Big news in the Diabetes Community’s tech space, as the FDA has granted what it dubs “breakthrough device designation” to a future closed loop system that combines a continuous glucose monitor with an insulin patch pump to rival the tubeless OmniPod.

On March 14, the FDA gave South Korean company EoFlow this fast-track designation for its Automated Insulin Delivery (AID) system called EoPancreas. This is the fourth time FDA has granted the new breakthrough device designation to a diabetes closed loop system since it was created in 2016 — Bigfoot Biomedical received it in November 2017 for their future AID tech, and Medtronic received it with pediatric approval of the Minimed 670G last summer and then again in February 2019 for a future “personalized closed loop system” the company is developing.

While EoFlow isn’t as well known as some others in this space, it’s a company we have seen over the years displaying its patch pump and connected mobile app at conferences like the ADA’s annual Scientific Sessions. The tubeless pump itself is called the EoPatch, and rumor had it they were working on a CGM but there hasn’t been much detail available to date. The JDRF partnered with the company a couple years back (the first time it funded any Korean closed loop research), and now they’re celebrating access to an accelerated regulatory review process that could translate to a sooner-than-expected launch here in the USA.

Here’s what we know about the EoPancreas, after talking with EoFlow’s President Luis Malave (a former Insulet executive over a decade ago and Minimed’s R&D director during the ’90s), as well as information online:

What is EoPancreas?

For those who haven’t heard of EoFlow before, it’s a South Korean company founded in 2011 that now has an office in San Jose, CA. Its founder and CEO Jesse Kim ran a semi-conductor startup in Silicon Valley after graduating from MIT and eventually started up EoFlow as a university incubation center in Seoul. Since October 2017, Malave has been part of the team working out of the California office.

Their suite of products that make up the EoPancreas system now includes:

Patch Pump: Referred to as the EoPatch, it’s a rectangular pager-sized insulin pump that adheres to the skin without the need for plastic tubing like traditional pumps use. It’s fully disposable and waterproof, lasting 72 hours on the body and holding up to 200 units of insulin. The design that will ultimately come to market may vary to some degree, but the form factor remains mostly the same. The existing first-generation EoFlow patch pump is quite a bit thinner (at 9.9mm x 32.4mm x 12.9mm) than the OmniPod (39mm x 52mm x 14.5mm). The EoPatch also uses a 30-gauge stainless steel needle inside to help minimize occlusions (clogging). But because the CGM would be built into the patch pump itself, chances are it would add a bit of thickness, roughly half a centimeter, we’re told. Malave also tells us they expect to launch just the patch pump in the U.S. first, as a sort of first-generation before adding in smart algorithms and eventually the built in CGM technology.

Receiver or Smartphone Control: The EoPatch version that’s already available in Korea uses a handheld device much like OmniPod’s Personal Diabetes Manager (PDM) to function; there are no buttons on the patch pump itself. Per the EoFlow website, what comes to market in America would use a special handheld controller with color touchscreen interface — locked-down Android smartphone style. Whether this PDM-style device is what we see launch with the full EoPancreas system remains to be seen, as the company is likely discussing smartphone app-control with regulators. This is already a discussion that Insulet is having with regulators for its next-gen OmniPod closed loop platforms, so we may see some movement there before long.

CGM Sensor: There isn’t a lot of detail out there publicly, but we’re told the EoPancreas will be integrated with existing CGM technology. Specifically, the company has reached an agreement to use the CT-100B CGM sensor made by China-based POCTech, which we’ve seen on display at conferences as a “me too” product that brags about its “tiny soft” .3mm sensor and accuracy. That CGM sensor will be built into the patch pump, though Malave tells us they also hope to collaborate with other CGM manufacturers to have those as options with the EoPancreas system. As noted, the POCTech CGM sensor will add a bit of thickness to the overall device design, Malave says. Given the FDA’s new “iCGM” (interoperable CGM) designation granted first to Dexcom G6, we can imagine where EoPancreas hopes to go as it moves forward.

EoCloud: Like most connected systems these days, the EoPancreas will offer its own cloud-based software, that its calling EoCloud. This will utilize Artificial Intelligence (AI) algorithms running on a proprietary platform to do the calculations that help it learn about each user, allowing customization of the closed loop control for each PWD (person with diabetes). We’re told the system’s smarts will be based on the TypeZero Technologies algorithm licensed in 2018 prior to that company’s acquisition by CGM maker Dexcom.

EoFlow expects further FDA discussions to materialize throughout this year, given the “breakthrough device designation” recently granted, with clinical trials happening in 2020 and an anticipated commercial launch at some point in 2021.

“Our company has a trajectory that we’re excited about,” Malave told DiabetesMine. “Humans like having only one thing they need to wear, and everything goes through the smartphone that we just can’t be without. It’s up to us, the technologists, to give them that and make sure they have options to personalize it the way they want.”

FDA’s “Breakthrough Device Designation” for Diabetes

The FDA Breakthrough Devices Program grants priority review to companies with promising new technology in chronic disease care. Participants are granted priority review, along with “interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.” Just created in 2016, this new designation for “novel, innovative” devices has been granted to ~110 items and led to approval of about 10 of them so far.

In the D-space, after Bigfoot Biomedical and Medtronic Diabetes, it may seem surprising that a little-known Korean company would be next to get this designation in the competitive race to get “Artificial Pancreas” technology to market.

To be honest, our team has always sort of rolled our eyes over EoFlow when seeing them at conferences or mentioned over the years. But the JDRF appears to have been ahead of the curve a couple years ago, when the org announced in early 2017 that it would be funding part of EoFlow’s research — the first time the T1D group put money behind this particular closed loop company, as well as a first for funding a Korean-based company in diabetes tech.

“Next-generation wearable designs that are smaller and employ user-centric design will remove barriers that prevent some people, especially small children, from using these life-saving and life-changing glucose management devices,” JDRF research scientist Dr. Jaime Giraldo said at the time.

Just how fast their products come to market is largely based on the FDA discussions, even with this special breakthrough designation status.

We asked FDA for more detail on the diabetes-related companies that have received this designation, but were told that information is considered confidential as part of the review process and it’s not shared unless a company decides to share that information first. As noted, it appears FDA has granted the designation to just four specific closed loop systems to date:

Bigfoot Biomedical received the designation in November 2017, though at the time it was still known as the “Expedited Access Pathway” before that was renamed as the Breakthrough Device Designation process.

Medtronic received it in June 2018 with the approval of its Minimed 670G for ages 7-14.

In February 2019, Medtronic again received this breakthrough fast-track designation for its future Personalized Closed Loop tech — something beyond its current system with more automation and personalized aspects.

EoFlow joins the list for the EoPancreas, which will involve review of the company’s pipeline tech including the patch pump on its own, an initial “smart” version, and then eventually the CGM-integrated closed loop system.

EoFlow’s Malave says this regulatory designation will allow the company to create “clear design and development milestones” with the FDA in order to “accelerate our ability to commercialize this important new technology.”

What’s important to know is that getting this designation is not a guarantee that any company’s tech will necessarily become available any faster. The ETA isn’t a set one-sized-fits-all timeline, as it depends on the technology and regulatory discussions. But this sure puts EoFlow in a better position to push towards its anticipated launch by 2021.

New Tubeless Insulin Pumps and Closed Loops

EoFlow is certainly not the only player developing a new closed loop/ AID / AP system using a tubeless “patch pump.” There are many more in development, including:

DiabeLoop: This French startup is developing its DGLB1, a hybrid closed-loop system that connects a CGM, patch pump and locked-down smartphone for control. Their first generation will use the multi-colored Kaleido hybrid patch-tubed pump that is a little rectangle that both sticks onto your body and has short traditional tubing that connects to an infusion set. While the Kaleido pump has actual buttons on it that can be used for dosing directly, their closed loop version will connect to the DiabeLoop system on a locked-down smartphone (Sony Xperia Z1) and feed in data from the Dexcom G6 CGM, using an algorithm to make dosing decisions. Diabeloop is also working with other partners that include the CellNovo hybrid patch-tube pump and could at some point down the road use that device, too. (See our past coverage of DiabeLoop here.)

OmniPod Horizon: While we’re also looking at a 2021 launch most likely, many in the D-Community are very excited about this next-gen product from OmniPod maker Insulet! Based on the now-launching OmniPod DASH platform that has integrated Bluetooth Low Energy, the Horizon will be a patch pump version of a closed loop system. Trials remain ongoing for this tech in development.

Roche Solo: People had pretty much given up on the Solo patch pump device that Roche acquired way back in 2010. Despite the first-gen device already being FDA approved, Roche Diagnostics made the corporate decision years ago not to launch it because it didn’t include an integrated blood glucose monitor, like OmniPod did — a head-shaking decision in hindsight. Yet it remained in the company’s development pipeline, and in 2018 Roche finally launched the Solo micro-pump in Europe. It’s a thin little semi-disposable device that is just a tiny bit larger than the OmniPod, but notably it’s detachable (!) and you can bolus directly from the little Solo patch pod itself using built-in buttons. Roche is also working to integrate CGM technology such as the implantable Eversense CGM, and will eventually make that part of its own closed loop system in development. We’ve yet to see anything materialize here in the USA, but that doesn’t mean the company isn’t prepping to file it here.

Lilly Diabetes: We’ve reported that Lilly is working on its own technology, a hybrid patch-tubed pump that sort of resembles a round tobacco tin that fits in the palm of your hand. The Pharma Giant is collaborating with Dexcom as a CGM partner and is developing this connected device that it describes as an Automated Insulin Delivery system that will “eventually have closed loop capabilities.” (see our past coverage here)

Tandem’s “t:sport” MiniPump: In the future pipeline, Tandem Diabetes Care is developing a mini pump that’s quite a bit smaller overall with a reduced cartridge size from its regular t:slim pump. The screen display will be eliminated in favor of having all the data directly displayed on a smartphone. It’ll be a disposal stick-on-your-body device, but not quite a full patch pump as it would still need a short four-inch infusion set connector (mini tubing). We got to see and hold a prototype of this mini pump in mid-2017 at Tandem’s San Diego HQ. With Tandem’s current Basal-IQ and near-term Control-IQ closed loop technology coming by year’s end, no doubt that this future mini-pump will offer that same type of closed loop capability.

SFC Fluidics: JDRF has also partnered with Arkansas-based SFC Fluidics, to develop an open-protocols patch pump closed loop system. There isn’t much detail out there to date, but SFC says it will develop “a fully functional patch pump that will operate on its own platform as well as publish its communication protocol so that approved devices can communicate with the patch pump.”

Beyond these patch pump systems in development, and those in the Do-It-Yourself #WeAreNotWaiting community that’s creating their own “hacked” versions using the OmniPod, there are also other AID systems using traditional tubed insulin pumps taht include Medtronic, Tandem Diabetes, and those such as:

Bigfoot Loop and Inject: The California startup is working on an Automated Insulin Delivery (AID) system that it’s referring to internally as Bigfoot Loop and Bigfoot Inject, based on its pump version that will use the acquired Asante Snap pump technology as well as a connected “smart insulin pen.”

iLet Bionic Pancreas: Out of Boston, this one is now under the umbrella of startup Beta Bionics and will use a dual-hormone setup for dosing both insulin and glucagon. The company is already on its fourth-generation prototype that we’re told will closely resemble the commercial version that’s expected to come to market at some point in the next 2-3 years.

We’re excited to see ALL of these potential closed loop offerings — especially the patch pump varieties — offering patients great choices. Congrats to EoFlow for the vote of confidence by FDA.

Moreover, we appreciate FDA willingness to fast-track companies making these types of next-gen tech possible!