VoyagerSphinx44
5月前
Between 2005 and 2018, the FDA cleared several CGM devices with a wide range of MARDs: 17.2%, 13.6%, 18.3%, and 8.7%-9.14%.
https://link.springer.com/article/10.1007/s41745-022-00348-3
The decision to clear a medical device depends on a variety of factors including safety, efficacy, and overall benefit-risk profile. If a new CGM demonstrates substantial advantages despite a slightly higher MARD, it could still be favorably reviewed.
In my opinion, the non-invasiveness, lack of consumables, and overall lower cost of the KNOW Labs device, along with consistent MARDs in the 11-12% range, makes it highly likely to receive FDA clearance in the near future.
RMacchio
8月前
the G7 and it seems to be able to give a MARD # of 8.5 and our Uband comes in at 11.1You can find the details of the Dexcom G7 study at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9208857/ and, if you review the study you will see that the the 8.2% MARD they report is based on a much different study than was conducted by KNW. I'm not a medical researcher but there seems to be enough of a difference in the testing to suggest that the two MARD values should not be compared - a couple of differences that seemed to jump out are:
- The Dexcom study used only participants that "had T1D, intensive insulin therapy T2D (T2D-IIT), or nonintensive insulin therapy T2D (T2D-NIIT)". Essentially, their study only involved Type 1 or Type 2 diabetics that were receiving treatment. The Know Labs MARD seems to include non-diabetics, pre-diabetics, Type 1 diabetics, and Type 2 diabetics. I would expect different MARD readings based on the population differences
- Most of the G7 MARD was based on normal usage across the 11 days that the device is working (the device has to be replaced on day 11). The MARD for the G7 was as high as 12.9% on the first day and tended to drop significantly by day 11 - the 8.2% MARD that they report is an average MARD across different days. The KNW MARD was based on readings after a glucose tolerance test. Again, you would expect different MARD readings as a result of different test protocols
I'm guessing that the testing that will be performed by KNW for FDA approval will be more rigorous and should provide results that can better compare to the performance reported for other devices on the market. In addition, the G7 device is the latest generation of Dexcom devices so you would hope that significant improvement has been made in the accuracy of the technology... the KnowU device is still undergoing development and should also continue to improve in accuracy. Finally, I don't think the KnowU needs to be the most accurate CGM device right out of the gate - if the accuracy is in the same ballpark then the cost and convenience benefits will probably be the biggest drivers of approval and adoption.
Regis999
9月前
"John Cronin was added to the Know Labs Board in November 2023 to play a pivotal role in its growth.
He is a Rock Star.
Why would someone like this join Know Labs?
“John Cronin is the founder and CEO of ipCapital Group, Inc., a leading global advisory company on intellectual property strategy and monetization. Cronin began his career at IBM where he was the sole inventor of breakthrough chip design technology that became the company’s most valuable patent, generating $500 million in revenue.
He went on to create the IBM Patent Factory and grew IBM’s patent portfolio from ninth to number one in the world. He played a pivotal role in increasing IBM’s patent licensing revenue from $30 million to over $2 billion a year. Cronin has been a strategic advisor and consultant to Know Labs, supporting the company’s expanding patent portfolio from 86 to 246 patents issued, pending and in process over the last twelve months, increasing its global leadership in the non-invasive blood glucose monitoring category.”
Biography
John Cronin is Chairman and CEO of ipCapital Group, Inc. (“ipCG”), an intellectual property consulting firm. Mr. Cronin founded ipCG in 1998.
Mr. Cronin and ipCG have worked with over 1,200 companies and approximately 10% of the Fortune 500 companies, hundreds of mid-size companies, and hundreds of startups and governmental laboratories. Over the years, Mr. Cronin has become a respected thought leader among executives who wish to align business issues with IP and translate strategies into actionable financial results. Mr. Cronin has inspired and trained thousands of engineers and scientists in the best practices of “how to invent.”
Mr. Cronin has authored greater than 1500 patents and applications across hundreds of technology spaces, leveraging the ipCapital Methodology."
mantix
11月前
Oh, I check in now and then. I sold enough stock for a 200% profit, but I’m hanging on to all the rest— which is plenty.
That MARD is getting close. Best bet, in my opinion, is to measure against blood glucose readings instead of Dexcom, which isn’t perfect, but that will mean a longer approval process.
It will be worth it in the end. :)