As many as 72% of transverse limb patients see arm and hand functions increase after treatment with ARC-EX therapy. A result that Dave Marver, Onward's CEO, is extremely pleased with.
Strong response
The Up-LIFT study, which measured the recovery of arm and hand functions after ARC-EX therapy in paraplegic patients, again revealed positive results. On the one hand, 72% of patients responded positively to electrical spinal cord stimulation via ARC-EX therapy. For a field of medicine where no effective solutions are available, these are excellent results. On the other hand, the study meets all primary safety and efficacy endpoints.
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At the start of the study, Onward had put forward a 50% threshold as a target to be considered a success. CEO Dave Marver adds that patients who participated in the study were only stimulated with the ARC-EX therapy for two months. "There is a real chance that the rate will increase even further as patients are treated for longer and the treatment is further improved as our experience grows," he says. Besides, this is the first time such a large study has been conducted in this condition: we are therefore in uncharted territory and in a learning process."
These results were shared on 27 April by Dr Jim Guest, neurosurgeon, clinical professor, department of neurological surgery for The Miami Project to Cure Paralysis, at the annual meeting of the American Academy of Neurology in Boston. 65 people participated in the study conducted across 14 sites in the US, Canada and Europe, including Nijmegen and Amsterdam.
Approval and expansion
Through the Up-LIFT study, Onward now has sufficient data to submit the ARC-EX device to the Food and Drug Administration (FDA) and European health authorities for approval. "We then hope to commercialise the ARC-EX device in the US by the end of the year or early 2024 and in Europe in early 2024," CEO Dave Marver underlines. According to Onward's latest data, 217,000 patients or 34% of the total number of people with spinal cord injuries could be treated with it and this market is worth a total of USD 2.6 billion.
He also emphasised that Onward has been working hard over the past few months to build the business in depth so as to be able to manage commercialisation. "We have continued to build our operational and commercial capabilities through, among other things, the expansion of sales teams in our key markets and of a fully-fledged marketing team. We have also invested heavily in support activities such as IT," Marver further explains.
Finally, CEO Dave Marver is looking forward to a well-filled pipeline that will see a lot of news published over the next two years.
