Big news in the Diabetes Community's tech space, as the FDA has granted what IT dubs "breakthrough twist designation" to a future closed curl system that combines a continuous glucose monitor with an insulin patch heart to competition the tubeless Omnipod.

On March 14, the FDA gave South Korean society EoFlow this fast-track designation for its Automated Insulin Legal transfer (AID) system named EoPancreas. This is the fourth time Food and Drug Administration has granted the new breakthrough device designation to a diabetes unsympathetic loop system since it was created in 2016 — Bigfoot Medical specialty accepted it in Nov 2017 for their future AID technical school, 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 illustrious As some others in this space, it's a company we have seen over the years displaying its patch ticker and joined mobile app at conferences like the ADA's period of time Knowledge domain Sessions. The tubeless pump itself is called the EoPatch, and rumor had information technology they were employed on a CGM only thither hasn't been much detail available to date. The JDRF partnered with the company a couple days back (the best meter information technology funded any Korean closed loop research), and now they're celebrating access to an fast 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 Chair Luis Malave (a erstwhile Insulet executive complete a decennary ago and Minimed's R&ere;D director during the '90s), as well as information online:

What is EoPancreas?

For those WHO haven't heard of EoFlow before, information technology's a South Korean company founded in 2011 that now has an office in Capital of Costa Rica, CA. Its laminitis and CEO Jesse Kim ran a semi-conductor startup in Silicon Valley after graduating from MIT and at length started functioning EoFlow every bit a university incubation center in Seoul. Since October 2017, Malave has been part of the team working out of the California power.

Their suite of products that comprise the EoPancreas system in real time includes:

Patch Pump: Referred to as the EoPatch, it's a rectangular pager-wolf-sized insulin pump that adheres to the skin without the pauperism for plastic tubing like traditional pumps use of goods and services. 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 grocery store may vary to much degree, but the form factor remains mostly the equal. The existing for the first time-generation EoFlow patch ticker is quite a little 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 avail belittle occlusions (clogging). But because the CGM would be built into the patch pump itself, chances are it would add a bit of heaviness, roughly half a centimeter, we'rhenium told. Malave also tells us they bear to launch just the patch heart in the U.S. commencement, A a sort out of first-generation before adding in smart algorithms and eventually the built in CGM applied science.

Receiver or Smartphone Control: The EoPatch version that's already available in Korea uses a hand-held device a good deal like OmniPod's Personal Diabetes Manager (PDM) to function; there are no buttons on the spot pump itself. Per the EoFlow website, what comes to commercialize in USA would use a special handheld controller with color touchscreen port — latched-down Android smartphone style. Whether this PDM-style device is what we see launching with the nourished EoPancreas system corpse 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 cringle platforms, so we may encounter some movement there shortly.

CGM Sensor: There isn't a great deal of detail out at that place publicly, just we're told the EoPancreas will be integrated with existing CGM engineering. Specifically, the company has reached an agreement to consumption the Nutmeg State-100B CGM detector made past China-based POCTech, which we've seen along display at conferences equally a "me too" product that brags about its "tiny soft" .3mm detector and accuracy. That CGM sensor volition Be built into the patch pump, though Malave tells us they also hope to collaborate with other CGM manufacturers to receive those as options with the EoPancreas system. Atomic number 3 famous, the POCTech CGM sensor will add a little of thickness to the overall twist design, Malave says. Minded the FDA's newfangled "iCGM" (interoperable CGM) designation granted first to Dexcom G6, we throne opine where EoPancreas hopes to blend as IT moves send on.

EoCloud: Like most connected systems these years, the EoPancreas will offer its own cloud-settled package, that its calling EoCloud. This bequeath utilise Artificial Intelligence (AI) algorithms functioning on a proprietorship program to do the calculations that helper it discover about each exploiter, allowing customization of the closed closed circuit control for each PWD (person with diabetes). We're told the scheme's smarts will be based on the TypeZero Technologies algorithmic rule licensed in 2018 prior to that ship's company's acquisition by CGM Lord Dexcom.

EoFlow expects further FDA discussions to materialize throughout this year, given the "breakthrough device assignment" recently granted, with clinical trials on in 2020 and an anticipated commercial launch at some head in 2021.

"Our company has a trajectory that we're excited about," Malave told DiabetesMine. "Humans like having only incomparable thing they want to wear, and everything goes through the smartphone that we just can't be without. IT's up to USA, the technologists, to break them that and make sure they consume options to individualise IT the way they deprivation."

Food and Drug Administration's "Breakthrough Gimmick Designation"

The FDA Breakthrough Devices Program grants priority review to companies with likely new technology in chronic disease care. Participants are granted priority review, along with "interactive communication regarding twist development and clinical test protocols, through to commercialisation decisions." Just created in 2016, this new naming for "novel, innovational" devices has been granted to ~110 items and led to approval of close to 10 of them so far.

In the D-space, after Bigfoot Medicine and Medtronic Diabetes, information technology may seem surprising that a unknown Korean company would be next to get this designation in the competitive race to flummox "Artificial Pancreas" technology to market.

To be honest, our team has always sort of rolled our eyes over EoFlow when sightedness them at conferences or mentioned all over the geezerhood. But the JDRF appears to throw been ahead of the curve a couple age ago, when the org announced in early 2017 that information technology would be financial backin part of EoFlow's research — the first time the T1D group put over money can this exceptional closed loop company, as well as a first for funding a Peninsula-founded keep company in diabetes tech.

"Succeeding-generation vesture designs that are smaller and employ user-centric intent will remove barriers that foreclose some people, especially small children, from using these liveliness-delivery and life-changing glucose management devices," JDRF research man of science Dr. Jaime Giraldo said at the time.

Just how fast their products concern market is mostly based connected the FDA discussions, even with this special breakthrough designation status.

We asked Food and Drug Administration for more contingent on the diabetes-related companies that have received this denomination, only were told that information is considered close as part of the review procedure and IT's not joint unless a company decides to portion that information archetypal. As noted, it appears FDA has acknowledged the designation to just cardinal specific closed loop systems to date:

  • Bigfoot Biomedical received the naming in November 2017, though at the sentence it was still known as the "Speeded up Admittance 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 once again received this find swift-track designation for its future Personalized Closed Loop tech — something beyond its current system of rules with more automation and individualised aspects.
  • EoFlow joins the list for the EoPancreas, which will involve reexaminatio of the company's pipeline technical school including the patch pump on its own, an first "smart" rendering, and then eventually the CGM-unified closed loop system.

EoFlow's Malave says this regulatory designation will allow the company to make "clear design and development milestones" with the FDA in order to "accelerate our ability to commercialise this important new technology."

What's important to know is that getting this designation is non a guarantee that any society's tech volition necessarily become available any faster. The ETA isn't a set unitary-sized-fits-every timeline, as it depends on the engineering and regulative discussions. But this certainly puts EoFlow in a better pose to fight towards its anticipated launch by 2021.

New tubeless tire insulin pumps and closed loops

EoFlow is certainly not the only musician developing a new closed-loop system/ AID / AP scheme using a tubeless "patch pump." At that place are many more in development, including:

DiabeLoop: This European country inauguration is nonindustrial its DGLB1, ahybrid closed-loop system that connects a CGM, patch ticker and fastened-fine-tune smartphone for control. Their number one generation will use the multi-colored Kaleido hybrid patch-tubed pump that is a miniscule rectangle that both sticks onto your body and has squat traditional tube that connects to an infusion set. While the Kaleido heart has actual buttons on information technology that can Be used for dosing directly, their closed loop version will join to the DiabeLoop system on a locked-mastered smartphone (Sony Xperia Z1) and feed in information from the Dexcom G6 CGM, using an algorithm to make dosing decisions. Diabeloop is also working with other partners that admit the CellNovo hybrid bandage-thermionic tube pump and could at some point down the road expend that device, too. (See our past reporting of DiabeLoop present.)

OmniPod Visible horizon: While we'Ra likewise looking a 2021 launch most likely, many in the D-Community are very reactive about this next-gen product from OmniPod maker Insulet! Founded 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 of rules. Trials remain current for this tech in ontogenesis.

Roche Solo: People had pretty much apt up on the Solo spot heart device that Roche nonheritable way back in 2010. Despite the first-gen device already being Food and Drug Administration approved, Roche Nosology successful the corporate decision years past non to launch information technology because it didn't include an integrated blood glucose monitor, corresponding OmniPod did — a head-shaking decision in hindsight. Still it remained in the company's growth line, and in 2018 Roche finally launched the Solo micro-pump in Europe. It's a papery little trucking rig-disposable device that is just a petite second larger than the OmniPod, but notably IT's detachable (!) and you fundament bolus immediately from the little Solo fleck fuel pod itself using intrinsic buttons. Roche is also working to integrate CGM technology such as the implantable Eversense CGM, and will eventually make that component part of its own closed loop system in growth. We've yet to see anything materialize here in the America, only that doesn't mean the company isn't prepping to file IT here.

Lilly Diabetes: We've according that Lilly is employed happening its have engineering, a hybrid patch-tubed ticker that sort out of resembles a round tobacco plant tin that fits in the laurel wreath of your hand. The Pharma Giant is collaborating with Dexcom as a CGM married person and is developing this connected gimmick that it describes as an Machine-controlled Insulin Delivery system that will "eventually sustain closed-loop system capabilities." (see our knightly insurance coverage here)

Tandem's "t:sport" MiniPump: In the coming pipeline, Bicycle-built-for-two Diabetes Tending is developing a mini pump that's quite a bit smaller overall with a reduced pickup size from its even t:slim pump. The screen display will be eliminated in favor of having all the data directly displayed happening a smartphone. It'll equal a disposal adhesive-your-body device, only not rather a full patch pump as it would still need a short four-inch infusion correct connecter (miniskirt 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 present-day Basal-Intelligence quotient and near-term Control-IQ closed loop applied science coming by twelvemonth's end, no doubt that this upcoming miniskirt-pump will offer that same type of closed loop capacity.

SFC Fluidics: JDRF has also partnered with Arkansas-settled SFC Fluidics, to develop an open-protocols patch heart blinking loop system. There isn't more than detail unstylish on that point to date, but SFC says it volition develop "a in full functional patch pump that will operate connected its own platform atomic number 3 well atomic number 3 publish its communication protocol so that approved devices can communicate with the patch pump."

On the far side these patch heart systems in development, and those in the Homemade #WeAreNotWaiting community that's creating their own "hacked" versions using the OmniPod, in that respect are also other AID systems victimisation traditional tubed insulin pumps taht include Medtronic, Tandem Diabetes, and those so much as:

Bigfoot Loop and Inject: The Golden State startup is working on an Automated Insulin Delivery (AID) system that IT's referring to internally as Bigfoot Loop and Bigfoot Come in, based on its ticker version that will use the acquired Asante Snap pump technology as asymptomatic arsenic a connected "sharp insulin pen."

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

We're excited to pick up ALL of these latent closed loop offerings — especially the patch heart varieties — offering patients great choices. Congrats to EoFlow for the right to vote of confidence by FDA.

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