Highlights:

• AI/ML Innovations Inc. wholly owned subsidiary, Health Gauge's AI-based Wearable Device (the Phoenix) was chosen to aggregate electronic patient-reported biometric measures (ePReBMs) in patients with respiratory diseases.
• This pilot project aims to test the feasibility and establish a multidimensional architecture for the long-term monitoring of patients with respiratory diseases, using the Health Gauge AI-based Wearable Device.
• The secondary endpoint for this study will be the potential predictive value of simple or combined measurements obtained from the Health Gauge AI-based Wearable Device for worsening or exacerbation of the baseline conditions, or for ER access or hospital admission.

TORONTO, ON / ACCESSWIRE / June 14, 2023 / AI/ML Innovations Inc. ("AIML" or the "Company") (CSE:AIML)(OTCQB:AIMLF)(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 wholly owned subsidiary, Health Gauge Inc., has been chosen for a University of Alberta clinical study. This pilot study aims to test the feasibility and establish a multidimensional architecture for long-term monitoring of patients with respiratory diseases, using the Health Gauge AI-based Wearable Device. The ultimate goal of this work is to empower a prompt and more accurate analysis of the health status of the patients and contribute to the validation of new instruments to assist clinicians and patients in clinical decision-making.

Randy Duguay, CEO of Health Gauge added, "The potential validation of our patented, AI-powered smartwatch solution for use as a predictive and monitoring aid for chronic respiratory diseases would be of tremendous value to all stakeholders involved. Chronic respiratory diseases are the most common cause of admission to the Emergency Department of the University of Alberta Hospital. Very few, and not accurate instruments are available to predict which patients will face an exacerbation of their condition and with which degree of severity. The current instruments used in the follow-up and decision-making for patients with respiratory diseases are more or less 100 years old. In addition, patient participation is advocated as an essential part of modern healthcare systems whereby direct access to quality information and sharing of clinical data are paramount to increase patient involvement in the whole healthcare process, with the hope of reducing unnecessary costs and of optimizing the available resources."

TRIAL SPECIFICS
Principal investigators for the trial from the UofA:
Dr. Giovanni Ferrara, MD Professor, Division of Pulmonary Medicine
Dr. Pierre Boulanger Professor, Computer Science Faculty of Engineering
Diagnosis and Main Inclusion Criteria:
Patients with interstitial lung disease (ILD), chronic obstructive respiratory disease (COPD), pulmonary hypertension (PH) and healthy controls.

Trial objectives:
The aim is to test the feasibility of using the Health Gauge AI-based Wearable Device, and to establish a multidimensional architecture, for the long-term monitoring of patients with respiratory diseases.

Primary Endpoint - to demonstrate the feasibility of integration of traditional clinical data (demographics, comorbidities, main symptoms, main radiological findings, pathology, lung function, routine blood work, ongoing medications and clinical outcomes), Quality of Life (QoL) and ePReBMs from the Health Gauge AI-based Wearable Device.

Secondary Endpoint - explore the possibility of predicting exacerbations/flares up of the respiratory condition of the patients.

ePReBMs: Health Gauge's proprietary AI-driven algorithms will provide data on:
- Heart rate and heart rate variability
- Blood pressure
- Pulse wave velocity
- Respiratory rate
- Temperature
- Arterial Saturation
- Sleep pattern (deep, light sleep, awake time), duration and time
- Daily physical activities (step count and distance) and calories burnt

Patients will wear the device for at least 8 hours per day (but ideally for 24 hours to record sleep physiologic parameters), at least 3 days per week, for 6 months. ePReBMS will be recorded by the Health Gauge AI-based Wearable Device. The parameters mentioned above will be measured regularly every 5 seconds, and in connection with changes in activity.

The specific primary outcome for this study will be:
Feasibility, as defined as the usage of the Health Gauge AI-based Wearable Device for at least 70% of the expected time.

The secondary outcomes for this study will be:
The potential predictive value of simple or combined measurements obtained from the Health Gauge AI-based Wearable Device for worsening or exacerbation of the baseline conditions, or for ER access or hospital admission.

Duration of Administration:
At least 3 days per week, 8 hours per day, for 6 months.

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About Health Gauge www.healthgauge.com
Health Gauge's patented solution is a personal health monitoring & management system, which combines the latest wearable health monitors with sophisticated artificial intelligence software tools and proprietary cloud computing software, to help caregivers, patients, and healthcare professionals access and utilize relevant data, resulting in better recovery outcomes and healthy living objectives through the ability to make immediate and better health choices.

The Health Gauge platform provides the right balance of team and technology with the Health Gauge Phoenix wearable, the mobile Health Gauge App, and our VirtualCare solution that includes secured messaging, health information management and sharing, and virtual client engagement. It blends artificial intelligence with the latest sensors in non-invasive bio signal collection, including activity, sleep monitoring, HR, HR variability, and other rich personal health data through ECG & digital pulse analytics.

About AI/ML Innovations Inc. https://aiml-innovations.com/
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 (100% 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 or the Company's filed documents at www.sedar.com.
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