Biotricity FDA Submission Update
Biotricity Moves to the Substantiative Phase of the Review Process.
REDWOOD CITY, Calif., May 20, 2020 (GLOBE NEWSWIRE) -- Inc. (OTCQB: ), a medical diagnostic and consumer healthcare technology company, is pleased to announce that it recently received communication from the FDA stating that its 510(k) submission for its next generation Bioflux Software Device is now in the Substantiative Phase of the review process with an expected response by the end of June. The Company is confident in its FDA submission process, having received two previous 510(k)s for its Bioflux Device and Bioflux Software.
A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, at the very least, as a legally marketed device. It is an interactive process with reviewers who use manufacturer evidence to assess the substantial equivalence of the new device. It typically is comprised of two phases: the initial review, followed by the substantiative review.
This FDA submission highlights Biotricity’s focus on innovation and expansion of its technology. Alongside technology, the company has focused on applying technology in a recurring revenue business model. This model has led to triple digit growth, albeit despite recent events, which have instead made its technology even more applicable. This is evidenced by continued sales through recent events and an expected 20% growth for the quarter.
“Biotricity has a track record in receiving FDA 510(k)s and is confident in the process. We look forward to completing this 510(k) and submitting additional 510(k)s later this year. We are excited about our continued development and look forward to launching our next generation technologies once the adequate regulatory clearances are obtained,” said Dr. Waqaas Al-Siddiq, Founder & CEO.
The future of healthcare is remote diagnostics and monitoring. With a focus on innovation and development, Biotricity is well positioned to be a part of this trend.
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About Biotricity Inc.
Biotricity is a modern medical technology company focused on delivering innovative, remote biometric monitoring solutions to the medical and consumer markets, including diagnostic and post-diagnostic solutions for chronic conditions and lifestyle improvement. Biotricity’s R&D continues to focus on the preventative healthcare market, with a vision of putting health management into the hands of the individual. The company aims to support the self-management of critical and chronic conditions with the use of innovative solutions to ease the growing burden on the healthcare system. To learn more, visit .
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.
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