OTC: ODYY
Odyssey Health, Inc.CIK 0001626644 · Surgical & Medical Instruments
This Annual Report on Form 10-K contains forward-looking statements based on expectations, estimates, and projections as of the date of this filing. Actual results may differ materially from those expressed in forward-looking statements. See Item 1A of Part I, “Risk Factors.” About this business →
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About Odyssey Health, Inc.
Source: Item 1 (Business) from the 10-K filed October 29, 2025. Description as filed by the company with the SEC.
Item 1.
Business
This Annual Report on Form 10-K contains forward-looking
statements based on expectations, estimates, and projections as of the date of this filing. Actual results may differ materially from
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.
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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
and screening device, and the Save-A-Life choking rescue device.
To date, none of our product candidates has received
regulatory clearance or approval for commercial sale.
We intend to acquire other technologies and assets
and plan to be a trans-disciplinary product development company involved in the development and commercialization of products and technologies
that may be applied over various medical markets.
We intend to license, improve and/or develop our
products and identify and select distribution channels. We plan to establish agreements with distributors to get products to market quickly
as well as to undertake and engage in our own direct marketing efforts. We will determine the most effective method of distribution for
each unique product that we include in our portfolio.
We intend to engage third party research and development
firms who specialize in the creation of medical products to assist us in the development. We will apply for trademarks and patents as
we develop proprietary products.
Financial Information about Industry Segments
We operate in one reportable segment, which includes
all of our business activities. See financial statements.
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Our Growth Strategy
If the Food and Drug Administration (“FDA”)
clears or approves our product candidates to be marketed commercially, we intend to enter into agreements with industry partners or qualified
distributors throughout the United States. A similar approach will be pursued if our product candidates are cleared or approved for marketing
outside of the United States. We intend to require such partners or distributors to pay us an initial license fee, as well as royalties
based on gross sales. Retaining exclusivity will be based on a mutually agreeable semi-annual or quarterly sales minimum. We have also
decided to focus on international growth because, generally, such international license agreements provide a stronger path to revenue
and earnings than purely domestic products.
Our objective is to eventually grow revenue through
marketing and sales of each of our product candidates, CardioMap and Save-A-Life. Although no assurances can be given, management anticipates
company growth from the following areas:
1)
Distribution or License Agreements. Once any of our products in development are approved by the appropriate regulatory agency, we will enter into distribution agreements with companies who have sales professionals with experience selling through a variety of sales methods. These distribution agreements will allow us to achieve sales and revenue more quickly in the medical products industries.
2)
Identify and develop our products for additional proprietary uses. When funding allows, we intend to pursue development of CardioMap technology for use in other areas of the human body, such as the brain, liver and kidney.
3)
The development and acquisition of new products. We intend to pursue the development and acquisition of other product candidates and market any new products, if cleared or approved by regulatory bodies. We intend, as capital resources permit, to develop such opportunities if and when they present themselves.
4)
Seek partners to assist in the further development of our drug device combination products. We intend to seek partners to assist with the further development and clinical trials of our technologies. Partnerships could be in the form of government grants or from industry medical companies.
We currently have no products authorized for commercial
distribution in the United States, Europe or any other country. Due to funding constraints and market conditions, the Save-A-Life will
be prioritized for further development. The CardioMap development program will remain suspended in the near term. All of our products
require regulatory clearance or approvals, and we cannot begin marketing and selling our product candidates until we obtain applicable
authorizations from the respective regulatory agency. FDA clearance or approval to market the products will be required to sell in the
United States.
About CardioMap
The CardioMap System is intended to be a heart
monitoring and screening device based on a novel method of Dispersion Mapping in electrocardiogram analysis for the early, non-invasive
testing for coronary heart disease (“CHD”). The heart monitoring system is intended to provide high quality 3-D visualization
and diagnosis of the heart using advanced signal analysis. The product is being designed for use in a professional setting or in remote
settings including in-home use. We have exclusive, royalty free rights to United States patent number 7,519,416 B2 related to the CardioMap
technology.
If FDA cleared or approved, CardioMap could provide
a better level of diagnosis with its improved sensitivity levels that can detect early warning signs that would normally be invisible
with standard EKG devices. The system could dramatically cut the costs associated with the detection of ischemic heart disease and will
prove to be an invaluable testing device for cardiologists, physicians, clinics, hospitals, the fitness industry, sports teams, emergency
facilities and general public. CardioMap was developed by VE Science Technology LLC, from whom we have purchased the product rights. We
have a working model of the device and associated software and plan to further develop the technology for clinical trials and a 510K FDA
submission when funding is secured. To sell, market and distribute the CardioMap product, clearance or approval from the FDA is required.
Such clearance or approval has not been obtained at this time.
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Product Development Plan:
Concept
Engineering Model
Prototype
Clinical Trial
FDA Submission
Complete
Complete
Complete
TBD
TBD
This product development plan is an estimate only.
The product development plan is subject to change based on our ability to fund the program, technical risks and regulatory approvals.
This project is not currently being funded.
About Save-A-Life
In July 2019, we purchased all intellectual property
including two patents for the choking rescue device: patent Number RE45, 535 E, and patent Number 8,454,624 B2. The Save-A-Life (“SAL”)
choking rescue device is currently in development and is designed to be a safe, and easy-to-use device for removing a lodged mass from
the throat of a choking victim. The device includes a pump for creating a vacuum chamber, which is connected seamlessly with a replaceable/disposable
mouthpiece. In an emergency, the SAL may be easily inserted into the victim’s mouth, which depresses the tongue providing a clear
application. By pressing an activation button on the device, the internal pump is intended to deliver the appropriate amount of instantaneous
vacuum to dislodge the mass without harm or damage to the person. The application is intended to be instantly effective as the device
will be operational and effective in a matter of seconds. To sell, market and distribute the Save-A-Life product, clearance or approval
from the FDA is required. FDA clearance or approval has not been obtained at this time. The product development plan for the Save-A-Life
is below.
Product Development Plan:
Concept
Engineering Model
Prototype
Clinical Trial
FDA Submission
Complete
Complete
Complete
TBD
TBD
This product development plan is an estimate only
and is subject to change based on funding, technical risks, the clinical pathway and regulatory approvals. This project is not currently
being funded.
Competition
We believe that the primary competition for our
products and services is from existing companies offering electrocardiogram (“EKG”) equipment and anti-choking devices,
as well as other pharmaceutical companies engaged in the development of orphan drugs.
SAL Competitive Analysis
Dechoker
The Dechoker is a device that can be used for
choking first aid on anyone 12 months or older, regardless of illness, disorder or other health-related condition. It utilizes a hand
powered pump system to extract blockages.
LifeVac
LifeVac is designed with a valve to prevent any
air from exiting through the mask. This designed valve prevents air from pushing food or objects downward. This creates a one-way suction
to remove the lodged food or object.
Act+Fast Heimlich maneuver training vests
Act+Fast™ Anti-Choking Trainer, Blue, 4-Pack.
This device enables students to develop confidence in their ability to perform the Abdominal Thrust Maneuver (“Heimlich”)
as recommended by the American Heart Association. It has been designed to be realistic and easy to use.
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CardioMap Competitive Analysis
None of the current rapid EKG devices have the
ability to digitally map the heart. Each of the below competitors give EKG read outs only.
CardioResting (Nasiff)
The CardioResting EKG is the first complete and
full-featured 12 lead PC based cardiology system. The EKG is durable, reliable and easy to learn. It performs and manages tests while
saving money and working with your existing equipment. The CardioResting system is electronic medical record (“EMR”) compatible
with an unlimited database.
Welch Allyn PC Based Electrocardiograph
The Welch Allyn device automatically transfers
patient information and test data into most EMRs without redundant work steps, misidentified patients, or delays from copying, scanning
and shredding EKG reports.
QardioCore
QardioCore is a wireless medical grade ambulatory
EKG monitoring system that can identify atrial fibrillation and other arrhythmias. No wires, gels or patches are required. No in-clinic
fitting nor technician needed - QardioCore is 100% deployed remotely.
Governmental Regulation
Product Regulation
Domestic
The processing, formulation, safety, manufacturing,
packaging, labeling, advertising and distribution of our products may be subject to certain regulations by one or more federal agencies,
including the FDA, Housing and Human Services (the “HHS”), the Federal Trade Commission (the “FTC”), the Consumer
Product Safety Commission (the “CPSC”), the United States Department of Agriculture (the “USDA”) and the Environmental
Protection Agency (the “EPA”), and by various agencies of the states and localities in which our products are sold.
To sell, market and distribute the CardioMap,
the Save-A-Life or the drug compound products, clearance or approval from the FDA is required. Such clearance or approval has not been
obtained at this time and our products are not currently available for commercial sale.
Foreign
Any products we eventually sell in foreign countries
are also subject to regulations under various local, national, and international laws that include provisions governing, among other things,
the formulation, manufacturing, packaging, labeling, advertising and distribution of drugs and medical products. Government regulations
in foreign countries may prevent or delay the introduction, or require the reformulation, of some of our products.
Employees
At the date hereof, we have two employees and
do not intend to hire additional employees in the foreseeable future.
Where you can find more information
Our Annual Report on Form 10-K, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Securities Exchange
Act of 1934, as amended (“Exchange Act”), are filed with the U.S. Securities and Exchange Commission (the “SEC”).
Such reports and other information filed by us with the SEC are available free of charge on our website at http://www.odysseyhealthinc.com when
such reports are available on the SEC website. The public may read and copy any materials filed by us with the SEC at the SEC’s
Public Reference Room at 100 F Street, NE, Room 1580, Washington, DC 20549. The public may obtain information on the operation of the
Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports, proxy and information
statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. The contents of these websites
are not incorporated into this filing. Further, our references to the URLs for these websites are intended to be inactive textual references
only.
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