One of the biggest issues when you have been around as long as we have it takes something truly astonishing to shock us. In the early days we were constantly amazed by all the wackiness that was going on. Now 20 plus years in we merely shrug our shoulders and chalk up the wackiness as one of the consistent aspects of our wacky world. No matter how much money is wasted, no matter how many life lessons are missed about the only thing that continues year after year is stupidity. With the ADA in full swing (although virtual this year) the flood gates have once again opened.
1. And no this is not a joke but according to the BioWorld website;
“San Diego startup Glysens Inc., which is developing implantable continuous glucose monitoring (ICGM) technology, closed a $15 million incremental financing. The funds will be used to support ongoing clinical trials and development of the company’s fully implanted, long-term CGM systems, including first-in-human evaluation of the third-generation Eclipse 3 ICGM.”
This funding announcement comes as Senseonics, who has an implantable sensor that’s FDA approved and works pretty well is about to go out of business. As we have noted many have come, taken a look at Senseonics and said thanks but no thanks. Yet these investors in Glysens must believe the company has a better mouse trap even though a better mouse trap isn’t needed. What was that we said last week about building a solution first and finding a problem to solve later. Seriously you just can’t make this stuff up.
2. With their Series C financing round now complete Bigfoot is again becoming BigMouth telling everyone that their Unity system will soon be submitted to the FDA. As we reported and have now confirmed with the company the Unity does not measure how much insulin is dosed rather only that insulin has been dosed. Just how this helps the patient is a mystery to us.
Perhaps that’s why the company has brought in a new medical director, maybe Dr. Malone can explain this to us. Maybe he can explain how knowing that a patient has just taken their insulin helps in anyway whatsoever.
We suspect the real reason Dr. Malone was hired was his resume which according to a Bigfoot press release;
“Bigfoot Biomedical, Inc. announced today the appointment of Dr. Jim Malone as Chief Medical Officer. Dr. Malone, an endocrinologist specializing in diabetes, spent 12 years in clinical practice and 21 years in clinical research, where he developed diabetes products and delivery devices at Eli Lilly & Company.”
Just in case anyone has forgotten Lilly was once an investor in Companion Medical, which as we keep noting is the only company that is anywhere near having a REAL Tyler. We should also note that Lilly themselves is developing their own version of Tyler but so far has yet to submit their Tempo button (think connected cap cover only its attached to the button of the pen) to the FDA.
Our guess and we think it’s a pretty good guess is that the Bigfoot Board of Directors and their investors were getting impatient and told the company to submit the Unity to the FDA even though what it does is pretty much worthless. They brought in Dr. Malone thinking with his connections he might get Lilly interested in dumping Tempo in favor of Unity.
Given that the Unity really doesn’t do all that much it’s likely it will be approved by the FDA. This will allow Bigfoot to do what they do best as when it goes to the FDA they’ll issue a press release, when its approved by the FDA another press release. Followed by more press releases when the Unity is commercialized.
This will keep the Board and investors happy while the company figures out how to get the Unity to actually measure how much insulin is dosed a piece of data that actually matters. Whether this can be done with the Unity we have no idea and honestly could care less. The fact is all the hardware used with Tyler with the exception of a the CGM sensor are commodities, interchangeable parts.
With a REAL Tyler what matters is that the hardware work and provide accurate data to the insulin dosing algorithm. Ok we shouldn’t have to say it but will IT’S NOT ABOUT THE DAMN TOYS.
3. From the Captain Obvious department Tandem is releasing data and posters telling everyone what we already know, namely the Control IQ works pretty damn well.
4. Onduo another company that has undergone a change in management is also releasing data which tells us something we also knew CGM just isn’t for insulin using patients but all patients with diabetes. Shocking right?
Here is just some of what the company said;
“Participants in the Onduo program experienced significant reductions in HbA1C, the standard measurement of glycemic control. The use of CGM in the highest risk group (baseline HbA1C over 9.0%) resulted in the greatest average HbA1C drop (-3.3%).
Diabetes-related distress, which is associated with poor health outcomes in T2D, improved significantly among participants with elevated baseline distress. Improvements in regimen-related and emotional distress were most notable.
In a prospective study, Onduo participants saw a significant 10.2% increase in time in target glucose range (time in range), which is equivalent to an additional 2.4 hours per day.”
There’s much more data but this data is significant from a different perspective as keep in mind that the Onduo program is pretty much the same as the Livongo program just with better glucose monitoring technology and a much deeper war chest. A war chest that can be used to do what we suspect the company will do, go 100% at risk offering their program for FREE only getting paid for producing verifiable improvements in patient outcomes.
Livongo may be enjoying the warmth of a rising stock price and lots of free positive publicity but it will get cold in a hurry should Onduo go 100% at risk. Not sure about anyone else but when you have two programs that basically do the same thing the same way FREE sounds pretty good.
As Momma Kliff would say all the way cool whiz bang in the world can’t beat FREE.