For the better part of a decade, we've been watching the development of a thin, wearable patch device that sticks onto the skin and delivers a quick couple units of insulin for boluses. That tech has been handed off a few times and now has a new owner, meaning it may finally hit the market in the next year or so.
On July 17, the Boston-area startup known as CeQur of this slim, three-day-wear device holding 200 units of insulin and delivering 2-unit bolus increments for meals or corrections.
Sound familiar? It's the former , first FDA approved in 2010 before being sold to Johnson & Johnson two years later and rebranded as the OneTouch Via. Referred to as a "patch pen" and a "wearable pen" over the years, the device got a second regulatory OK in mid-2017. But that came amid J&J's corporate restructuring and eventual decision to sell off its diabetes device divisions, so now it's bounced into the hands of as the latest parent.
In many ways, this particular change-of-hands makes perfect sense, since CeQur's been developing a similar type of D-tech for several years now. Dubbed the PAQ, their product is a three-day wearable patch device that delivers both basal and bolus insulin, but is more like a traditional insulin pen and doesn't include all the bells and whistles of a traditional insulin pump. CeQur says it plans to submit PAQ to the FDA in late 2018, with hopes to bring it to market sometime by summer 2019.
"This is an exciting time for us, as this moving us very quickly from being an R&D organization to a commercial organization," says CeQur's Executive Chairman Eric Milledge, who ironically has insider knowledge here -- having spent 34 years at J&J, including head up the LifeScan group and leading the Animas insulin pump acquisition more than a decade ago. "We'll have two products launching next year to begin bringing in revenue for us."
CeQur is largely targeting Multiple Daily Injection (MDI) users who live with either type 1 or type 2 diabetes, describing its technology as a simple, uncomplicated wearable insulin delivery system at a lower price point than traditional insulin pumps. One of the taglines is "freeing people from injections."
Here's a rundown on CeQur's two devices, which are both being designed for people with either type 1 or type 2 but likely wouldn't be used at the same time, as their functionality overlaps:
PAQ (Three-Day Basal + Bolus Device)
First off, the PAQ device that CeQur was originally developing offers both bolus and basal dosing, and has been referred to as a "patch pen" because it delivers insulin more like a traditional pen than a pump with programming and other features.
But CeQur tells us it is moving away from the words "patch" and "pump" because those have specific connotations in the medical and diabetes communities. Instead, they're now using the terms "wearable insulin pen" or "wearable insulin device" to describe their products.
Specs of the PAQ are as follows:
- this flat pod is about three inches in diameter, holding up to 330 units of U100 insulin in a disposable reservoir for three days of continuous delivery
- it's waterproof for bathing, showering or swimming up to six feet
- as of now, it's being designed for wear on the abdomen
- it's attached to the skin via adhesive, with no infusion set
- there is no programming like you would have with traditional insulin pumps, from changing up basal rates or having different alerts and beeps; and so there is no handheld controller or receiver with the PAQ
- includes seven preset/fixed basal doses that can't be changed, ranging from 16 to 60 units
- users just click a button on the side of the pod to get a fixed 2-unit bolus
- the first-gen won't have any connectivity built in, but it does have a "Messager" gadget that snaps onto the PAQ and vibrates four times if it's out of insulin, if there's an occlusion error, or if the device is nearing its three-day wear limit. CeQur plans to build that out to offer data-sharing and smartphone connectivity in the future.
PAQ has been in development for years, with many past rumors that it was nearing FDA submission. But CeQur now says it's spent that time raising money and researching the market, as well as fine-tuning its product in order not to rush a product launch -- something it says is a failing of many med-tech companies. Now, the plan is to submit a 510(K) filing with the FDA in the fourth quarter of 2018.
The hope is to be ready to launch the device by June 2019, when the American Diabetes Association's SciSessions is held.
Bolus-Only Device from Calibra
The bolus only device became a product of J&J when that pharma giant acquired Silicon Valley-based Calibra Medical in 2012. At the time, it had already been FDA-cleared as of July 2010. But after the J&J acquisition and rebranding as the OneTouch Via, it was re-submitted and approved by FDA again in June 2017. Yet as noted, the device never launched thanks to the J&J's corporate restructuring and eventual decision to pull away from diabetes devices.
In October 2017, J&J announced plans to shut down its Animas insulin pump division for good. Both the Calibra/OneTouch Via division and the glucose monitoring Lifescan line were left up in the air. Since then, a , and we now know the fate of the former Calibra tech. CeQur says that when they saw news of J&J evaluating its diabetes divisions and Calibra, they made made contact to explore the possibilities.
Here are the basics on this wearable device, which has yet to be offiicially renamed but is being referred to internally at CeQur simply as the "Calibra" or "PAQ Bolus" --
- it's a slim, plastic unit about two inches long, one inch wide, and a quarter of an inch thick that's worn on the skin for up to three days
- holds 200 units of fast-acting insulin, allows the user to take boluses in 2-unit increments by just pressing two buttons on the side simultaneously (including through clothing, for more discreet use)
- does not give any basal doses, so the user would still have to inject a long-acting insulin in addition to wearing this device
- no handheld controller or display, and it doesn't retain any dosing memory
CeQur execs tell us that with the acquisition from J&J, all the manufacturing will now be transferred from the existing Puerto Rico facility to a new (yet to be named) third-party contract manufacturer based elsewhere. They'll also have to file this yet again with the FDA, which could take nine months or longer.
As of now CeQur expects to have this product ready to file early next year before an eventual launch by July 2019.
Access and Need for 'Wearable Insulin Pens'
While CeQur hasn't finalized a price-point, it refers to the ballpark cost of that's been on the market for several years now and is widely available in the US. That disposable pump is worn for 24 hours, and the retail cost is roughly $300-400 for the base system and starter supplies, depending on your pharmacy or distributor.
As always, Your Insurance May Vary as does Medicare coverage, so we'll just have to wait and see what coverage ends up materializing for CeQur's new devices.
CeQur's VP of Clinical and Commercialization Jay Warner says the PAQ and "PAQ Bolus" three-day-wear devices set the company up well for moving into the market, especially at a time when CGM tech is becoming more mainstream. He expects that PWDs will want more options to move from injection-only therapy to these "stick-ons" that are very discreet and can therefore help reduce stigma for those who might be concerned about injecting in public.
"It's exciting working for a company focused on freeing people from injections," says Warner, who comes from Eli Lilly's diabetes product commercialization team, where he worked on product development to sales. "We'll have two fantastic assets that can help patients eliminate injections. There is a lot of pent-up demand for this."
Clearly, capturing patients on insulin who are not yet pumpers is all the rage in the diabetes industry these days. There's also a very large type 2 diabetes population that may be just starting insulin therapy, who will be interested in the options CeQur has to offer.
Data actually shows that over 50% of people with T2D who are on insulin miss their regular doses (!) And for those with T1D, who might not always want to wear a full-featured insulin pump or might want to take a break from using pens, this could also be a more affordable option.
Whether people end up seeig a benefit of the CeQur tech remains to be seen, but we wish the company well and look forward to seeing another choice on the market for those who want it.