Dear Friends,
I am pleased to share that we have submitted our De Novo application to the US Food and Drug Administration (FDA) for regulatory clearance to market our first product, the ARC-EX® System, in the United States. This is a significant step forward in our goal to commercialize the ARC-EX System in the US in Q4 2024 and in Europe in mid-2025.
The ARC-EX System delivers targeted stimulation, called ARC-EX Therapy™, non-invasively through the skin to the spinal cord and is designed to restore upper limb function after spinal cord injury (SCI). This article in Mass Device has more information on our therapies and the submission.
Once cleared by the FDA, the ARC-EX System will be the first-ever commercially available spinal cord stimulation therapy to restore upper extremity function after SCI. Our Up-LIFT global pivotal trial showed 72% of participants with chronic incomplete tetraplegia responded to ARC-EX Therapy, demonstrating clinically meaningful improvement in both strength and function; all primary safety and effectiveness endpoints were also met1. Up-LIFT was conducted at 14 leading neurorehabilitation centers in the US, Canada, the UK, and the Netherlands.
This regulatory submission is the culmination of years of innovation, study, and determination. We are grateful to our worldwide clinical trial investigators, study participants, and the broader SCI Community for inspiring and helping us achieve our mission to restore movement, function, and independence in people with SCI.
Warm regards,
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Dave Marver
CEO