What changed in this filing

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Item 1. Business

2025-10-29 compared with 2024-11-13 · 81 added, 107 removed, 129 unchanged (59% of the section changed)

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mean Odyssey Health, Inc., a Nevada corporation, unless the context indicates otherwise.

Odyssey is a publicly held holding 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

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.

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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 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

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we develop proprietary products.

Asset Purchase Agreement with Oragenics, Inc.

On October 4, 2023, we entered into an Asset Sale

Agreement (the “Agreement”) with Oragenics, which closed on December 28, 2023.

Pursuant to the Agreement, we sold certain

assets related to the treatment of brain related illnesses and diseases (the “Assets”) with a total carrying value of $48,367

to Oragenics in exchange for (i) $1,000,000 in cash;

(ii) 8,000,000 shares of convertible Series F preferred stock;

and (iii) the assumption

of $325,672 of our accounts payable.

The total value of consideration received was $16,449,054, which resulted in a gain of $16,400,687.

The Assets include drug candidates for treating mild

traumatic brain injury (“mTBI”), also known as concussion, and for treating Niemann Pick Disease Type C (“NPC”),

as well as our proprietary powder formulation and its nasal delivery device.

We received $500,000 upon the execution of the

Agreement on October 4, 2023, and received the additional $500,000 on December 11, 2023, upon our stockholder approval for the sale of

Following the closing of the Agreement on December 28, 2023, we received 8,000,000 shares of Series F preferred stock.

receipt, 511,308 shares of the Series F preferred stock, which represented 19.9% of the then outstanding shares of Oragenics common stock,

converted into 511,308 shares of Oragenics restricted common stock.

The Oragenics restricted common stock became freely tradeable on June

28, 2024, subject to Rule 144 restrictions and limitations that limit us from selling no more than an amount equal to the greater of (i)

1% of the total shares of Oragenics common stock outstanding or (ii) the average of the previous four-week trading volume during each

quarterly period.

Prior to closing, we were required to obtain the consent

of Mast Hill Fund, L.P (“Mast Hill”) to consummate the closing of the Agreement.

As part of the consent, we entered into a

pledge agreement with Mast Hill granting a security interest in 154,545 of the total preferred shares, and collectively with all of the

common shares or other securities into which the preferred shares are converted or exchanged into common shares, until the Mast Hill debt

The remaining shares of convertible Series F preferred

stock will convert upon Oragenics shareholder approval and upon certain listing and change in control criteria being achieved.

See Notes 4 and 6 of Notes to Consolidated Financial

Statements for additional information.

Financial Information about Industry Segments

We do not report our financial results by segment.

We operate in one reportable segment, which includes

all of our business activities.

See financial statements.

Our Growth Strategy

If the 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

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.

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

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.

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 and our 50% ownership 50% ownership in unique neurosteroid

drug compound intended to treat rare brain disorders.

Although no assurances can be given, management anticipates company growth from

the following areas:

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:

Distribution or License Agreements.

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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.

We also intend to utilize our proprietary nasal delivery system to deliver other drugs to the brain to treat brain related medical issues.

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.

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.

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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 pharmaceutical companies who have an interest in brain related drug therapies.

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.

We have development programs for our devices, which are in various stages

of development.

Due to funding constraints and market conditions, the CardioMap and the Save-a-Life choking rescue device programs have

been suspended.

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.

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 ECG 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 USPTO patent number 7,519,416 B2 related to the CardioMap technology.

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

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 ECG devices.

with standard EKG devices.

The system could dramatically cut the costs associated with the detection of ischemic heart disease and will

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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

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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being funded.

We believe that the primary competition for our products

and services is from existing companies offering EKG equipment and anti-choking devices, as well as other pharmaceutical companies engaged

in the development of Orphan drugs.

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

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 is designed with a valve to prevent any air

from exiting through the mask.

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 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.

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Act+Fast Heimlich maneuver training vests

Act+Fast™ Anti-Choking Trainer, Blue (AHA),

This device enables students to develop confidence in their ability to perform the Abdominal Thrust (Heimlich) Maneuver as recommended

by the American Heart Association (AHA).

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.

CardioMap Competitive Analysis

None of the current rapid EKG devices have the ability

to digitally map the heart.

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 ECG is the first complete and full-featured

12 lead PC based cardiology system.

The ECG is durable, reliable and easy to learn.

It performs and manages tests while saving money and

working with your existing equipment.

Our system is EMR compatible with an unlimited database.

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

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 is a wireless medical grade ambulatory

ECG monitoring system that can identify atrial fibrillation and other arrhythmias.

EKG monitoring system that can identify atrial fibrillation and other arrhythmias.

No wires, gels or patches are required.

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in foreign countries may prevent or delay the introduction, or require the reformulation, of some of our products.

At the date hereof, we have four employees and do

not intend to hire additional employees in the foreseeable future.

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

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business