Know Labs (OTCQB:KNWN) is transforming non-invasive medical diagnostics with its Bio-RFID technology platform that uses electromagnetic energy in the form of radio waves to identify and measure what’s going on inside the body, from glucose to alcohol to oxygen and metabolized drugs, instantly and with a high degree of accuracy.
“Our technology has the potential to identify and measure molecular signatures in the body and represents a paradigm shift away from a blood draw and finger stick devices,” Ron Erickson, chairman and founder of Know Labs, says in an interview with BioTuesdays.
“We have built a non-invasive sensor that measures molecular frequencies and translates them into precise biometrics.”
Mr. Erickson explains that Bio-RFID, which stands for radio frequency identification, uses patented radio and microwave frequency spectroscopy to measure analytes, like glucose molecules, in the body. “The results are analyzed instantly with proprietary algorithms and our AI platform.”
In addition, the Bio-RFID platform can be integrated into a variety of pain-free wearable, mobile or bench-top devices, without expensive consumables like test strips or disposable sensor patches, he adds.
The company is initially developing a non-invasive blood glucose monitoring medical device to offer cost-effective solutions for people with Type 1 and Type 2 diabetes, people with pre-diabetes, and people with no diabetes but interested in monitoring their blood glucose levels.
Know Labs’ first two products in its pipeline are KnowU, an on-demand blood glucose monitoring device, and UBand, a wearable continuous glucose monitoring device. The KnowU device merely requires an individual to place their hand on a sensor that produces a digital readout. Both are non-invasive.
New data from the CDC shows that 133 million people in the U.S. are living with diabetes or prediabetes, about one-third of the U.S. population. The market for continuous glucose monitoring is approximately $3.5-billion in North America.
“Bio-RFID represents a significant breakthrough that can make a meaningful difference in human health and wellness, with the potential to revolutionize care for people with diabetes and pre-diabetes,” Mr. Erickson contends.
“Following FDA clearance, we intend to expand Bio-RFID to other medical diagnostic applications, including detecting and measuring levels of ketones, alcohol, metabolized drugs or other substances in the body.”
Earlier this month, Know Labs received two new foundational U.S. patents to protect the ability to create and utilize any database built with data captured through non-invasive sensors.
“This widens the technological gap between Know Labs and others pursuing non-invasive diagnostics,” Mr Erickson suggests. “In simple terms, this means Know Labs now controls any analyte database built with data captured through non-invasive sensors.”
According to Mr. Erickson, Know Labs has successfully patented the process to accurately and non-invasively collect data, build a database from this data, and process it with AI algorithms. “All of these parts are critical to launch a commercial diagnostic platform and now we control them.”
The company has 78 issued and pending patents across the electromagnetic energy spectrum that protect the use of Bio-RFID in many applications. Additional patents are in progress.
Know Labs has run hundreds of internal proof-of-concept studies validating the Bio-RFID technology and comparing its accuracy to FDA-cleared devices, such as the Accu-Check fingerstick, Abbott’s FreeStyle Libre and the Dexcom G6.
In October 2021, the company reported that Bio-RFID demonstrated an average MARD of 5.8%, compared with devices on the market. MARD, or mean absolute relative difference, is the most common metric used by the medical community to assess the performance of glucose monitoring systems. Values under 10% are regarded to have good analytical performance. Finger stick devices tend to be in the range of 5% to 10% MARD.
“Our results confirm that Bio-RFID can successfully measure blood glucose levels non-invasively and continuously, with a high level of clinical accuracy required by medical diagnostic devices,” Mr. Erickson says.
Know Labs is currently conducting a 200-person internal clinical trial of Bio-RFID, previously approved by an independent institutional review board. The study will help refine its algorithms and demonstrate Bio-RFID’s accuracy in a large population, while collecting additional data for a pre-submission meeting with the FDA later this year. A final FDA cleared clinical trial could begin in 2023.
Mr. Erickson says the company intends to use the De Novo regulatory pathway as it does not rely on comparisons to a predicate device where equivalence must be shown. In addition, as a novel device, the FDA could consider an accelerated path to market for Know Labs, Bio-RFID and its first device.
The company also plans to partner with leading medical research institutions in 2022 to secure institutional validation for Bio-RFID with human subjects to further demonstrate the technology and collect additional data for an FDA meeting.
In parallel to these activities, Mr. Erickson said Know Labs will be completing the working prototype of its first product, the KnowU non-invasive glucose monitor, and hopes to uplist to a major national stock exchange this year.
In 2019, Know Labs signed an accord with Racer Technology, a medical device and wearables manufacturer, based in Singapore with plants across Asia that are FDA registered and meet international product certification compliance. Racer is a manufacturing partner of several prominent companies, including Philips, Medtronic, Boston Scientific, Proctor & Gamble and Fitbit.
“We have significant ambitions as an emerging leader in non-invasive medical diagnostics to provide useful and life-saving information to enhance the health and wellness of people around the world,” Mr. Erickson said.
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