RYAH Smart Inhaler receives medical device certification for ISO 13485:2016/MDSAP and EN ISO 13485:2016
Both the hardware and digital companion software provide inhalation monitoring, patient feedback, and lab results of therapeutic products with access to objective data to better support therapeutic decisions covered by certifications
TORONTO, ON / ACCESSWIRE / December 8, 2021 / RYAH Group, Inc. (CSE:RYAH) ("RYAH" or the "Company") announced today that its subsidiary, RYAH Medtech, Inc., has received ISO 13485:2016/MDSAP and EN ISO 13485:2016 certification for its proprietary Internet of Things (IoT)-powered dry herb inhaler (the "RYAH Smart Inhaler") and software application associated with the device. This certification is a regulatory requirement and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
ISO 13485:2016 is an internationally recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements. RYAH's ISO 13485:2016/MDSAP certification conforms to the requirements for a quality management system in the countries of Australia and Canada, bringing the RYAH Smart Inhaler one step closer to medical device registration in both jurisdictions. Preceded by two-stage audit completion, these certifications mark a crucial step for the Company's history, as it reflects the international recognition of the design and development, manufacturing, and distribution of smart-inhaler, software application, and accessories.
"This is a monumental achievement for RYAH Group, Inc. and its subsidiary, RYAH Medtech, Inc., as we continue to reimagine plant-based medicine delivery solutions for doctors, clinics and their patients looking for a safe inhalation device with valuable monitoring capabilities," said Gregory Wagner, Chief Executive Officer of the Company. "The approval of the RYAH Smart Inhaler device along with its accompanying software is one of the first of its kind in plant based inhalation devices. It marks a new era for RYAH Group Inc., and is an example of our commitment to utilize data and digital offerings for enabling customized, personalized therapy regimens as an achievable goal for patients and physicians."
Global sales of handheld cannabis medical vaporizers are expected to top US$ 26 billion in 2031. According to a report by Persistence Market Research, the market is estimated to register a compound annual growth rate of close to 22% during the forecast period from 2021 to 2031. The report indicates that "demand for metered vaporizers from European countries is visibly increasing, and the main factors paving way for this demand are growing consumer awareness of metered dosages coupled with initiatives by vaporizers manufacturers to replace non-metered with metered variants."
The RYAH Smart Inhaler is a volume-management device for dry-herb plant based formulations. Paired with a proprietary software application, it allows users to control their dosing regimen, register their usage, and voluntarily provide anonymous data that can further be analyzed and used for regulatory improvements, research and awareness.
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.
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 the completion of medical device registration in Australia and Canada. 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's financial condition and development plans do not change as a result of unforeseen events; (ii) there will continue to be a demand and market opportunity for the Company's product offerings; and (iii) the current and future economic conditions will neither affect 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.
Neither the Canadian Securities Exchange (the "CSE") nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.
For additional information, please contact:
+1 917 210 0543
Chief Executive Officer
+1 917 210 0543
KCSA Strategic Communications
+1 646 379 7971
SOURCE: RYAH Medtech, Inc.
View source version on accesswire.com: