Clinical Trials Arena

Onward Medical gears up for FDA submission for ARC-EX Therapy

Onward’s non-invasive neuromodulation therapy, which is FDA breakthrough device designated, has shown positive results in a pivotal trial.

Onward Medical remains on track to send a submission to the US Food and Drug Administration (FDA) for approval of its non-invasive neuromodulation therapy.

“We are preparing to submit a De Novo application for ARC-EX Therapy to FDA in the near future,” Onward’s CEO, Dave Marver said. Marver was speaking at the 2024 North American Neuromodulation Society Annual Meeting (ANS) in Las Vegas, Nevada, US, held from January 18-21

The submission is likely to occur in the first half of 2024, based on a previous statement by the US-based company’s CEO made during a business update last November.

Onward has received FDA breakthrough device designations for its ARC therapy. The designation speeds up assessment and review of submitted devices.

Onward’s ARC therapy has made waves in the neuromuscular space for its potential to help spinal cord injury patients move limbs. The therapy delivers targeted, programmed spinal cord stimulation. Onward has developed two devices depending on how the stimulation is administered -either by implantable (ARC-IM) or external (ARC-EX) systems.

Onward is also investigating its 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.

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

ARC-EX has demonstrated positive results in a pivotal study in people with chronic tetraplegia – paralysis of all four limbs. Data from the Up-LIFT study – a prospective, single-arm pivotal study designed to evaluate the safety and effectiveness of the device – showed a 72% responder rate. The therapy met all primary and safety effectiveness endpoints in the improvement of upper extremity strength and function after spinal cord injury.

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).