Biotricity Files FDA 510(k) for a new Form Factor of its Biotres Cardiac Monitoring Device to Expand its Revenue Growth

Rhea-AI Summary

Biotricity, Inc. (Nasdaq: BTCY) announced a 510(k) submission to the FDA for a new form factor of its Biotres Cardiac Monitoring Device. This device targets the $5 billion holter monitor market, focusing on lower-risk patients. Key features include 3-channel ECG recording, a rechargeable battery lasting 48 hours, wireless connectivity for faster diagnoses, a user-friendly design, and a modular approach for future enhancements. The company aims to improve patient lives and reduce healthcare costs through innovative technology.

Positive

• FDA submission for Biotres may lead to expanded market opportunities.
• 3-channel recording provides a competitive edge over existing 1 or 2 channel devices.
• Rechargeable battery enhances usability with 48-hour continuous monitoring.
• Wireless connectivity reduces diagnostic turnaround time, improving patient experience.
• User-friendly design improves patient compliance and satisfaction.

Negative

• None.

Designed to support revenue growth by expanding biotres form factors for the early detection of cardiac arrhythmias in the $5 billion-dollar holter monitor market

REDWOOD CITY, CA / ACCESSWIRE / December 12, 2022 / Biotricity, Inc. (Nasdaq:BTCY) ("Biotricity" or the "Company"), a medical diagnostic and consumer healthcare technology company, today announced that it made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for a new form factor of 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 believe this variation of Biotres is an important step to having an expanded product portfolio with maximum variety for the $5B holter monitoring market."

"Biotres, is a holter for low-risk patients and is designed for comfort and 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, 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.

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

SOURCE: Biotricity, Inc.

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https://www.accesswire.com/731279/Biotricity-Files-FDA-510k-for-a-new-Form-Factor-of-its-Biotres-Cardiac-Monitoring-Device-to-Expand-its-Revenue-Growth

FAQ

What is Biotricity's recent FDA submission for?

Biotricity submitted a 510(k) application for a new form factor of its Biotres Cardiac Monitoring Device.

What is the significance of the Biotres Cardiac Monitoring Device?

It targets the $5 billion holter monitor market, providing vital monitoring for lower-risk cardiac patients.

What are the unique features of the Biotres device?

The Biotres device features 3-channel ECG recording, a 48-hour rechargeable battery, wireless connectivity, and a user-friendly design.

How does the Biotres device improve patient care?

It allows for continuous monitoring, reduces diagnostic delays, and is designed for comfort and usability.