Onward Medical Receives FDA green light to begin pivotal ARC-IM blood pressure study

Onward announced that it has received FDA investigational device exemption (IDE) approval to initiate the pivotal Empower BP study with the ARC-IM implantable system to address blood pressure instability after spinal cord injury (SCI). First patient enrolment in the pivotal study is anticipated before YE25, and we look forward to the detailed interim analysis from an earlier feasibility study due later this year, as well as additional details on the pivotal study design and timelines. We reiterate our € 10.4 TP and Buy rating.