Know Labs Completes Non-Invasive Glucose Monitoring Prototype

Know Labs has reached the next stage in developing its proprietary Bio-RFID technology: the Generation (Gen) 1 Device.

Gen 1 incorporates Know Labs’ Bio-RFID sensor—which has proven to be technically feasible and stable in delivering repeatable blood glucose measurements (in a lab environment)—in a portable device.

There are currently no medical-grade, commercially available, non-invasive means of measuring blood glucose. By completing Gen 1, Know Labs is closer to achieving its goal of delivering the world’s first U.S. Food and Drug Administration-cleared non-invasive blood glucose monitor for those living with diabetes and pre-diabetes worldwide.

The Gen 1 prototype is a portable research lab, designed to be a powerful data collection device. Data collection in clinical research is the foundation for further algorithm development and refinement. This device will allow Know Labs to scale data collection tenfold, including testing across more diverse participant populations and scenarios.

“The completion of Gen 1 marks a significant engineering achievement for the company and, more broadly, for innovation in medical diagnostics. Many have tried to non-invasively ascertain glucose and have not succeeded or remain years away from success. Know Labs and our partners overcame engineering complexities over several years and through hundreds of iterations to achieve this level of progress,” Know Labs Chairman/CEO Ron Erickson said. “The Bio-RFID sensor is a novel technology that is leading the way to an entirely new branch of science, and Gen 1 takes us closer to our goal of enabling a better way of life for people living with diabetes.”

Over the last five years, Know Labs has developed the Bio-RFID platform technology, which consists of a radio frequency (RF) sensor (the hardware) and a method to collect and interpret billions of data points (the software) to identify and measure a wide range of different analytes inside and outside the body. With Gen 1, Know Labs has made lab testing, and therefore clinical research, fully portable and, as a result, scalable. The modular design enables iterative research and development to allow Know Labs to better learn, test, refine and redesign on an ongoing basis.

The device was built by the Know Labs team in partnership with mechanical, electrical, and firmware engineering, and industrial design experts at Igor Institute and Bould Design, and renowned microelectronics and systems engineer, Reza Kassayan, M.D., all of whom were critical in overcoming the many complexities to bring Gen 1 to life.

“The engineering achievement of Gen 1 is the first of its kind. Our team has taken the sophisticated capabilities of our research lab and miniaturized every critical element to fit into a pocket-sized device, with more on-board computing power than a desktop PC, built-in machine learning capabilities, a long battery life, and it is fully configurable to support our many development initiatives. This system is designed to be the ultimate research and development tool,” Know Labs Chief Product Officer Steve Kent stated. “As we deploy Gen 1 into this next research phase, our focus is on high-quality data collection, refining our algorithms based on this new data, and understanding all the scenarios in which our glucose monitoring device may be used.”

Further clinical research with the new Gen 1 Device is expected to generate tens of billions of data observations to process, which enables Know Labs to continue refining and optimizing algorithms to manage and interpret these large datasets. For 2023, Know Labs remains focused on external validation of its technology and contributing to its growing body of peer-reviewed evidence. The company will make further refinements to the Gen 1 Device as it works toward realizing its vision for the KnowU and UBand and marketing the product.

Know Labs Inc.’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, which can be integrated into various wearable, mobile or bench-top form factors. This patented and patent-pending technology can 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 the Bio-RFID technology will be in a product marketed as a non-invasive glucose monitor that provides users with real-time blood glucose level data.