Beta Bionics Announces FDA Clearance of Mint™, the Company’s Transformative Patch Pump, and Unveils 3D Intelligence™ as its Next-Generation Insulin Dosing Algorithm
Beta Bionics received FDA 510(k) clearance for Mint, its two-piece reusable/disposable patch pump that requires no recharging and integrates with leading CGMs, with full U.S. commercialization expected in Q1 2027 -- ahead of its previous target. The company also unveiled 3D Intelligence, a next-generation insulin dosing algorithm under FDA 510(k) review, offering three selectable algorithm experiences; launches are planned as iLet 3D by end of 2026 and Mint 3D alongside Mint, both subject to clearance.
Key figures
- Drug Name
- Mint (patch pump)
- Guidance
- FY2026 total revenue approximately $121 million to $126 million (previously $131 million to $136 million), reflecting up to $10 million of potential Q4 2026 revenue deferral; 37%-39% of new patient starts reimbursed via pharmacy channel and 58.5%-59.5% gross margin reiterated
- Ilet 3d us launch
- end of 2026 (subject to FDA clearance)
- Mint full us launch
- Q1 2027 (ahead of previous target)
- Ilet real world users
- more than 40,000
- Q4 2026 revenue deferral
- up to $10 million
- Prior fy26 revenue guidance
- $131 million to $136 million
- Fy26 gross margin reiterated
- 58.5% to 59.5%
- Mint pharmacy coverage year 1
- at least 50% of insured U.S. lives
- Updated fy26 revenue guidance
- $121 million to $126 million
- Mint pharmacy coverage at launch
- approximately 40% of insured U.S. lives
- Fy26 new patient pharmacy channel
- 37% to 39%
- Mint 2027 manufacturing capacity units
- 1500000
AI analysis
Red flags4 · Pro
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.