Saluda plans a phased U.S. launch beginning in the second half of calendar 2026, with broader commercial rollout commencing later in calendar 2026, as surgeon training and field inventory scale. The Company expects a gradual contribution to revenue as the surgical channel develops. The addition of a paddle lead is expected to enhance productivity within Saluda’s existing U.S. commercial organization by enabling engagement with neurosurgeons and orthopedic surgeons and expanding procedural coverage within existing accounts.

The CAP24 paddle lead expands Saluda Medical’s SCS portfolio and enables use of the Evoke® System with EVA™ Sensing Technology in surgical paddle lead procedures, extending access to the Company’s physiologic closed-loop, ECAP-based therapy in the U.S.