The U.S. diabetes world has long been awaiting the next patch pump that would bring some competition to the popular Omnipod tubeless insulin delivery device. But is progress on closed loop and “Artificial Pancreas” technology perhaps slowing the introduction of another pump choice in the American market?
UK-based Cellnovo has been promising a new type of ‘hybrid patch pump’ for years – dating back to 2011. It finally hit the international market several years ago, and just recently launched in Australia. The company continues promising a launch in the U.S. soon, but that never seems to materialize, even as it moves forward on its closed loop tech – suggesting that Cellnovo may be dragging its feet on introducing its first-gen stand-alone pump to market here in favor of waiting to launch its broader CGM-integrated solution.
(Enter frustrated sigh here…)
Cellnovo actually did submit its 510(k) paperwork to the FDA a year ago in November 2016, and the regulatory agency has apparently asked for more data and clarifications. During its third quarter earnings call, Cellnovo execs said they “remain optimistic” for FDA approval at some point in 2018.
But based on recent news reports, Cellnovo could spring on the closed loop scene before long. So maybe they’re holding out for a bigger launch? And just maybe it’ll be worth the wait…?
Cellnovo: A ‘Hybrid’ Micro Pump
The product is not exactly a patch pump as those familiar with Omnipod have come to think of them. Rather, this Cellnovo device consists of a short infusion set that attaches to a small rectangular pump roughly the size of a tea bag. It looks like it dangles from the body, but in fact, it adheres to the skin with built-in adhesive.
So it’s sort of a mashup of a tubed and non-tubed pump, which the company insists offers the best of both worlds, with the following features:
- it’s small and discreet, with basal and bolus dosing commanded via a handheld color touchscreen controller, which also has an integrated blood glucose meter
- just like with Omnipod, there are no buttons on the micro-pump, but if you forget the controller, the pump continues delivering basal
- because it delivers insulin via infusion 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 by family members and healthcare professionals
- on the downside, it holds a max 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 handset is connected to “Cellnovo Online” cellular network with those costs covered entirely by the company.
We’re 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 other glucose monitors and AP tech.
Cellnovo’s AP Plans
As to its closed loop development, the company is working on three pathways to AP tech, they tell us:
Pepper: A system based on this collaborative patient-empowerment through peer decision-support project, supported by the European Union’s H2020 program. Study data 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 first announced in June 2016, using the Cellnovo pump along with the Dexcom CGM and TypeZero’s InControl AP algorithm. In April 2017, the two companies signed a global commercial agreement and the AP software integration is being finalized now, Cellnovo says. That paves the way for a pilot validation study expected in the near future.
Diabeloop: This is the biggest newsmaker in recent months, as Cellnovo is collaborating with the France-based startup on a diabetes closed loop system using a proprietary algorithm built into Cellnovo’s patch pump. A clinical trial is in progress on this tech, with the first part being completed earlier this year showing “very positive feedback from investigator sites.” The second arm of that study is set to begin by the end of 2017. The two companies are still finalizing the terms of a commercial agreement, we’re told.
They seem to be hedging their bets on partners by design. “Generally, Cellnovo’s aim is to be able to offer an Artificial Pancreas solution coupled with its system to ensure the best experience for patients and maximize the value,” says Communications and Digital Marketing Director, Bommy Lee.
We continue to look forward to seeing what comes of all this closed loop furor.
Of course, it’d also be nice to know that valuable new products aren’t being held up in the pipeline while future AP tech is being explored. Ya know?