Medical Device Network

Onward wins grant from Christopher & Dana Reeve Foundation to advance BCI study

The $1.1m grant will fund the enrolment of an additional four participants to be implanted with Onward’s ARC-BCI system.

Onward Medical has won a $1.1m grant from the Christopher & Dana Reeve Foundation to support an ongoing study of its Onward ARC-BCI System to restore thought-driven movement of the hands and arms after spinal cord injury (SCI).

The grant is set to support an additional four participants to be implanted with the brain-computer interface (BCI) system. The early feasibility study evaluates the use of BCI to restore the thought-driven use of the hands and arms after SCI. The first participant in the study received their investigational ARC-BCI implant in August 2023.

The ARC-BCI platform pairs Onward’s ARC-IM system with BCI technology from CEA-Clinatec, which registers brain intention to move upper extremities and decodes signals using AI. The ARC-IM stimulator then captures the decoded information to precisely stimulate the spinal cord.

Onward has already shared data showing that the combination has demonstrated positive results in providing movement for the paralysed lower legs. The company won US Food and Drug Administration (FDA) breakthrough device designation for the technology in February 2024, then shortly after was accepted into the FDA’s new Total Product Lifecycle Advisory Program (TAP).

BCI’s are chips implanted in brain tissue that take brain signals and translate them into commands. The measured signals, which can be described as ‘thoughts’, are relayed to a secondary, external device which then carries out a specific function. The tech has received significant attention due to Elon Musk’s company Neuralink, which has now implanted two paralysed patients with its device, Telepathy.

Other companies, including Brown University spinout BrainGate, are also making movements in the space. The company reported a successful case study last month, highlighting that its technology translates brain signals into speech with an accuracy of up to 97%, meaning patients with speech impairments could benefit from the implant.

However, all eyes are on Onward as it aims to commercialise its non-invasive ARC-EX therapy in the US, following an April 2024 FDA De Novo application submission. This submission is supported by positive data from the Up-LIFT study (NCT04697472).

Onward Medical’s CEO Dave Marver said: “While other companies are using BCI technology to interface with computers, Onward is leading the pursuit of BCI-augmented movement restoration. We are grateful to the Christopher & Dana Reeve Foundation for its support, which enables us to expand this important study.”