−Removed: This Annual Report on Form
−Removed: 10-K contains forward-looking statements based on expectations, estimates, and projections as of the date of this filing.
−Removed: Actual results
−Removed: may differ materially from those expressed in forward-looking statements.
−Removed: See Item 1A of Part I—“Risk Factors.”
−Removed: Odyssey Group International,
−Removed: was formed as a Nevada corporation in March 2014.
−Removed: Our principal executive offices are located at 2372 Morse Ave., Irvine, CA 92614.
+Added: This Annual Report on Form 10-K contains forward-looking
+Added: statements based on expectations, estimates, and projections as of the date of this filing.
+Added: Actual results may differ materially from
+Added: those expressed in forward-looking statements.
+Added: See Item 1A of Part I—“ Risk Factors .”
+Added: Odyssey Health, Inc.
+Added: was formed as a Nevada
+Added: corporation in March 2014.
+Added: Our principal executive offices are located at 2300 West Sahara Avenue, Suite 800 - #4012, Las Vegas,
+Added: Nevada, 89102.
The registration statement effectuating our initial public offering became effective in July 2015.
−Removed: Our shares of common stock
−Removed: are listed on the OTCPink Marketplace (“OTC”) and there is currently very little public market for our common stock.
−Removed: As used herein, when we refer
−Removed: to “Odyssey”, “ODYY,”
−Removed: the “Company,”
−Removed: “our Company,”
−Removed: “we,”
−Removed: “us”
−Removed: and “our,”
−Removed: we mean Odyssey Group International, Inc., a Nevada corporation, unless the context indicates otherwise.
−Removed: Odyssey is a publicly held
−Removed: holding company with an emphasis on the development and acquisition of medical products and health related technologies.
−Removed: We are focused
−Removed: on developing and acquiring technologies that have a technological advantage and a substantial market opportunity within significant target
−Removed: markets across the globe.
−Removed: The corporate mission is to create or acquire distinct technologies and intellectual property with an emphasis
−Removed: on acquisition targets that will generate positive cash flow.
−Removed: Our strategic mission is to deliver financial results, which yield high
−Removed: rates of returns for our shareholders and partners.
−Removed: Our leadership team has significant experience and capabilities to commercialize our
−Removed: technologies and submit to the appropriate regulatory agencies for marketing approval.
−Removed: Our business model is to develop or acquire unique medical related products, engage
−Removed: third parties to manufacture such products and then distribute the products through various distribution channels, including third parties.
−Removed: We are developing potentially life-saving technologies:
−Removed: the CardioMap®
+Added: Our shares of common stock are listed on the OTCPink
+Added: Marketplace (“OTC”) and there is currently very little public market for our common stock.
+Added: As used herein, when we refer to “Odyssey”,
+Added: “ODYY,” the “Company,” “our Company,” “we,” “us” and “our,” we
+Added: mean Odyssey Health, Inc., a Nevada corporation, unless the context indicates otherwise.
+Added: Odyssey is a publicly held holding company focused
+Added: on acquiring and developing medical products.
+Added: We are developing technologies that have a technological advantage, superior clinical utility,
+Added: and a substantial market opportunity within significant target markets across the globe.
+Added: The corporate mission is to create or acquire
+Added: distinct technologies and intellectual property with an emphasis on acquisition targets that will generate positive cash flow.
+Added: Our leadership
+Added: team has significant experience and capabilities to commercialize our technologies and submit them to the appropriate regulatory agencies
+Added: for marketing approval.
+Added: Our business model is to develop or acquire unique
+Added: medical-related products, engage third parties to assist in the development and manufacturing of such products, and then distribute the
+Added: products through various distribution channels, including third parties.
+Added: We own potentially life-saving technologies:
+Added: the CardioMap®
heart monitoring and screening device;
−Removed: the Save A Life choking
−Removed: rescue device;
−Removed: PRV-001 and PRV-002 which are unique neurosteroid drug compounds intended to treat concussions and rare brain disorders.
−Removed: To date, none of our product candidates has received regulatory clearance or approval for commercial sale.
−Removed: We intend to acquire other
−Removed: technologies and assets and plan to be a trans-disciplinary product development company involved in the development and commercialization
−Removed: of products and technologies that may be applied over various medical markets.
−Removed: We intend to license, improve
−Removed: and/or develop our products and identify and select distribution channels.
−Removed: We plan to establish agreements with distributors to get products
−Removed: to market quickly as well as to undertake and engage in our own direct marketing efforts.
−Removed: We will determine the most effective method
−Removed: of distribution for each unique product that we include in our portfolio.
−Removed: We intend to engage third
−Removed: party research and development firms who specialize in the creation of medical products to assist us in the development.
−Removed: We will apply
−Removed: for trademarks and patents as we develop proprietary products.
+Added: the Save A Life choking rescue device;
+Added: and PRV-002 which is a unique neurosteroid drug compound
+Added: intended to treat mild traumatic brain injuries also known as concussions.
+Added: We on fifty percent of another unique neuro-steroid, PRV-001,
+Added: intended to treat rare brain disorders.
+Added: To date, none of our product candidates has received regulatory clearance or approval for commercial
+Added: We intend to acquire other technologies and assets
+Added: and plan to be a trans-disciplinary product development company involved in the development and commercialization of products and technologies
+Added: that may be applied over various medical markets.
+Added: We intend to license, improve and/or develop our
+Added: products and identify and select distribution channels.
+Added: We plan to establish agreements with distributors to get products to market quickly
+Added: as well as to undertake and engage in our own direct marketing efforts.
+Added: We will determine the most effective method of distribution for
+Added: each unique product that we include in our portfolio.
+Added: We intend to engage third party research and development
+Added: firms who specialize in the creation of medical products to assist us in the development.
+Added: We will apply for trademarks and patents as
+Added: we develop proprietary products.
Financial Information about Industry Segments
−Removed: We do not report our financial
−Removed: results by segment.
+Added: We do not report our financial results by segment.
See financial statements.
Our Growth Strategy
−Removed: If the FDA clears or approves
−Removed: our product candidates, we intend to enter into agreements with qualified distributors throughout the United States.
+Added: If the FDA clears or approves our product candidates
+Added: to be marketed commercially, we intend to enter into agreements with qualified distributors throughout the United States.
A similar approach
6 unchanged sentences
license agreements provide a stronger path to revenue and earnings than purely domestic products.
−Removed: Our objective is to grow revenue
−Removed: through marketing and sales of each of our product candidates, CardioMap®
−Removed: and Save a Life, if they gain regulatory approvals.
−Removed: no assurances can be given, management anticipates company growth from the following areas:
+Added: Our objective is to grow revenue through marketing
+Added: and sales of each of our product candidates, CardioMap® and Save a Life, and the two neuro-steroids, PRV-002 and PRV-001 if they gain
+Added: regulatory approvals.
+Added: Although no assurances can be given, management anticipates company growth from the following areas:
Distribution or License Agreements.
−Removed: In most cases, we will enter into distribution agreements with
−Removed: companies who have sales professionals with experience selling through a variety of sales methods.
−Removed: These distribution agreements will
−Removed: allow us to more quickly achieve sales and revenue in the health products industries.
−Removed: 2) Generate revenues from sales of CardioMap®
−Removed: and Save a Life.
−Removed: We intend to market
−Removed: CardioMap®
−Removed: and Save a Life through third party distributors and through our own efforts.
−Removed: 3) Identify and develop CardioMap®
−Removed: for additional proprietary uses of the product.
−Removed: pursue development of CardioMap®
−Removed: technology for use in other areas of the human body, such as the brain, liver and kidney.
+Added: In most cases, we will enter into distribution agreements with companies who have sales professionals with experience selling through a variety of sales methods.
+Added: These distribution agreements will allow us to more quickly achieve sales and revenue in the health products industries.
+Added: Generate revenues from sales of CardioMap® and Save a Life.
+Added: When approved for sale by regulatory agencies we intend to market our products through third party distributors and through our own efforts.
+Added: Identify and develop our products for additional proprietary uses.
+Added: When funding allows, w e intend to pursue development of CardioMap® technology for use in other areas of the human body, such as the brain, liver and kidney.
+Added: 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.
−Removed: We intend to pursue development and acquisition
−Removed: of other product candidates and market any new products, if cleared or approved.
−Removed: We intend, as capital resources permit, to develop such
−Removed: opportunities if and when they present themselves.
+Added: We intend to pursue development and acquisition of other product candidates and market any new products, if cleared or approved.
+Added: We intend, as capital resources permit, to develop such opportunities if and when they present themselves.
Seek partners to assist in the further development of our drug device combination products.
−Removed: intend to seek partners to assist with the further development and clinical trials of both PRV-001 and PRV-002.
−Removed: Partnerships could be
−Removed: in the form of government grants or from industry pharmaceutical companies who have an interest in brain related drug therapies.
−Removed: We currently have no products
−Removed: authorized for commercial distribution in either the United States, Europe or any other country.
−Removed: We are developing devices and pharmaceutical
−Removed: drugs, which are in various stages of development, and which will require regulatory clearance or approvals and we cannot begin marketing
−Removed: and selling our product candidates until we obtain applicable authorizations from the respective regulatory agency.
−Removed: FDA clearance or approval
−Removed: to market the products will be required to sell in the United States.
−Removed: About CardioMap®
−Removed: The CardioMap®
−Removed: is intended to be a heart monitoring and screening device based on a novel method of Dispersion Mapping in ECG analysis for the early,
−Removed: non-invasive testing for coronary heart disease (“CHD”).
−Removed: The heart monitoring system is intended to provide high quality 3-D
−Removed: visualization and diagnosis of the heart using advanced signal analysis.
−Removed: The product is being designed for use in a professional setting
−Removed: or in remote settings including in-home use.
−Removed: We have exclusive, royalty free rights to USPTO patent number 7,519,416 B2 related to the
−Removed: CardioMap technology.
−Removed: FDA cleared or approved, CardioMap®
−Removed: could provide a better level of diagnosis with its improved sensitivity levels that can detect early warning signs that would normally
−Removed: be invisible with standard ECG devices.
−Removed: The system can dramatically cut the costs associated with the detection of ischemic heart disease
−Removed: and will prove to be an invaluable testing device for cardiologists, physicians, clinics, hospitals, the fitness industry, sports teams,
−Removed: emergency facilities and general public.
−Removed: CardioMap®
−Removed: was developed by VE Science Technology LLC, from whom we have purchased the product
−Removed: We have a working model of the device and associated software and plan to further develop the technology for clinical trials and
−Removed: a 510K FDA submission.
−Removed: To sell, market and distribute the CardioMap®
−Removed: product, clearance or approval from the FDA is required.
−Removed: clearance or approval has not been obtained at this time.
+Added: We intend to seek partners to assist with the further development and clinical trials of both PRV-001 and PRV-002.
+Added: Partnerships could be in the form of government grants or from industry pharmaceutical companies who have an interest in brain related drug therapies.
+Added: We currently have no products authorized for commercial
+Added: distribution in either the United States, Europe or any other country.
+Added: We have development programs for devices and pharmaceutical drugs,
+Added: which are in various stages of development.
+Added: Currently we are only funding the development of PRV-002 intended to treat concussion.
+Added: to funding constraints and market conditions the CardiMap ® and the choking rescue device programs have been suspended.
+Added: All of our products require regulatory clearance or approvals and we cannot begin marketing and selling our product candidates until we
+Added: obtain applicable authorizations from the respective regulatory agency.
+Added: FDA clearance or approval to market the products will be required
+Added: to sell in the United States.
+Added: About CardioMap®
+Added: The CardioMap® System is intended to be a
+Added: heart monitoring and screening device based on a novel method of Dispersion Mapping in ECG analysis for the early, non-invasive testing
+Added: for coronary heart disease (“CHD”).
+Added: The heart monitoring system is intended to provide high quality 3-D visualization and
+Added: diagnosis of the heart using advanced signal analysis.
+Added: The product is being designed for use in a professional setting or in remote settings
+Added: including in-home use.
+Added: We have exclusive, royalty free rights to USPTO patent number 7,519,416 B2 related to the CardioMap technology.
+Added: FDA cleared or approved, CardioMap® could
+Added: provide a better level of diagnosis with its improved sensitivity levels that can detect early warning signs that would normally be invisible
+Added: with standard ECG devices.
+Added: The system could dramatically cut the costs associated with the detection of ischemic heart disease and will
+Added: prove to be an invaluable testing device for cardiologists, physicians, clinics, hospitals, the fitness industry, sports teams, emergency
+Added: facilities and general public.
+Added: CardioMap® was developed by VE Science Technology LLC, from whom we have purchased the product rights.
+Added: We have a working model of the device and associated software and plan to further develop the technology for clinical trials and a 510K
+Added: FDA submission when funding is secured.
+Added: To sell, market and distribute the CardioMap® product, clearance or approval from the FDA
+Added: Such clearance or approval has not been obtained at this time.
Product Development Plan:
2 unchanged sentences
FDA Submission
−Removed: This product development plan
−Removed: is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
−Removed: About Save-a-Life®
−Removed: In July of 2019 we purchased
−Removed: all intellectual property including two patents for the choking rescue device:
+Added: This product development plan is an estimate only.
+Added: The Product Development Plan is subject to change based on our ability to fund the program, technical risks and regulatory approvals.
+Added: About Save-a-Life®
+Added: In July 2019, we purchased all intellectual property
+Added: including two patents for the choking rescue device:
patent Number RE45, 535 E, and patent Number 8,454,624 B2.
−Removed: The Save a Life®
−Removed: (“SAL”) choking rescue device is currently in development and being designed to be a safe, and easy to
−Removed: use device for removing a lodged mass from the throat of a choking victim.
−Removed: The device includes a pump for creating a vacuum chamber, which
−Removed: is connected seamlessly with a replaceable/disposable mouthpiece.
−Removed: In an emergency the SAL may be easily inserted into the victim’s
−Removed: mouth, which depresses the tongue providing a clear application.
−Removed: By pressing an activation button on the device, the internal pump is
−Removed: intended to deliver the appropriate amount of instantaneous vacuum to dislodge the mass without harm or damage to the person.
−Removed: The application
−Removed: is intended to be instantly effective as the device will be operational and effective in a matter of seconds.
−Removed: To sell, market and distribute
−Removed: the Save-a-Life product, clearance or approval from the FDA is required.
−Removed: Clinical trials for the device will be conducted on anatomically
−Removed: correct models to demonstrate device performance.
−Removed: The regulatory pathway is expected to be a 510k submission to the FDA once successful
−Removed: clinical data is obtained.
−Removed: FDA clearance or approval has not been obtained at this time.
+Added: The Save a Life® (“SAL”)
+Added: 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
+Added: the throat of a choking victim.
+Added: The device includes a pump for creating a vacuum chamber, which is connected seamlessly with a replaceable/disposable
+Added: In an emergency, the SAL may be easily inserted into the victim’s mouth, which depresses the tongue providing a clear
+Added: By pressing an activation button on the device, the internal pump is intended to deliver the appropriate amount of instantaneous
+Added: vacuum to dislodge the mass without harm or damage to the person.
+Added: The application is intended to be instantly effective as the device
+Added: will be operational and effective in a matter of seconds.
+Added: To sell, market and distribute the Save-a-Life product, clearance or approval
+Added: from the FDA is required.
+Added: Clinical trials for the device will be conducted on anatomically correct models to demonstrate device performance.
+Added: The regulatory pathway is expected to be a 510k submission to the FDA once successful clinical data is obtained.
+Added: FDA clearance or approval
+Added: has not been obtained at this time.
The Development Plan for the Save-a-Life is below.
3 unchanged sentences
FDA Submission
−Removed: Product Development Plan is
−Removed: an estimate only and is subject to change based on funding, technical risks and regulatory approvals.
+Added: This product development plan is an estimate only
+Added: and is subject to change based on funding, technical risks, the clinical pathway and regulatory approvals.
About the neurosteroid PRV-001
−Removed: The neurosteroid, PRV-001,
−Removed: is intended to improve function and lifespan in pediatric disorders where de-myelination and cell death is widespread in the cortex, subcortical
−Removed: nuclei, brainstem and cerebellum regions of the brain.
−Removed: The new chemical entity is designed to work through gene amplification to simultaneously
−Removed: remove intra-neuronal debris while promoting antioxidant capacity and myelin repair/cell proliferation.
−Removed: Disorders like Nieman Pick Type
−Removed: C disease are multi-faceted in their pathology and require a treatment that can work at many levels to stop progression.
−Removed: compound for the neurosteroid being developed has completed an initial safety study in rats.
−Removed: Results of preclinical studies suggest that
−Removed: PRV-001 may improve neuromotor, cognitive and mental performance.
−Removed: To sell the PRV-001 neurosteroid, further development and clinical studies
−Removed: are required.
−Removed: PRV-001 will also require approval by the FDA in order to be sold in the United States.
−Removed: Per our agreement with Prevacus,
−Removed: a Tallahassee, Florida based biotech company, we have fifty percent ownership in the drug compound and associated intellectual property.
−Removed: There are issued patents covering methods of PRV-001 synthesis.
−Removed: Product Development Plan for
+Added: The neurosteroid, PRV-001, is intended to improve
+Added: function and lifespan in pediatric disorders where Central Nervous System (CNS) de-myelination and cell death is widespread in the cortex,
+Added: subcortical nuclei, brainstem, and cerebellar regions.
+Added: PRV-001, a new chemical entity, is designed to work through gene amplification
+Added: to simultaneously remove intra-neuronal debris while promoting antioxidant capacity and myelin repair/cell proliferation.
+Added: Disorders like
+Added: Nieman Pick Type C disease are multi-faceted in their pathology and require a treatment that can work at many levels to stop progression.
+Added: The chemical compound for the neurosteroid being developed has completed an initial safety study in rats.
+Added: Results of preclinical studies
+Added: suggest that PRV-001 may improve neuromotor, cognitive and mental performance.
+Added: To market the PRV-001 neurosteroid, further development
+Added: and clinical studies are required.
+Added: PRV-001 will also require approval by the FDA to be sold in the United States.
+Added: Per our agreement with Prevacus, Inc.
+Added: a Tallahassee,
+Added: Florida based biotech company, we have fifty percent (50%) ownership in the drug compound and associated intellectual property.
+Added: agreement also called for a joint venture to be created by the two companies.
+Added: The term to create the joint venture has expired and a joint
+Added: venture is no longer planned.
+Added: The United States Patent and Trademark Office issued patents covering methods of PRV-001 synthesis.
+Added: Product Development Plan for PRV-001:
Pre-clinical Animal Studies
FDA Submission
−Removed: This product development plan
−Removed: is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
+Added: This product development plan is an estimate and
+Added: is subject to change based on funding, technical risks and regulatory approvals.
About the neurosteroid PRV-002
−Removed: On March 1, 2021, we purchased
+Added: On March 1, 2021, Odyssey Health, Inc.
one hundred percent (100%) of the drug compound PRV-002 from Prevacus, Inc.
1 unchanged sentence
being developed for the treatment of mTBI (concussion).
−Removed: Results of preclinical studies suggest that PRV-002 has equivalent, and potentially
+Added: Results of preclinical studies suggest that PRV-002 has an equivalent, and potentially
superior, neuroprotective effects compared to related neurosteroids.
−Removed: In animal models of concussion PRV-002 reduced the behavioral pathology
−Removed: associated with brain injury symptoms such as short-term memory loss, depression/anxiety-like behavior and motor-sensory impairment.
−Removed: drug is administered through the nasal passage from a novel device.
−Removed: PRV-002 is lipophilic and can cross the blood-brain barrier thus supporting
−Removed: its potential to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow through
−Removed: gene amplification.
−Removed: The drug has completed toxicology
−Removed: studies in rat and dog.
−Removed: Studies show that PRV-002 has a safety margin over 200X it’s predicted efficacious dose.
−Removed: PRV-002 to date
−Removed: has been shown to be stable up to 104 degrees for 6-months.
−Removed: The drug candidate is currently being spray-dry manufactured into a powder
−Removed: that will be filled into the novel breath-propelled nasal device developed by Odyssey.
−Removed: The device is light weight and easy to use in the
−Removed: Odyssey’s novel nasal device is breath-propelled causing the soft palate to close in the back of the nasopharynx.
−Removed: This mechanism
−Removed: traps PRV-002 in the nasal cavity allowing for a more abundant and faster drug availability in the traumatized brain.
−Removed: Safety studies have
−Removed: established a dosing regimen of 2X/day for fourteen (14) days.
−Removed: Clinical Trial Phase I is site-set in Melbourne, Australia with a Contract
−Removed: Research Organization (CRO), Nucleus Network Inc.
−Removed: The country of Australia provides a twenty percent (20%) currency exchange advantage
−Removed: and a 43.5% rebate at the end of our fiscal year from the Australian government on all Research and Development performed in Australia.
−Removed: The trial is expected to begin in November 2021.
−Removed: A comprehensive Investigator’s
−Removed: Brochure has been created and submitted to the Alfred Ethics Committee by our CRO in Australia.
−Removed: Approval has been granted to initiate
−Removed: the phase 1 human trial and subjects have been enrolled.
−Removed: The phase 1 trial will have two components to it, phase 1a and 1b.
−Removed: designed to determine the safety profile of the drug in healthy human subjects.
−Removed: Phase 1a will have forty-eight subjects using a Single
−Removed: Ascending/Multiple Ascending (SAD/MAD) drug administration design.
−Removed: For both the SAD and MAD portions there will be 4 groups, placebo,
−Removed: low dose, middle dose and high dose.
−Removed: All dosages are within the animal preclinical efficacy and safety range.
−Removed: The SAD component is a 1X
−Removed: treatment and the MAD component is a 1X/day treatment for 5-days.
−Removed: Blood and urine samples will be collected at multiple time points for
−Removed: safety pharmacokinetics.
−Removed: Standard safety monitoring will be provided for each bodily system.
−Removed: Phase 1b will begin following the completion
−Removed: of the final safety report from Phase 1a establishing no safety concerns.
−Removed: In Phase 1b PRV-002 will be administered to 24 acutely-concussed
−Removed: patients, 2x a day for 14-days.
−Removed: The trial will be low powered and evaluate safety as well as efficacy measurements to be used in Phase
−Removed: 2/3 clinical trials.
−Removed: Based on the Phase 1a and 1b data we plan to submit an application for an Investigational New Drug with the FDA and
−Removed: conduct a phase 2 trial in the United States.
−Removed: Patents on PRV-002 have been
−Removed: filed and/or issued:
+Added: In animal models of mild brain injury PRV-002 reduced the behavioral
+Added: pathology associated with brain injury symptoms such as short-term memory loss, depression/anxiety-like behavior, and motor-sensory impairment.
+Added: The drug is administered through the nasal passage from a novel device.
+Added: PRV-002 is lipophilic and can cross the blood-brain barrier thus
+Added: supporting its potential to rapidly eliminate swelling, oxidative stress, and inflammation in the brain while restoring proper blood flow
+Added: through gene amplification.
+Added: The drug has completed toxicology studies in rat
+Added: Studies show that PRV-002 has a safety margin over 200X its predicted efficacious dose.
+Added: PRV-002 to date has been shown to be
+Added: stable up to 104 degrees for 18-months.
+Added: The drug candidate is spray-dry manufactured into a powder and filled into the intranasal device.
+Added: The device is lightweight and easy to use in the field.
+Added: Odyssey’s novel intranasal device is breath-propelled causing the soft palate
+Added: to close in the back of the nasopharynx.
+Added: This mechanism traps PRV-002 in the nasal cavity allowing for a more abundant and faster drug
+Added: availability in the traumatized brain.
+Added: Safety studies have established a dosing regimen of 2X/day for fourteen (14) days.
+Added: clinical trial was performed in Melbourne, Australia with a Contract Research Organization (CRO), Avance Clinical Pty Ltd and Nucleus
+Added: Network Pty Ltd.
+Added: The country of Australia provides a greater than twenty six percent (26%) currency exchange advantage and a forty-three
+Added: and one half percent (43.5%) rebate at the end of our fiscal year from the Australian government on all Research and Development performed
+Added: in Australia.
+Added: A comprehensive Investigator’s Brochure
+Added: was created and approved by the Alfred Ethics Committee by Odyssey Health’s CRO in Australia.
+Added: Phase 1 was designed to determine
+Added: the safety profile of the drug in healthy human subjects.
+Added: It was double-blinded, randomized and placebo controlled (3:1, drug:
+Added: Phase 1 used a Single Ascending/Multiple Ascending (SAD/MAD) drug administration design.
+Added: The SAD component was a 1X treatment (low, medium,
+Added: or high dose) and the MAD component was a 1X/day treatment for five (5) consecutive days (low and medium dose).
+Added: Blood and urine samples
+Added: were collected at multiple time points for safety pharmacokinetics.
+Added: Standard safety monitoring was provided for each body system.
+Added: Forty (40) human subjects (31 males, 9 females)
+Added: were successfully enrolled in Phase I.
+Added: The Safety Review Board, made up of medical doctors, has reviewed the trial data and has determined
+Added: the drug is safe and well tolerated at all dosing levels.
+Added: In Phase II clinical trial, PRV-002 will be administered
+Added: to acutely concussed patients, 2x a day for fourteen (14) days.
+Added: Based on the Phase I data, we plan to apply for an Investigational New
+Added: Drug application with the FDA and conduct a Phase II trial in the United States.
+Added: Patents on PRV-002 have been filed and/or issued
+Added: and a patent has been filed on the nasal delivery device:
Composition of matter for PRV-002 and analogs
1 unchanged sentence
Synthetic methods for PRV-002
−Removed: Development Plan
+Added: Product Development Plan:
Pre-clinical Animal Studies
−Removed: Food and Drug
−Removed: Administration Submission
−Removed: September 2021
−Removed: This product development plan
−Removed: is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
−Removed: We believe that the primary
−Removed: competition for our products and services is from existing companies offering EKG equipment and anti-choking devices, as well as other
−Removed: pharmaceutical companies engaged in the development of Orphan drugs.
+Added: FDA Submission
+Added: December 2023
+Added: February 2025
+Added: This product development plan is an estimate and
+Added: is subject to change based on funding, technical risks and regulatory approvals.
+Added: We believe that the primary competition for our
+Added: products and services is from existing companies offering EKG equipment and anti-choking devices, as well as other pharmaceutical companies
+Added: engaged in the development of Orphan drugs.
+Added: SAL Competitive Analysis
+Added: The Dechoker is a device that can be used for
+Added: choking first aid on anyone 12 months or older, regardless of illness, disorder or other health-related condition.
+Added: It utilizes a hand
+Added: powered pump system to extract blockages.
+Added: LifeVac is designed with a valve to prevent any
+Added: air from exiting through the mask.
+Added: This designed valve prevents air from pushing food or objects downward.
+Added: This creates a one-way suction
+Added: to remove the lodged food or object.
+Added: Act+Fast Heimlich maneuver training vests
+Added: Act+Fast™ Anti-Choking Trainer, Blue (AHA),
+Added: This device enables students to develop confidence in their ability to perform the Abdominal Thrust (Heimlich) Maneuver as recommended
+Added: by the American Heart Association (AHA).
+Added: It has been designed to be realistic and easy to use.
+Added: CardioMap® Competitive Analysis
+Added: Note, none of the current rapid EKG devices have
+Added: the ability to digitally map the heart.
+Added: Each of the below competitors give EKG read outs only.
+Added: CardioResting (Nasiff)
+Added: The CardioResting ECG is the first complete and
+Added: full-featured 12 lead PC based cardiology system.
+Added: The ECG is durable, reliable and easy to learn.
+Added: Performs and manages tests while saving
+Added: money and working with your existing equipment.
+Added: Our system is EMR compatible with an unlimited database.
+Added: Welch Allyn PC Based Electrocardiograph
+Added: Automatically transfer patient information and
+Added: test data into most EMRs without redundant work steps, misidentified patients, or delays from copying, scanning and shredding ECG reports.
+Added: QardioCore is a wireless medical grade ambulatory
+Added: ECG monitor system that can identify atrial fibrillation and other arrhythmias.
+Added: No wires, gels or patches are required.
+Added: No in-clinic fitting
+Added: nor technician needed - QardioCore is 100% deployed remotely.
Governmental Regulation
Product Regulation
−Removed: The processing,
−Removed: formulation, safety, manufacturing, packaging, labeling, advertising and distribution of our products may be subject to certain regulation
−Removed: by one or more federal agencies, including the FDA, Housing and Human Services (the “HHS”), the Federal Trade Commission (the
−Removed: “FTC”), the Consumer Product Safety Commission (the “CPSC”), the United States Department of Agriculture (the
−Removed: “USDA”) and the Environmental Protection Agency (the “EPA”), and by various agencies of the states and localities
−Removed: in which our products are sold.
−Removed: To sell, market and distribute
−Removed: the CardioMap®, the Save a Life or the drug compound products, clearance or approval from the FDA is required.
−Removed: Such clearance or approval
−Removed: has not been obtained at this time and our products are not currently available for commercial sale.
−Removed: we eventually sell in foreign countries are also subject to regulation under various national, local and international laws that include
−Removed: provisions governing, among other things, the formulation, manufacturing, packaging, labeling, advertising and distribution of drugs
−Removed: and medical products.
−Removed: Government regulations in foreign countries may prevent or delay the introduction, or require the reformulation,
−Removed: of some of our products.
−Removed: At the date hereof, we have
−Removed: four employees and intend to hire additional employees in the foreseeable future.
+Added: The processing, formulation, safety, manufacturing,
+Added: packaging, labeling, advertising and distribution of our products may be subject to certain regulation by one or more federal agencies,
+Added: including the FDA, Housing and Human Services (the “HHS”), the Federal Trade Commission (the “FTC”), the Consumer
+Added: Product Safety Commission (the “CPSC”), the United States Department of Agriculture (the “USDA”) and the Environmental
+Added: Protection Agency (the “EPA”), and by various agencies of the states and localities in which our products are sold.
+Added: To sell, market and distribute the CardioMap®,
+Added: the Save a Life or the drug compound products, clearance or approval from the FDA is required.
+Added: Such clearance or approval has not been
+Added: obtained at this time and our products are not currently available for commercial sale.
+Added: Any products we eventually sell in foreign countries
+Added: are also subject to regulation under various national, local and international laws that include provisions governing, among other things,
+Added: the formulation, manufacturing, packaging, labeling, advertising and distribution of drugs and medical products.
+Added: Government regulations
+Added: in foreign countries may prevent or delay the introduction, or require the reformulation, of some of our products.
+Added: At the date hereof, we have four employees and
+Added: do not intend to hire additional employees in the foreseeable future.
Where you can find more information
−Removed: Our Annual Report on Form
−Removed: 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)
−Removed: of the Securities Exchange Act of 1934, as amended (“Exchange Act”), are filed with the U.S.
−Removed: Securities and Exchange Commission
−Removed: (the “SEC”).
−Removed: Such reports and other information filed by us with the SEC are available free of charge on our website
−Removed: at http://www.odysseygi.com when such reports are available on the SEC website.
−Removed: The public may read and copy any materials filed
−Removed: by us with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Room 1580, Washington, DC 20549.
−Removed: The public may obtain
−Removed: information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
−Removed: The SEC maintains an Internet site that
−Removed: contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.
−Removed: The contents of these websites are not incorporated into this filing.
−Removed: Further, our references to the URLs for these websites are intended
−Removed: to be inactive textual references only.
+Added: Our Annual Report on Form 10-K, Quarterly Reports
+Added: 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
+Added: Act of 1934, as amended (“Exchange Act”), are filed with the U.S.
+Added: Securities and Exchange Commission (the “SEC”).
+Added: 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
+Added: such reports are available on the SEC website.
+Added: The public may read and copy any materials filed by us with the SEC at the SEC’s
+Added: Public Reference Room at 100 F Street, NE, Room 1580, Washington, DC 20549.
+Added: The public may obtain information on the operation of the
+Added: Public Reference Room by calling the SEC at 1-800-SEC-0330.
+Added: The SEC maintains an Internet site that contains reports, proxy and information
+Added: statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.
+Added: The contents of these websites
+Added: are not incorporated into this filing.
+Added: Further, our references to the URLs for these websites are intended to be inactive textual references
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.