FDA clears Beta Bionics Mint patch pump; 3D Intelligence 510(k) submitted

Beta Bionics, Inc.

• Mint FDA clearance announced Sept 14, 2026; full U.S. launch expected Q1 2027, ahead of prior target; at least 1.5M disposable units capacity in 2027.
• 510(k) for 3D Intelligence insulin-dosing algorithm submitted; if cleared, powers iLet 3D by end 2026 and Mint 3D at launch.
• Mint launches exclusively via pharmacy channel; ~40% insured U.S. lives at launch, rising to ≥50% within first year.
• Real-world iLet data: >84% users meet ADA hypoglycemia goals; average HbA1c 8.9% to GMI 7.3% (n=14,952).
• Securities class action filed Sept 4, 2026 (Holtzman vs. Beta Bionics) alleging misstatements on iLet; company to defend vigorously.