Odyssey Health Faces Going Concern Doubt Amid Zero Revenue, Product Delays

TL;DR

**ODYY is a speculative bet on unproven medical devices with zero revenue and a looming cash crunch; avoid unless you're comfortable with extreme risk.**

AI Summary

Odyssey Health, Inc. (ODYY) reported no revenue for the fiscal year ended July 31, 2025, continuing a history of operating losses and cash flow deficits since its inception in March 2014. The company is a development-stage entity focused on acquiring and developing medical products, specifically the CardioMap heart monitoring device and the Save-A-Life choking rescue device. Neither product has received regulatory clearance or approval for commercial sale, and both are currently in the 'TBD' stage for clinical trials and FDA submission. Due to funding constraints, the Save-A-Life device will be prioritized for further development, while the CardioMap program is suspended. The company estimates its current cash on hand will not support operations through the balance of the calendar year 2025, indicating substantial doubt about its ability to continue as a going concern without additional equity financing. ODYY's market value of common equity held by non-affiliates was $1,770,764 as of January 31, 2025, with 99,853,763 shares outstanding as of October 29, 2025.

Why It Matters

Odyssey Health's inability to generate revenue and its reliance on future equity financing pose significant risks for investors, who face potential total loss of investment if the company cannot secure funding. For employees (currently two), the lack of operational cash flow creates job insecurity. Customers and the broader market are impacted by the delayed availability of potentially innovative medical devices like CardioMap and Save-A-Life, especially given competition from established players like Dechoker and LifeVac in the anti-choking market, and Nasiff and Welch Allyn in EKG devices. The company's struggle highlights the immense capital and regulatory hurdles in the medical device sector.

Risk Assessment

Risk Level: high — The company explicitly states, "There is substantial doubt about our ability to continue as a going concern" due to a lack of revenue generation since inception and an estimated cash runway that will not support operations through the balance of the calendar year 2025. This, coupled with the fact that "none of our product candidates has received regulatory clearance or approval for commercial sale," presents an extremely high operational and financial risk.

Analyst Insight

Investors should exercise extreme caution and consider this a highly speculative investment. Given the explicit 'going concern' warning and zero revenue, potential investors should wait for concrete evidence of significant capital infusion and regulatory approvals for their products before considering any position.

Financial Highlights

debt To Equity

Not Disclosed

revenue

$0

operating Margin

Not Disclosed

total Assets

Not Disclosed

total Debt

Not Disclosed

net Income

Not Disclosed

eps

Not Disclosed

gross Margin

Not Disclosed

cash Position

Not Disclosed

revenue Growth

N/A

Revenue Breakdown

Key Numbers

• $0 — Revenue (No revenue generated since inception for the fiscal year ended July 31, 2025.)
• $1,770,764 — Market Value of Non-Affiliate Common Equity (As of January 31, 2025, reflecting the company's small market capitalization.)
• 99,853,763 — Shares of Common Stock Outstanding (As of October 29, 2025.)
• 2 — Number of Employees (As of the filing date, indicating minimal operational staff.)
• 2014 — Year of Inception (Company formed in March 2014, highlighting a long development stage without commercial products.)
• 2025 — Fiscal Year End (July 31, 2025, for which this 10-K is filed.)

Key Players & Entities

• Odyssey Health, Inc. (company) — registrant
• ODYY (company) — ticker symbol
• CardioMap (company) — heart monitoring device in development
• Save-A-Life (company) — choking rescue device in development
• FDA (regulator) — Food and Drug Administration
• Dechoker (company) — competitor in anti-choking devices
• LifeVac (company) — competitor in anti-choking devices
• VE Science Technology LLC (company) — developer of CardioMap technology
• OTC Bulletin Board (company) — market for common stock
• SEC (regulator) — Securities and Exchange Commission

FAQ

Risk Factors

• Substantial Doubt About Going Concern [high — financial]: The company is in the development stage with no operating history or revenue. Current cash on hand is insufficient to support operations through the balance of calendar year 2025, indicating a material uncertainty about its ability to continue as a going concern without additional equity financing.
• History of Losses and Lack of Profitability [high — financial]: Odyssey Health has incurred operating losses and cash flow deficits since its inception in March 2014. There is no assurance of future profitability, and the lack of historical financial data makes it difficult for investors to evaluate prospects.
• Product Development and Regulatory Hurdles [high — operational]: Both the CardioMap and Save-A-Life devices are in the development stage and have not received regulatory clearance or approval for commercial sale. The CardioMap program is suspended due to funding constraints, and Save-A-Life is prioritized.
• Dependence on External Financing [high — financial]: The company's ability to continue operations and meet obligations is dependent on obtaining necessary external financing, primarily through equity and debt. There is no certainty that such funds will be available on acceptable terms.
• Limited Public Market for Stock [medium — market]: Odyssey Health's shares are listed on the OTCQB Marketplace, and there is very little public market for its common stock, which can impact liquidity and valuation.
• Development Stage Company Risks [medium — operational]: As a development-stage entity, the company faces inherent risks associated with bringing new medical products to market, including technological challenges, manufacturing complexities, and market acceptance.

Industry Context

Odyssey Health operates in the highly competitive medical device industry, focusing on innovative technologies like heart monitoring and choking rescue devices. The industry is characterized by long development cycles, significant R&D investment, and stringent regulatory requirements. Companies often face challenges in obtaining FDA approval and achieving market penetration against established players.

Regulatory Implications

The company's medical products, CardioMap and Save-A-Life, are subject to rigorous regulatory review processes by agencies like the FDA. Failure to obtain necessary clearances or approvals for these devices poses a significant risk to commercialization and revenue generation, as neither product has yet achieved this milestone.

What Investors Should Do

1. Monitor financing activities closely.
2. Evaluate the progress of the Save-A-Life device.
3. Assess the long-term viability of the business model.
4. Understand the risks associated with development-stage companies.

Key Dates

• 2014-03-01: Company Inception — Marks the beginning of Odyssey Health's operations as a development-stage entity focused on medical products.
• 2015-07-01: Registration Statement Effective — Indicates the company's initial public offering became effective, allowing for public trading of its stock.
• 2025-01-31: Market Value of Non-Affiliate Common Equity — Provides a snapshot of the company's market capitalization as of this date, reflecting investor sentiment and valuation.
• 2025-07-31: Fiscal Year End — The end of the reporting period for the 10-K filing, for which no revenue was reported.
• 2025-10-29: Shares of Common Stock Outstanding — Indicates the total number of shares outstanding as of this date, relevant for per-share calculations and ownership dilution.

Glossary

Development Stage Entity

A company that has begun to devote substantial effort to a new business plan or other business activity that has yet to be realized or for which significant operations have not yet commenced. (Odyssey Health is classified as a development stage entity, meaning it has not yet generated revenue or achieved profitability, highlighting its early-stage risks.)

Going Concern

An assumption that a company will continue to operate for the foreseeable future, typically at least 12 months from the reporting date. (The filing explicitly states substantial doubt about Odyssey Health's ability to continue as a going concern due to its financial condition and lack of revenue.)

Regulatory Clearance/Approval

The process by which government agencies (like the FDA in the US) review and authorize medical devices or drugs for commercial sale based on safety and efficacy. (Odyssey Health's products, CardioMap and Save-A-Life, have not yet received this crucial clearance, preventing commercialization and revenue generation.)

OTC Market

Over-The-Counter market, a decentralized market where financial instruments are traded directly between two parties without the need for a central exchange. (Odyssey Health's shares trade on the OTCQB Marketplace, which is generally associated with lower liquidity and higher volatility compared to major exchanges.)

Year-Over-Year Comparison

The fiscal year ended July 31, 2025, shows no revenue, continuing the trend from previous periods. The company's financial condition remains precarious, with substantial doubt about its ability to continue as a going concern, a risk factor that has likely persisted. No new products have achieved regulatory clearance, and the focus remains on navigating the development and funding challenges inherent in its business model.

Key Financial Figures

• $0.001 — nge on which registered Common Stock ($0.001 par value) ODYY OTC Indicate by che
• $0.0215 — d by reference to the last sales price ($0.0215) as reported by the OTC Bulletin Board,

Filing Documents

• odyssey_i10k-073125.htm (10-K) — 1222KB
• odyssey_ex1017.htm (EX-10.17) — 8KB
• odyssey_ex1037.htm (EX-10.37) — 11KB
• odyssey_ex1066.htm (EX-10.66) — 13KB
• odyssey_ex1067.htm (EX-10.67) — 59KB
• odyssey_ex1901.htm (EX-19.1) — 39KB
• odyssey_ex3101.htm (EX-31.1) — 8KB
• odyssey_ex3102.htm (EX-31.2) — 8KB
• odyssey_ex3201.htm (EX-32.1) — 4KB
• odyssey_ex3202.htm (EX-32.2) — 4KB
• 0001683168-25-007842.txt ( ) — 6219KB
• odyy-20250731.xsd (EX-101.SCH) — 46KB
• odyy-20250731_cal.xml (EX-101.CAL) — 48KB
• odyy-20250731_def.xml (EX-101.DEF) — 204KB
• odyy-20250731_lab.xml (EX-101.LAB) — 382KB
• odyy-20250731_pre.xml (EX-101.PRE) — 346KB
• odyssey_i10k-073125_htm.xml (XML) — 702KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 5 Item 1B. Unresolved Staff Comments 27 Item 1C. Cybersecurity 28 Item 2.

Properties

Properties 28 Item 3.

Legal Proceedings

Legal Proceedings 28 Item 4. Mine Safety Disclosures 28 28 PART II Item 5. Market for the Registrant's Common Stock, Related Shareholder Matters, and Issuer Purchases of Equity Securities 29 Item 6. Reserved 30 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operation

Management's Discussion and Analysis of Financial Condition and Results of Operation 30 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 35 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 35 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 36 Item 9A.

Controls and Procedures

Controls and Procedures 36 Item 9B. Other Information 37 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 37 PART III Item 10. Directors, Executive Officers, and Corporate Governance 38 Item 11.

Executive Compensation

Executive Compensation 44 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters 49 Item 13. Certain Relationships and Related Transactions, and Director Independence 50 Item 14. Principal Accountant Fees and Services 51 PART IV Item 15. Exhibits and Financial Statement Schedules 53 Item 16. Form 10-K Summary 56

Signatures

Signatures 57 i ODYSSEY HEALTH, INC. AND SUBSIDIARIES PART I Item 1.

Business

Business This Annual Report on Form 10-K contains forward-looking those expressed in forward-looking statements. See Item 1A of Part I, "Risk Factors." Odyssey Health, Inc. was formed as a Nevada corporation in March 2014. Our principal executive offices are located at 2300 West Sahara Avenue, Suite 800 - #4012, Las Vegas, Nevada, 89102. The registration statement effectuating our initial public offering became effective in July 2015. Our shares of common stock are listed on the OTCQB Marketplace ("OTC") and there is currently very little public market for our common stock. As used herein, when we refer to "Odyssey", "ODYY," the "Company," "our Company," "we," "us" and "our," we mean Odyssey Health, Inc., a Nevada corporation, unless the context indicates otherwise. General Odyssey Health, Inc. and its subsidiaries, Odyssey Medical Devices, Inc. and Odyssey Group International Australia, Pty Ltd., is a publicly held company focused on acquiring and developing medical products. We are developing technologies that have a technological advantage, superior clinical utility, and a substantial market opportunity within significant target markets across the globe. The corporate mission is to create or acquire distinct technologies and intellectual property with an emphasis on acquisition targets that will generate positive cash flow. Our leadership team has significant experience and capabilities to commercialize our technologies and submit them to the appropriate regulatory agencies for marketing approval. Our business model is to develop or acquire medical-related products, engage third parties to develop and manufacture such products and then distribute the products through various distribution channels, including third parties. We have two different technologies in research and development stage; the CardioMap heart monitoring

Risk Factors

Risk Factors RISK FACTORS An investment in our securities has a high degree of risk. Before you invest you should carefully consider the risks and uncertainties described below and the other information in this prospectus. Any of the risks and uncertainties set forth herein could materially and adversely affect our business, results of operations and financial condition, which in turn could materially and adversely affect the trading price or value of our securities. Additional risks not currently known to us or which we consider immaterial based on information currently available to us may also materially adversely affect us. As a result, you could lose all or part of your investment. Risks Related to Our Financial Position and Need for Capital We are a development stage company with little operating history, a history of losses and we cannot assure profitability. We have been incurring operating losses and cash flow deficits since the inception of such operations. Our lack of operating history, and the lack of historical pro forma consolidated financial information, makes it difficult for investors to evaluate our prospects for success. Prospective investors should consider the risks and difficulties we might encounter, especially given our lack of an operating history or historical pro forma consolidated financial information. There is no assurance that we will be successful, and the likelihood of success must be considered in light of our relatively early stage of operations. As we have not begun to generate revenue, it is extremely difficult to make accurate predictions and forecasts of our finances. There is no guarantee that our products or services will be attractive to potential consumers. There is substantial doubt about our ability to continue as a going concern. We are in the development stage and are currently seeking additional capital, mergers, acquisitions, joint ventures, partnerships and other business arrangements to expand our produc

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View this 10-K filing on SEC EDGAR