As we've often noted, one of the best ways to find out what's new and hot in diabetes technology is to follow the industry's "earnings calls" -- those quarterly webcasts designed to update investors on predicted product pipelines and business flow in the months ahead. These calls also offer us patients a sneak peek into what we can expect down the road.
With the end of the first quarter approaching at the end of March, the big diabetes tech companies are currently updating investors on their scope of business from the past year and what they have on tap for 2017. Quite a lot of interesting news came out of calls over the past few weeks by Tandem Diabetes Care, Medtronic, Dexcom, Insulet and others.
Here's a rundown of what we learned by listening in:
Tandem Diabetes Care
Anyone plugged in to the financial side of Tandem Diabetes knows business isn't good these days for the California insulin pump company, which first brought us the novel touchscreen t:slim pump five years ago.
Business woes have been plaguing the company for months and Tandem's been trying to bring in revenue however it can, including a March 1 filing with the SEC for a follow-up public offering aimed at garnering more money. It's also not a good sign when a company files with the SEC notice that it's going to pay cash bonuses to two top execs to stay with the company throughout the spring and summer.
Speculation is swirling about how long Tandem can last and whether a buyout might be coming sooner rather than later, but right now nothing's official.
Meanwhile, Tandem continues promising that it has big innovations in D-Tech on tap.
Remote Pump Updater: A hopeful sign came March 2, when Tandem announced it was finally ready to launch its Device Updater that was approved by the FDA last summer. This is a first in the insulin pump world, allowing a pump to be updated remotely from home, just like a smartphone can be. Soon, anyone who bought a t:slim before April 2015 (when new software features were built into those devices), can use this software updater to bring their older t:slim pumps up to date with the latest version of software. Tandem has also filed with the a submission FDA for approval to use this Remote Updater with its new t:slim X2 platform for future CGM integration (more on that below).
New Infusion Set Connector: Ahead of Tandem's March 8 earnings call the company announced plans to launch a new infusion set connector dubbed the t:lock. For those uninitiated in insulin pumps: This pump uses a Luer-Lock tube connector that's a universal design and works for most insulin pump models, except the proprietary ones made for Medtronic pumps. Tandem offers four types of infusion sets (t:90, t:30, Comfort, and Contact sets; the Cleo was phased out last year) and before the t:lock you could use other Luer-Lock infusion sets. After the end of this year, anyone using t:slim pumps will have to use infusion sets that have this specific t:lock connector.
According to a Tandem spokesman, "The t:lock connector is not actually proprietary -- it has been used by other companies, for other therapies. Tandem has customized it for use with our insulin pumps. The t:lock should not impact patient experience, and users will still be able to get supplies, either from distributors or Tandem directly. The vast majority of users use the sets Tandem has always provided."
OK, the fact is you'll have to get the sets directly from Tandem or a distributor and they must have this unique t:lock connector... That's proprietary, folks. The marketing materials describe this as being "based on direct customer feedback" and a helpful innovation that saves 4.5 units of insulin and cuts down the timing of filling the reservoir by more than 30 seconds. This will start rolling out in the coming months, and Tandem expects all customers to be switched over to use these t:lock connectors by year's end.
Dexcom Integration: Tandem has submitted to the FDA its integration with the Dexcom G5, allowing for the above-mentioned Remote Updater to give pumpers access to G5 data directly on their t:slim X2 devices. The company's preparing for a mid-2017 launch, and expects to be ready get this on the market within 30 days of regulatory approval. 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 -- something that indicates to us, at least, that Tandem may be planning to charge other customers to update their X2 devices for CGM functionality.
Closed-Loop System: Tandem is working on its first automated insulin delivery system, following a pre-submission meeting with the FDA in December 2016 regarding pivotal trial development. Five trial sites have been determined and this NIH-funded work is expected to end by the end of October, meaning we could see a submission by year's end or early 2018 and possibly a launch sometime next year. As detailed before, this first-gen system will have a Predictive Low Glucose Suspend (PLGS) feature that would automatically shut off insulin delivery when a hypo is predicted based on the Dexcom CGM. For its second generation, Tandem plans to integrate an algorithm created by TypeZero Technologies for a "treat-to-target" system to adjust insulin doses to keep users continually aiming for a particular blood sugar number. That will use the Dexcom G6, which will likely be available starting next year. That is also expected by the end of 2018.
Medtronic held is quarterly earnings call on Feb. 21. While it didn't offer much update on their future pipeline, the company's leadership was of course excited about the upcoming launch of the Minimed 670G -- the first Hybrid Closed Loop that can automatically sense glucose values based on CGM readings, and adjust insulin basal doses accordingly to keep users in the vicinity of a pre-set 120 mg/dL target. While you still have to bolus for corrections and meals, this next-generation technology that was FDA approved in September 2016 has been more than a decade in the making and it's the first of many closed loop iterations to come, from Medtronic and beyond.
On March 6, Medtronic Diabetes announced that it was beginning a "staggered rollout" of the 670G. The company has been promising a Spring 2017 launch for months now, but it turns out that isn't exactly the case for most people interested in this D-tech. Instead, it will be at least June or later summer before most PWDs will have access to it, thanks to this incremental launch plan:
- Early March (now started): Begins with ~100 MedT employees who are a subset of the larger Priority Access Program group, plus a small number of Health Care Practitioners (HCPs) who will be early system "testers." MedT is working to figure out the most diverse group to do a "dry-run" of these systems.
- Mid to Late March: Will expand to slightly larger group of external customers who are registered in their Priority Access Program.
- June: Launch to the entire Priority Access Program group.
- End Summer/Early Fall: Full commercial launch in the U.S. for new and existing customers.
More details on the Priority Access Program and the company's 670G rollout can be found here. This is generating a lot of buzz these days across the board in the diabetes device industry.
From sources outside the recent earnings call, we know there's more than just the Hybrid Closed Loop on the near-term horizon.
Stand-Alone Guardian Connect: We reported on Medtronic's plans for a next-gen stand-alone CGM system back in October 2014, and are now told the company has renamed it the Guardian Connect (consistent with its Minimed Connect data-viewing platform, no doubt), and it will use the same Guardian 3 CGM sensor being unveiled with the 670G system. It's already been approved internationally, and is before the FDA for review now. We pressed for more detail, but the company would only say the plan is to launch in late 2017 once it gets the FDA's nod.
Minimed 690G: We were excited to see coverage from the Advanced Technologies and Treatments for Diabetes (ATTD) event in France in February outlining the next-gen tech that MedT has in mind. Say hello to the Minimed 690G, a more fully automated version of the closed loop we're now just starting to see launched here in the States. From what we saw of screen images, the form factor looks mostly the same as the 670G but it offers a fuzzy-logic algorithm that enables automatic bolusing, meal dosing and exercise input factored into the system. This is one of four closed loop systems being studied in the ongoing NIH-funded closed loop research (along with Tandem/TypeZero's InControl system, Beta Bionics' iLET, and the University of Cambridge research on the FlorenceM system). As of now, there's no timing on this but we can assume it's slated for roughly 2020 if the R&D goes accordingly to plan.
The California-based CGM company held its quarterly earnings call on Feb. 28. While the Centers for Medicare and Medicaid Services (CMS) limited coverage decision is a monumental stepping stone toward getting Medicare coverage for CGMs across the board, it hasn't yet materialized into a finalized process. Meanwhile, we're all pretty excited about the latest in the Dexcom's pipeline and its future tech plans:
- Touchscreen Receiver: an upgraded version of the current Dexcom Receiver will improve on durability and speaker issues for alerts and alarms. Currently pending at the FDA.
- G5x Transmitter: an upgrade to the G5 system that will be more compact, and even smaller than the previous G4 model. Currently pending at the FDA.
- New One-Button Insertion Device: expected at some point mid-year. From prototype images we've seen, it appears to resemble the Medtronic Enlite sensor inserter that can be operated with one hand. Currently pending at the FDA.
G5 Mobile App: Dexcom has filed firmware updates to its iOS-compatible G5 app, which may
include new features such as Insulin on Board (IOB) information as well as
other retrospective data analysis reports. The company is also awaiting regulatory OK for its Android-compatible version of the G5 app.
- Next-generation G6 sensor: pivotal trial work for the next-generation G6 sensor continues, and Dexcom plans to file that with the FDA by the end of September. The goal: Launch in early 2018. The G6 will be a true leap forward in CGM tech, with 10 days of wear instead of the current 7, only one daily calibration required instead of two, and improved accuracy and reliability. Given how quickly the FDA has moved on D-tech in recent years, we're optimistic!
Verily Collaboration: Dexcom is also continuing its work on the first-generation tech with Verily (formerly Google Life Sciences) that will be a miniaturized, dime-sized version of a CGM sensor that requires no calibration. Since it's based on the G6 planned for launch in the first half of 2018 (depending on regulatory review), Dexcom hopes for commercialized at the end of '18. The second-generation is planned for roughly 2020 or 2021.
Smart Insulin Pens: Interestingly, Dexcom also said on its earnings call that they're interested in exploring the smart insulin pen market -- particularly on the heels of key clinical trial data showing the benefits of CGM for those on injections only, and not insulin pumps. "We're very bullish on the opportunity for smart pens," CEO Kevin Sayer said. "The real value in these systems will be integrating that insulin on board (IOB) information from a smart pen, together with our CGM data, in a single unified app on the phone. We can do some pretty powerful stuff there. So, when you start demonstrating outcomes with a smart pen together with CGM data and providing patients with dosing support information, behavior modification information, really, at a fraction of the cost of some more complex systems, I think we really have a home run there."
We hope so. As always, we can't wait to see what's next from Dexcom.
In its Feb. 28 earnings call, Boston-based OmniPod-maker Insulet highlighted its plans for 2017 after recapping the business end from the past year. Largely, there weren't any updates on D-Tech that we haven't heard before:
- OmniPod DASH: As we reported last Fall, the big news is Insulet's development of its next-gen, touchscreen OmniPod DASH platform that will have a new touchscreen PDM and Bluetooth-enabled Pod. That has not yet been submitted to the FDA from what we've heard, and even though Insulet says it's now doing the clinical human factors work on this device, it's still planning for a launch late 2017. We expect to see this new platform on display at the ADA Scientific Sessions in June, and as of now the company's expecting a phased rollout that goes through the first few months of 2018.
- Closed-Loop Tech: Early clinical work continues on Insulet's Horizon closed loop technology, which will at first bring us a hybrid closed loop at some point in late 2019 and eventually a more fully automatic closed loop system.
- Access and Awareness: Insulet says it's also discussing Medicare coverage of OmiPod and expanding its sales and awareness efforts across the U.S. during 2017. Later this year, Podders can also expect to see an online patient portal for training on the patch pump as well as an online resource for investigating both insurance benefits and financial assistance programs for OmniPod.
While there wasn't a whole lot of meaty stuff coming out of recent earnings calls from other players in the diabetes tech world, there are a few noteworthy nuggets worth sharing:
Abbott Diabetes: During the company's late January earnings call that it was expecting the FreeStyle Libre Flash Glucose Monitoring (FGM) system to be *finally* become available in the U.S. sometime in the second half of 2017. The company filed for approval mid-2015, and while the blinded professional version got regulatory clearance last Fall and is already available, the consumer version remains pending with the FDA.
Roche: Hardly anything on diabetes was mentioned during this Pharma giant's Feb. 1 earnings call. Still, there's some D-intrigue surrounding Roche. Following the company's decision to stop selling insulin pumps in the U.S. at the start of 2017, its latest Accu-Chek Guide meter is still not available after getting approval last summer; it's a bit of a head-scratcher as to what is taking so long on that one.
And updates from attendees of the big ATTD meeting in France in February indicate that Roche was showing off its own CGM system under development that will be called the Accu-Chek Insight CGM.
While that future product has been discussed and displayed for years now, there appears to a lot of buzz now about Roche bringing it to the U.S. soon, and about more D-Tech partnerships with other companies. For example, Roche and Medtronic recently announced an exclusive deal to create a Bluetooth-enabled glucose meter that can be used with MedT pumps. And while nothing's yet in ink, we also heard rumor recently that Roche could be talking with closed loop startup Bigfoot Biomedical about future possibilities. We'll be keeping a close eye on the Roche as the year progresses.
JnJ Diabetes Companies: We're all still on the edge of our seats waiting to see what Johnson and Johnson decides to do with its Lifescan/ OneTouch /Animas diabetes tech brands. The company has announced publicly that it's exploring strategies on the future of all its diabetes business, with options ranging from restructuring to possibly selling off certain divisions. Hopefully, their many diabetes tools that so many of us have come to rely on don't disappear.
So D-peeps, any thoughts to share on all this new stuff coming down the pike? Or anything to add?