Biotricity Receives FDA 510(k) Clearance for its Biotres Cardiac Monitoring Device

Biotres is designed to continuously record ECG data for early detection of cardiac arrhythmias

The Biotres addresses the $2 Billion-dollar holter market

REDWOOD CITY, Calif., Jan 24, 2022 — Biotricity Inc., a medical diagnostic and consumer healthcare technology company, reported it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Biotres Cardiac Monitoring Device, a three-lead device for ECG and arrhythmia monitoring that is intended for lower risk patients.

Dr. Waqaas Al-Siddiq, Biotricity Founder and CEO commented, “We are extremely proud of this accomplishment and its potential to reshape the future of cardiac prevention and monitoring with this novel platform. With Biotres receiving 510(k) clearance, we now have another option for providing a secondary product for doctors and hospitals to meet their patients’ cardiac monitoring needs. Coupled with the recent successful non-dilutive financing, we believe we are well capitalized to execute the expansion of our commercialization efforts.”

“Biotres, is a holter for low-risk patients and is designed for comfort for long-term wear,” he added. “Cardiac disease remains a chronic issue, requiring persistent intervention, monitoring and management and we believe Biotres may provide a critical tool for improving patient lives and reducing costs.”

Designed to address the current limitations of existing holter monitors technologies, Biotres offers the following feature set:

• 3 Channel Recording – A wearable holter patch device that can provide continuous 3 channel recording of ECG (heart) data. All other known holter patch devices are 1 channel or 2 channels.
• Rechargeable Battery – It can be worn continuously for 48 hours, in connectivity mode, before needing to be charged for 1 hour, enabling continuous data collection for extended periods of time without any intervention, a distinction not possible with traditional holter patch solutions.
• Wireless Connectivity – Utilizes Bluetooth technology to offload data, reducing the time for diagnoses. Current holter patch solutions can take up to a week before diagnoses are available due to manual data downloading and a lack of connectivity.
• User-Friendly Design – Easy to understand and comfortable to wear during regular day-to-day activities.
• Modular Design – Designed with the flexibility to support our strategy of adding future features and functionality to the Biotres platform.
• Unique Business Model – the design of Biotres enables providers to bill directly, creating a revenue stream with a simplified workflow for providers while reducing risk and diagnostic turnaround time for patients.

The Biotres not only expands our product portfolio, it opens up a new market and increases Biotricity’s Total Addressable Market from $1B to $5.7 Billion and will be widely available for sale starting April 1, 2022.

About Biotricity Inc.

Biotricity is reforming the healthcare market by bridging the gap in remote monitoring and chronic care management. Doctors and patients trust Biotricity’s unparalleled standard for preventive & personal care, including diagnostic and post-diagnostic solutions for chronic conditions. The company develops comprehensive remote health monitoring solutions for the medical and consumer markets. To learn more, visit www.biotricity.com.