ONWARD has announced the that it has received breakthrough device designation status from the US Food and Drug Administration (FDA) for their ARC-IM platform for blood pressure and trunk control in people with spinal cord injury.
This is the third such breakthrough device designation for ONWARD, following previous awards for ARC-EX for upper extremity function and ARC-IM for mobility.
ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The system is operated via a tablet programmer and smartwatch.
The STIMO study demonstrated the ability of this technology to enable long-paralysed people to stand and walk again with little or no assistance and a recently published Nature paper showed the potential for this same therapy to normalise blood pressure in people with spinal cord injury.
Dave Marver, chief executive officer of ONWARD, said: “Blood pressure and trunk control are two of the many challenges people with spinal cord injury must manage in order to navigate their daily lives.
“We are excited about this award and thankful to the FDA for recognising the potential of our technology to improve the quality of life for those with spinal cord injury.”