TORONTO, ON / ACCESSWIRE / July 7, 2022 / AI/ML Innovations Inc. (AIML: CSE) (AIMLF: OTCQB)(FWB:42FB), a company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to announce that its minority-owned subsidiary, Tech2Heal SAS, reports that it is launching an independent clinical study to evaluate the effectiveness of its depression and anxiety therapy platform, Qookka. The study is being conducted in partnership with a public hospital and research laboratory located in Paris, France. Tech2Heal is committed to showing its ability to operate within highly regulated healthcare systems.

The purpose of the study is to assess the acceptability of Tech2Heal's mental health digital therapy by both health care providers and patients, as well as to evaluate the evolution of the severity of the patients' depressive or anxiety disorders at the completion of the program. The ultimate goal of this, and follow-on studies, is to gain approvals and certification of Qookka as a "Class IIa" medical device from European health authorities.

"Our objective is to be a universally reimbursed prescription digital therapeutics in mental health within the next two years" said Fabrice Pakin, CEO of Tech2Heal. "Our ambition is to be at the forefront of making evidence-based mental health care universally accessible. Although the public coverage of prescription digital therapeutics in Europe is still new, prescription numbers are increasing. But in order to allow for the mass prescription of digital therapeutics, prescribers and patients will need to become aware of its existence, and believe in its value. Germany's DiGA model drew considerable attention to universally reimbursed prescription digital therapeutics, and countries such as France and the US are building similar frameworks".

"We at AI/ML are very excited by the advancement of Qookka to clinical studies" said Tim Daniels, Chairman of AI/ML Innovations Inc. "In addition to Tech2Heal's plans for Qookka to be recognized as a medical device in Europe, we are also looking forward to the possibility of deploying the technology in the North American marketplace through AI/ML's majority owned subsidiary, AI Rx Inc., which owns the distribution rights to this exciting technology in the US and Canada. Importantly, the introduction of bipartisan legislation to enable public coverage of prescription digital therapeutics in the US was recently announced. The bill will establish benefit categories for digital therapeutics, and create a coverage and reimbursement framework that will provide access to millions of beneficiaries of Medicare and Medicaid".

Fabrice Pakin continued:

"Our migration away from a business model that was focused on digital wellness, to a full emphasis on digital mental therapeutics is now complete. When we analyzed the market, it became evident that mental health wellness is an overcrowded, highly competitive space, that provides little compelling evidence of sustained positive impact on employees. Given this, we do not believe that the "wellness" trend is durable. Additionally, we chose to wind down our physical wellness center located in the south of France, as a large number of companies globally have chosen to continue to allow employees to work remotely as a permanent solution, in spite the pandemic concerns abating. It is imperative that we devote our precious resources towards a business model that affords us the best opportunity for long term success. For Qookka, that is digital mental health therapeutics".

Qookka is an award winning, proprietary digital therapy for anxious and depressed patients. The rapid increase in mental health disorders globally, combined with a shortage of professionals and resources in the mental health field, have led to a health crisis. Qookka's clinically supported approach is based on Acceptance and Commitment Therapy (ACT) belonging to the 3rd wave of Cognitive Behavioral Therapy (CBT), combined with personalized therapy modules for patients and their families, and a multidisciplinary medical dashboard for remote monitoring of patient progress.

About Tech2Heal

Tech2Heal is a Paris, France based healthcare innovator specializing in digital health technologies with the objective of creating a compassionate, collaborative and patient-centered healthcare ecosystem. T2H has developed a portfolio of health-tech products and services designed to improve an individual's mental and physical well-being by utilizing a unique blend of proprietary digital assets and remote live counselling.

Tech2Heal's premier products include:

Qookka - clinically supported and evidence-based digital therapy for anxious and depressed patients delivered via a secure digital platform

Alakin - a bespoke, digital HEALTHcare MAnagement Platform ("health.map") designed for healthcare providers and pharma. Assisted self-care become reality for patients and care team members alike.

For more information: https://www.tech2heal.com/

About AI/ML Innovations Inc.

AI/ML Innovations Inc. has realigned its business operations to capitalize on the burgeoning fields of artificial intelligence (AI) and machine learning (ML), with an initial investment focus on emerging digital health and wellbeing companies that leverage AI, ML, cloud computing and digital platforms to drive transformative healthcare management solutions and precision support delivery across the health continuum. Through strategic partnerships with Health Gauge (70% owned by AIML), Tech2Heal (up to 22% ownership rights, with 9.44% currently owned), AI Rx Inc. (70% owned by AIML) and other planned accretive investments, the Company continues to capitalize on expanding growth areas, to the benefit of all the Company's stakeholders. AI/ML's shares are traded on the Canadian Securities Exchange under the symbol "AIML", the OTCQB Venture Market under "AIMLF", and the Frankfurt Stock Exchange under "42FB".

On behalf of the Board of Directors
Tim Daniels, Executive Chairman

For more information about AI/ML Innovations:

For detailed information please see AI/ML's website at https://aiml-innovations.com/ or the Company's filed documents at www.sedar.com.

For further information: Blake Fallis at (778) 405-0882 or [email protected].

Corporate video: https://www.youtube.com/watch?v=k2QSjo7clXc&feature=youtu.be

Official YouTube Channel: https://www.youtube.com/channel/UCCfOj2P_Fu3TOK6Jl1G9vEQ

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Cautionary and Forward-Looking Statements

Certain information in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company, including but not limited to, the uncertainty of competition by other industry players, the impact of general economic conditions, industry conditions, dependence upon regulatory approvals and the ability to raise additional capital as may be needed in the future. Readers are cautioned that the assumptions used in preparing such information, although considered reasonable at the time of preparation, may prove imprecise and undue reliance should not be placed on forward-looking statements. Forward-looking statements in this press release are expressly qualified by this cautionary statement.

The forward-looking statements in this press release are made as of the date of this press release, and the Company undertakes no obligations to update publicly or to revise any of the included forward-looking statements, whether because of new information, future events or otherwise, except as expressly required by applicable securities law.

SOURCE: AI/ML Innovations Inc.