Onward Medical stays on monitor to ship a submission to the US Meals and Drug Administration (FDA) for approval of its non-invasive neuromodulation remedy.
“We’re getting ready to submit a De Novo software for ARC-EX Remedy to FDA within the close to future,” Onward’s CEO, Dave Marver mentioned. Marver was talking on the 2024 North American Neuromodulation Society Annual Assembly (ANS) in Las Vegas, Nevada, US, held from January 18-21
The submission is more likely to happen within the first half of 2024, primarily based on a earlier assertion by the US-based firm’s CEO made throughout a enterprise replace final November.
Onward has acquired FDA breakthrough system designations for its ARC remedy. The designation hurries up evaluation and assessment of submitted gadgets.
Onward’s ARC remedy has made waves within the neuromuscular area for its potential to assist spinal twine damage sufferers transfer limbs. The remedy delivers focused, programmed spinal twine stimulation. Onward has developed two gadgets relying on how the stimulation is run -either by implantable (ARC-IM) or exterior (ARC-EX) programs.
Onward can also be investigating its expertise in combination with brain-computer interfaces (BCIs). BCIs allow neural communication between the mind and an output system, akin to spinal twine stimulators developed by Onward.
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A market model by GlobalData estimates the worldwide neuromodulation system market might be value $11.4bn by 2033, up from $6bn in 2022.
ARC-EX has demonstrated optimistic leads to a pivotal examine in individuals with continual tetraplegia – paralysis of all 4 limbs. Information from the Up-LIFT examine – a potential, single-arm pivotal examine designed to guage the security and effectiveness of the system – confirmed a 72% responder fee. The remedy met all major and security effectiveness endpoints within the enchancment of higher extremity energy and performance after spinal twine damage.
Onward can also be exploring using its expertise past solely neuromuscular makes use of. In January 2024, the corporate initiated a feasibility study to evaluate its ARC-IM neurostimulator’s capability to enhance haemodynamic instability in spinal twine damage sufferers. The Netherlands-based HemON NL examine follows the HemON examine (NCT05111093).