ONWARD - ARC Therapy
We are working to enable people with spinal cord injury to move again, aided by ARC Therapy™ – targeted, programmed stimulation of the spinal cord. In addition to restoring movement, we have observed other potential benefits from spinal cord stimulation that we may explore such as improved bladder control, sexual function, and blood pressure regulation.
ONWARD`s ARC Therapy is designed to deliver targeted, programmed stimulation of the spinal cord to restore movement and other functions in people with spinal cord injury
These benefits have been observed in published pre-clinical and human feasibility studies
ARCEX is our external, non-invasive platform, which consists of a wearable stimulator and wireless programmer. We received FDA Breakthrough Device Designation to demonstrate that ARCEX Therapy restores or improves physical movement of hand and arm function to people with spinal cord injury. Investigators in the US, Canada and Europe are currently screening candidates for participation in the Up-LIFT Study. You can learn more about the Up-LIFT Study below.
ARCIM is our implantable platform, which consists of an implantable pulse generator and lead that is placed near the spinal cord. ARCIM is controlled by wearable components and a smartwatch. The STIMO study demonstrated the ability of this technology to enable long-paralyzed people to stand and walk again with little or no assistance. We received FDA Breakthrough Device Designation for ARCIM in 2020 to restore the recovery of leg motor functions in people with spinal cord injury and in 2021 for use of the system to stabilize blood pressure and to support trunk stability.
Other potential indications we may explore for ARCIM include reduced spasticity and improved sexual function, bladder, and bowel control. We expect to begin our FDA pivotal trial for the highest priority indications within 24 months. Please register below if you have an interest in participating.
The Up-LIFT Trial will evaluate the safety and effectiveness of ARCEX Therapy in restoring strength and function of upper extremities in people with spinal cord injury. We plan to enroll 65 subjects at up to 15 sites in the US, Canada, UK, and Europe.
