There’s an interview of the head of a small CGM company that I hadn’t heard of. They claim to have 56,000 patients using their CGM. http://www.diabetesincontrol.com/david-zeng-transcript/
Their features are smaller needle, smaller transmitter, reading on the phone app every 3 minutes, 1-week sensor life, 1 calibration per day. Two search keywords are iWel and Glutalor.
They had a booth at ADA '17, and their home page is https://www.glutalormed.com/
That is really intriguing.
I am surprised by the interview. In 2016, they were not yet approved in the EU. Their management team is not listed on the website site. The HQ is in Pennsylvania. How did this small US company get 56,000 patients in Europe in 1 year?
I am extremely skeptical.
The answers were some of the worst answers I have ever read. The interview sounded like speaking with a classic snakeoil salesperson.
Spin and evasion.
I do not think it was said that the “56,000” or whatever number were from Europe but rather they were from “other countries”.
This sounds 100% like a Chinese company trying to masquerade as a US Based company.
I would be totally wrong. But that is the smell right off the bat.
Animas had 90,000 pump customers.
Tandem has 50 ~ 60,000 pump customers.
Senseonics has nearly 2,000 unique users on Eversense in Europe.
This company supposedly has 50 or 56,000 users?
“In May, 2005, the “short-term” continuous glucose examination system of DEXCOM was approved by the FDA, and in November, 2005, the Chinese SFDA authorized San Meditech’s Dynamic glucose monitoring system (DGMS®).”
I concur with your assessment. What I can’t tell is whether they actually have a decent product. They claim they are preparing their FDA submission and are aiming for US product launch in late '18. So we’ll have to read the FDA submission to get any indication of plausibility.
Are the FDA submissions public? I would LOVE to be able to read the FDA submissions.
I HATE having to take the word of companies as it relates to FDA submissions.
My first guess is they may have a patent issue or two. But that is 100% pure speculation based on absolutely nothing.
Wonder how it will compare with Medtronics latest standalone CGM.
Quite the enthusiastic article !!!
I stand corrected. As you say, the pre-approval submission probably is treated as highly proprietary.
I was vaguely remembering the PMA documents that appear on the FDA site, like the Dexcom G4 item in https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120005 but on checking back I see that those reports only come out after the FDA gives its approval.
Darn. I thought you had an access to share.
(That would have been excellent. lol)
When I read the interview, I also picked up a few clues.
Totally. I saw that Facebook ad and knew there was something fishy going on.