Pick of The Week
 

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.

RECENT COVERAGE
 

Odyssey Health, Inc. (ODYY) Updates Progress of its Concussion Drug Development Program; Communicating with the FDA for permission to start phase II clinical trial of its PRV-002 Drug Candidate

October 18, 2022 9:45 AM

Several developed nations have passed a host of sanctions against Russia in a global bid to stop its misguided war in Ukraine. Months after Russia declared war on Ukraine and breached its borders, dozens of countries placed sanctions on Russian exports, limited the movement of Russian money and cut the country off from critical exports.

• Odyssey acquired IP and all rights to PRV-002, its lead drug candidate for the treatment of concussions, on March 1, 2021, and has since made notable progress in a strategic move to have the drug approved by the FDA
• Since the acquisition, the company has completed IND enabling studies and all cohorts for Phase I SAD and MAD clinical trials for its lead drug candidate
• In pre-clinical studies PRV-002 has demonstrated equivalent, if not superior neuroprotective effects compared to related neurosteroids, offering proof of reduced behavioral pathology associated with brain injury symptoms, easily crossing the blood-brain barrier to rapidly eliminate swelling, oxidative stress, and inflammation in the brain
• Odyssey’s management is pleased with the progress so far, as the drug advances in its clinical and regulatory pathway and, subsequently, tapping into the concussion treatment market projected to be valued at $8.9 billion by 2027

On March 1, 2021, Odyssey Health (OTC: ODYY), a medical company with a focus on unique, life-saving medical products that offer clinical advantages to unmet clinical needs, acquired intellectual property (“IP”) and all rights to PRV-002, its lead drug candidate for the treatment of concussions (https://ibn.fm/u275p). For a condition affecting millions worldwide, Odyssey recognized a significant unmet medical need and set off to offer a viable solution to the problem.