Commission on March 20, 2025 (the " Form 10-K ").

 For your convenience, our
response is prefaced by the exact text of the Staff's comment in bold, italicized text.

 Form 10-K for the Fiscal Year Ended December 31, 2024

 Item 8. Financial Statements and Supplemental Data

 Note 3 – Summary of Significant Accounting Policies, page F-7

 1. We note your response and proposed disclosure to prior
comment five and reissue our comment in part. Please confirm that your future filings will include the ASC 280-10-50 disclosure requirements
to provide your measure of segment profit/loss, significant segment expense, and other requirements that may be applicable to your single
operation segment.

 RESPONSE :

 The Company filed its Form
10-Q for the quarterly period ended March 31, 2025 on May 15, 2025. The Company included in that filing, and will include in subsequent
filings, the segment disclosures required by ASC 280-10-50, as amended by ASU 2023-07. The applicable portion of Note 2 to the Company's
Form 10-Q for the quarterly period ended March 31, 2025 reads as follows:

 Segments

 The Company uses the "management approach" in determining reportable
operating segments. The management approach considers the internal organization and reporting used by the Company's chief operating
decision maker ("CODM"), who is our chief executive officer, for making operating decisions and assessing performance as the
source for determining the Company's reportable segments. Management, including the CODM, reviews operating results solely by monthly
revenue and operating results of the Company and, as such, the Company has determined that the Company has one operating segment as defined
by ASC Topic 280 "Segment Reporting".

 One hundred percent of the Company's revenues are generated from
products testing for major types of cardiovascular disease, and therefore the Company has one operating segment for financial reporting
purposes. The Company's principal products are its Epi+Gen CHD and PrecisionCHD tests. Epi+Gen CHD assesses the risk for a coronary
heart disease event, including a heart attack, in the next three years. PrecisionCHD aids in diagnosing and managing coronary heart disease.
The tests can be paid for by provider organizations, patients, and/or employers. Customers are generally charged for tests utilized for
the minimum committed test volume and the pricing can vary based on organization type, size and volume.

 Reportable segment information is presented below:

 March 31,
 December 31,

 2025
 2024

 Current Segment
 assets

 Cash
 $ 9,688,719
 $ 7,827,487

 Accounts
 receivable
 9,552
 18,612

 Prepaid
 expenses and other current assets
 837,222
 944,683

 Total current
 segment assets
 10,535,493
 8,790,782

 Long-term
 segment assets

 Property
 and equipment, net
 640,992
 672,861

 Right
 of use assets, net
 390,171
 432,397

 Intangible
 assets, net
 1,333
 5,333

 Deposits
 12,850
 12,850

 Patent
 costs, net
 701,279
 701,089

 Total
 segment assets
 $ 12,282,118
 $ 10,615,312

 The accounting policies of the product testing segment are the same as
those described in the summary of significant accounting policies. The measure of segment assets is reported on the balance sheet
as total consolidated assets.

 Reportable segment operating results are presented below:

 Three
 Months Ended March 31,

 Revenue
 2025
 2024

 Product
 Test sales
 $ 940
 $ 15,928

 Total
 Segment Revenue
 $ 940
 $ 15,928

 Segment
 Operating expenses

 Payroll
 and related costs
 $ 601,046
 $ 2,935,775

 Rent
 and facility expense
 66,393
 41,555

 Legal
 and professional expense
 301,520
 349,737

 Consulting
 and contractor expense
 160,802
 222,778

 Insurance
 expense
 156,567
 181,737

 Filing
 fees expense
 20,131
 75,153

 Transfer
 agent expense
 6,382
 13,566

 Software
 and web computing expense
 78,591
 72,213

 Board
 compensation expense
 49,612
 50,000

 Investor
 relations expense
 3,750
 61,095

 Other
 segment items (a)
 97,248
 120,332

 Research
 and development expense
 2,200
 10,840

 Sales
 and marketing expense
 41,820
 34,402

 Amortization
 expense
 45,438
 4,793

 Interest
 expense, net
 4,504
 5,536

 Total
 Segment Net Income
 $ (1,635,064 )
 $ (4,163,584 )

 (a)

 Other segment items included in segment net income include shipping expense, taxes expense, subscription fees expense, bank fees expense and other overhead expense.

 The
Company will incorporate similar disclosure regarding its single operating segment in its future periodic reports.

 On
behalf of the Company and its management, I acknowledge that the Company and its management are responsible for the adequacy and accuracy
of their disclosures, notwithstanding any review, comments, action or absence of action by the Staff.

 Please
direct any questions that you may have with respect to the foregoing, or if any additional supplemental information is required by the
Staff, please contact Elisa Luqman at eluqman@cdio.ai.

 Very truly yours,

CARDIO DIAGNOSTICS HOLDINGS, INC.

By: /s/ Elisa Luqman ________________________
Name: Elisa Luqman
Title: Chief Financial Officer