Onward Medical had another successful implant of its investigational ARC-BCI system to restore power limb mobility after spinal cord injury (SCI).
 
ARC-BCI merges Onward’s ARC-IM (an implanted technology that delivers targeted stimulation to the spinal cord) with the investigational WIMAGINE brain-computer interface (BCI) from CEA-Clinitec. This creates a “DigitalBridge” across the injured spinal cord.
 
The implant procedure was performed on September 12 by Jocelyne Bloch, MD, head of functional neurosurgery at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland. It marks the third human implant of the BCI with ARC-IM therapy to restore thought-enabled movement after SCI and the second for lower limb mobility.
 
“The procedure went smoothly, and early signs are encouraging,” said Dr. Bloch. “We look forward to sharing more information in the coming months as the participant progresses in their rehabilitation and we publish observations from the study.”
 
This implantation is part of an ongoing clinical feasibility study, which is supported by a grant from the European Innovation Council under the Reverse Paralysis project and coordinated by .NeuroRestore, a Swiss neuroscience research institute. The researchers are also exploring use of the ARC-BCI system to address upper limb movement challenges after SCI in a separate early feasibility clinical study funded by the Christopher & Dana Reeve Foundation.
 
The WIMAGINE BCI is epidurally implanted and has seven years of human safety data. ARC-IM therapy has now been applied in over 30 study patients.
 
Earlier this year, Onward revealed ARC-BCI was accepted into the U.S. Food and Drug Administration (FDA) Total Product Lifecycle Advisory Program (TAP). Before the acceptance, the company announced ARC-BCI was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration. This is the company’s 10th such award.