- Collaboration to study the potential anti-inflammatory effects of inhalation of cannabis and CBD, for both prevention and treatment of COVID-19, using RYAH Smart Inhaler devices
- The clinical study will seek to enroll between 5,000 and 11,000 of OMNI's patients across several U.S. states
- Session data, along with monitoring of pharmacodynamics and pharmacokinetics of cannabis use, will be presented to the FDA as part of the effort for national legalization of cannabis for medical use
TORONTO, ON / ACCESSWIRE / December 16, 2021 / 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.
This press release contains certain forward-looking information and forward-looking statements within the meaning of applicable securities legislation (collectively "forward-looking statements"). All statements contained in this press release that are not statements of historical fact should be considered forward-looking statements. Forward looking statements are often identified by terms such as "may", "should", "anticipate", "expect", "potential", "believe", "intend" or the negative of these terms and similar expressions. Specifically, forward-looking statements in this press release include but are not limited to, statements related to (i) the clinical study to be conducted by OMNI (including the scope and timing thereof), (ii) the Letter of Intent and the Company's expectations with respect to the anticipated scope of such agreement, and (iii) OMNI and its business goals and objectives. Forward-looking statements reflect the Company's current views and intentions with respect to future events based on current information available to the Company, and are necessarily subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with or inherent in (i) the general business, technological, and economic conditions; (ii) the expected benefits of the Company's product offerings and the anticipated results and experience of users thereof; (iii) the Company's ability to execute on key priorities, implement business strategies and/or pursue business opportunities, (iv) changes to, or the application of, laws and regulations; and (v) such other applicable factors set out in the Company's public disclosure documents available under the Company's profile on SEDAR at www.sedar.com. Readers are further cautioned that the assumptions used in the preparation of such forward-looking statements (including, but not limited to, the assumption that (i) the Company and OMNI will each be able to execute on their respective business plans and obtain and maintain all necessary permits and authorizations to execute such business plans, (ii) neither the Company's nor OMNI's financial condition and development plans will change as a result of unforeseen events; (iii) there will continue to be a demand and market opportunity for the Company's product offerings; and (iv) the current and future economic conditions will neither affect the clinical study and the business and operations of the Company nor the Company's ability to capitalize on anticipated business opportunities), although considered reasonable by management of the Company at the time of preparation, may prove to be imprecise and result in actual results differing materially from those anticipated, and as such, undue reliance should not be placed on forward-looking statements. Should any such risk factor affect the Company in an unexpected manner, or should assumptions underlying the forward-looking information prove incorrect, the actual results or events may differ materially from the results or events predicted. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions, or expectations upon which they are placed will occur.
The forward-looking statements included in this press release are made as of the date of this press release, and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities laws. All forward-looking statements contained in this press release are expressly qualified by this cautionary statement.
This press release includes market and industry data that has been obtained from third party sources, including industry publications. The Company believes that the industry data is accurate and that its estimates and assumptions are reasonable, but there can be no assurance as to the accuracy or completeness of this data. Third party sources generally state that the information contained therein has been obtained from sources believed to be reliable, but there is no assurance as to the accuracy or completeness of included information. Although the data is believed to be reliable, the Company has not independently verified any of the data from third party sources referred to in this press release or ascertained the underlying economic assumptions relied upon by such sources.
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SOURCE: RYAH Medtech Inc.
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