TORONTO, Ontario – RYAH Group, Inc. (CSE:RYAH) (“RYAH” or the “Company”) is pleased to announce a collaboration with OMNI Medical Services (“OMNI”) to perform a clinical study in the United States with patients using inhalation of medical cannabis to evaluate coronavirus disease (“COVID-19”) related treatment methods. The collaboration with OMNI will study the potential anti-inflammatory effects of cannabis and cannabidiol (“CBD”) for both prevention and treatment of COVID-19.
The planned study is anticipated to run for five years, with Phase II enrollment starting in the second quarter of 2022 and ending in 2024. The study will look to enroll between 5,000 and 11,000 of OMNI’s patients across several states including Florida, Ohio, and Michigan, with plans to expand into the Carolinas (pending passing of medical cannabis legislation in 2022). The research protocol was submitted in May 2021 and has been reviewed by the U.S. Food and Drug Administration (the “FDA”).
OMNI is currently pursuing funding through the National Institutes of Health to further support the planned study. The patient monitoring data derived from the RYAH Smart Inhaler and ecosystem, along with monitoring of pharmacodynamics and pharmacokinetics of cannabis use, will be presented by OMNI to the FDA as part of the effort for national legalization of cannabis for medical use.
Dr. Ryan Lakin, OMNI’s Chief Medical Officer and Managing Partner, states, “We’re pleased to collaborate with RYAH Group with our nationally recognized clinical research network of physicians working to fight the opioid epidemic, and improve the quality of treatment outcomes. Together with RYAH, this clinical study will examine the potential anti-inflammatory effects of cannabis and CBD for both prevention and treatment of COVID-19. We anticipate extracting a significant amount of new information from this study and generating scientific data that can be peer reviewed and advance research into this growing field of medicine.”
As of December 13, 2021, the number of COVID-19 cases worldwide had reached over 270 million. In addition, the number of deaths from COVID-19 was around 5.3 million. The United States is the country with the highest number of confirmed cases and deaths.
According to the Centers for Disease Control and Prevention, “multisystem inflammatory syndrome (MIS) is a rare but serious condition associated with COVID-19 in which different body parts become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. MIS can affect children (MIS-C) and adults (MIS-A).”
“We’re excited to be working with OMNI on this thoughtful and timely study on the evaluation of novel preventative and treatment measures related to inflammatory effects from COVID-19,” said Gregory Wagner, Chief Executive Officer of the Company. “RYAH is honored to be selected to participate in this important project with OMNI, to be contributing to valuable data aggregation, and to raise our understanding of plant-based inhalation methods on potentially addressing anti-inflammatory effects of COVID-19.”
RYAH and OMNI recently announced the signing of a non-binding letter of intent for RYAH to acquire OMNI (the “Letter of Intent”).
Separately, the Company is pleased to announce a non-brokered private placement of units of the Company (“Units”) for aggregate gross proceeds of up to C$1,500,000, at an issue price of C$0.05 per Unit (the “Private Placement”). Each Unit will consist of (i) one Class A subordinate voting share of the Company, and (ii) one share purchase warrant of the Company (a “Warrant”). Each Warrant is exercisable for a period of up to 24 months at an exercise price of C$0.065. The Company is pleased to announce that it intends to close the initial tranche of the Private Placement on or about December 20, 2021, with such tranche expected to consist of the issuance of an aggregate of 3,556,000 units for aggregate gross proceeds of C$177,800.
About RYAH Group, Inc.
RYAH is a connected device, and big data and technology company focused on valuable predictive analysis in the global medical plant and nutraceutical intake industry. Its robust artificial intelligence platform aggregates and correlates Health Insurance Portability and Accountability Act (HIPAA)-compliant patient data, intended to help doctors and patients personalize plant-based treatments to predict treatment outcomes better. The data collection is relevant for clinics, doctors, dispensaries and pharmaceutical companies, and licensed processors (LPs) to monitor and manage formulation effects on patients and demographics. RYAH gathers deep and insightful data on the complete patient session and formulation lifecycle with a strong intellectual property portfolio. For more information, visit www.ryahgroup.com.
About Omni Medical Services
Since its founding in 2011, Omni Medical Services has been a U.S. multi-state leader in providing specialized professional Medical Marijuana Certifications and alternative therapies. Omni operates its network of contract physicians to evaluate qualifying patients and provide a recommendation for State certification. The Company does not grow, process distribute or sell cannabis. Omni Medical Services provides premium standards of care, with trusted compassionate services, exceptional efficiency and the highest level of professionalism.
For more information, visit www.omnidoctors.com.