Memorandum

Medtronic 4Q15 (F3Q16) – Record high sales on strong adoption of MiniMed 640G, MiniMed Connect; PMA submission for Guardian Connect next week; 670G pivotal ending, FDA submission before July – March 2, 2016

Executive Highlights

  • Medtronic reported record-high worldwide revenue of $474 million, growing 6% as reported and a strong 11% operationally year-over-year (YOY). International sales of $181 million grew 7% as reported, including striking 24% operational growth in developed markets. A first-time accompanying slide deck cited impressive 65% pump growth in Europe on strong sales of the MiniMed 640G, an acceleration from last quarter’s “nearly 40%” growth. US sales grew 5% on adoption of MiniMed Connect.
  • An FDA PMA submission is expected next week for Guardian Connect, Medtronic’s standalone, Bluetooth-enabled Enlite 3 mobile CGM targeted at MDIs. An EU launch is expected in ~May-July of this year.  
  • An FDA PMA submission for the MiniMed 670G/Enlite 3 hybrid closed loop is targeted “before the end of June 2016.” Enrollment in the US pivotal study will complete in the “next few weeks.” A remarkable “>75% of patients” enrolled in 670G US pivotal study have opted-into the FDA’s continued access program.

Medtronic reported F3Q16 financial results yesterday in a call led by CEO Omar Ishrak, which included a first-time accompanying slide deck (Diabetes is slide seven). We enclose the top ten highlights below, followed by a pipeline summary and an automated insulin delivery competitive landscape review. There was no diabetes-relevant Q&A.

Financial Highlights

1. Record-high worldwide revenue of $474 million grew 6% as reported, a strong 11% operationally year-over-year (YOY), and 5% sequentially. This marks three straight quarters of double-digit operational growth, and balanced growth contributions across geographies.

2. US Diabetes revenue totaled $293 million in F3Q16, growing 5% as reported YOY, 5% sequentially, and tying for Medtronic’s highest US sales ever. Management cited adoption of MiniMed Connect ($199; launched in September) as the driving factor in US growth.

3. International sales of $181 million grew 7% as reported, including a striking 24% operational growth in developed markets ($144 million). The accompanying slide deck (shown for the first time) cited impressive 65% pump growth in Europe on strong sales of the MiniMed 640G, an acceleration from last quarter’s “nearly 40%” growth. This quarter marks three straight of 17%+ YOY operational growth in international developed markets.

4. The type 1-focused Intensive Insulin Management (IIM) division grew in the low double digits operationally, driven by strong MiniMed 640G sales in Europe and Australia. It’s impossible to know how much of the 640G sales traction reflects upgrades vs. new pumpers, though we assume more are upgrades.

5. Medtronic reported “high-single-digit” growth in the Diabetes Service & Solutions (DSS) business on “solid” consumables sales, revenue from Diabeter, and continued strong customer adoption of MiniMed Connect. MiniMed Connect began shipping on September 28 ($199), and as we predicted after the December call, growth accelerated with the wider rollout this quarter. The also suggests competition from Dexcom’s G5 – which launched around the same time last fall – did not hamper uptake significantly.

6. The type 2-focused non-intensive diabetes therapies (NDT) business grew over 250%, led by strong global sales of the iPro2 CGM (US, Latin America, Europe, and Russia were all mentioned on the slide). This was the second consecutive quarter that the NDT division doubled revenue, suggesting an excellent trajectory from a low base of sales

Pipeline Highlights

7. An FDA PMA submission is expected next week for Guardian Connect, Medtronic’s standalone, Bluetooth-enabled Enlite 3 mobile CGM targeted at MDIs (displayed at ATTD last month). This is now on track to hit the JPM 2016 guidance to launch by April 2017 in the US. Medtronic also expects to launch Guardian Connect in ~May-July this year (“early FY17”) in Europe; as of ATTD last month, it was under CE Mark review. This is direct competition to Dexcom’s G5.

8. An FDA PMA submission for the MiniMed 670G/Enlite 3 hybrid closed loop is targeted “before the end of June 2016,” meaning a launch by April 2017 is still possible (an ~10-12-month FDA review). Mr. Ishrak said that enrollment in the US pivotal study will complete in the “next few weeks,” suggesting it is in the home stretch. This is slightly different from Dr. Fran Kaufman’s expectation at ATTD that the trial would end in 25 days (right about now). A remarkable “>75% of patients” enrolled in 670G US pivotal study have opted-into the FDA’s continued access program. There was no update on the MiniMed 640G in the US, presumably confirming the JPM 2016 plan not to launch it in the US.

9. The accompanying slide deck shared plans to launch an Android version of the MiniMed Connect app before June 2016, the first timing ever shared. This update will expand the potential market and keep pace with Dexcom’s plan to launch an Android version of G5 this year. This is coming to market through the Samsung partnership announced at ADA 2015

10. The call did not comment on timing for other near-term pipeline products: (i) the FlowSmart infusion set with partner BD (launching around March-April 2016; see BD’s February call); (ii) a summer 2016 launch of the hypoglycemia prediction app with IBM Watson (see CES); (iii) next-gen CareLink Pro reports in the next 12 months (including analytics to optimize pump basal and bolus settings; per ATTD); and (iv) the data downloading partnership with Glooko (expected in 1H16, according to Glooko).

Financial Highlights

1. Record-high worldwide revenue of $474 million grew 6% as reported, a strong 11% operationally year-over-year (YOY), and 5% sequentially. The YOY comparison was on the easier side, as growth was more modest in F3Q15: 3% as reported and 6% operationally. Still, the performance this quarter (F3Q16) marked record worldwide sales, three straight quarters of double-digit operational growth, and very balanced operational growth across geographies (US: 5%; international (developed): 24%; international (emerging): 13%) and across all three business units [see below]). Management pointed to two factors driving sales: “strong adoption” of the MiniMed 640G outside the US and “strong demand” for MiniMed Connect in the US. Indeed, the US business contributed a 56% share of the quarter’s growth vs. a 44% share for the international business.

Figure 1: Medtronic Worldwide, US, and International Sales (2013-2015)

Table 1: Medtronic Diabetes Worldwide Sales

 

F3Q15

F4Q15

F1Q16

F2Q16

F3Q16

Worldwide Sales (millions)

$449

$467

$445

$450

$474

Year-on-Year (YOY) Growth:
   Reported

   Operational

3%

6%

2%

8%

7%

15%*

5%

11%

6%

11%

Sequential Growth

4%

4%

-5%

1%

5%

*High-single digits excluding an extra selling week.

2. US Diabetes revenue totaled $293 million in F3Q16, growing 5% as reported YOY, 5% sequentially, and tying for Medtronic’s highest US sales ever. Management cited adoption of MiniMed Connect ($199) as the driving factor in US growth, unlike the past two years of quarterly updates that have mostly credited the MiniMed 530G. Presumably the 530G is still growing, but perhaps competition from the Tandem t:slim G4 (launched last September), Animas Vibe (launched last January), or Dexcom G5 (launched last September) are making growth more difficult. Record sales certainly suggest continued 530G uptake, and the 5% YOY revenue growth did come on a tough comparison to ~12% “actual” YOY growth in F3Q15 (subtracting out deferred revenue from F3Q14). This quarter (F3Q16) was the first time in the past year that Medtronic’s US business did not supply 100% of sales growth – that probably reflects very strong 640G growth in Europe combined with better reported growth internationally (less currency impact).  

Table 2: Medtronic Diabetes Sales – US

 

F3Q15

F4Q15

F1Q16

F2Q16

F3Q16

US Sales (millions)

$279

$293

$274

$280

$293

US Sales Growth (YOY)

3% (12%)*

8%

13%

9%

5%

US Sequential Sales Growth

9%

5%

-7%

2%

5%

US Contribution to Overall Medtronic Diabetes Reported Growth

69%

100%

100%

100%

56%

*12% growth was “actual” YOY growth subtracting out deferred revenue recognized in F3Q14

3. International sales of $181 million grew 7% as reported, including a striking 24% operationally in developed markets ($144 million) and 13% operationally in emerging markets ($37 million). The accompanying slide deck (shown for the first time) cited 65% pump growth in Europe on strong sales of the MiniMed 640G, an acceleration from last quarter’s “nearly 40%” growth. It was odd this was not mentioned in prepared remarks, as the growth is pretty impressive. The MiniMed 640G launched last January, though sales seem to be picking up steam – presumably the ramp took some time and the YOY comparisons are on the easier side. This quarter marks three straight of 17%+ YOY operational growth in international developed markets. It’s impossible to know how much of the 640G sales traction reflects upgrades vs. new pumpers, though we assume more are upgrades. International sales increased 7% sequentially, the biggest improvement in the past seven quarters.

  • The emerging market business in diabetes is still early, with sales of $37 million still representing ~20% of Medtronic Diabetes’ total international sales. This was consistent with last quarter’s ~21% and up slightly from F1Q16’s ~18%, though emerging market sales are still not growing substantially at this point. We wonder if Medtronic will launch lower-cost pumps or sensors to increase adoption in these areas. As a reminder, Medtronic only started breaking these sales out for diabetes three quarters ago.

Table 3: Medtronic Diabetes Sales – International

 

F3Q15

F4Q15

F1Q16

F2Q16

F3Q16

International Sales (millions)
   Developed Markets
   Emerging Markets

$170
*
*

$174
$139
$35

$171
$140
$31

$170
$135
$35

$181
$144
$37

Sales Growth (YOY)
  
Reported
   Operational**

3%
12%

- 8%
~8%

- 2%
~18%

-2%
~17%
 

7%
~24%
 

Sequential Sales Growth

-2%

2%

-2%

-1%

-1%

International Contribution to Overall Reported Growth

31%

0%

0%

0%

0%

* Not yet reported; ** F4Q15-F3Q16 operational growth listed for developed markets, which represents ~80% of the business.

  • Prepared remarks mentioned UK NICE’s recent decision to recommend the MiniMed Paradigm Veo in patients with disabling hypoglycemia. Management did not quantify the potential impact of this decision. Despite NICE’s ruling not to recommend the Animas Vibe (“insufficient evidence”), we saw the decision in a mostly positive light: (i) it suggests cost-effectiveness-focused payers do value reductions in hypoglycemia; and (ii) it bodes well for more automated insulin delivery, which will more effectively reduce hypoglycemia (predictive suspend) and potentially improve A1c (hybrid closed loop). See our detailed coverage from early February here.

4. The type 1-focused Intensive Insulin Management (IIM) division grew in the low double digits operationally, driven by strong MiniMed 640G sales in Europe and Asia Pacific. This declined from “mid-teens” growth one quarter ago (F2Q16), though it was consistent with F1Q16’s “low double-digit growth.” This is only the third quarter management has broken out business-segment growth, so there is no basis for YOY comparison. Actual sales have never been broken out for this business, though we would guess it’s the largest of the three.  

 

F1Q16

F2Q16

F3Q16

IIM YOY Operational Growth

Low double digits

Mid-Teens

Low double digits

  • We remain uncertain about the products that flow into the separate divisions. This business is mostly durable pump sales, but what about ongoing CGM sensor and transmitter sales – are those considered “consumable” (and thus in the Diabetes Services & Solutions business, see below), or do those sales flow into IIM?

5. Medtronic reported “high-single-digit” growth in the Diabetes Service & Solutions (DSS) business on “solid” consumables sales, revenue from Diabeter, and continued strong customer adoption of MiniMed Connect. MiniMed Connect began shipping on September 28 ($199), and as we predicted after the December call, growth accelerated with the wider rollout this quarter (F3Q16). Management said the device’s uptake and user feedback “remains extremely positive,” and it is “the only system providing remote access to pump and sensor data on a user’s smartphone (Insulet could be second to market with such an offering, likely late this year or early in 2017 with its next-gen PDM and app; more in its 4Q15 update). It is notable that MiniMed Connect did so well in the quarter, suggesting competition from Dexcom’s G5 – which launched around the same time last fall – did not hamper uptake significantly.

 

F1Q16

F2Q16

F3Q16

DSS YOY Operational Growth

High-single digit

Mid-single digit

High-single digit

  • The MiniMed Connect iPhone/iPod touch app now has 56 reviews and 3.5 stars on the iTunes App Store, up from 39 reviews and the same rating in December. Dexcom’s G5 app has improved to 3.5 stars from its 3.0 star rating in December, perhaps because one update to G5 has launched so far, or because early adopters give harsher grades. These are better scores than connected BGM apps: Roche’s Accu-Chek Connect app has just two stars on 20 reviews, while LifeScan’s OneTouch Reveal app (Verio Flex, VerioSync) has 2.5 stars on 287 reviews. [Note: These ratings are for the latest versions of the aforementioned apps, unless there aren’t enough reviews, in which case “all versions” has been used.] This is a tough crowd, as we’ve said before, though it’s not all doom and gloom – Facebook’s latest app has just 3.0 stars (nearly 2,000 reviews). The move to mobile is pushing traditional diabetes device companies to become software and app developers, and that is no easy task.
  • “We continue to grow the number of contracted patients and expect to expand Diabeter beyond the Netherlands over time.” Management did not offer any other updates on the IT-enabled diabetes clinic it acquired nearly one year ago for an unspecified sum. As noted in our interview with Diabetes Group President Hooman Hakami, the acquisition is part of Medtronic’s highly ambitious goal to serve 20 million patients with diabetes by 2020, an approximate 20-fold increase (!) from the installed base of ~700,000 patients worldwide (as of April).

6. The type 2-focused non-intensive diabetes therapies (NDT) business grew over 250%, led by strong global sales of the iPro2 CGM (US, Latin America, Europe, and Russia were all mentioned on the slide). This was the second consecutive quarter that the NDT division doubled revenue, suggesting an excellent trajectory from a low base of sales (this is Medtronic Diabetes’ newest business, though it arguably has the greatest upside long-term).

  • Management highlighted last quarter’s partnership with distributor Henry Schein, which is already stimulating interest in iPro2 from primary care physicians. Henry Schein reaches an impressive 55% of US physician offices, so there is tons of runway here to expand professional CGM. Medtronic has also received “strong feedback” on the value of Pattern Snapshot, the one-page CareLink iPro CGM download report launched in November.

 

F1Q16

F2Q16

F3Q16

NDT YOY Operational Growth

60%-range

~100%

250%+

  • How big is the professional CGM market now? Is there more upside in endocrinologists or PCPs? Do PCPs have time to set patients up on the technology and review the retrospective data? How much easier can it become to do this? What other business models are possible here (e.g., could a Medtronic clinical team review the data for PCPs?). For actual PCP views on CGM, contact Richard Wood, CEO of the diabetes market research company, dQ&A
  • Professional CGM is quickly becoming a more dynamic field as Abbott plans to launch FreeStyle Libre Pro in the US this year (submitted to FDA in 2Q15). Dexcom seems more focused on the real-time patient side near-term, though the company is building a provider-facing version of Clarity, and perhaps the partnership with Google or other future products will do things on the professional CGM front. Given the number of type 2s not at goal, there is tremendous room for all three companies (and more!) to improve patient outcomes.
  • We are curious what other future products are planned for Medtronic’s NDT division– simple patch devices for type 2 insulin delivery? A type-2 focused CGM? The company has told us both products are in the works, though the key goals are a tall order for any company: easy-to-use, affordable, and actionable. There will be much greater competition in both these product areas in the coming years – can Medtronic set itself apart?

Pipeline Highlights

7. An FDA PMA submission is expected next week for Guardian Connect, Medtronic’s standalone, Bluetooth-enabled Enlite 3 mobile CGM targeted at MDIs (displayed at ATTD last month). This is now on track to hit the JPM 2016 guidance to launch by April 2017 in the US. For context, the PMA for Dexcom’s G5 had a speedy six-month FDA review, and this app should build on the already-cleared MiniMed Connect app (just as G5 built on the already-cleared Dexcom Share app). Medtronic expects to launch Guardian Connect in ~May-July this year (“early FY17”) in Europe; as of ATTD last month, it was under CE Mark review.

  • From what we saw at ATTD, the Guardian Connect Bluetooth transmitter is the familiar clamshell design, though it will send CGM data via Bluetooth directly to a mobile app on Apple iOS at launch. Medtronic reps said there were no plans to launch a standalone receiver in Europe, so patients will only get the transmitter and app. That is similar to the no-handheld-needed FreeStyle LibreLink Android app (which is still invite-only in Sweden, from what we can tell) and an advantage over Dexcom’s G5 (which comes with a backup receiver).
    • Given Dexcom’s G5 setup, we assume Guardian Connect will also launch in the US with a required backup receiver. It would be a regulatory and business win if Medtronic could launch with an app alone in the US, particularly because it would lower the startup cost vs. Dexcom’s G5. That said, Dexcom was always adamant that the FDA would require a backup receiver; it would be surprising if Guardian Connect could launch without one. If it does need one, we wonder what it will look like – will Medtronic simply add a screen and simple user interface to the MiniMed Connect keychain device?

  • We see Guardian Connect as a key competitive answer to Dexcom’s G5 and Abbott’s LibreLink, plus an important Medtronic foray into MDI (Medtronic’s current real-time CGM requires a paired pump). Though we have known about this device since September 2014 (pivotal study completed in August 2015), this is the first time it has ever been on display in final commercial form in an exhibit hall. We’re elated to see the sensor field moving incredibly rapidly to make systems more convenient to use – who would have thought two years ago that we’d have all three players with smartphone apps to view data?! We hope data collection can move quickly so that access questions are at the forefront and broad access is possible.

8. An FDA PMA submission for the MiniMed 670G/Enlite 3 hybrid closed loop is targeted “before the end of June 2016,” meaning a launch by April 2017 is still possible (an ~10-12-month FDA review). As a reminder, this launch timeline was very ambitiously set back at JPM 2015 and confirmed at JPM 2016 in January. Mr. Ishrak said that enrollment in the US pivotal study will complete in the “next few weeks,” suggesting it is in the home stretch. This is slightly different from Dr. Fran Kaufman’s expectation at ATTD that the trial would end in 25 days (right about now). Whatever the study completion timing, it is an impressive two to three months earlier than we expected (May 2016, per ClinicalTrials.gov). Medtronic expects 100 completers. It was not mentioned, but we assume Medtronic will not launch the MiniMed 640G in the US, confirming the suggestion from JPM 2016.

  • The accompanying slide deck noted that a remarkable “>75% of patients” enrolled in 670G US pivotal study have opted-into the FDA’s continued access program. This is an impressive stat, suggesting serious patient enthusiasm for this device, particularly in the clinical trial participants that are likely early adopters. Though we first heard of this successful patient-led petition at DTM 2015 and again at ATTD 2016, this was the first quantification ever provided – the enthusiasm is even higher than we had guessed. Apart from the benefit for these patients, it also suggests FDA has become more confident in the real-world safety of closed loop systems. That might result in a speedier review, though it’s always hard to predict.
  • We’ll be interested to see what the three-month pivotal trial outcomes look like – will these be at ADA 2016? What kind of time-in-range, A1c improvements, and reductions in hypoglycemia should be expected? We’d note that the pivotal study is single-arm and will only have 100 completers, so it won’t be ideal for comparing the system’s efficacy to other interventions. We believe Medtronic opted for the fastest, most efficient study to get the 670G on the market, and the larger post-approval outcomes study (see below) will generate the comparative efficacy data everyone is keen to see.
  • At ATTD, Dr. Kaufman disclosed that Medtronic is planning a major 1,000-patient post-approval outcomes study of the MiniMed 670G (the biggest study Medtronic Diabetes has ever done). The multinational trial will enroll a representative type 1 population (spectrum of A1cs and ages), randomizing patients to three groups for six months: pump alone, sensor-augmented pump (no automation), or the MiniMed 670G (IF only there was a fourth group on MDI!). The primary endpoint will be glycemic control AND hypoglycemia, with a six-month follow-up period. The study will generate excellent real-world outcomes data, and we especially hope it is powered to show changes in severe hypoglycemia and tracks healthcare costs.
  • Dr. Kaufman also showed a schematic to explain how the MiniMed 670G algorithm works, the most detailed we’ve ever seen. It begins with patient specific parameter estimation and daily adaptation. At the start of hybrid closed loop, there is a sensor accuracy check, along with a glycemic target adjustment for a smooth transition to closed-loop. The 670G will revert to open loop if the sensor is inaccurate. Medtronic is using an ePID controller, which has “normal mode” and “exercise mode.” Dr. Kaufman mentioned targets of 120 and 150 mg/dl, respectively, though it was not clear if these are set or can be adjusted. The device has a max insulin limit, and it will switch to safe mode or the pre-programmed basal rate in cases like sensor failure.
  • At this point, 21 investigator-initiated studies (including eight 670G studies) have informed the design of the MiniMed 670G system. Dr. Kaufman admitted that the company has not been as aggressive in publishing data on the system. The system has been stressed with exercise, unannounced meals, sensor failure calibrations, lost transmission, maximal insulin delivery, and in pediatrics. This put into perspective the resource challenges other companies are probably facing – building a closed-loop device is seriously expensive and time consuming.

9. The accompanying slide deck shared plans to launch an Android version of the MiniMed Connect app before June 2016, the first timing ever shared. The MiniMed Connect keychain uploader device only communicates with an Apple iOS app right now, limiting the product to patients with an iPhone, iPod touch, or iPad. This update will expand the potential market and keep pace with Dexcom’s plan to launch an Android version of G5 this year. Caregivers can currently monitor patients from any Internet-connected device (no app needed), so this launch won’t impact remote viewing. We assume this is coming to market through the Samsung partnership announced at ADA 2015, which planned to build out an Android version of MiniMed Connect and other apps optimized for Samsung devices. It’s great to see this big-name partnership making meaningful strides in less than a year.

10. The call did not comment on timing for other near-term pipeline products: (i) the FlowSmart infusion set with partner BD (launching around March-April 2016, per BD’s February call); (ii) a summer 2016 launch of the hypoglycemia prediction app with IBM Watson (per CES); (iii) next-gen CareLink Pro reports in the next 12 months (including analytics to optimize pump basal and bolus settings; per ATTD); and (iv) the data downloading partnership with Glooko (expected in 1H16, according to Glooko). Down the road, Medtronic also has plans for a 10-day wear fifth-gen sensor (one calibration per day, MARD 11%; data shown at ATTD); building Bluetooth directly into its hybrid closed loop (eliminating MiniMed Connect; no timing stated); its next-gen closed loop integrating the DreaMed algorithm (automated correction boluses based on CGM values, no fingerstick confirmation needed); a simple CGM sensor for type 2 (mentioned at DTM 2015); and potentially patch pumps.

Pipeline Summary

Pipeline Product

 

Latest Timeline

MiniMed 670G

Hybrid closed-loop with integrated Enlite 3 CGM sensor

Pivotal study to wrap up in next few weeks, FDA PMA submission before the end of June 2016. Launch expected by April 2017 in the US and April 2018 in the EU.

Guardian Connect CGM

Bluetooth-enabled transmitter, standalone Enlite 3 CGM, mobile app

FDA PMA submission in March 2016; US launch by April 2017.

EU launch in ~May-July 2016 (“early FY17”) in Europe

 

Android version of MiniMed Connect app

Before June 2016

BD FlowSmart Infusion Set

Launch around March-April 2016, per BD’s February call

Hypoglycemia prediction app with IBM Watson

Summer 2016 (per CES and ATTD)

 

Glooko integration for pump/CGM data management

1H16 (according to Glooko)

Next-gen CareLink reports (including analytics to optimize pump basal and bolus settings)

By February 2017

Next-gen artificial pancreas incorporating DreaMed MD-Logic algorithm

Algorithm licensed from DreaMed Diabetes in April 2015; timing unclear, but likely 2018+.

Harmony CGM sensor (fifth generation)

10-day wear, one calibration per day, 90-minute warm up, redundancy via two sensor flexes

MARD of 10.9% vs. the Bayer Contour Next Link meter (n=55 sensors, 5,709 evaluation points); most recent data shown at ATTD 2016.

Building Bluetooth directly into hybrid closed loop

Mentioned at ATTD 2016

Simple CGM sensor for type 2 diabetes

Mentioned at DTM 2015

Patch pumps for type 1 and type 2 diabetes

In development, per Dr. Bruce Bode at AACE 2015. No specifics.

MiniMed Flex

“Hybrid pump” with a smaller footprint, ability to wear on or off the body

First introduced at 2014 Analyst Day, but no updates since.

Automated Insulin Delivery Competitive Landscape

Company / Academic Group

Product

Latest Timing

Recent Coverage

Medtronic

- MiniMed 670G/Enlite 3 (hybrid closed loop)

- Fully automated closed loop (includes the algorithm licensed from DreaMed Diabetes)

- Pivotal study expected to complete in March 2016; FDA PMA submission before end of June; US launch expected by April 2017

- Following 670G

Enclosed

ATTD 2016

Tandem

 

- Predictive low glucose suspend with Dexcom CGM

- Hypoglycemia-Hyperglycemia Minimizer with Dexcom CGM

- Pivotal trial in 2016, launch in 2017

- Pivotal study in 2017, potential launch by end of 2018

Tandem 4Q15

International Diabetes Closed Loop (IDCL) Consortium (TypeZero, UVA, and nine other academic institutions)

Cellnovo + other undisclosed pump companies

Commercial grade version of DiAs hybrid closed loop algorithm that can be embedded in a pump or reside on smartphone. Will use Dexcom CGM. Trial will use multiple pumps; Cellnovo has signed on thus far.

International Diabetes Closed-Loop Trial slated to begin in 2016 at ten international sites

Six-months per person, n=240, commercial-grade DiAs vs. sensor-augmented pump therapy. FDA submission could occur after first six months of the 2.5-year study.

ATTD 2016

NIH Funded $12.7 million International Diabetes Closed Loop Trial designed with a PMA submission in mind

 

Bigfoot Biomedical

Asante pump body (disposable), custom built, durable, Bluetooth-enabled controller (no screen or buttons) that talks to Dexcom CGM and includes a control algorithm. Smartphone to serve as the window to the system and complete user interface.

Pivotal study in 1H17, FDA submission by the end of 2017; commercial launch by the end of 2018.

JPM 2016

(Presentation at Digital Health Showcase and Demo at Health 2.0)

Insulet

OmniPod with Mode AGC hybrid closed loop algorithm (commercial version of UCSB algorithm), built-in Bluetooth, paired with smartphone app and/or backup PDM handheld. Will use Dexcom CGM.

On-body clinical trials starting later this year, pivotal study “toward the end of 2017.”

Insulet 4Q15

MGH/BU

Bionic Pancreas iLet (24-hour, hybrid or fully closed loop, insulin-only or insulin+glucagon, dual chambered pump with built-in algorithm, Dexcom CGM). May launch as insulin-only product, with glucagon to be added later.

Pivotal trial in early 2017

ATTD 2016

Animas

Hypoglycemia-Hyperglycemia Minimizer with Dexcom CGM

Currently planning pivotal study; no timing specifics

ATTD 2016

Cambridge

Upcoming studies will use Medtronic’s MiniMed 640G/Enlite 3 + an Android phone running Cambridge’s MPC.

Commercialization plans unknown. Three upcoming studies ranging from three to 24 months in length.

ATTD 2016

Cellnovo

- IDCL Consortium Partner

- Diabeloop consortium partner

 

- See above

- First clinical trials were expected to start at the end of 2015, and development and CE marking programs will run until 2018

ATTD 2016

Cellnovo 4Q15

Roche

Working internally on a new CGM, with future potential application to an artificial pancreas device

“On our agenda”

CGM expected to launch in EU in 2016

ATTD 2016

 

-- by Adam Brown and Kelly Close