ONWARD Medical has been awarded another breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its ARC-BCI system.
 
ARC-BCI uses brain-computer interface (BCI) tech in tandem with its ARC-IM therapy to restore thought-driven lower limb mobility following spinal cord injury (SCI). The breakthrough status was supported by clinical data from two feasibility studies, according to the company.
 
The latest award allows ONWARD priority review, the opportunity to interact with the FDA throughout premarket regulatory review, and potential to seek reimbursement for the ARC-BCI system.
 
An implanted BCI records brain activity and captures signals indicating a person’s potential to move. ARC-BCI then uses artificial intelligence to decode the signals and translate them into instructions for the ARC-IM system, which converts the instructions into stimulation of the injured spinal cord.
 
In essence, it creates a “digital bridge” to restore communication between the brain and the body, allowing movement driven by thought after paralysis.
 
“Brain-computer interface technology unlocks the transformative potential to enhance ARC-IM with thought-driven control of movement after paralysis,” said ONWARD CEO Dave Marver. “We look forward to learning more about the potential for this combination of ARC Therapy and a BCI to help people with spinal cord injury live more independently. We are also grateful to the FDA for recognizing our innovations and their potential to help people with profound unmet needs.”
 
A BCI was paired with ARC-IM therapy for the first time in history in 2021 to restore lower limb movement—including walking—after SCI. The study was published in May 2023, highlighting the participant’s augmented control over paralyzed legs with the BCI’s addition.
 
ONWARD was previously awarded breakthrough status for multiple indications of its ARC therapy platforms, including mobility and blood pressure regulation. The company aims to launch its first product later this year.