Know Labs Study Validates Technical Feasibility of its Novel Sensor for Non-Invasive Glucose Monitoring
May 05 2023 - 9:00AM
Business Wire
Study demonstrates the Bio-RFID™ sensor
can deliver stable, repeatable results in predicting blood glucose
concentrations using the Dexcom G6® as a reference device
Know Labs, Inc. (NYSE American: KNW), an emerging developer of
non-invasive medical diagnostic technology, today announced the
results of its latest technical feasibility study titled,
“Technical Feasibility of a Novel Sensor for Non-Invasive Blood
Glucose Monitoring Compared to Dexcom G6®.” Know Labs is presenting
these results today, May 5, at the American Association of Clinical
Endocrinology (AACE) Annual Meeting in Seattle, WA.
From December 2022 through February 2023, Know Labs conducted a
series of internal studies to validate the technical feasibility of
its Bio-RFID™ sensor technology at quantifying blood glucose
concentration (BGC) in five healthy participants, using the Dexcom
G6® as a reference device. Bio-RFID is a novel platform technology
using electromagnetic energy in the form of radio waves to
non-invasively capture molecular signatures and convert them into
physiologically meaningful information.
The purpose of this technical feasibility study was to
demonstrate hardware and software infrastructure stability, and to
collect additional data to determine the accuracy of the sensor at
quantifying BGC in vivo non-invasively using radio frequency, by
means of training a neural network (NN) model to predict readings
of the Dexcom G6® as a proxy for BGC.
In the aggregate – across five individual participants, 46 tests
and 92 samples, which collected 4.7 million data points per sample
or roughly 430 million data points for all samples – the study
resulted in a mean absolute relative difference (MARD) of 20.6% and
performed with 46% of predictions within the U.S. Food and Drug
Administration’s (FDA) recommended limit for accuracy for new blood
glucose monitors.
“We have successfully completed our foundational studies, we
have a stable sensor that delivers repeatable results, and we have
developed software infrastructure to manage and interpret large,
novel datasets,” said Steve Kent, Chief Product Officer at Know
Labs. “As you increase sample size, it is expected that there are
changes in accuracy, resulting from variability in testing
conditions, biological diversity, and other factors. This is the
goal of expanded data collection, and we will continue to share
results as we collect more high resolution data, from more
participants, across more testing scenarios.”
During the data collection period, participants placed their
forearms on the Bio-RFID sensor and consumed liquid D-Glucose to
simulate a glucose spike. Participants' BGC was monitored for three
hours while readings from the Bio-RFID sensor and the Dexcom G6®
were simultaneously logged. Data were collected on a continuous
basis, using sweeps across the 500 MHz to 1500 MHz range at 0.1 MHz
intervals, collecting values at 10,001 frequencies per sweep. Know
Labs then used these data from the Bio-RFID sensor to train a NN
model to predict BGC readings of the Dexcom G6® reference
device.
“Today’s methods of testing BGC come with several disadvantages,
from the pain of finger pricks and inserting probes for continuous
monitors to the high cost and environmental waste these methods
produce,” said Ron Erickson, CEO and Chairman at Know Labs. “This
study demonstrates our progress toward getting the first
FDA-cleared non-invasive glucose monitoring device in the hands of
the nearly 40 million people living with diabetes in the U.S. We’ve
achieved so much over the last several months. We’ve refined data
collection methods and increased our participant population, with
our dataset growing from 3 in our exploratory study to 92 in this
study, a 30-fold increase in the sample size. To-date, we’ve
collected 1.4 billion data points that are now being used to refine
our glucose value prediction algorithm.”
This technical feasibility study is part of ongoing clinical
research that Know Labs is conducting as the company prioritizes
validation of the Bio-RFID technology. A Technical Report of the
company's Proof of Concept (N=1) results is publicly available at
www.knowlabs.co/research-and-validation.
The study abstract and AACE 2023 Annual Meeting Poster can be
viewed at www.knowlabs.co.
About Know Labs, Inc.
Know Labs, Inc. is a public company whose shares trade on the
NYSE American Exchange under the stock symbol “KNW.” The Company’s
technology uses spectroscopy to direct electromagnetic energy
through a substance or material to capture a unique molecular
signature. The Company refers to its technology as Bio-RFID™. The
Bio-RFID technology can be integrated into a variety of wearable,
mobile or bench-top form factors. This patented and patent-pending
technology makes it possible to effectively identify and monitor
analytes that could only previously be performed by invasive and/or
expensive and time-consuming lab-based tests. The first application
of our Bio-RFID technology will be in a product marketed as a
non-invasive glucose monitor. It will provide the user with
real-time information on blood glucose levels. This product will
require U.S. Food and Drug Administration clearance prior to its
introduction to the market.
Safe Harbor Statement
This release contains statements that constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. These statements appear in a number of places in this
release and include all statements that are not statements of
historical fact regarding the intent, belief or current
expectations of Know Labs, Inc., its directors or its officers with
respect to, among other things: (i) financing plans; (ii) trends
affecting its financial condition or results of operations; (iii)
growth strategy and operating strategy; and (iv) performance of
products. You can identify these statements by the use of the words
“may,” “will,” “could,” “should,” “would,” “plans,” “expects,”
“anticipates,” “continue,” “estimate,” “project,” “intend,”
“likely,” “forecast,” “probable,” “potential,” and similar
expressions and variations thereof are intended to identify
forward-looking statements. Investors are cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties, many of which are beyond Know
Labs, Inc.’s ability to control, and actual results may differ
materially from those projected in the forward-looking statements
as a result of various factors. These risks and uncertainties also
include such additional risk factors as are discussed in the
Company’s filings with the U.S. Securities and Exchange Commission,
including its Annual Report on Form 10-K for the fiscal year ended
September 30, 2022, Forms 10-Q and 8-K, and in other filings we
make with the Securities and Exchange Commission from time to time.
These documents are available on the SEC Filings section of the
Investor Relations section of our website at www.knowlabs.co. The
Company cautions readers not to place undue reliance upon any such
forward-looking statements, which speak only as of the date made.
The Company undertakes no obligation to update any forward-looking
statement to reflect events or circumstances after the date on
which such statement is made.
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For Know Labs Media Inquiries Contact: Matter Health
Laura Bastardi Knowlabs@matternow.com Ph. (603) 494-6667
Know Labs, Inc. Contact: Jordyn Hujar jordyn@knowlabs.co
Ph. (206) 629-6414
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