Irvine, California-based Beta Bionics said it expects to fully commercialize Mint by the end of the second quarter of 2027. This represents an accelerated timeline compared to previous expectations for the end of 2027.
The automated insulin delivery system launch still remains subject to FDA clearance, but would mark the company’s entry into the tubeless patch pump market currently dominated by Insulet and its Omnipod 5.
Beta Bionics set its timeline based on the FDA’s initial responses to its Mint alternate controller-enabled (ACE) insulin pump 510(k) application and the progress it has made in scaling its manufacturing processes. It expects manufacturing capacity to meet anticipated demand at launch.
“We believe that Mint, which stands for Mini Insulin Therapy, will represent a meaningful advancement for people with diabetes,” said Sean Saint, President & CEO of Beta Bionics. “In pairing our fully adaptive insulin dosing algorithm with Mint, subject to regulatory clearance, we expect to deliver an innovation to the market that expands choice of form factor for our existing customers, and choice of insulin dosing algorithm for existing and prospective patch pump users.”
While Insulet continues to lead the patch pump market, it can expect some entrants in the very near future, aside from Beta Bionics. Tandem Diabetes Care said earlier this month that it plans a second-quarter FDA submission for its tubeless Mobi option. Meanwhile, MiniMed expects to submit its Fit patch pump to the FDA by the fall of 2027.
More about the Mint patch pump technology from Beta Bionics
Beta Bionics, which completed a $234.6 million IPO in January, currently competes in the automated insulin delivery with the iLet bionic pancreas system.
With Mint, the company expects to offer a new wearable extension of its existing “bionic” technology.
The company said that its device will come in at a similar size to industry leader Insulet’s pump and will be compatible with its proprietary and FDA-approved interoperable automated glycemic controller (iAGC), the first and only fully adaptive insulin dosing algorithm. Beta Bionics labels it the “most advanced insulin dosing algorithm available in the [U.S.].”
According to Beta Bionics, it plans for Mint to have compatibility with industry-leading continuous glucose monitors (CGMs). Those include the Dexcom G7 and G7 15 Day, as well as Abbott’s FreeStyle Libre 3 Plus. It also expects control capabilities from iOS and Android smartphones.
One feature Beta Bionics highlighted is that Mint requires no recharging, as well as no phone during the disposable patch change process. Its controller is expected to last for around two years.
The device features a 200-unit insulin reservoir and three days of wear time, plus an additional 12-hour grace period. It’s also waterproof for wearability during showers and swimming. The device offers a two-piece reusable and disposable architecture designed to limit environmental waste.
Beta Bionics plans to make Mint exclusively available in the pharmacy channel. It can leverage existing market access footprints for iLet in the pharmacy channel to build coverage. The company plans to share more details once it secures FDA clearance.
When the company first unveiled the Mint system to analysts last year, they noted that they were “impressed by the form factor of the patch pump and its ease of use.”
