Report
Onward Medical NV - Road to market for ARC-EX wide open
*This morning, ONWD announced successful completion of ARC-EX upgrade works and subsequent testing by a medical equipment lab which was a requirement for commercial launch. Importantly, this was the last hurdle to overcome before submitting the de novo dossier to the FDA. We are confident in approval towards the end of the year taking into account the 1/ Breakthrough Device Designations received from the FDA, acknowledging the high unmet need for a patient-friendly and efficacious therapy to improve arm/hand mobility for spinal cord injury patients, 2/ convincing data generated through rigorous clinical trial testing.*Remember that this device update is not necessary
Underlying
ONWARD MEDICAL NV
Provider
Degroof Petercam
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