Dive Brief:
- Beta Bionics received Food and Drug Administration clearance on Friday for the company’s first insulin patch pump.
- The device, called Mint, has a three day wear time and a 200-unit insulin reservoir. It is designed with a mixture of disposable and reusable components.
- Leerink Partners analyst Mike Kratky wrote in a research note Monday that the FDA authorization should help level the playing field with competitor Insulet, which has dominated new device starts with its patch pump.
Dive Insight:
Beta Bionics, which announced the clearance on Monday, plans to start a full U.S. launch of Mint in the first quarter of 2027 and plans to make the new patch pump available exclusively through the pharmacy channel. Beta Bionics expects to produce at least 1.5 million total disposable units in 2027.
Mint is smaller than its competitor’s patch pump, Beta Bionics said.
The authorization will make Beta Bionics the second company to bring a tubeless patch pump to market, Kratky wrote, adding that the extracted launch is well ahead of the company’s initial expectations for the end of 2027.
“[Beta Bionics] having a commercially available patch pump represents a major product enhancement, as this remains a key consideration for patients when deciding between pumps,” Kratky wrote.
Mint will be compatible with continuous glucose monitors made by Abbott and Dexcom. Separately, Senseonics, which makes an implantable CGM that can be worn for a year, announced it would integrate with Beta Bionics’ current tubed insulin pump, iLet Bionic Pancreas. The company did not say if that partnership will extend to Mint.
Beta Bionics also said it has submitted a new dosing algorithm to the FDA for 510(k) clearance. The new algorithm, called 3D Intelligence, has three algorithm settings depending on the user’s insulin requirements.
One option lets users continue to use the algorithm currently available with Beta Bionics’ iLet device. An updated version incorporates learnings from Beta Bionics’ real world experience with iLet. Finally, Beta Bionics is offering an algorithm that provides a more measured response when correcting high glucose levels.
Beta Bionics lowered its revenue forecast for 2026 by $10 million, as it expects some potential iLet users may choose to wait for the launch of Mint next year. The company now expects revenue in a range of $121 million to $126 million for the year.
