Innovation

Biotricity submitted 510(k) U.S. FDA filing for Biotres

Biotres is a compact and discreet 3 channel holter solution

JANUARY 05, 2021 | BY BIOTRICITY

REDWOOD CITY, Calif., Jan 05, 2021 (GLOBE NEWSWIRE)Biotricity Inc. (OTCQB:BTCY), a medical diagnostic and consumer healthcare technology company, announced today that it made a 510(k) submission to the U.S. Food and Drug Administration (FDA), on December 31 2020, for Biotres. The company expects this process to take at least 4 months, and if the Company’s 510(k) application is cleared by the FDA the Company expects a product launch thereafter.

As announced previously, Biotres is a 3-lead patch product for ECG and arrhythmia monitoring for patients at risk for or being diagnosed with certain cardiac issues. Biotres can work as a Holter, Event Loop, and Extended Holter.

“We are excited to announce the 510(k) FDA submission for Biotres and look forward to building out our product offerings further in 2021,” stated Waqaas Al Siddiq, CEO of Biotricity. “We believe that Biotres addresses demand from some of our existing customers and a need in the holter market.”

The Biotres is a holter product that was developed to address the challenges that exist with current holter patch products. The Biotres is designed with the following key features:

  • 3 Channel Recording – A wearable holter patch device that can provide continuous 3 channel recording of ECG (heart) data. All other holter patch devices are 1 channel or 2 channels.
  • Rechargeable Battery – The device can be worn continuously for 48 hours, before needing to be charged for 1 hr., enabling continuous data collection for extended periods of time without any intervention, something not possible with traditional holter patch solutions.
  • Wireless Connectivity – The unique device 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.

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.

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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. There cannot be any assurance that the Company will ever become profitable. During the three months ended June 30, 2020 the Company incurred a net loss attributable to common stockholders of $3.4 million. 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:

Media contacts

Donna Loughlin Michaels
LMGPR
408.393.5575
donna@lmgpr.com

Investor relations:

Biotricity Investor Relations
Investors@biotricity.com
1.800.951.3348