I have been following the progress of Bigfoot Biomedical with interest: the founder, Jeffrey Brewer, is trying to do the right thing (closed loop controlled by a smartphone), and he did it as a T1, but mostly as the parent of a T1:
So, obviously, I have been sympathetic. In 2015, Bigfoot acquired the assets of Asante (Snap insulin pump), which had just gone belly up, and signed a deal with Dexcom. Both made sense, since the Snap insulin pump was actually really well received by its users – so Bigfoot was able to acquire pump technology very cheaply, and already had FDA approval for the pump. Dexcom was a clearcut shot towards closed loop control – you need a CGM for that.
Since that time, silence on progress, or, when there are news, they are dissonant:
no news on progress of clinical trials.
product pipeline: the original 2017 goal for product delivery now seems to have slipped to 2019, with tentative FDA approval by 2018.
additional capital round: in Jan 2017, Bogfoot had to raise more capital (they got it from the new JDRF investment fund). While not bad in itself, this means they must have diluted quite a bit before reaching any of their product delivery goals.
Dexcom deal: Bigfoot ended its deal with Dexcom, the best CGM provider in existence, to sign up with Abbott (Freestyle Libre) giving for reason the need to calibrate the Dexcom. Well - not only is the Libre not FDA approved yet, but we already have heard of problems with Abbott customer support, while Dexcom customer support is second to none. So, in one move, Bigfoot significantly increased its delivery risk and decreased its likelihood of good customer support.
Bigfoot just acquired Timesulin, a insulin pen cap with timer. There is some weak rationale for that – but it is a clear defocus from the original closed loop control delivery that Bigfoot had started on.
vague mission statement: Bigfoot mission statement is now very elusive: “designing simpler, safer, and more effective solutions for people with insulin-requiring diabetes.” This allows them to do pretty much anything they feel like at any time. No discipline is imposed on the company by its mission statement - dangerous in my opinion, based on my startup past
So where is Bigfoot going? What do you think? I was very excited by their first couple of years. I think they may be stumbling right now.
This part is puzzling for a pump company, except if they did it for the resources they could acquire with the acquisition. Bigfoot just acquired Timesulin, a insulin pen cap with timer.
This is not too surprising. It’s not often this stuff meets announced release dates, the 670G being the only exception I can think of. product pipeline: the original 2017 goal for product delivery now seems to have slipped to 2019, with tentative FDA approval by 2018.
A while ago I heard some strange things about them that made me kind of wonder about their AP ideas. It seemed to be an over-simplification, like they weren’t really going after the “A Team” diabetics. But I don’t know what their current philosophy is.
Compare this to another small pump company struggling to compete against the corporate giants.
Still waiting on the (imminent) FDA approval of the Tandem t:slim X2 and Dexcom G5 integration.
Press releases cut-n-pasted:
(Some additional removals from some of the more blah blah blah)
Aug. 8, 2017 - The USPTO issues U.S. Patent No. 9,715,327 to Tandem Diabetes Care covering safety features for the prevention of unintended changes in touchscreen-enabled ambulatory infusion pumps, including insulin pumps. The patent will be effective until 2033.
Aug. 15, 2017 - Enrollment is underway in an at-home clinical trial assessing Tandem Diabetes Care’s t:slim X2 Insulin Pump featuring its predictive low glucose suspend (PLGS) technology, designed to suspend insulin delivery when low blood glucose is predicted and resume insulin delivery when glucose levels start to rise.
Aug. 23, 2017 - Tandem Diabetes Care, today announced the launch of the t:lock™ Connector for its insulin pump cartridges and infusion sets. All of the infusion sets currently offered by the Company will be made available with the new t:lock Connector, produced and supplied by Unomedical.
Aug. 24, 2017 - The USPTO issues U.S. Patent No. 9,737,656 to Tandem Diabetes Care covering the use of a software application operating on a remote consumer electronic device to initiate, program and deliver a medicament (substance used for medical treatment) bolus to a patient using a medical infusion pump where the pump provides an indication of the bolus (e.g., by audible or vibration alert). The patent is in effect until 2035.
The best announcement for the company is the t:lock, thus meaning that every set that gets used on their system will result in cash flow for them. Obviously, the other announcements are great for the patients.
It is good for the company as far as revenue, but it is bad for the users. Whenever there is a proprietary technology, the user’s choice is restricted.
If there was a back-order from one infusion set company (tandem, roche, animas), you used to be able to choose a different infusion set and it would work. The interchangeability was a good thing for users.
What if pharmacy companies changed it so you could only use one particular needle for a NovoLog pen, and a different type of needle Humalog pen? How would people respond to that? They would be furious. But that is kind of the same thing with the infusion sets now. They are pretty much all proprietary (except for animas and the good old Luer lock).
While I agree with you in principal, I think this company is doing the right thing and we want them around both because we love their product but also because MDT needs competition or they will stop innovating. Looking at their stock price, I bet you can’t guess when the UHC decision came down and wiped out 1/3 of their business. (hint: 3 months prior to the drop when they had to announce earnings). If this is what it takes to keep them viable, I am all for it.
This decision is unconscionable, and a disaster for PWDs. No insurance company should be able to dictate to the CP what the appropriate equipment should be for the patient.
I agree with both opinions… I feel that interchangeability is a win for consumers. But I also want to see Tandem survive. It seems a shame that it should come at the cost of the consumers – which it does in this case.
Well sure, but it is two different things. I understand they are doing it for revenue, and they need to, and I want them to stick around.
But often times what is best for the company is at odds with what is best for the DC.
The infusion decision does not affect me at all, so I have no dog in this fight.
I like Tandem. But I am a big proponent of consumer choice (and being able to build your own solution), so their decision is at odds with my basic principal. But regardless, I wish them well. I don’t want them to dry up.
The number one reason UHC has offered for the decision to restrict choice for its subscribes to the Medtronic pumps:
“Patient safety was a key consideration. The 2012 ASPIRE study found that pumps with a Threshold Suspend feature help reduce the frequency and duration of low blood sugar events.”
So do you think UHC will still be saying the same thing when Tandem has this feature as well? Or will UHC change their wording and come up with a different reason to be forcing people onto Medtronic? In my experience, UHC does these arrangements for one reason. It all comes down to money. I remember when UHC did a very similar thing between Quest Diagnostics and LabCorp of America for diagnostic testing. It was all about money money money.
Tandem Diabetes Pipeline:
Predictive Low Glucose Suspend (PLGS)
Our first-generation Automated Insulin Delivery (AID) system is planned to include a Predictive Low Glucose Suspend (PLGS) algorithm. The algorithm will use CGM data to help predict future hypoglycemia (low blood sugar) before it happens and is designed to adjust insulin to help minimize the frequency and or duration of hypoglycemic events. The algorithm was developed internally in consultation with thought leaders in Automated Insulin Delivery and Artificial Pancreas research.
You, of course, answered your question. This is about money, not about safety. Safety was just the nice way to say we have reached a decision to minimize your choice but we don’t want to take flak about that. So, just like in many states, we are doing it for the kids…
If interested, update on the Tandem (TNDM) stock price. +44% bump yesterday (on heavy volume) from the early morning announcement of FDA approval for the X2/G5 integration.
EDIT: lol - Today it looks like TNDM is dropping back down to the 80 cents range. In any event - getting the FDA approval certainly shows real progress.
UHC certainly should allow free choice of Tandem as that (insulin suspend) was the UHC publicly stated reason for going with Medtronic. I doubt UHC actually will as I have zero doubts that this was all about a backroom deal and money changing hands. But maybe I am just overly pessimistic. Who knows. Time will tell.
The Tandem study for the insulin suspend (PLGS) is not even scheduled to have the results back until November and then it has to go to the FDA so it is still quite a ways out. Tandem has this listed in their pipeline as a Summer 2018 launch but clearly a lot has to happen and the FDA works on their own timeframe.
Still in the grand scheme of things, one could view Summer of 2018 as “right around the corner”. I guess it all depends on your perspective.
Summer 2018 is definitely “right around the corner” in FDA speak. I, like you, am pessimistic about UHC. The good news with insulin pump studies, is that you can download the system into existing pump users, and there are enthusiastic patients ready to help you out, so finishing the studies is quick.
