−Removed: This Annual Report
−Removed: on Form 10-K contains forward-looking statements based on expectations, estimates, and projections as of the date of this filing.
−Removed: Actual results may differ materially from those expressed in forward-looking statements.
−Removed: See Item 1A of Part I—“Risk
−Removed: Factors.”
+Added: This Annual Report on Form
+Added: 10-K contains forward-looking statements based on expectations, estimates, and projections as of the date of this filing.
+Added: Actual results
+Added: may differ materially from those expressed in forward-looking statements.
+Added: See Item 1A of Part I—“Risk Factors.”
Odyssey Group International,
was formed as a Nevada corporation in March 2014.
−Removed: Our principal executive offices are located at 2372 Morse Ave., Irvine,
+Added: Our principal executive offices are located at 2372 Morse Ave., Irvine, CA 92614.
The registration statement effectuating our initial public offering became effective in July 2015.
−Removed: Our shares of common
−Removed: stock are listed on the OTCQB Marketplace (“OTC”) and there is currently very little public market for our common stock.
−Removed: As used herein, when
−Removed: we refer to “Odyssey”, “ODYY,”
+Added: Our shares of common stock
+Added: are listed on the OTCPink Marketplace (“OTC”) and there is currently very little public market for our common stock.
+Added: As used herein, when we refer
+Added: to “Odyssey”, “ODYY,”
the “Company,”
3 unchanged sentences
and “our,”
−Removed: we mean Odyssey Group International, Inc., a Nevada corporation, unless the context indicates
−Removed: Recently the United
−Removed: States Congress passed the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), which provides for certain
−Removed: exemptions from various reporting requirements applicable to public companies that are reporting companies and are “emerging
−Removed: growth companies.”
−Removed: We are an “emerging growth company”
−Removed: as defined in Section 3(a) of the Exchange Act (as amended
−Removed: by the JOBS Act, enacted on April 5, 2012), and we will continue to qualify as an “emerging growth company”
−Removed: earliest to occur of:
−Removed: (a) the last day of the fiscal year during which we have total annual gross revenues of $1,000,000,000 (as
−Removed: such amount is indexed for inflation every five years by the SEC) or more;
−Removed: (b) the last day of our fiscal year following the fifth
−Removed: anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under
−Removed: the Securities Act;
−Removed: (c) the date on which we have, during the previous three-year period, issued more than $1,000,000,000 in non-convertible
−Removed: or (d) the date on which we are deemed to be a “large accelerated filer,”
−Removed: as defined in Exchange Act Rule 12b–2.
−Removed: Generally, a registrant
−Removed: that registers any class of its securities under Section 12 of the Exchange Act is required to include in the second and all subsequent
−Removed: annual reports filed by it under the Exchange Act a management report on internal control over financial reporting and, subject
−Removed: to an exemption available to registrants that meet the definition of a “smaller reporting company”
−Removed: in Exchange Act
−Removed: Rule 12b-2, an auditor attestation report on management’s assessment of internal control over financial reporting.
−Removed: for so long as we continue to qualify as an emerging growth company, we will be exempt from the requirement to include an auditor
−Removed: attestation report in our annual reports filed under the Exchange Act, even if we do not qualify as a “smaller reporting
−Removed: company”.
−Removed: In addition, as an emerging growth company, we are able to avail ourselves to the reduced disclosure obligations
−Removed: regarding executive compensation in our periodic reports and proxy statements and not to present to our stockholders a nonbinding
−Removed: advisory vote on executive compensation, obtain approval of any golden parachute payments not previously approved or present the
−Removed: relationship between executive compensation actually paid and our financial performance.
−Removed: We have irrevocably elected to comply
−Removed: with new or revised accounting standards even though we are an emerging growth company.
−Removed: Odyssey was formed
−Removed: as a publicly held holding company with an emphasis on the development and acquisition of medical products and health related technologies.
−Removed: We are focused on building and acquiring technologies that have a technological advantage and a substantial market opportunity
−Removed: within significant target markets across the globe.
−Removed: The corporate mission is to create or acquire distinct technologies and intellectual
−Removed: property with an emphasis on acquisition targets that will generate positive cash flow.
−Removed: Our strategic mission is to deliver financial
−Removed: results, which yield high rates of returns for our shareholders and partners.
−Removed: The Company’s leadership team has significant
−Removed: experience and capabilities to further refine the technologies and submit to the appropriate regulatory agencies for marketing
−Removed: Our business model
−Removed: is to develop or acquire medical related products, engage third parties to manufacture such products and then distribute the products
−Removed: through various distribution channels, including third parties.
−Removed: The Company has product development projects in three different
−Removed: life saving technologies;
+Added: we mean Odyssey Group International, Inc., a Nevada corporation, unless the context indicates otherwise.
+Added: Odyssey is a publicly held
+Added: holding company with an emphasis on the development and acquisition of medical products and health related technologies.
+Added: We are focused
+Added: on developing and acquiring technologies that have a technological advantage and a substantial market opportunity within significant target
+Added: markets across the globe.
+Added: The corporate mission is to create or acquire distinct technologies and intellectual property with an emphasis
+Added: on acquisition targets that will generate positive cash flow.
+Added: Our strategic mission is to deliver financial results, which yield high
+Added: rates of returns for our shareholders and partners.
+Added: Our leadership team has significant experience and capabilities to commercialize our
+Added: technologies and submit to the appropriate regulatory agencies for marketing approval.
+Added: Our business model is to develop or acquire unique medical related products, engage
+Added: third parties to manufacture such products and then distribute the products through various distribution channels, including third parties.
+Added: We are developing potentially life-saving technologies:
the CardioMap®
−Removed: heart monitoring and screening device, the Save A Life choking rescue device and a
−Removed: unique neurosteroid drug compound intended to treat rare brain disorders.
−Removed: We intend to acquire
−Removed: other technologies and assets and plan to be a multi-disciplinary product development company involved in the discovery, development
−Removed: and commercialization of products and technologies that may be applied over various medical markets.
−Removed: We intend to license,
−Removed: improve and/or develop our products and identify and select distribution channels.
−Removed: We intend to establish agreements with distributors
−Removed: to get products to market quickly as well as to undertake and engage in our own direct marketing efforts.
−Removed: We will determine the
−Removed: most effective method of distribution for each unique product that we include in our portfolio.
−Removed: We intend to engage
−Removed: third party research and development firms who specialize in the creation of medical products to assist us in the development.
−Removed: We intend to apply for trademarks and patents as we develop proprietary products.
−Removed: For a complete description
−Removed: of our business, financial condition, results of operations and other important information, we refer you to our filings with the
−Removed: SEC that are incorporated by reference in this Annual Report, including our Annual
−Removed: Report on Form 10-K for the year ended July 31, 2019 and our Quarterly
−Removed: Reports on Form 10-Q for the periods ended October 31, 2019, January 31, 2020 and April 30, 2020, as amended by the filings
−Removed: of Form 10K/A for the period ended July 31, 2019 and Quarterly Reports on Form 10-Q/A for the periods ended October 31, 2019, January
−Removed: 31, 2020 and April 30, 2020 filed and with the Securities and Exchange Commission on November 13, 2020.
−Removed: For instructions on how
−Removed: to find copies of these documents, see the section entitled “Where You Can Find More Information”.
−Removed: Financial Information about Industry
−Removed: We do not report our
−Removed: revenues or expenses by segment.
+Added: heart monitoring and screening device;
+Added: the Save A Life choking
+Added: rescue device;
+Added: PRV-001 and PRV-002 which are unique neurosteroid drug compounds intended to treat concussions and rare brain disorders.
+Added: To date, none of our product candidates has received regulatory clearance or approval for commercial sale.
+Added: We intend to acquire other
+Added: technologies and assets and plan to be a trans-disciplinary product development company involved in the development and commercialization
+Added: of products and technologies that may be applied over various medical markets.
+Added: We intend to license, improve
+Added: and/or develop our products and identify and select distribution channels.
+Added: We plan to establish agreements with distributors to get products
+Added: to market quickly as well as to undertake and engage in our own direct marketing efforts.
+Added: We will determine the most effective method
+Added: of distribution for each unique product that we include in our portfolio.
+Added: We intend to engage third
+Added: party research and development firms who specialize in the creation of medical products to assist us in the development.
+Added: We will apply
+Added: for trademarks and patents as we develop proprietary products.
+Added: Financial Information about Industry Segments
+Added: We do not report our financial
+Added: results by segment.
See financial statements.
Our Growth Strategy
−Removed: Once the U.S.
−Removed: and Drug Administration (the “FDA”) clears us to market the CardioMap®
−Removed: and Save a Life products, we intend to enter
−Removed: into agreements with qualified distributors throughout the United States and internationally, including:
−Removed: Europe, South America,
−Removed: Africa, India and China.
−Removed: We intend to require such distributors to pay us an initial license fee, as well as royalties based on
−Removed: Retaining exclusivity, we will bill based on a mutually agreeable semi-annual or quarterly sales minimum.
−Removed: determined to focus on international growth because, generally, such international license agreements provide a stronger path to
−Removed: revenue and earnings than purely domestic products.
−Removed: Our objective is to
−Removed: grow revenue through marketing and sales of each of our products, CardioMap®
−Removed: and Save a Life, once they gain regulatory approvals.
−Removed: Although no assurances can be given, management anticipates company growth from the following areas:
+Added: If the FDA clears or approves
+Added: our product candidates, we intend to enter into agreements with qualified distributors throughout the United States.
+Added: A similar approach
+Added: will be pursued if our product candidates are cleared or approved for marketing outside of the United States.
+Added: We intend to require such
+Added: distributors to pay us an initial license fee, as well as royalties based on gross sales.
+Added: Retaining exclusivity, will be based on a mutually
+Added: agreeable semi-annual or quarterly sales minimum.
+Added: We have determined to focus on international growth because, generally, such international
+Added: license agreements provide a stronger path to revenue and earnings than purely domestic products.
+Added: Our objective is to grow revenue
+Added: through marketing and sales of each of our product candidates, CardioMap®
+Added: and Save a Life, if they gain regulatory approvals.
+Added: no assurances can be given, management anticipates company growth from the following areas:
1) Distribution or License Agreements.
−Removed: In most cases, we will enter into distribution agreements with companies who have sales professionals with experience selling through a variety of sales methods.
−Removed: These distribution agreements will allow us to more quickly achieve sales and revenue in the health products industries.
+Added: In most cases, we will enter into distribution agreements with
+Added: companies who have sales professionals with experience selling through a variety of sales methods.
+Added: These distribution agreements will
+Added: allow us to more quickly achieve sales and revenue in the health products industries.
2) Generate revenues from sales of CardioMap®
and Save a Life.
−Removed: We intend to market CardioMap®
+Added: We intend to market
+Added: CardioMap®
and Save a Life through third party distributors and through our own efforts.
1 unchanged sentence
for additional proprietary uses of the product.
−Removed: We intend to identify new areas of the human body to map utilizing CardioMap®
−Removed: technology such as the brain, liver and kidney.
+Added: pursue development of CardioMap®
+Added: technology for use in other areas of the human body, such as the brain, liver and kidney.
4) The development and acquisition of new products.
−Removed: We intend to market any new products that may be developed or acquired.
−Removed: We intend, as capital resources permit, to develop such opportunities if and when they present themselves.
+Added: We intend to pursue development and acquisition
+Added: of other product candidates and market any new products, if cleared or approved.
+Added: We intend, as capital resources permit, to develop such
+Added: opportunities if and when they present themselves.
+Added: 5) Seek partners to assist in the further development of our drug device combination products.
+Added: intend to seek partners to assist with the further development and clinical trials of both PRV-001 and PRV-002.
+Added: Partnerships could be
+Added: 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
+Added: authorized for commercial distribution in either the United States, Europe or any other country.
+Added: We are developing devices and pharmaceutical
+Added: drugs, which are in various stages of development, and which will require regulatory clearance or approvals and we cannot begin marketing
+Added: and selling our product candidates until we obtain applicable authorizations from the respective regulatory agency.
+Added: FDA clearance or approval
+Added: to market the products will be required to sell in the United States.
About CardioMap®
The CardioMap®
−Removed: System will be an internet service based on the new development of Dispersion Mapping Method in ECG analysis for the
−Removed: early, non-invasive testing of a heart disease (“CHD”).
−Removed: The heart monitoring system is intended to provide high quality
−Removed: 3-D visualization and diagnosis of the heart using advanced signal analysis.
−Removed: The product is being designed for use in a professional
−Removed: setting or in remote settings including home use.
−Removed: Once FDA cleared, CardioMap®
+Added: is intended to be a heart monitoring and screening device based on a novel method of Dispersion Mapping in ECG analysis for the early,
+Added: non-invasive testing for coronary heart disease (“CHD”).
+Added: The heart monitoring system is intended to provide high quality 3-D
+Added: visualization and diagnosis of the heart using advanced signal analysis.
+Added: The product is being designed for use in a professional setting
+Added: or in remote settings including in-home use.
+Added: We have exclusive, royalty free rights to USPTO patent number 7,519,416 B2 related to the
+Added: CardioMap technology.
+Added: 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.
−Removed: The system is designed to dramatically cut the costs associated with the detection of ischemic
−Removed: heart disease and will prove to be an invaluable testing device for cardiologists, physicians, clinics, hospitals, the fitness
−Removed: industry, sports teams, emergency facilities and general public.
+Added: The system can dramatically cut the costs associated with the detection of ischemic heart disease
+Added: and will prove to be an invaluable testing device for cardiologists, physicians, clinics, hospitals, the fitness industry, sports teams,
+Added: emergency facilities and general public.
CardioMap®
−Removed: was developed by VE Science Technology LLC, from
−Removed: whom we have purchased the product rights.
−Removed: In order to sell, market and distribute the CardioMap®
−Removed: product, clearance from the
−Removed: FDA is required.
−Removed: Such clearance has not been obtained at this time.
−Removed: Product Development
+Added: was developed by VE Science Technology LLC, from whom we have purchased the product
+Added: We have a working model of the device and associated software and plan to further develop the technology for clinical trials and
+Added: a 510K FDA submission.
+Added: To sell, market and distribute the CardioMap®
+Added: product, clearance or approval from the FDA is required.
+Added: clearance or approval has not been obtained at this time.
+Added: Product Development Plan:
Engineering Model
1 unchanged sentence
FDA Submission
−Removed: The product development
−Removed: plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
+Added: This product development plan
+Added: is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
About Save-a-Life®
+Added: In July of 2019 we purchased
+Added: all intellectual property including two patents for the choking rescue device:
+Added: patent Number RE45, 535 E and patent Number 8,454,624 B2.
The Save a Life®
−Removed: (“SAL”) choking rescue device is in development and being designed to be a safe, and easy to use device for removing
−Removed: a lodged mass or bolus from the throat of a choking victim.
−Removed: The device includes a pump for creating a vacuum chamber, which is
−Removed: connected seamlessly with a replaceable/disposable mouthpiece.
+Added: (“SAL”) choking rescue device is currently in development and being designed to be a safe, and easy to
+Added: use device for removing a lodged mass from the throat of a choking victim.
+Added: The device includes a pump for creating a vacuum chamber, which
+Added: 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.
−Removed: By pressing a button on the device, the device will deliver the
−Removed: appropriate amount of instantaneous vacuum to dislodge the mass or bolus in the throat without harm or damage to the victim.
−Removed: application will be instantly effective as the device is operational and effective in a matter of seconds.
−Removed: In order to sell, market
−Removed: and distribute the Save-a-Life product, clearance from the FDA is required.
−Removed: Such clearance has not been obtained at this time.
−Removed: The Development Plan for commercializing the Save-a-Life product is below.
−Removed: Product Development
+Added: By pressing an activation button on the device, the internal pump is
+Added: intended to deliver the appropriate amount of instantaneous vacuum to dislodge the mass without harm or damage to the person.
+Added: The application
+Added: is intended to be instantly effective as the device will be operational and effective in a matter of seconds.
+Added: To sell, market and distribute
+Added: the Save-a-Life product, clearance or approval from the FDA is required.
+Added: Clinical trials for the device will be conducted on anatomically
+Added: correct models to demonstrate device performance.
+Added: The regulatory pathway is expected to be a 510k submission to the FDA once successful
+Added: clinical data is obtained.
+Added: FDA clearance or approval has not been obtained at this time.
+Added: The Development Plan for the Save-a-Life is below.
+Added: Product Development Plan
Engineering Model
1 unchanged sentence
FDA Submission
−Removed: Complete –
−Removed: in testing phase
−Removed: Product development
−Removed: plan are estimates only and are subject to change based on funding, technical risks and regulatory approvals.
−Removed: The Save a Life
−Removed: has a number of advantages and features.
−Removed: The highlights are:
−Removed: Easy to Use –
−Removed: The product is designed to be used by adults and children.
−Removed: The tongue depressor vacuum tube is inserted versus trying to place and keep a mask on a traumatized patient.
−Removed: Management also believes the product can be self-administered.
−Removed: Smart Patented Design - The product is designed specifically to immobilize the palate from reflex spasm and open the air passage using a replaceable tongue depressor vacuum tube.
−Removed: A controlled vacuum action (manual or CO2 powered), with specific negative pressure, has been carefully calculated enabling the lifting of a lodged mass from the throat, so it may be ejected by reflexive coughing.
−Removed: This device utilizes a negative pressure to gently uplift the object from the larynx, at which point it will be coughed upward and outward reflexively.
−Removed: Used on Anyone –
−Removed: The SAL is designed to be used on infants (20 months plus) to elderly adults.
−Removed: Also, it can be use on pregnant women and others who the Heimlich maneuver cannot help.
+Added: Product Development Plan is
+Added: an estimate only and is subject to change based on funding, technical risks and regulatory approvals.
About the neurosteroid PRV-001
−Removed: The Prevacus neurosteroid,
−Removed: PRV-001 will seek to improve function and lifespan in pediatric disorders where de-myelination and cell death is widespread in
−Removed: the cortex and cerebellum regions of the brain.
+Added: The neurosteroid, PRV-001,
+Added: is intended to improve function and lifespan in pediatric disorders where de-myelination and cell death is widespread in the cortex, subcortical
+Added: nuclei, brainstem and cerebellum regions of the brain.
The new chemical entity is designed to work through gene amplification to simultaneously
remove intra-neuronal debris while promoting antioxidant capacity and myelin repair/cell proliferation.
−Removed: Disorders like Nieman Pick
−Removed: Type C disease are multi-faceted in their pathology and require a treatment that can work at many levels to stop progression.
−Removed: chemical compound for the neurosteroid being developed has completed initial safety tests in mice.
−Removed: Toxicology studies have been
−Removed: performed and show a 380-fold safety margin.
−Removed: Preclinical efficacy studies show improvements in cognitive function and neuromotor
−Removed: In order to sell the PRV-001 neurosteroid, further development and clinical studies are required.
−Removed: PRV-001 will also
−Removed: require approval by the FDA in order to be sold in the United States.
−Removed: Product Development
+Added: Disorders like Nieman Pick Type
+Added: C disease are multi-faceted in their pathology and require a treatment that can work at many levels to stop progression.
+Added: compound for the neurosteroid being developed has completed an initial safety study in rats.
+Added: Results of preclinical studies suggest that
+Added: PRV-001 may improve neuromotor, cognitive and mental performance.
+Added: To sell the PRV-001 neurosteroid, further development and clinical studies
+Added: are required.
+Added: PRV-001 will also require approval by the FDA in order to be sold in the United States.
+Added: Per our agreement with Prevacus,
+Added: a Tallahassee, Florida based biotech company, we have fifty percent ownership in the drug compound and associated intellectual property.
+Added: There are issued patents covering methods of PRV-001 synthesis.
+Added: Product Development Plan for
Pre-clinical Animal Studies
FDA Submission
−Removed: Safety study complete
−Removed: The product development
−Removed: plan is an estimate only and is subject to change based on funding, technical risks and regulatory approvals.
−Removed: We believe that the
−Removed: primary competition for our products and services is from existing companies offering EKG equipment and anti-choking devices, as
−Removed: well as other pharmaceutical companies engaged in the development of Orphan drugs.
+Added: This product development plan
+Added: is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
+Added: About the neurosteroid PRV-002
+Added: On March 1, 2021, we purchased
+Added: one hundred percent of the drug compound PRV-002 from Prevacus, Inc.
+Added: PRV-002 is a fully synthetic, non-naturally occurring neurosteroid
+Added: being developed for the treatment of mTBI (concussion).
+Added: Results of preclinical studies suggest that PRV-002 has equivalent, and potentially
+Added: superior, neuroprotective effects compared to related neurosteroids.
+Added: In animal models of concussion PRV-002 reduced the behavioral pathology
+Added: associated with brain injury symptoms such as short-term memory loss, depression/anxiety-like behavior and motor-sensory impairment.
+Added: drug is administered through the nasal passage from a novel device.
+Added: PRV-002 is lipophilic and can cross the blood-brain barrier thus supporting
+Added: its potential to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow through
+Added: gene amplification.
+Added: The drug has completed toxicology
+Added: studies in rat and dog.
+Added: Studies show that PRV-002 has a safety margin over 200X it’s predicted efficacious dose.
+Added: PRV-002 to date
+Added: has been shown to be stable up to 104 degrees for 6-months.
+Added: The drug candidate is currently being spray-dry manufactured into a powder
+Added: that will be filled into the novel breath-propelled nasal device developed by Odyssey.
+Added: The device is light weight and easy to use in the
+Added: Odyssey’s novel nasal device is breath-propelled causing the soft palate to close in the back of the nasopharynx.
+Added: This mechanism
+Added: traps PRV-002 in the nasal cavity allowing for a more abundant and faster drug availability in the traumatized brain.
+Added: Safety studies have
+Added: established a dosing regimen of 2X/day for fourteen (14) days.
+Added: Clinical Trial Phase I is site-set in Melbourne, Australia with a Contract
+Added: Research Organization (CRO), Nucleus Network Inc.
+Added: The country of Australia provides a twenty percent (20%) currency exchange advantage
+Added: and a 43.5% rebate at the end of our fiscal year from the Australian government on all Research and Development performed in Australia.
+Added: The trial is expected to begin in November 2021.
+Added: A comprehensive Investigator’s
+Added: Brochure has been created and submitted to the Alfred Ethics Committee by our CRO in Australia.
+Added: Approval has been granted to initiate
+Added: the phase 1 human trial and subjects have been enrolled.
+Added: The phase 1 trial will have two components to it, phase 1a and 1b.
+Added: designed to determine the safety profile of the drug in healthy human subjects.
+Added: Phase 1a will have forty-eight subjects using a Single
+Added: Ascending/Multiple Ascending (SAD/MAD) drug administration design.
+Added: For both the SAD and MAD portions there will be 4 groups, placebo,
+Added: low dose, middle dose and high dose.
+Added: All dosages are within the animal preclinical efficacy and safety range.
+Added: The SAD component is a 1X
+Added: treatment and the MAD component is a 1X/day treatment for 5-days.
+Added: Blood and urine samples will be collected at multiple time points for
+Added: safety pharmacokinetics.
+Added: Standard safety monitoring will be provided for each bodily system.
+Added: Phase 1b will begin following the completion
+Added: of the final safety report from Phase 1a establishing no safety concerns.
+Added: In Phase 1b PRV-002 will be administered to 24 acutely-concussed
+Added: patients, 2x a day for 14-days.
+Added: The trial will be low powered and evaluate safety as well as efficacy measurements to be used in Phase
+Added: 2/3 clinical trials.
+Added: Based on the Phase 1a and 1b data we plan to submit an application for an Investigational New Drug with the FDA and
+Added: conduct a phase 2 trial in the United States.
+Added: Patents on PRV-002 have been
+Added: filed and/or issued:
+Added: Composition of matter for PRV-002 and analogs
+Added: Use for treating traumatic brain injury
+Added: Synthetic methods for PRV-002
+Added: Development Plan
+Added: Pre-clinical Animal Studies
+Added: Food and Drug
+Added: Administration Submission
+Added: September 2021
+Added: This product development plan
+Added: is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
+Added: We believe that the primary
+Added: competition for our products and services is from existing companies offering EKG equipment and anti-choking devices, as well as other
+Added: pharmaceutical companies engaged in the development of Orphan drugs.
Governmental Regulation
Product Regulation
−Removed: processing, formulation, safety, manufacturing, packaging, labeling, advertising and distribution of our products may be subject
−Removed: to certain regulation by one or more federal agencies, including the FDA, Housing and Human Services (the “HHS”), the
−Removed: Federal Trade Commission (the “FTC”), the Consumer Product Safety Commission (the “CPSC”), the United States
−Removed: Department of Agriculture (the “USDA”) and the Environmental Protection Agency (the “EPA”), and by various
−Removed: agencies of the states and localities in which our products are sold.
−Removed: In order to sell, market
−Removed: and distribute the CardioMap®, the Save a Life or the drug compound products, clearance or approval from the FDA is required.
−Removed: Such clearance or approval has not been obtained at this time and our products are not currently available for commercial sale.
−Removed: products we eventually sell in foreign countries are also subject to regulation under various national, local and international
−Removed: laws that include provisions governing, among other things, the formulation, manufacturing, packaging, labeling, advertising and
−Removed: distribution of drugs and medical products.
−Removed: Government regulations in foreign countries may prevent or delay the introduction,
−Removed: or require the reformulation, of some of our products.
−Removed: At the date hereof,
−Removed: we have three employees (one full-time and two part-time) and intend to hire additional employees in the foreseeable future.
+Added: The processing,
+Added: formulation, safety, manufacturing, packaging, labeling, advertising and distribution of our products may be subject to certain regulation
+Added: by one or more federal agencies, including the FDA, Housing and Human Services (the “HHS”), the Federal Trade Commission (the
+Added: “FTC”), the Consumer Product Safety Commission (the “CPSC”), the United States Department of Agriculture (the
+Added: “USDA”) and the Environmental Protection Agency (the “EPA”), and by various agencies of the states and localities
+Added: in which our products are sold.
+Added: To sell, market and distribute
+Added: the CardioMap®, the Save a Life or the drug compound products, clearance or approval from the FDA is required.
+Added: Such clearance or approval
+Added: has not been obtained at this time and our products are not currently available for commercial sale.
+Added: we eventually sell in foreign countries are also subject to regulation under various national, local and international laws that include
+Added: provisions governing, among other things, the formulation, manufacturing, packaging, labeling, advertising and distribution of drugs
+Added: and medical products.
+Added: Government regulations in foreign countries may prevent or delay the introduction, or require the reformulation,
+Added: of some of our products.
+Added: At the date hereof, we have
+Added: four employees and intend to hire additional employees in the foreseeable future.
Where you can find more information
−Removed: The Company’s
−Removed: Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant
−Removed: to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended (“Exchange Act”), are filed with the
−Removed: Securities and Exchange Commission (the “SEC”).
−Removed: Such reports and other information filed by the Company with
−Removed: the SEC are available free of charge on the Company’s website at http://www.odysseygi.com when such reports are
−Removed: available on the SEC website.
−Removed: The public may read and copy any materials filed by the Company with the SEC at the SEC’s Public
−Removed: Reference Room at 100 F Street, NE, Room 1580, Washington, DC 20549.
−Removed: The public may obtain information on the operation of the
−Removed: Public Reference Room by calling the SEC at 1-800-SEC-0330.
−Removed: The SEC maintains an Internet site that contains reports, proxy and
−Removed: information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.
−Removed: of these websites are not incorporated into this filing.
−Removed: Further, the Company’s references to the URLs for these websites
−Removed: are intended to be inactive textual references only.
+Added: Our Annual Report on Form
+Added: 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)
+Added: of the Securities Exchange Act of 1934, as amended (“Exchange Act”), are filed with the U.S.
+Added: Securities and Exchange Commission
+Added: (the “SEC”).
+Added: Such reports and other information filed by us with the SEC are available free of charge on our website
+Added: at http://www.odysseygi.com when such reports are available on the SEC website.
+Added: The public may read and copy any materials filed
+Added: by us with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Room 1580, Washington, DC 20549.
+Added: The public may obtain
+Added: information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
+Added: The SEC maintains an Internet site that
+Added: contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.
+Added: The contents of these websites are not incorporated into this filing.
+Added: Further, our references to the URLs for these websites are intended
+Added: to be inactive textual references only.
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.