** UPDATE: Cellnovo declared on March 29, 2019 that information technology would be ceasing all yield, manufacturing, and marketing of its hybrid patch-tubed pump, and the device would not glucinium offered to any new patients.

The U.S. diabetes humankind has long been awaiting the next piece heart that would bring some competition to the popular Omnipod tubeless insulin pitch device. Simply is progress on closed-loop system and "Artificial Pancreas" applied science perhaps slowing the introduction of another pump quality in the American market?

UK-based Cellnovo has been promising a new type of 'hybrid patch ticker' for years – dating back to 2011. IT finally hit the international commercialize several years ago, and just recently launched in Australia. The company continues promising a launching in the U.S. soon, but that never seems to materialise, even as it moves full-face on its closed-loop system technical school – suggesting that Cellnovo may comprise dragging its feet on introducing its first-gen suffer-alone pump to marketplace here in favour of of waiting to launching its broader CGM-integrated solution.

(Enter frustrated sigh Here…)

Cellnovo actually did relegate its 510(k) paperwork to the FDA in Nov 2016, and the regulatory authority has plain asked for more data and clarifications. During its third draw and quarter earnings hollo, Cellnovo execs said they "rest bullish" for FDA approval at some betoken in 2018.

Merely based on recent news reports, Cellnovo could spring on the closed-loop system scene in front long. Soh perchance they're holding out for a bigger launch? And just perchance it'll be worth the wait…?

Cellnovo: A 'Hybrid' Small Pump

The merchandise is non exactly a bandage pump as those common with Omnipod have come to remember of them. Sooner, this Cellnovo device consists of a short infusion set that attaches to a modest rectangular pump roughly the size of a Camellia sinensis bag. It looks equivalent it dangles from the body, but in fact, it adheres to the skin with built-in adhesive.

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Thusly it's rather a mashup of a tubed and non-tubed ticker, which the companion insists offers the best of both worlds, with the following features:

  • it's small and discreet, with primary and bolus dosing commanded via a hand-held colour touchscreen controller, which as wel has an integrative blood glucose cadence
  • just like with Omnipod, there are no buttons on the micro-pump, but if you draw a blank the controller, the pump continues delivering basal
  • because it delivers insulin via extract set, it can be detached and reattached
  • the handheld controller connects to the Web, updating data in near real-time and allowing users to log carb and exercise info. It also allows for real-time monitoring past family members and healthcare professionals
  • on the downside, it holds a grievous bodily harm of just 150 units for three days (vs. Omnipod, which holds up to 200 units)
  • the current system uses ANT technology for communication between the handset and pump, and the French telephone is connected to "Cellnovo Online" living thing network with those costs covered entirely aside the company.

We'ray also told that Cellnovo's R&D teams are finalizing the next-gen system with integrated Bluetooth protocol, which eliminates the need for the handheld controller (!), and enables communication with CGM systems and separate glucose monitors and AP tech.

Cellnovo's AP Plans

Arsenic to its closed-loop system development, the keep company is working on three pathways to AP tech, they tell us:

Pepper: A organisation based on this collaborative patient-authorization through and through peer decision-funding project, supported by the European Union's H2020 program. Study information on this project has been presented throughout the year at diabetes conferences internationally, showing early feedback on prototypes that are expected to be studied into 2018.

TypeZero: This partnership was number one declared in June 2016, using the Cellnovo pump on with the Dexcom CGM and TypeZero's InControl AP algorithm. In April 2017, the two companies communicative a global moneymaking agreement and the AP software integration is beingness finalized now, Cellnovo says. That paves the way for a pilot validation study potential in the near future.

Diabeloop: This is the biggest newsmaker in recent months, as Cellnovo is collaborating with the France-supported startup along a diabetes closed iteration system victimization a proprietary algorithmic program built into Cellnovo's patch pump. A clinical test is in progress on this technical school, with the firstborn office existence completed earlier this year showing "very positive feedback from investigator sites." The second arm of that study is located to begin past the end of 2017. The two companies are still finalizing the terms of a commercial agreement, we're told, but the hope is in 2018 on that point may be a archetypal-gen system ready to go on.

Boilers suit, Cellnovo appear to be hedging their bets on partners by design. "Generally, Cellnovo's aim is to glucinium capable to bid an Artificial Pancreas solution coupled with its system to guarantee the best experience for patients and maximize the value," says Communications and Digital Marketing Managing director, Bommy Lee.

We continue to look gardant to seeing what comes of all this closed loop furor.

Naturally, IT'd also be Nice to know that valuable new products aren't being held up in the pipeline piece next AP tech is being explored. Ya be intimate?