Myant Initiates Skiin Clinical Trial with PACE at Southlake Regional Health Centre to Validate the Use of Textile-Based Solutions for the Capture of ECG and Other Biometrics in Adults and Elderly
TORONTO, ON – August 25, 2020 – Myant Inc., global pioneers in textile computing, has announced the initiation of a clinical study to validate the efficacy and feasibility of Myant’s textile-based monitoring solutions--commercialized under the brand Skiin--to capture medical-grade biometric data across numerous form factors for both adults and elderly populations. The study, to be conducted with Partners in Advanced Cardiac Evaluation (PACE) in affiliation with Southlake Regional Health Centre (Newmarket, Ontario), represents another step towards Myant’s goal of the classification of Skiin as a medical device under FDA and Health Canada regulations. By demonstrating the ability to capture biometric data via garments in clinical settings, as compared to clinical gold standards, Myant is redefining the way health is managed and lowering barriers to care for people, whomever they are and wherever they may be. Continuous Medical Grade Diagnostics for All People Through Clothing While biometric monitoring has been an area of great interest for wearables manufacturers, the products available on the market are typically limited in the breadth of biometric data captured, focus mostly on discrete user-input driven measurement modalities, and are implemented in form factors like wrist worn devices that represent barriers to adoption for many segments of the population aside from physically and cognitively abled adults. Myant’s biometric monitoring system, soon to be commercially available under the brand name Skiin, addresses these gaps by providing continuous biometric-sensing in a form factor--clothing--that is already adopted by virtually all segments of society. The initiation of clinical trials aims to validate the use of Skiin as a medical device with numerous form factors ranging from 3-lead ECG-enabled undergarments to 12-lead ECG Holter monitor vests, ushering in a new paradigm in remote patient monitoring and the democratization of healthcare. As part of these studies, Myant will be validating the ECG signal acquired through its textile based sensory system as well as incorporating other biometrics (like respiration, temperature, biomechanics, etc.) and contextual information (like activity, location, and more) to provide a holistic view on a patient’s health and well-being which can be used by healthcare professionals and caregivers to better anticipate and prevent medical conditions before they manifest as acute or chronic issues. Clinical Trial with PACE Cardiology (Southlake Regional Health Centre) The clinical trial conducted in partnership with Partners in Advanced Cardiac Evaluation (PACE, affiliated with Southlake Regional Health Centre) in Newmarket, Ontario, will involve over 1,000 patients in less than a year (focusing on adults, especially older adults with higher cardio-vascular risks) with the intent to validate the ability of the Skiin system to reliably capture medically relevant electrocardiogram (ECG) data. This data will be used to develop, validate and optimize the next generation of Myant algorithms, meant to analyze signals collected from Myant’s proprietary textile-based dry contact electrodes. This will also drive the evolution of machine learning algorithms that can identify various heart rhythm issues such as atrial fibrillation, QT interval changes, and other types of arrhythmia (e.g. sinus arrhythmias, premature beats, bradycardia, tachycardia, heart blocks etc.). The trial will be led by Dr. Yaariv Khaykin, cardiac electrophysiologist and chief medical informatics officer for Southlake Regional Health Centre. Skiin: From Wellness Product to Medical Device and Beyond “This clinical trial is an important step in Myant’s roadmap of providing access to healthcare, continuously and seamlessly, with the objective of obtaining Health Canada and FDA approval for the classification of Skiin as a Class II medical device. Through this trial, and others being planned, we are demonstrating the potential of our textile computing platform which serves as a medium for the collection and delivery of continuous biometrics. These garments will be the first of many, enabling the promise of telemedicine and working towards reducing the disparity in access to health care world wide,” said Milad Alizadeh-Meghrazi, VP of R&D at Myant. The classification of Skiin as a medical device will come at a time when the ability to remotely access healthcare is more relevant than ever. Myant was recently announced as a recipient of federal funding for the development and deployment of Skiin as a response to the COVID-19 pandemic, enabling those in remote communities to access care without having to risk exposure by travelling to points of care. Subsequent to this trial, Myant will also be introducing and testing additional sensory capabilities (e.g. SpO2 measurement, pulse wave analysis, blood pressure, and digital stethoscope capabilities) which will provide physicians, nurses and caregivers an even more comprehensive understanding of the physiological state of the patient. For more information about clinical trials or Myant, please contact: Dr. Bastien Moineau, MSc, PT, PhDR&D Lead, Rehabilitation and Physiotherapy Specialist @ [email protected] Milad Alizadeh-Meghrazi, MASc, PhD (c)Vice President of Research, Development and Partner Integration @ [email protected] Ilaria VaroliExecutive Vice [email protected] About Myant Inc. Myant has created the world’s first Textile Computing platform that continuously and ambiently connects people to their bodies, to each other, and to the world around them. Using connected textiles that can sense and react to the human body and a platform that enables machine learning driven health and performance outcomes, Myant is on a mission to transform human connectedness. With an extensive patent portfolio, key exclusive relationships within the textile computing industry, a multidisciplinary team of researchers, engineers, data scientists, fashion designers and knitting specialists, and over 80,000 ft² of manufacturing capacity, Myant is changing the way people across society connect. Connect with us to find out how we can help you create innovative solutions powered by connected textiles and the Myant Platform. For more information about Myant, please visit www.myant.ca.