Saluda Medical

Executive Summary

Saluda Medical is a Netherlands-based medical device company that has developed the Evoke® System, the first closed-loop spinal cord stimulation (SCS) platform for chronic pain management. Unlike traditional open-loop SCS devices, the Evoke System continuously senses the spinal cord's evoked compound action potentials (ECAPs) and adjusts stimulation in real time, delivering personalized and objective therapy. This innovation eliminates the guesswork in neuromodulation by automatically maintaining stimulation within a therapeutic window, thereby improving outcomes and reducing side effects. The Evoke System received FDA approval in November 2022 and is commercialized in the U.S., with ongoing expansion into European and other global markets. The company is well-positioned to capture a significant share of the $3.5 billion global SCS market, driven by the growing demand for non-opioid pain management solutions. Key competitive advantages include superior clinical evidence (e.g., the ECAP study showed 80% responder rates at 24 months) and a technology moat in closed-loop stimulation. Near-term growth will be fueled by expanding reimbursement coverage, positive long-term data readouts, and potential label expansions into other pain indications. Saluda's private status limits public catalysts but upcoming events could include major payer decisions, new clinical trial results, or strategic partnerships that validate its platform and drive adoption.

Upcoming Catalysts (preview)

• Q3 2026Expanded Medicare Coverage Decision for Evoke System65% success
• Q4 2026Publication of 5-Year ECAP Study Outcomes80% success
• Q1 2027CE Mark Approval for European Market Launch70% success