Executive Summary / Key Takeaways

• Odyssey Health, Inc. ($ODYY) stands at a pivotal juncture, transitioning from a development-stage entity with a history of losses to a potential revenue-generating medical technology company, primarily driven by the recent sub-licensing of the BreastCheck® non-invasive breast abnormality test.
• The company's core strategy revolves around acquiring and developing medical products with technological advantages, aiming for positive cash flow, and leveraging third-party partnerships for development, manufacturing, and distribution, with a strategic focus on international growth.
• Despite a significant accumulated deficit of $62.75 million and a working capital deficit of $6.95 million as of July 31, 2025, the introduction of BreastCheck® offers a concrete path to initial revenue, a critical step in addressing its "going concern" status.
• Odyssey's competitive positioning is that of a niche innovator against larger, more established medical device and pharmaceutical giants, relying on specialized technology like CardioMap's digital heart mapping and Save-A-Life's emergency choking rescue device, though these remain in development with funding constraints.
• Key investment considerations include the successful commercialization and market acceptance of BreastCheck®, the company's ability to secure ongoing financing to support its lean operations and product development, and its capacity to overcome significant regulatory hurdles and internal control deficiencies.

A Strategic Reorientation Towards Commercialization

Odyssey Health, Inc., established in March 2014, embarked on a mission to acquire and develop unique medical products and intellectual property, aiming to carve out a niche in the healthcare sector with technologies offering superior clinical utility and substantial market opportunities. Its foundational business model emphasizes leveraging third-party expertise for product development, manufacturing, and distribution, a lean approach designed to maximize efficiency. The company's history reflects a dynamic journey, including the acquisition of the Save-A-Life choking rescue device patents in July 2019 and the drug program for mild brain trauma (ONP-2) in January 2021. However, a significant strategic pivot occurred in December 2023 with the divestiture of its brain injury drug candidates to Oragenics, Inc. (OGEN), a transaction that yielded $1.00 million in cash and 8.00 million shares of convertible preferred stock, generating a substantial gain of $16.40 million. This move underscored a re-evaluation of its portfolio and a focus on assets with a clearer path to market.

The company's overarching strategy is to achieve growth through regulatory approvals, strategic distribution or license agreements, particularly in international markets which management believes offer a stronger path to revenue, and the continuous development and acquisition of new products. This strategic framework is now significantly bolstered by a recent development that promises to redefine Odyssey's trajectory.

Technological Edge in Emerging Markets

Odyssey Health's investment thesis is fundamentally tied to its ability to bring differentiated medical technologies to market. The company's portfolio currently includes two primary technologies in the research and development stage, alongside a newly sub-licensed product.

The CardioMap System is envisioned as a novel heart monitoring and screening device, utilizing Dispersion Mapping in electrocardiogram analysis for early, non-invasive detection of coronary heart disease (CHD). This technology aims to provide high-quality 3-D visualization and diagnosis of the heart, potentially offering improved sensitivity levels to detect early warning signs often missed by standard EKG devices. The strategic intent is to dramatically cut costs associated with ischemic heart disease detection, positioning it as an invaluable tool across various medical settings, from clinics to in-home use. Odyssey holds exclusive, royalty-free rights to a U.S. patent related to CardioMap technology. However, its development program is currently suspended due to funding constraints.

The Save-A-Life (SAL) choking rescue device is designed to be a safe and easy-to-use device for removing lodged masses from the throat of choking victims. The device incorporates a pump for creating a vacuum chamber connected to a replaceable mouthpiece, intended to deliver an instantaneous vacuum to dislodge the mass effectively and without harm. The application is designed to be instantly effective, operational within seconds. This device is being prioritized for further development, reflecting its potential in emergency medical situations.

A transformative development for Odyssey is the sub-licensing agreement entered into on October 14, 2025, with NeuRX Health, Inc. for BreastCheck®. This non-invasive test for breast abnormalities provides immediate results within 15 minutes. BreastCheck® is FDA registered in the U.S. and registered with relevant authorities in the EU and UK, positioning it as a first-line screening tool. This technology offers a significant advantage by providing rapid, accessible screening, potentially increasing early detection rates and reducing the need for more invasive or time-consuming initial diagnostic procedures. The "so what" for investors is clear: BreastCheck® represents Odyssey's most immediate and concrete pathway to revenue generation, marking a critical transition from a purely development-stage company.

The company's business model is predicated on a growing trend towards preventative medicine in healthcare, which seeks to reduce overall healthcare costs. Technologies like CardioMap and BreastCheck®, if successfully commercialized, align directly with this trend by enabling early diagnosis and preventative care, potentially offering cost-saving benefits to insurance providers and healthcare systems.

The Uphill Financial Battle and Glimmers of Hope

Odyssey Health's financial narrative has been characterized by significant challenges. The company has a limited operating history and has consistently incurred operating losses and cash flow deficits since its inception. For the fiscal year ended July 31, 2025, Odyssey reported a net loss attributable to common stockholders of $1.74 million, an increase from $905,771 in fiscal year 2024. This increase was largely due to the absence of the substantial $16.40 million gain from the sale of product candidates that boosted fiscal 2024 results. As of July 31, 2025, the company's accumulated deficit stood at $62.75 million, with a working capital deficit of $6.95 million. Cash and cash equivalents were a mere $19,084, which management explicitly stated was insufficient to support operations through the end of the calendar year.

Despite these significant financial hurdles, there are operational efficiencies being realized. General and administrative expenses decreased by 51% in fiscal 2025 compared to fiscal 2024, driven by lower executive salaries, reduced business activity, and decreased legal fees. This indicates a concerted effort to manage costs in a capital-constrained environment. The company has also actively sought financing, securing a $300,000 promissory note in August 2024 and another $100,000 promissory note in October 2025, alongside the sale of its Oragenics common stock for $69,787 in fiscal 2025. These actions highlight ongoing efforts to secure the necessary capital for continued operations and product development.

The independent registered public accounting firm has issued an explanatory paragraph regarding substantial doubt about Odyssey's ability to continue as a going concern, emphasizing the critical need for additional financing to meet its obligations and execute its business plan. The company's ability to raise capital is subject to market conditions and lender willingness, and any future equity or convertible debt issuances could dilute existing stockholders.

Competitive Arena: A Niche Player Among Giants

Odyssey Health operates in a competitive landscape dominated by large, well-capitalized players in the medical device and pharmaceutical industries. Its primary competition stems from established companies offering EKG equipment and anti-choking devices, as well as pharmaceutical companies developing specialized drugs.

In the heart monitoring segment, Odyssey's CardioMap, with its unique digital mapping capability, aims to differentiate itself from traditional EKG devices offered by competitors such as CardioResting Nasiff, Welch Allyn, and QardioCore. While these competitors provide EKG readouts, CardioMap's potential for 3-D visualization and early detection offers a distinct technological advantage. However, the development of CardioMap is currently suspended, leaving this competitive advantage unrealized.

For its Save-A-Life device, Odyssey faces competition from established anti-choking devices like Dechoker and LifeVac, as well as training tools such as ActFast Heimlich maneuver vests. Odyssey's device is designed for instant effectiveness and ease of use, potentially offering a simpler and quicker solution in emergency situations compared to some existing products.

The entry into the breast abnormality screening market with BreastCheck® places Odyssey in a rapidly growing sector, currently valued in the low tens of billions of dollars and projected to double or more over the next 8-10 years. This growth is fueled by technological advances, including imaging, AI, and genomics, and a global emphasis on early detection. BreastCheck's non-invasive, rapid-result nature positions it to compete with existing screening methods by offering a convenient first-line option.

Compared to industry behemoths like Medtronic (MDT), Abbott Laboratories (ABT), Johnson & Johnson (JNJ), and Pfizer (PFE), Odyssey is a significantly smaller entity. These larger competitors possess extensive R&D capabilities, vast global distribution networks, and substantial financial resources, enabling them to innovate rapidly and achieve broad market penetration. For instance, Medtronic and Abbott lead in comprehensive cardiovascular solutions and diagnostics, while Johnson & Johnson and Pfizer dominate in pharmaceutical development, including neurological treatments.

Odyssey's competitive advantages lie in its agility and focused innovation in niche areas. Its proprietary technologies, when fully developed and approved, could offer specialized benefits that larger, more diversified companies might overlook or be slower to integrate. However, Odyssey's smaller scale presents vulnerabilities, including potentially higher per-unit costs and limited resources for extensive clinical trials, marketing, and global distribution. These factors could impact its profitability and market share against rivals with superior operational efficiencies and established brand recognition. The company's reliance on third parties for manufacturing and distribution, while a lean strategy, also introduces dependencies that larger competitors might mitigate through in-house capabilities.

Outlook and Critical Risks

Odyssey Health's immediate outlook is heavily influenced by the anticipated commercialization of BreastCheck®. Management expects to begin generating initial revenue from BreastCheck® in the near future, a critical step that could mark its transition from a development-stage to a revenue-generating medtech company. This represents a significant milestone, offering a tangible pathway to address the company's long-standing lack of revenue and negative cash flows.

However, the path forward is fraught with risks. The most pressing is the "going concern" warning, reflecting the company's precarious financial position and its dependence on securing additional capital. While efforts to raise funds through debt and equity issuances are ongoing, there is no guarantee that such financing will be available on acceptable terms. A failure to secure adequate funding could force the company to delay, scale back, or even cease operations.

Regulatory approval remains a substantial hurdle for all of Odyssey's product candidates. The process is expensive, time-consuming, and uncertain, with no assurance of FDA clearance or approval for commercial sale. Delays or rejections could severely impact the company's ability to generate revenue. Furthermore, the company's reliance on third parties for R&D, manufacturing, and distribution introduces operational risks, as the performance and compliance of these partners are beyond Odyssey's direct control.

Intellectual property protection is another critical risk. The company's ability to compete depends on adequately protecting its patents and trade secrets, and it may face costly litigation to defend these rights or against infringement claims from third parties. Finally, internal control deficiencies, specifically "insufficient resources" and "inadequate segregation of duties" in finance and accounting, pose a risk to accurate financial reporting and could erode investor confidence. While management is committed to improving these controls, the current state highlights operational vulnerabilities.

Conclusion

Odyssey Health, Inc. stands at a defining moment, poised to potentially transform its financial narrative with the imminent commercialization of BreastCheck®. This non-invasive breast abnormality test represents a tangible opportunity for the company to generate its first revenues, a crucial step away from its long-standing development-stage status and the associated "going concern" risks. The strategic pivot towards products with clearer market pathways, coupled with a lean operational model, underpins the core investment thesis: that Odyssey can leverage niche technological advantages to capture market share in growing healthcare segments.

While the company's history of losses and ongoing capital requirements present significant challenges, the potential for BreastCheck® to provide immediate revenue, alongside the long-term promise of technologies like CardioMap and Save-A-Life, offers a compelling, albeit high-risk, investment proposition. The ability to secure consistent financing, navigate complex regulatory landscapes, and effectively execute its commercialization strategy for BreastCheck® will be paramount. For investors, Odyssey Health represents a speculative opportunity in a medical technology innovator, where the successful launch and market adoption of its lead product could unlock substantial value and fundamentally alter its competitive standing against industry giants.