AIFRED HEALTH ANNOUNCES HEALTH CANADA APPROVAL FOR THE SALE AND COMMERCIALIZATION OF ITS AI-DRIVEN CLINICAL DECISION SUPPORT DEVICE TO OPTIMIZE TREATMENT CHOICE IN MAJOR DEPRESSION

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Sep 17, 2024, 07:30 ET

MONTREAL, Sept. 17, 2024 /PRNewswire/ - Aifred Health, an award-winning digital healthcare company, today announced the receipt of a Canadian Medical Device License for its AI-driven clinical decision support software medical device (CDSS) that provides healthcare professionals with decision support for the treatment of moderate to severe depression. Aifred's proprietary technology was developed to personalize treatment management and choice for patients suffering from moderate to severe depression where treatment guidelines call for the use of medication and where clinicians lack adequate tools to personalize and optimize the choice and management of treatment.

Commenting on the Canadian approval and next steps, Donald Olds, Aifred's Executive Chairman commented that "We believe that our technology represents the first of its kind in North America, where AI-supported clinical decision support, using patient-supplied information, has demonstrated significant clinical benefits for patients being treated for moderate to severe clinical depression. Our approach replaces the difficult and time-consuming process of trial and error, and significantly improves the patient's response to front-line therapy by personalizing the choice of approved and effective agents. This use of AI to address and solve the treatment choice dilemma for the treatment of depression represents a giant step forward towards our common goal of personalizing medical treatment. Our team is excited to move forward to commercialization in Canada, while completing our regulatory approval filing for the US market.

In parallel, we have established proof of principle in another mental health disease area and are confident that our technology has the potential to work across multiple disease fronts, where physicians are facing the same challenge – which of the approved medications for a given human disease will be most effective for the patient in front of me today."

Using patient and clinician-completed questionnaires that integrate into the clinical workflow, Aifred's CDSS was developed with and for treating clinicians (family doctors, nurse practitioners and psychiatrists) who today have limited tools to personalize the choice of the multiple available approved treatments for patients, leading to what for many patients and their families is a lengthy and painful trial-and-error process. Aifred's software supports clinical decision making and improves this experience for patients and clinicians alike. Aifred's recent clinical trial in the US and Canada demonstrated that the use of Aifred's technology in a clinical setting significantly improved the rate of remission among patients treated with access to the CDSS compared to patients treated without.

Marina Massingham, Director at Aifred Health noted "To achieve Health Canada approval for an AI-powered medical device is a tremendous accomplishment for a startup, made possible only by the tireless work and dedication of members of the Aifred team past and present over the past seven years."

Dr. David Benrimoh, Chief Scientific Officer, Aifred Health, added: "We collaborated with clinicians and key clinical centres across the US and Canada, including key US Veterans Affairs (VA) hospitals, for more than 4 years to inform and guide the development of a decision support tool that will integrate into clinical workflow and be used by treating physicians to transform care and address the critical challenge of treatment choice and management in the area of moderate to severe depression. Crucially, our platform does not require the use of time-consuming advanced tests, allowing decisions to be made in real time. We are extremely excited by the data we have generated to support the clinical efficacy of our device and by the recent Health Canada licensing to begin commercialization in Canada. Our study demonstrated that our platform can be helpful in the treatment of patients with moderate to severe depression, which can be challenging to treat. In parallel, we are working diligently to complete our US regulatory application and to publish our clinical data as we work towards the widespread adoption of our tool and its expansion in other disease areas where treatment choice is a major challenge and where the need for personalized medicine is glaring."

About Aifred Health's Technology

Aifred Health used deep learning models and data pre-processing techniques developed in-house to generate models of differential treatment response. These models can be used in any situation where multiple treatments for a condition are available and are trained to predict treatment outcomes for individual treatment options. These models are housed in a digital mental health platform which supports treatment management and clinical decision-making.

About Aifred Health

Aifred Health, a Montreal-based digital healthcare company, is delivering clinician-focused solutions for the treatment of mental health including a world-class AI approach to providing clinical decision support in mental health. In June 2021, Aifred's AI technology placed # 1 in North America and #2 in the world in the Global IBM WATSON AI XPRIZE. Aifred completed its Agency authorized clinical trial for decision support in major depression in Q4 2024 and has promising work already underway to extend its technology to a second indication in mental health. For more information, please visit www.aifredhealth.com.

SOURCE Aifred Health Inc.