---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-392088"
form_type: "8-K"
ticker: "BBNX"
cik: "0001674632"
company_name: "Beta Bionics, Inc."
filed_at: "2026-09-15T20:58:41+00:00"
generated_at: "2026-09-15T20:59:20.831182+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-392088
- form_type: 8-K
- ticker: BBNX
- cik: 0001674632
- company_name: Beta Bionics, Inc.
- filed_at: 2026-09-15T20:58:41+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1674632/000119312526392088/0001193125-26-392088-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1674632/000119312526392088/d153052d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-392088
- JSON: https://secwatch.observer/filing/0001193125-26-392088.json
- Plain text: https://secwatch.observer/filing/0001193125-26-392088.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.