MetaMedical™ Solutions Inc

Onward’s ARC-EX therapy hits success in pivotal trial for spinal cord injury

Onward Medical’s ARC-EX therapy is going from strength to strength after results from a pivotal trial investigating the device demonstrated significant improvements in recovery from spinal injuries.

The US-based company released a snapshot of the Up-LIFT trial’s data in January 2024, but the full study’s results were just published in Nature Medicine.

Onward’s ARC-EX delivers targeted, programmed spinal cord stimulation non-invasively, rather than via implanted electrodes.

The treatment led to improvements in upper limb strength, function, and sensation in patients with chronic tetraplegia due to cervical spinal cord injury.

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.

The study’s lead author and co-principal investigator Chet Moritz said: “Trial results far exceeded our hypothesis of a 50% response rate to ARC-EX Therapy, giving new hope to people with spinal cord injury and rehabilitation providers.”

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Onward reported that primary endpoints of efficacy and safety were met.

The technology could soon hit the shelves in the US. Onward submitted a De Novo application to the US Food and Drug Administration (FDA) last month. The company also has plans to follow suit with a marketing application in Europe.

Onward has developed another device that, unlike ARC-EX, delivers stimulation by implantable electrodes (ARC-IM). The company implanted the first human with the system to restore limb function in September 2023. It is also investigating the technology in combination with brain-computer interfaces (BCIs). BCIs enable neural communication between the brain and an output device, such as spinal cord stimulators developed by Onward.

Onward is also exploring the use of its technology beyond solely neuromuscular uses. In January 2024, the company initiated a feasibility study to assess its ARC-IM neurostimulator’s ability to improve haemodynamic instability in spinal cord injury patients. The Netherlands-based HemON NL study follows the HemON study (NCT05111093).

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

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