The STIMO study showed the potential of ARC-IM platform to enable long-paralysed people to stand and walk again with little or no assistance
The FDA breakthrough device status enables to use ARC-IM platform for blood pressure and trunk control in people with spinal cord injury. (Credit: kalhh from Pixabay)
Medical technology firm ONWARD has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its ARC-IM platform for blood pressure and trunk control in people with spinal cord injury.
Earlier, the company secured breakthrough device designations for ARC-EX for upper extremity function and ARC-IM for mobility.
ARC-IM features an implantable pulse generator and lead, which is placed near the spinal cord.
A tablet programmer and smartwatch will be used to operate the ARC-IM platform.
According to the company, the STIMO study showed the potential of ARC-IM platform to enable long-paralysed people to stand and walk again with little or no assistance.
ONWARD CEO Dave Marver 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 recognizing the potential of our technology to improve the quality of life for those with spinal cord injury.”
Under the designation, the regulator will offer ONWARD with priority review and a chance to coordinate with FDA’s experts across the premarket review phase as the technology advanced toward eventual commercialisation.
ONWARD has designed the ARC Therapy to deliver via implantable (ARC-IM) or external (ARC-EX) systems.
In April this year, the company secured $32m funding for the development and commercialisation of its ARC Therapy.
The ARC Therapy will help provide targeted and programmed stimulation to the spinal cord to restore movement and other functions in people with spinal cord injury.
Its first FDA pivotal trial, dubbed Up-LIFT, started in January this year. The firm aims to recruit up to 65 subjects at around 15 centres across the world.