Companies / Saluda Medical

Medical device company profile

Saluda Medical

Medical device manufacturer commercializing Evoke, an implantable closed-loop spinal cord stimulation system for chronic pain management.

Medical Device ManufacturerNeurology, Mental Health & PainNeural Interfaces & NeurostimulationPain Management

Headquarters🇺🇸Bloomington, Minnesota, United States

Founded2011

Commercial statusCommercially availableEvoke spinal cord stimulation system is commercially available; FDA PMA approved in the United States.

Employees201–500 ^[3]LinkedIn company-size range · Checked 2026-11-01

Estimated revenueNot confirmed

Disclosed fundingUS$100 million ^[8]Closing announced in January 2025, led by Redmile Group. Individual financing round, not cumulative funding.

Official websitewww.saludamedical.com ↗

Company overview

Saluda Medical is a medical device manufacturer founded in 2011, with U.S. headquarters in Bloomington, Minnesota and operations in Australia and Europe. Led by President and CEO Mike Mathias, the company develops and commercializes neural-sensing technology for neuromodulation.

Its Evoke spinal cord stimulation system measures evoked compound action potentials (ECAPs), the spinal cord’s electrical response to stimulation. In closed-loop mode, the implanted stimulator adjusts current after each pulse to maintain the level of neural activation prescribed by the clinician.

The commercial platform combines implantable stimulation hardware, leads, programming tools and patient controls. EVA sensing technology assists personalized programming, while SmartLoop technology maintains the targeted neural response. Evoke’s clinical evidence includes the double-blind randomized EVOKE study, with published follow-up through 36 months.

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Leadership

6 people

Mike MathiasPresident & Chief Executive Officer ^[7]

James EricksonChief Financial Officer ^[7]

Kristin CapliceChief Legal Officer ^[7]

Aidan O’SullivanChief Operations Officer ^[7]

David FirstChief People Officer ^[7]

Dean KarantonisChief Technology Officer ^[7]

Products & regulatory status How does MedTechIndex get this information?

Summary

FDA approved the Evoke Spinal Cord Stimulation System under PMA P190002 on February 28, 2022. Its indication is as an aid in managing chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. ^[2]

The platform has continued to evolve through PMA supplements. On June 29, 2026, FDA approved the CAP24 paddle lead and passing elevator, together with supporting programming software and labeling changes, under P190002/S039. ^[1]

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances: —
De Novo grants: 1+
PMA approvals: —
Recall events

Latest recorded source review: 2026-11-01.

Commercial portfolio snapshot

Documented commercial product families.

Saluda Medical Evoke stimulator and leads with clinician programming display — Image: Saluda Medical

Implantable neuromodulation system

Evoke spinal cord stimulation system ↗

Rechargeable implanted stimulator, leads, clinician programming tools and patient controls for spinal cord stimulation. ECAP sensing measures neural activation; SmartLoop closed-loop technology adjusts stimulation current after each pulse to maintain the clinician-set target. EVA assists personalized programming. The system includes percutaneous lead options and the CAP24 surgical paddle lead. ^[5][6][2][1]

Commercially available · FDA PMA approved