Know Labs, Inc. provided an update on its outlook for 2022, as the company executes its plan to bring the first FDA-cleared non-invasive glucose monitoring devices to market. Know Labs is currently conducting an internal clinical trial of Bio-RFIDTM, its proprietary technology that has the potential to transform non-invasive medical diagnostics. Bio-RFID uses patented radio and microwave frequency spectroscopy to non-invasively detect and measure the presence of analytes, such as glucose, in the human body.

The 200-person trial, approved earlier in the year 2022 by an independent Institutional Review Board (IRB), offers an opportunity to further demonstrate Bio-RFID's accuracy in a large population. Bio-RFID has delivered high levels of accuracy and a Mean Absolute Relative Difference (MARD) under 6% when compared with other FDA-cleared glucose monitoring devices in internal tests with a smaller population size. Additionally, Know Labs plans to partner with a leading medical research institution to secure institutional validation for Bio-RFID with human subjects, which will help the company further demonstrate its technology and collect additional data for a pre-submission meeting with the FDA.

In parallel to these activities, Know Labs will be completing the working prototype of its first product, the KnowU non-invasive glucose monitor. This unit and subsequent devices will be manufactured by the company's manufacturing partner, Racer Technologies, valued manufacturer for many of the world's leading producers of FDA-cleared medical devices and wearable products. As Know Labs prepares for FDA clinical trials, the company has selected the regulatory pathway it intends to pursue and present to the FDA in a pre-submission meeting.

Some adjustments to the regulatory strategy may be required when the activities above are completed.