Pivotal trial to demonstrate 80% patient improvement
A closed-loop spinal cord stimulation device was tested across multiple sites in Australia, demonstrating over 80% patient improvement and 82% opioid reduction. The evidence secured CE Mark and FDA approvals, helping thousands reclaim their lives.
Imagine a world in which you are in pain 24/7, with no end in sight.
You’ve tried everything – from rest, to therapy, to medicine – but to no avail. As difficult as this sounds, it is reality for one in five people in the world. Saluda Medical set out to change this. The company developed an implantable Spinal Cord Stimulation (SCS) system. This was a closed-loop system that would send signals through the spine, listen to the body, and make real-time adjustments to provide pain relief. Sounds revolutionary, but innovation alone wasn’t enough. To bring this breakthrough to the market, Saluda needed rigorous, clinical evidence — this is where Mobius stepped in.
Our goal was to turn Saluda’s vision into validated reality.
Working in tandem with the Saluda team, we designed a prospective, multicentre, open-label study in 50 subjects in Australia. The study was initially designed to run for a 12-month period and then amended to run for 24 months. This included several patient touchpoints including initial screening, implanting temporary leads, implanting the SCS system, and ensuring multiple touchpoints for pain assessment and reprogramming. Mobius managed the study end-to-end including recruitment, amendments, site monitoring, and data management.
The results were irrefutable.
Over 80% of the patients experienced a clinically meaningful improvement in quality of life. 82% of patients were able to reduce or eliminate opioid use. The studies demonstrated both the short-term benefits and the long-term effectiveness of the SCS system. These results helped Saluda gain regulatory approval in Europe (CE Mark). This also supported an Investigational Device Exemption (IDE) that later helped Saluda gain FDA approval for their device.
Today, their device is available to both patients and caregivers – helping thousands of people break free from chronic pain and reclaim their lives.
At Mobius, we are experts at taking innovations from blueprint to breakthrough, together. If you have an innovation that can advance care – reach out.
Key outcomes
- 80%+ of patients experienced meaningful improvement in quality of life
- 82% reduced or eliminated opioid use
- Regulatory approvals: CE Mark (Europe) + FDA (United States)
- Long-term effectiveness demonstrated in extended 24-month trial