Saluda Medical is a Sydney, Australia-based medical device company (with US headquarters in Bloomington, MN) that developed the Evoke closed-loop spinal cord stimulation system, the first SCS device capable of instantaneously measuring the spinal cord's electrophysiological response to stimulation using evoked compound action potentials (ECAPs) and automatically adjusting therapy over 100 times per second to maintain optimal neural activation.

The EVOKE pivotal study, the first double-blind, randomised, controlled trial in SCS history, demonstrated statistically superior outcomes for closed-loop vs open-loop SCS at 3, 12, and 36 months. The Avalon study provided 24-month evidence of sustained 89.5% responder rates and 68% high-responder rates. FDA approval was received in 2022, followed by CE Mark and TGA approval.

Saluda's differentiation lies in replacing subjective patient feedback with objective neurophysiological measurement as the basis for therapy optimisation, fundamentally changing the SCS programming paradigm. The company is privately held and received $215 million Series C funding in 2021. Evoke represents the most clinically validated closed-loop SCS innovation in the chronic pain market.