In case you're wondering what's up with troubled insulin pump company Tandem Diabetes Care and how it handled itself at the largest diabetes conference of the year, here's an update.
With recent financial woes, no one knows what the touchscreen pump maker's future holds. But some symbolic assurance came in early June surrounding the American Diabetes Association's 77th Scientific Sessions in San Diego, home turf of the young company that entered the market just five years ago.
While they weren't showing off much new on the ADA exhibit hall floor, or even on the science side, the company hosted a Media Day at its nearby headquarters on the Friday just prior -- ostensibly to promote the message that they're still going strong.
Although many fear the company may not outlive the current financial crisis, one thing is clear: Tandem Diabetes won't go down without a fight, and it isn't compromising its principles of working to best serve patients and the broader D-tech ecosystem. In fact, Tandem has a lot packed into its near-term pipeline that is pretty darn exciting for the Diabetes Community.
ON ROCKY FOOTING
First, let's take a quick look at how the company got on such rocky financial footing.
Just last year, Tandem was excited about its patient base and product developments, especially its almost-ready-to-be-announced X2 platform that would allow remote D-device updating from home. It was even expanding its sales force as we entered the middle of 2016, keeping pace with the roughly 53,000 insulin pumps on the market.
Then suddenly, a three-punch to the gut changed everything:
- The UHC Deal: Medtronic announced an exclusive, preferred brand deal with United HealthCare, effective July 1, 2016 -- meaning those with UHC insurance would be restricted to MedT insulin pumps and urged to not consider competitive brands. Our D-Community cried foul and even started a #DiabetesAccessMatters protest campaign to spread word among the D-device industry, payers and healthcare providers. Tandem soon began feeling the effect of the agreement with fewer new customers in the latter half of the year. At the Media Day, it was quite enlightening to hear Tandem execs say that they, too, had been given opportunities to enter these exclusive-payer deals, but that they've refused for the sake of preserving patient choice (!).
- Hello, 630G and 670G: Then, another Medtronic surge of news came in August with the announcement of its updated 630G pump-CGM system being launched here in the U.S. Although MedT hadn't talked publicly about this model (which was not quite as advanced as the 640G available internationally), it captured conversation. And soon after, the milestone announcement came in early Fall about the 670G getting FDA clearance, as the first-ever "Hybrid Closed Loop" system in the world. While that wasn't going to hit market until Spring 2017 at the earliest, the announcement hit the competition hard and Tandem says it saw a dip in pump and supply purchases at the end of last year.
- New x2 Platform: As noted, Tandem's been excited about this innovative, game-changing way of approaching diabetes device tech upgrades. But when the X2 announcement came in October 2016, it became clear that the first iteration of X2 would not integrate with CGM, since that required separate, more intense FDA scrutiny. In fact, it's still before the regulatory agency and is expected yet this summer. When potential customers heard that the latest, "groundbreaking" tech from Tandem would not initially offer integration with Dexcom's CGM, many saw that as a step backwards. It even made the t:slim G4 obsolete. And of course, that also hit Tandem's bottom line.
Stock prices plummeted and investors started getting very worried, along with many patients. It didn't help to boost confidence that established pharma giant Roche decided at the end of last year to stop selling insulin pumps in the U.S., and that JnJ began a strategic evaluation of whether it would even stay in the diabetes device market with Animas/Lifescan/OneTouch. We've seen what has happened over the years with other insulin pumps such as Deltec's Cozmo and the Asante Snap going defunct, and all of that brought even more baggage to this bleak business picture for Tandem.
Tandem has borrowed money, and the company's top brass has specifically stated they wish they weren't in need of this lifeline to stay afloat.
And so, leading up to June 2017, people were wondering: Can Tandem even survive?
At the Media Day, I lost count how many times I heard reassurances along the lines of, "We aren't going anywhere" and "We are going to be OK."
Clearly, that's PR spin, but we hope it turns out to be the case. And from what we see in their short-term product pipeline, it does look promising that Tandem can turn their business around.
COOL PRODUCTS COMING SOON
At #2017ADA, Tandem was touting its remote upgrade program with the slogan, "Pump that gets updated, not outdated" -- even displaying this in ads at the San Diego airport where thousands of attendees were a captive audience. We know from the Media Day that a handful of main things are in the works:
G5 Integration: Tandem has already submitted to the FDA its integration with the Dexcom G5, allowing for its remote Device Updater to give pumpers access to G5 data directly on their t:slim X2 devices. The company remains prepared for a Summer 2017 launch depending on regulatory timing, and it's vowed to launch within 30 days of getting that FDA clearance. Interestingly, Tandem says that update will be referred to as "Pendleton," a nod to its practice of naming all the updates after local California beaches. Tandem also points out that anyone who purchases the Tandem t:slim X2 before this approval will be able to update the CGM software at no cost. This is one of the most-anticipated aspects of the Device Updater (roughly 1,500 pumpers have signed up so far). Right now, the Updater can only be used via a USB-computer, but they're exploring whether wireless updating could be offered in the future.
Mobile App:There will be a mobile app available with the G5 integration, with an ETA sometime in '18. At Media Day, we got to see some slide images of the app, but since it's not approved yet those couldn't be shared. The initial version will have BT-beamed data from the G5-integrated X2 pump-CGM device with alerts and reminders, as well as auto-uploading to its t:connect software in the cloud to share with providers and connectivity to BG meters. Eventually, Tandem plans to weave in a remote bolus calculator, auto setup features, real-time CGM data (instead of just retroactive), training and education materials, and more data-sharing features allowing for decision-support aspects based on pattern recognition. Tandem also says they're designing it to be paired with just ONE smartphone, to avoid confusion and the option to remotely bolus a child/user. Some posed a question about whether a food database could be included as well, and the Tandem folks seemed interested in exploring that.
t:flex X2: Yes, a larger version of the t:flex pump is in the works, according to Tandem. This would be a 480-unit reservoir device just like the regular t:flex available now, but will also include the BT-enabled remote updating component. Timing's TBD on that officially, but the initial development and launch planning has at least started. Maybe by end of 2018...?
New Case: OK, this may be less of a big deal for some, but it's exciting to see innovation continuing on new pump cases that clip to your belt. Tandem teamed up with a cell phone case manufacturer to craft these durable cases that are resistant to abrasion and grease and have a stainless steel rotating clip. These will come in a handful of colors and are expected soon, this summer.
While many are honing in on closed loop technology these days, and Tandem certainly has that on its radar, it wasn't a big focus for the company at this year's ADA conference or their Media Day. Tandem did present some early feasibility study data on its Predictive Low Glucose Suspend (PLGS) tech expected in 2018, and we did get some mention of the later Type Zero closed loop it's developing beyond that. All of that's expected in the next year or two.
But the biggest items of interest involved infusion sets that are expected in the next few months, as well as the cool mini-pump that Tandem is developing.
Infusion Sets and the New t:lock Connector: This was in the news earlier in the year, but there's been some confusion among PWDs about what exactly is changing. Tandem iis rebranding with a new infusion set and taking on the sales aspect itself for the first time.
Up until now, customers could choose from a variety of infusion sets that are actually all made by UnoMedical, but carry different brand names depending on which insulin pump you use. So a Tandem pump customer may get a Tandem-specific set, but it's actually sold by Animas (via a middle-man distributor).
The company says it's lost out on millions over the past several years by not selling infusion sets themselves. Now, Tandem is changing that with its t:lock connector announced earlier this year -- something the company describes as not proprietary, that allows users to save 4.5 units of insulin per set/tubing change and cut down the refill time by 30 seconds.
Most interestingly, Tandem showed us this color chart that I dubbed "The Periodic Table of Infusion Sets."
Editor's Note: After publishing our original article, we clarified with Tandem that the infusion sets listed on the table in white will not be compatible with the new t:lock, meaning that there will be less choice going forward as to infusion sets.
Next-Gen t:sport Mini Pump: Wow, we got a first look at what Tandem's next-generation mini device!
It's at least preliminarily called the t:sport.
It will be quite a bit smaller overall and reduced cartridge size from the regular t:slim pump, and the screen display will be eliminated, in favor of having all the data displayed directly on a smartphone. It will be a disposal stick-to-your body device, but not quite a full patch pump, as it would still need the four-inch infusion set connector for tubing.
Very cool! There's no official launch timeline yet, but Tandem is clearly excited about this smaller discreet pump.
There was some other good discussion ranging from how Tandem is keeping an eye on cyber security with its next-gen tech and mobile health offerings, to how it's partnering with patient advocacy groups like FitBlog, College Diabetes Network, and Connected in Motion.
We also got a tour of the Tandem manufacturing facility, something I'd seen before during my June 2015 visit just before the t:slim G4 was launched. But it was good to go through the facility again, especially in light of all the current business concerns; this place can produce 30,000 complete pumps from a single shift each year, or roughly 120/day, and more than one million cartridges come from a single shift of Tandem manufacturing (or 4,000 cartridges a day)!
So we're encouraged and hoping for the best, and of course anxiously watching for what comes next for Tandem... Like many, we'll be plugged into the next quarterly investor earnings call planned for roughly mid-July.