Biotricity Receives FDA 510(k) Clearance for its Biotres Cardiac Monitoring Device
Biotricity, Inc. (NASDAQ:BTCY) has received 510(k) clearance from the FDA for its Biotres cardiac monitoring device, targeting the $2 billion holter market.
This innovative device allows continuous 3-channel ECG recordings for lower-risk patients, with features including a rechargeable battery, wireless connectivity, and user-friendly design. Biotres expands Biotricity's Total Addressable Market from $1 billion to $5.7 billion, with sales expected to begin on April 1, 2022. The CEO emphasizes its potential to enhance cardiac care and reduce costs.
- Received FDA 510(k) clearance for Biotres, indicating regulatory approval.
- Product enhances total addressable market from $1B to $5.7B.
- Innovative features improve patient monitoring, reducing diagnostic times and costs.
- None.
Biotres is designed to continuously record ECG data for early detection of cardiac arrhythmias
The Biotres addresses the
REDWOOD CITY, CA / ACCESSWIRE / January 24, 2022 / Biotricity, Inc. (NASDAQ:BTCY) ("Biotricity" or the "Company"), a medical diagnostic and consumer healthcare technology company, today 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
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 products for chronic conditions. The Company develops comprehensive remote health monitoring solutions for the medical and consumer markets. To learn more, visit www.biotricity.com.
Important Cautions Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words "may," "should," "would," "will," "could," "scheduled," "expect," "anticipate," "estimate," "believe," "intend," "seek," "project," or "goal" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements may include, without limitation, statements regarding (i) the plans, objectives and goals of management for future operations, including plans, objectives or goals relating to the design, development and commercialization of Bioflux or any of the Company's other proposed products or services, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company's future financial performance, (iv) the regulatory regime in which the Company operates or intends to operate and (v) the assumptions underlying or relating to any statement described in points (i), (ii), (iii) or (iv) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain additional financing, the significant length of time and resources associated with the development of its products and related insufficient cash flows and resulting illiquidity, the Company's inability to expand the Company's business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company's failure to implement the Company's business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
Contacts:
Investor Relations:
Biotricity Inc.
1-800-590-4155
investors@biotricity.com
Public Relations
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SOURCE: Biotricity, Inc.
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FAQ
What is Biotricity's new product Biotres?
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