Odyssey Health Inc. (OTC: ODYY)

Odyssey Health Inc. (OTC: ODYY) is a medical technology company focused on developing lifesaving medical products that offer technological and clinical advantages over current standards of care.

The company's portfolio of product technologies is diverse, featuring four unique medical products in development. Odyssey's goal is to deliver superior products with enhanced clinical utility and market potential, thereby yielding a high rate of return for its shareholders and partners. It is guided by a senior management team with significant experience relating to refining technologies, building commercial systems and forging strategic partnerships.

Product Portfolio

Pharmaceuticals

Odyssey has two pharmaceutical products in development:

• PRV-002 is a novel compound for the treatment of concussion, which currently has no FDA-approved drug. In pre-clinical studies, PRV-002 has been shown to significantly improve both neuroscore and memory score following injury in rats subjected to concussion models. Importantly, the first-in-class novel neurosteroid demonstrated no drug-related toxicity in these trials.

  PRV-002 is currently being evaluated in a phase I clinical trial for the treatment of concussion. On July 12, 2022, Odyssey announced the successful completion of all three cohorts of its Phase I Single Ascending Dosing (SAD) clinical trial of PRV-002 in healthy human subjects. After reviewing data from the SAD trial, a safety review committee unanimously approved the start of the Multiple Ascending Dosing (MAD) portion of the Phase I clinical trial. Odyssey is currently scheduling a meeting with the FDA to present the findings from the phase I trial, and phase II trial sites are being identified and study design is being created with the site's medical leadership and the Odyssey Medical Advisors.

  Odyssey has also highlighted the potential of PRV-002 for additional indications such as Alzheimer's disease, Parkinson's disease, ALS and chromic traumatic encephalopathy (CTE).

• PRV-001 is a novel compound intended to treat Niemann-Pick disease, a rare neurodegenerative-lysosomal storage disorder that affects an estimated 1 in 150,000 individuals in the U.S., demonstrating a 5x higher incidence in Middle Eastern populations.

  Odyssey expects to receive Orphan Drug designation from the FDA for PRV-001, which would accelerate its pathway to FDA approval and provide seven years of market exclusivity.

Medical Devices

Odyssey is also developing two medical device candidates:

• CardioMap® is intended to provide early, non-invasive testing for heart disease. The system offers a number of potential advantages over traditional EKGs, including requiring less training to operate, offering heightened sensitivity and coming in a small and portable form factor. CardioMap is being developed for a 510(k) regulatory pathway, which requires a study to demonstrate equivalence to legacy EKG offerings.

  When approved, CardioMap is expected to be the only device in its class that has a predictive value, illustrating 'grey' areas where deterioration has begun but not yet led to pathology. Odyssey expects this feature to provide a powerful incentive for doctors to use the CardioMap device in end markets such as hospitals, doctors' offices, rehabilitation centers and sports medicine practices.

• Save-A-Life (SAL) is a patented, single-action, instantaneous, handheld, mechanical anti-choking device that creates a vacuum chamber in the mouth to dislodge throat obstructions in a matter of seconds, all without harm to the victim. The device is currently in development, with a proof of concept established.

  Odyssey believes that, once FDA-approved, its anti-choking device will quickly become the "accepted" standard and leader in the treatment of choking incidents globally. Its low-cost manufacturing and convenient portable design give SAL a competitive edge over competing devices utilizing cumbersome masks.

Market Opportunities

Odyssey's varied development pipeline positions it to address a number of sizable market opportunities with significant unmet medical need. Concussions alone currently account for medical costs of roughly $10-15 billion annually in the U.S., despite the lack of a currently approved FDA drug treatment. This need is particularly apparent in the military and sports industry, where the likelihood of athlete head-injury recurrence is estimated at 75%.

With its CardioMap platform, Odyssey is targeting the global cardiac monitoring market, which was valued at $28 billion in 2021 by Insight Partners and forecast to reach $43 billion by 2028.

Save-A-Life targets a similarly underserved market. Choking is the fourth-leading cause of death in children, and approximately 5,000 choking deaths occur each year in the U.S. While 95% of these deaths result from in-home incidents, current choking rescue devices fail to address in-home applications.

Management Team

J. Michael Redmond is the President, CEO and Chairman of Odyssey. He has over 30 years of commercial experience in medical device companies, previously serving as CEO of Parallax Health Sciences Inc., V.P. of Business Development for DxTech Inc. and V.P. of Sales and Marketing for Bioject Medical Technologies Inc. While at Bioject, Mr. Redmond helped raise over $15 million in capital, entered into several licensing and distribution deals with major biotech and pharmaceutical companies and grew the market cap of the company from under $10 million to over $400 million. He started his career at Abbott Labs and holds a B.A. from Denison University.

Christine M. Farrell is the company's CFO and Secretary. Prior to joining Odyssey, Ms. Farrell was Vice President of Finance for Bioject Medical Technologies Inc. She also held accounting and financial management positions with Spar-Tek Industries, a manufacturer of high quality and cutting-edge technology for the plywood industry, and Action Machinery, a seller of new and used robotic machine tools and equipment. Ms. Farrell holds a B.A. in Accounting from the University of Washington and an M.B.A. from Willamette University.