Know Labs, a creator of innovative medical diagnostic solutions, announced significant progress in the development of its wearable UBAND non-invasive Continuous Glucose Monitor (CGM).
Increased accuracy and precision in laboratory test subject measurements have allowed the Company to expedite its focus on an FDA-approved CGM, causing it to curtail plans for its previously announced calorie counter product for the consumer market.
Dr. James “Andy” Anderson, M.D., Know Labs Chief Medical Officer, stated, “The UBAND CGM will be submitted for review under the FDA’s De Novo pathway. There is nothing else like it in the continuous glucose monitoring market, nor in the broader medical diagnostic world. Our Advisory Board of world class experts in diabetes care will bring together prominent investigators from around the country for clinical trials of this unique product.”
“An FDA-approved wearable non-invasive CGM has always been our goal. It will revolutionize lifestyle management for people with diabetes and those at significant risk for developing this pandemic disease. We initially believed our first product would be a wearable calorie counter for the consumer market,” said Know Labs, Inc. CEO Phil Bosua. “At this point we have seen such dramatic progress in the lab we can now go straight for that ultimate goal and reach the large global market of people with diabetes allowing them to continuously monitor their blood glucose without the need for finger sticks or needles for the insertion of filaments or sensors. The truly non-invasive device and lower costs will also make the UBAND CGM ideal for individuals with pre-diabetes who are trying to modify their lifestyle by diet and exercise. Our dream of creating a wearable FDA-approved non-invasive CGM is just around the corner.”
The unique technology at Know Labs is based upon a strong intellectual property foundation. Mark Tapsak, Ph.D., formerly a system designer for CGM developer Dexcom, recently joined the Company as Vice President for Intellectual Property, charged with expanding and fortifying the Know Labs IP portfolio.
Know Labs’ move to build its wearable UBAND CGM for its FDA De Novo clinical trials is supported by its manufacturing partner Racer Technology, a global medical device and wearables manufacturer.
“We are curtailing any activities that take our focus away from the CGM,” said Company Chairman and Founder Ron Erickson. “We believe we are on the cusp of bringing to market the holy grail of the medical diagnostics industry. We are full speed ahead on our clinical path.”
Source: Company Press Release.