Onward’s ARC-EX delivers targeted, programmed spinal cord stimulation non-invasively, rather than via implanted electrodes. Image credit: Shutterstock / Martin Capek.

Onward Medical has shared stimulation insights from two of its non-invasive spinal cord stimulation clinical studies, which could help guide stimulation programming decisions.

The programming data, published in Neuromodulation: Technology at the Neural Interface, summarises effective stimulation parameters from the Up-LIFT and LIFT Home trials, which were evaluating the company’s highly anticipated ARC-EX therapy.

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Onward’s ARC-EX delivers targeted, programmed spinal cord stimulation non-invasively, rather than via implanted electrodes. The therapy is being used to help restore limb function in patients with spinal cord injury.

The reported stimulation framework used analysis of device parameters, usage data, and feedback from both the clinician and participant. Onward said the study investigators “recognised the importance of simplifying programming processes for their peers.”

Active electrodes were mostly placed between C3/C4 and C6/C7, with a return electrode typically positioned bilaterally over the anterior superior iliac spine. Stimulation was delivered with a 10-kHz carrier frequency and typically a 30-Hz burst frequency, and biphasic waveforms used in most sessions. Onward said that device-related adverse events were not correlated with specific waveforms or amplitudes and did not occur frequently. The research paper suggested a hierarchical order of parameter adjustments that starts with current amplitude and ends with burst frequency.

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Chet Moritz, one of the co-principal investigators of the Up-LIFT trial, said: “These programming insights were developed based on our experience with 60 participants in the Up-LIFT trial, and we expect them to be very helpful in determining the optimal parameters for stimulation for a wide range of patients in the clinic.”

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Onward is moving its ARC-EX system towards commercial launch, having submitted a De Novo application to the US Food and Drug Administration (FDA) in April 2024. The analysis of stimulation parameters will help provide important information for the device’s clinical implementation for upper extremity functional restoration in spinal cord injury patients.

The Up-LIFT study (NCT04697472) enrolled 65 tetraplegic participants across the US, Europe, and Canada. After an average of 25 stimulation sessions, 72% of the 60 study participants who completed the trial demonstrated improvement in both strength and function. No serious adverse events related to the therapy were reported, meaning the primary endpoints for safety and effectiveness were met.

A market model by GlobalData estimates the global neuromodulation device market will be worth $11.4bn by 2033, up from $6bn in 2022.