Thursday, June 10, 2021
Know Labs, Inc., an emerging leader in non-invasive medical diagnostics, today announced successful results from an independent pre-clinical study validating the company’s Bio-RFID™ platform technology.
Know Labs is developing a novel medical device using the Bio-RFID technology that it expects will be the world’s first non-invasive continuous glucose monitor, making finger sticks and micro-needle monitoring devices obsolete and changing care for the world’s 1.5 billion people with diabetes or pre-diabetes. The successful test of the Bio-RFID technology is an important step toward submission of a diagnostic medical device for FDA approval.
The purpose of the independent pre-clinical research was to confirm that Know Labs’ Bio-RFID technology is able to precisely and non-invasively measure and identify a variety of analytes in vitro by detecting their unique radio frequency spectral responses.
“In the past, we’ve rarely spoken publicly about our test results,” said Phil Bosua, Know Labs CEO. “Our energy has been on our research priorities here in the lab. But now we would like to share what we know is a significant milestone – independent verification from a respected research institution that our Bio-RFID technology works.”
The next phase of testing for the Bio-RFID technology will involve clinical human studies measuring blood glucose non-invasively in the body. Data collected from these studies will be included in materials presented to the FDA in a pre-submission meeting. Subsequent clinical trials will be conducted and submitted in the company’s application to the FDA. Know Labs will provide updates on its regulatory strategy and timeline in the coming months.
The report detailing the results will be submitted for publication in a peer reviewed journal. Upon publication, the report will be made available.