N-22 — Regulatory decision
2026
That is something I'm hopeful very early in 2026 that we will be able to release into the marketplace.Source filing
SI biotech catalysts & pipeline
SHOULDER INNOVATIONS INC · Data as of 2026-09-08
Upcoming catalysts
InSet (I-Series) — NDA/BLA submission
H1 2027
We are planning FDA submission for InSet Neo in the first half of 2027.Source filing
InSet (I-Series) — NDA/BLA submission
in 2027
Additionally, we are targeting FDA submission in 2027 for a new concept for reverse procedures, branded InSet One.Source filing