Update on the RYAH Smart Inhaler: Trials, Studies, Approvals, and Opportunities

TORONTO, ON / ACCESSWIRE / June 15, 2022 / RYAH GROUP Inc. Following issues raised by various shareholders about the lack of information shared by former management, the new management team intends to provide regular updates on business progress. This initial update concerns RYAH's first product, the Smart Inhaler, and the various clinical and scientific studies employing it to deliver medical marijuana.

RYAH's Smart Inhaler Description:

Used in conjunction with RYAH's mobile App, the inhaler is arguably the best dry herb vaporizer on the market. Its convection heater evenly vaporizes the contents, unlike most vaporizers which tend to burn some of the herb, creating undesirable lung irritants. The patented mouthpiece is designed to ensure a pleasant draw at any temperature the user selects. Finally, through its unique IoT connection, the device controls and reports each inhalation and estimated amounts of THC and CBD consumed, helping the patient follow their prescription. RYAH MD, a web-based App, enables prescribing doctors to track patient usage and therapeutic outcomes.

United Kingdom Trial:

RYAH is supplying all inhalers along with a customized App, supporting the UK's first regulatory-approved clinical trial, "CANPAIN", of the efficacy of cannabis for treating about 5,000 patients suffering from pain. Celadon Pharmaceuticals plans to distribute RYAH products to the National Health Service (NHS) following the clinical trial, conducted by Celadon's subsidiary, LVL Health. During the trial, RYAH expects to supply 5,000 inhalers and 500,000 cartridges, and then substantially more when generally available through the NHS.

United States Veterans Trial:

Royal Emerald Pharmaceuticals, of California, has signed a revenue sharing MoU with RYAH, to use the Smart Inhaler to administer Federally grown medical marijuana to US Veterans nationwide, for treatment of post-traumatic stress disorder (PTSD).

United States COVID Trial:

Omni Medical Services, of Michigan, is also planning multi-state clinical trials, involving up to 11,000 participants, pending FDA approval of the RYAH Smart Inhaler for dose delivery, to study the potential anti-inflammatory effects of cannabis for the prevention and treatment of COVID-19.

If the foregoing US studies proceed as planned, RYAH should supply in excess of 10,000 inhalers and 1,000,000 cartridges. Longer term, the US market potential is enormous.

European Union Trials

Various clinical trials are planned by RYAH partners in the EU, upon achieving Medical Device Regulation (EU MDR) certification of the Smart Inhaler, expected this year. It is too early to discuss details, but over time, RYAH expects to supply tens of thousands of inhalers and millions of cartridges for trials, and then considerably more as individual EU countries decide to embrace medical cannabis within their national healthcare systems.

Additional Markets:

Based on pending approval as a medical device in Australia, Cannatrek is planning to distribute the RYAH Smart Inhaler there.

RYAH's authorized representative in New Zealand, Medical Kiwi has achieved medical device registration, and plans to distribute the RYAH Smart Inhaler.

In Israel, Bazelet is chaperoning the Smart Inhaler through medical device certification and plans to distribute it. Although a small country, Israel is one of the largest national markets for medical cannabis based on per capita usage.

Based on the above, RYAH expects to supply thousands of additional inhalers and hundreds of thousands of cartridges to Australia, New Zealand and Israel within the coming year.

Milan, Italy Research:

The THC Lab, at the University of Milan, conducted an investigation of the operational efficiency of the RYAH Smart Inhaler. Based on the success of the first study, the University of Milan is currently doing further tests of the RYAH Smart Inhaler employing an artificial lung.

Global Wellness Market:

RYAH's new CEO, Dr. Dave Richards, has said "While absolutely pleased with our progress achieving medical device certifications, approvals and clinical trials leading to opening up various national health systems, we are also going to address the global mass market for wellness. Although the medical market is huge, with millions of patients who will want RYAH Smart Inhalers provided by their health services or insurance, the market for wellness and recreational use of marijuana is even bigger. I consider recreational use an aspect of the wellness market, given that people use cannabis if it makes them feel good. Feeling good is wellness."

Toward the goal of addressing a global mass market, RYAH is actively developing a refillable cartridge solution for the Smart Inhaler 1.0, as well developing the next generation, Smart Inhaler 2.0, with enhanced features and functionality for both medical devices, and non-medical-device versions for wellness use.

Distribution deals have been established or are in discussion with various dispensaries including Holistic and Curaleaf in the US; Northern Green and Black Rose Organics in Canada; Cannaray and Hilltop Leaf in the UK; Greenstein, 420 Pharma and Therismos in Germany; Transvaal Apotheek and Cannabis Zorg in the Netherlands; and Pure Holdings in Switzerland. Further, RYAH is looking at various e-commerce options for distributing products globally.

Sales Forecast:

Dr. Dave Richards said "It is too early to offer a forecast of the potential sales to the wellness mass market. However, based on supplying clinical trials alone, RYAH should enjoy revenues in excess of $8 million over the next year or so, from sales of Smart Inhalers and accessories."

About RYAH Group Inc.:

RYAH is a big data and technology company enabling valuable AI-powered predictive analytics of the efficacy of plant-based medicines and other nutraceuticals administered through its range of innovative IoT-connected medical devices including inhalers, patches, and pens. RYAH's robust big data platform, the only one of its kind in this space, aggregates and analyzes HIPAA-compliant patient data, helping doctors and patients personalize treatments, control dosages, and better predict and monitor outcomes. Beyond specific medical uses, RYAH supports the use of a variety of nutraceuticals by users for wellness purposes, including personal enjoyment - i.e., recreational use. The collection and analyses of objective and subjective usage data, along with data derived through natural language processing of various scientific and other relevant literatures, will enable highly valuable insights for a wide variety of stakeholders, starting with the users themselves, and extending to clinicians, medical scientists, insurance providers, dispensaries, licensed growers, producers, pharmaceutical producers, and more. Through the above, a relentless focus on innovation, and track record of developing win-win collaborative partnerships within relevant industries, RYAH is continuously building a unique and highly valuable IP portfolio and big data assets ready to be monetized.

AI: Artificial Intelligence

IoT: Internet of Things

HIPAA: Health Insurance Portability and Accountability Act

IP: Intellectual Property

R&D: Research and Development

NFT: Non-Fungible Token

Disclaimers:

This press release contains certain forward-looking statements, including, without limitation, statements containing the words "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect", "in the process" and other similar expressions which constitute "forward-looking information" within the meaning of applicable securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, our expectations regarding the acceptance of our products by the market, our strategy to develop new products and enhance the capabilities of existing products, our strategy with respect to research and development, the impact of competitive products and pricing, new product development, and uncertainties related to the regulatory approval process. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties and other risks detailed from time-to-time in the Company's on-going filings with the securities regulatory authorities, which filings can be found at www.sedar.com. Actual results, events, and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable securities laws.

For further information contact:

Dr. David R. Richards, CEO: drichards@ryah.com
+1.703.453.7170

Mr. Jules Gagnon, AVP, Investor Relations: jgagnon@ryah.com
+1.514.781.7030

SOURCE: RYAH Medtech Inc