Dive Brief:
- Beta Bionics said Thursday that it plans to debut its first insulin patch pump by the end of the second quarter of 2027, subject to Food and Drug Administration clearance.
- The device, called Mint, would be compatible with Beta Bionics’ interoperable automated glycemic controller, a software that allows for the pump to automatically adjust insulin delivery based on readings from a glucose sensor.
- Beta Bionics provided the update based on the FDA’s initial responses to the company’s 510(k) application and progress in scaling up manufacturing for the device.
Dive Insight:
Beta Bionics first unveiled the prototype for Mint last year at the American Diabetes Association’s Scientific Sessions. The device is expected to have a similar size and wear time, at three days, to Insulet’s patch pumps on the market. It would have a 200-unit insulin reservoir.
Mint differs by containing a mix of reusable and disposable components. Beta Bionics plans to make the device exclusively available in the pharmacy channel, building on its existing agreements for its current iLet insulin pump.
CEO Sean Saint said in a statement that by pairing the company’s adaptive insulin dosing algorithm with Mint, the company will give customers more choices.
Beta Bionics expects to have enough manufacturing capacity for the device at launch. Leerink Partners analyst Mike Kratky wrote in a research note that “both the timing of the launch and management’s ability to establish and ramp manufacturing capacity have been key points of investor debate since the IPO and potential overhangs on the stock, in our view.”
Beta Bionics’ shares increased by more than 11% to $11.82 by Friday close.
Beta Bionics is one of several diabetes tech companies developing patch pumps to compete with market leader Insulet. Tandem Diabetes Care and Medtronic spinoff MiniMed have also announced planned patch pumps. Tandem said it plans to file a 510(k) submission this quarter for a tubeless version of its small, durable pump, and Medtronic plans to submit its patch pump to the FDA this fall.
