Members Convene at Company Laboratory for First Meeting
Know Labs, Inc. (KNWN) – a creator and provider of diagnostic solutions, announced today the formation of its Medical, Scientific and Regulatory Advisory Board, the initial members of the Advisory Board and its first meeting.
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The Advisory Board was formed to provide counsel and guidance to the Company and its senior management, CEO Phil Bosua and Chairman and Founder, Ron Erickson. The Advisory Board is chaired by Know Labs Chief Medical Officer, James (Andy) Anderson, M.D.
The initial members of the Advisory Board in addition to Dr. Anderson are G. Alexander (Zan) Fleming, M.D. and David C. Klonoff, M.D.
In assembling the Know Labs Advisory Board, Dr. Anderson remarked, “I wanted to bring together a team of experienced diabetes, obesity and cardiovascular disease experts who can guide us as we bring the remarkable Know Labs technology to the market. I have no doubt we will be successful and will make a significant difference in people’s lives. I look forward to the active engagement of the Advisory Board as we progress toward approval and launch of our first group of non-invasive UBAND wearable devices including the UBAND Calorie Counter and the first truly non-invasive UBAND Continuous Glucose Monitor. Our just concluded meeting at the Know Labs laboratory was extremely productive. We are all excited by the promise of the Know Labs technology in diabetes and cardiometabolic disease, and the future expansion into additional health and wellness, and medical therapeutic areas.”
Dr. Fleming, speaking for the group, said, “We were drawn to Know Labs by their innovative technology and their exuberant commitment to success as well as our long term trusted working relationship with Andy Anderson. We leave our first meeting full of energy and enthusiasm for the Know Labs technology, its team and its application to human health and diagnostics. We will give laser focus to assisting with bringing the UBAND CGM to market as soon as possible.”
The backgrounds of the members of the Advisory Board provide a broad breadth and depth of experience to guide Know Labs as it first introduces its non-invasive wearable UBAND Calorie Counter to then be followed by submission to the US Food and Drug Administration of its non-invasive wearable UBAND Continuous Glucose Monitor.
Alexander (Zan) Fleming, M.D.
Dr. Fleming is President and Chief Executive Officer of Tolerion, a biotechnology company developing disease-modifying treatments for Type 1 diabetes and other autoimmune diseases. He is also Founder and Executive Chairman of Kinexum, a company of professionals from across the world with diverse expertise in developing drugs, biotech products, medical devices and digital health technologies. Dr. Fleming received his M.D. and internal medicine training from Emory University, fellowship training in endocrinology at Vanderbilt University and metabolism at National Institutes of Health, where he was a senior fellow.
At the US Food and Drug Administration from 1986-98, Dr. Fleming was responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. He led reviews of landmark approvals including metformin, as well as the first statin, human insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. Dr. Fleming oversaw clinical review of the earliest biotech products including human insulin and growth hormone. He helped to shape FDA policies and practices related to therapeutic review and regulatory communication. He was a major contributor to FDA's Good Review Practice (GRP) initiative and led the committee responsible for education and training at CDER. He conceived and directed the first FDA pilot project to utilize the internet for regulatory communication.
Dr. Fleming’s regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was on assignment from FDA during 1991-92. Dr. Fleming was a member of the expert working groups on Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH) and participated on other ICH committees including the Common Technical Document working group.
Dr. Fleming is lead author of the book, Optimizing Development of Therapies for Diabetes. He has frequently published scientific articles and book chapters, the most recent chapter, “Regulatory Considerations for Early Clinical Development,” is in Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development, published by Springer in January 2019. He has been a member of many corporate and advisory boards to academic and commercial institutions and professional societies. He serves on the joint technology working groups of the European Association for the Study of Diabetes and American Diabetes Association.
Dr. Fleming coined the term, Metabesity, which refers to the constellation of diabetes, obesity, cardiovascular disease, neurodegenerative and the aging process itself, all of which share common metabolic root causes and potential preventive therapies. He organized the first Congress on Metabesity in London in October 2017, which will be followed by the second Congress in Washington, D.C. in 2019.
David C. Klonoff, M.D.
Dr. Klonoff is a practicing endocrinologist specializing in the development and use of diabetes technology. He is Medical Director of the Dorothy L. and James E. Frank Diabetes Research Institute of Mills-Peninsula Medical Center in San Mateo, California and a Clinical Professor of Medicine at UCSF. Dr. Klonoff is a graduate of UC Berkeley (junior year Phi Beta Kappa) and UCSF Medical School (junior year Alpha Omega Alpha). His postgraduate training in internal medicine and endocrinology included two years at UCLA Hospital and three years at UCSF Hospital.
Dr. Klonoff coined the term “diabetes technology”. He received an FDA Director’s Special Citation Award in 2010 for outstanding contributions related to diabetes technology. In 2012 Dr. Klonoff was elected as a Fellow of the American Institute of Medical and Biological Engineering (AIMBE) and cited as among the top 2% of the world’s bioengineers for his engineering work in diabetes technology. He received the 2012 Gold Medal Oration and Distinguished Scientist Award from the Dr. Mohan’s Diabetes Specialities Centre and Madras Diabetes Research Foundation of Chennai, India. Dr. Klonoff was invited to speak to the US Congressional Diabetes Caucus in 2017, participate in the White House Health and Cybersecurity Roundtable in 2015, and speak at the European Parliament in 2010.
Dr. Klonoff is the Founding Editor-in-Chief of Journal of Diabetes Science and Technology. He has authored over 200 articles in PubMed-indexed journals and has been a Principal Investigator on over 110 clinical trials of diabetes drugs and devices. Dr. Klonoff was the lead investigator for the first randomized controlled multicenter trial of an outpatient artificial pancreas product and published the results in the New England Journal of Medicine. He was an advisor and/or investigator for the first, second, third, and fourth CE-marked noninvasive glucose monitors. He founded the Diabetes Technology Meeting and the Digital Diabetes Congress.
Dr. Klonoff has served on 56 grant review panels including for NIH, CDC, NASA, NSF, US Army, NOAA, ADA, and JDRF; plus, agencies in nine foreign countries. He chairs the Scientific Advisory Board of the Texas A&M/UCLA/FIU/Rice PATHS-UP Engineering Research Center and the CLSI Continuous Glucose Monitor technical guideline committee, POCT05. He is an affiliate member of the Baylor University Center for Space Medicine. Dr. Klonoff is a member of the Healthcare Sector Coordinating Council Joint Cyber Working Group for Medical Devices/Healthcare. He chaired DTSec and DTMoSt, the world’s 1st and 2nd consensus medical device cybersecurity standards. For this work Dr. Klonoff was featured in an article in Wired Magazine.
About Know Labs, Inc.
Know Labs, Inc. is a public company whose shares trade under the stock symbol “KNWN.” The company’s technology directs structured light or radio waves through a substance or material to capture a unique molecular signature. The Company refers to these signatures as ChromaID™ and Bio-RFID™. ChromaID and Bio-RFID are used to identify, detect, or diagnose substance markers or biomarkers that may be invisible to the human eye. ChromaID and Bio-RFID scanner modules can be integrated into a variety of wearable, mobile or bench-top form factors. This patented and patent pending, award-winning technology makes it possible to effectively conduct analyses that could only previously be performed by invasive and/or large and expensive lab-based tests. For more information on Know Labs, visit the company’s website at www.knowlabs.co
Safe Harbor Statement
This release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements appear in a number of places in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of Know Labs, Inc., its directors or its officers with respect to, among other things: (i) financing plans; (ii) trends affecting its financial condition or results of operations; (iii) growth strategy and operating strategy. The words may, would, will, expect, estimate, can, believe, potential and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond Know Labs, Inc.’s ability to control, and actual results may differ materially from those projected in the forward-looking statements as a result of various factors.