AIFRED HEALTH CONCLUDES NORTH AMERICAN CLINICAL TRIAL & INITIATES U.S AND CANADIAN REGULATORY APPROVAL PROCESS FOR ITS AI-DRIVEN CLINICAL DECISION SUPPORT DEVICE TO OPTIMIZE TREATMENT CHOICE IN MAJOR DEPRESSION

MONTREAL, Jan. 25, 2024 /PRNewswire/ - Aifred Health, an award-winning digital healthcare company, today announced the conclusion of its North American Clinical Trial and initiation of the preparation of regulatory filings to seek US and Canadian approval for its novel AI-driven clinical decision support platform. Aifred's proprietary technology was developed to personalize treatment 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.

Aifred's technology was developed using high quality clinical data from clinical trials evaluating therapeutic treatments of depression. Using patient and clinician-completed questionnaires that integrate into the clinical workflow, Aifred's software device was developed with and for treating clinicians (family doctors, nurse practitioners and psychiatrists) who today have limited tools to personalize and facilitate the management of the therapeutic choice for patients, leading to what is for many patients a lengthy and painful trial-and-error process. Aifred's software is intended to support clinical decision making and improve this experience for patients and clinicians alike.

Commenting on the trial and next steps, Marina Massingham, Aifred President & CEO, noted: "We are incredibly proud to have concluded the trial, the first of its kind in the world for an AI-based clinical decision support tool in mental health, and excited to begin the preparation of our regulatory filings for the US FDA and Health Canada. Since our technology placed #1 in North America and #2 in the world in the IBM Watson AI XPRIZE, our team has been working tirelessly to prove the efficacy of our AI-driven device to meet the challenge of personalizing treatment choice that exists in many disease indications, but which is of such consequence in the treatment of moderate to severe depression and other related mental health conditions."

We have worked with some of the leading experts and centers of excellence for the treatment of depression in North America and are gratified by their support and enthusiasm as we tackle the key problem of improving personalized depression treatment, for the benefit of patients, families, employers, and healthcare systems. We are particularly grateful to have officially partnered with the US Dept. of Veterans Affairs (VA) and US Government for this trial and for the strong participation of the VA hospitals that have been an integral part of the trial. Finally, I would like to highlight the support of our key investors who have ensured that Aifred Health is fully funded through the projected approval of our technology in Canada and the US."

Dr. David Benrimoh, Chief Scientific Officer, Aifred Health, added: "We have been collaborating with clinicians and key clinical centres for more than 4 years to inform and guide our 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 in the area of moderate to severe depression. We are working to complete the analysis of the data collected during the trial and to prepare it for peer-reviewed publication and submission to regulatory authorities in order to pave the way for widespread adoption of our tool."

Aifred Health uses 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.

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 initiated its regulatory approval clinical trial for decision support in major depression in Q2 2022 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.