• Odyssey Health is a medical company developing unique, life-saving products that address unmet clinical needs such as concussion, which does not have an FDA-approved therapeutic
• The company has developed PRV-002, a neurosteroid for the treatment of concussion, and an intranasal delivery device that delivers the drug into the upper chamber of the nasal cavity for onward travel into the brain
• Odyssey’s just concluded Phase I clinical trial shows that PRV-002 is safe and well tolerated
• The findings from the study are likely to benefit the military as well as the NFL, given military personnel and players frequently suffer concussions

In 2002, NFL Pro Hall of Famer and former center Michael Lewis Webster became the first ex-NFL player to be diagnosed through autopsy with chronic traumatic encephalopathy (“CTE”), a degenerative brain disorder believed to be caused by repeated concussions (https://ibn.fm/ZxgeE). Since then, doctors, the NFL in general, and medical companies like Odyssey Health (OTC: ODYY) have learned a lot about concussions and CTE. On its part, the NFL has progressively implemented a raft of player safety policies aimed at protecting players.

Despite the spate of safety policies, which include fines and suspensions to players, football remains a dangerous sport that sees players with massive physiques collide with one another. It is no question that this physicality can cause damage to the brain and body, and a recent incident, which has elicited widespread criticism and uproar from fans and coaches alike, demonstrates the danger posed. In the last week of September – week three, the football community watched in horror as Dolphins Quarterback Tua Tagovoiloa sustained yet another concussion just a week after he had been taken out of a game and probed for a possible concussion, with criticism pouring as to why the Dolphins coaching staff had included him in the day’s playing roster in the first place.

The criticism and concern around concussions are valid. As of 2017, over 100 ex-NFL players had received postmortem diagnoses of CTE (https://ibn.fm/epRtP). In addition, scores of players have been forced into early retirement after they suffered a concussion (https://ibn.fm/V956u). In understanding the dangers, coaches like the New England Patriots’ Bill Belichick have learned the telltale signs of unwell players. Belichick has even had to take players out of games because he suspected they had sustained a concussion, sometimes going against medical staff who had cleared them to play (https://ibn.fm/wMvbj). But an intervention that could potentially improve the efficacy of the NFL’s concussion protocol and prevent the development of concussion symptoms by reducing brain swelling, inflammation, and oxidative stress as well as normalizing blood flow to the brain is in the works.

The intervention being developed by Odyssey as a potential treatment for concussion is a novel non-naturally occurring neurosteroid by the name PRV-002 delivered through the company’s patent-pending breath-propelled intranasal drug delivery device. Odyssey believes the drug candidate could boost the chances of successful recovery for concussed patients by taking advantage of the drug-device combination’s ability to facilitate quick administration of PRV-002.

A dry powder that does not require special handling or refrigeration, PRV-002 can sit on the sidelines of football games, allowing medical staff to administer it immediately if they suspect a player has sustained a concussion. According to Odyssey, the intranasal delivery device delivers the dry powder into the upper chamber of the nasal cavity without being swallowed or inhaled. The drug then travels along the cranial nerve toward the brain, where it crosses the blood-brain barrier within 5 minutes of administration and spreads throughout the brain within 30 minutes, reversing the effects of a concussion.

The drug candidate was recently administered to healthy volunteers as part of a just-concluded Phase I clinical trial, which demonstrated that PRV-002 was safe and well tolerated (https://ibn.fm/JWh5R). Next, Odyssey is planning to undertake a Phase II study that will investigate PRV-002’s efficacy in concussed patients. The company will initially conduct its evaluations in select military training camps, where military personnel frequently sustain concussions during training. Eventually, however, Odyssey wishes to move into athletic models working in conjunction with the National Collegiate Athletic Association’s (“NCAA”) medical centers, possibly by 2023 (https://ibn.fm/e3bO7).

The findings from the upcoming study are likely to benefit military personnel and NFL players who are highly vulnerable to concussions. According to the latest data from the Military Health System, for example, 377,425 members of the U.S. Armed Forces had suffered a concussion (also known as mild traumatic brain injury) between 2000 and the first quarter of this year (https://ibn.fm/G8zAp). On the other hand, NFL’s injury data shows that in each of the five years to 2019, the total number of concussions suffered during practice and gameplay was well above 200. And although the figures dropped in 2020 and 2021 due to COVID-19 and a change in the NFL season structure, respectively, over 170 concussions were reported in each of these seasons (https://ibn.fm/6sYAI).

For more information, visit the company’s website at www.OdysseyHealthInc.com.

NOTE TO INVESTORS: The latest news and updates relating to ODYY are available in the company’s newsroom at https://ibn.fm/ODYY

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