Beta Bionics FDA Clears Mint Patch Pump, U.S. Launch in 2027

By Greg Peters • Wednesday, September 16 10:48 • Permanent Link

Beta Bionics said the FDA cleared Mint, its new patch pump, and that it expects U.S. commercialization to begin in the first quarter of 2027.

The company said Mint will be launched with manufacturing capacity for at least 1.5 million disposable units in 2027. It also said Mint is expected to be sold exclusively through the pharmacy channel, with about 40% of insured U.S. lives initially able to buy it through pharmacy benefits, rising to at least 50% within the first year of full commercialization.

Alongside Mint, Beta Bionics unveiled 3D Intelligence, its next-generation insulin dosing algorithm, and said it has already been submitted to the FDA in a 510(k) filing. The company expects to commercialize the algorithm in the U.S. by the end of 2026 as iLet 3D, and then with Mint at the time of Mint’s full launch in early 2027.

The company said 3D Intelligence is built around three selectable algorithm modes: Original, which is the current iLet algorithm already used by more than 40,000 users; Optimized, an enhanced version based on real-world use; and Conservative, designed to respond more measuredly to high glucose levels.

Beta Bionics also cut its 2026 revenue outlook. It now expects full-year revenue of $121 million to $126 million, down from a prior forecast of $131 million to $136 million. The company said the reduction reflects as much as $10 million in deferred fourth-quarter revenue, as some prospective iLet users may wait for Mint.

For 2026, Beta Bionics reiterated its expectation that 37% to 39% of new patient starts will be reimbursed through the pharmacy channel. It also kept its gross margin outlook at 58.5% to 59.5%.

Looking to 2027, the company said Mint is expected to offset any revenue delayed in late 2026, while pharmacy channel revenue should rise as a share of total revenue. It also said Mint is expected to be modestly dilutive to 2027 gross margin, before becoming accretive at scale. Today the company's shares have moved 5.36% to a price of $20.26. If you want to know more, read the company's complete 8-K report here.

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