ONWARD Medical licences Clinatec's WIMAGINE BCI in bid to commercialise brain‑spine interface for paralysis

ONWARD Medical, an EIC Transition beneficiary, has signed an exclusive licence with CEA-Clinatec to develop and commercialise the WIMAGINE brain-computer interface as part of its investigational ARC-BCI system. The move brings together Clinatec's implantable BCI hardware and ONWARD's spinal cord stimulation therapies with the explicit goal of restoring thought-controlled movement in people with spinal cord injury.

What ONWARD is licensing and why it matters

Clinatec's WIMAGINE BCI was developed at the CEA-backed biomedical research centre and has accumulated several years of human safety data. ONWARD says the WIMAGINE device is well suited to its applications and that exclusive rights provide a path to being the first company to bring a BCI-enabled system for restoring movement to market. The ARC-BCI concept pairs a device that decodes motor intentions from the cortex with spinal cord stimulation that converts those intentions into patterned stimulation to reanimate muscles below a spinal lesion.

Clinical progress so far

ONWARD and partners have already run early human studies combining BCI decoding and spinal stimulation. The first investigational BCI implant involving ONWARD, EPFL and CEA-Clinatec dates to 2021. Additional combined implants followed in September 2023 and September 2024 aimed at restoring upper limb and leg movement respectively. ONWARD reports that ARC-IM therapy has been applied to more than 30 study participants to date and that WIMAGINE has seven years of human safety data. More implants are planned.

Separately ONWARD has published pivotal trial data for its non-invasive ARC-EX system. The Up-LIFT trial involved 65 participants across multiple centres and reported that primary safety and effectiveness endpoints were met with substantial proportions of participants showing improved upper limb strength, sensation or quality of life. Those results underpin ONWARD's broader strategy but do not by themselves validate an implantable BCI plus implantable stimulator.

Technical explanation in plain language

Funding, partnerships and the research ecosystem

The ReverseParalysis project is an EIC Transition-funded initiative coordinated by ONWARD and supported by grants from the Christopher and Dana Reeve Foundation among others. The European Innovation Council provides funding and support to help move technologies from laboratory stage toward market readiness. Clinatec is part of CEA, a major French public research organisation, and has been a notable centre for neurotechnology research. The exclusive licence transfers rights for WIMAGINE's development and commercialisation to a private company and formalises a path to scale but concentrates IP in a single commercial actor.

Why the licence is notable and what remains to be proven

An exclusive licence for an implantable BCI is a significant commercial step because it allows ONWARD to integrate hardware, software and stimulation therapy into a single regulated product. The company positions itself as a candidate to be first to market with a BCI-enabled system for restoring movement after paralysis. However considerable obstacles remain. The current human evidence base is small and early. Long-term safety, durability of benefit, device reliability and infection or hardware failure risks need large controlled trials and extended follow up. Regulatory clearance for combined implantable systems typically requires rigorous pivotal studies and manufacturing scale up to meet medical device regulation and post-market surveillance requirements.

Commercial questions also persist. Implantable BCIs and associated stimulation implants are complex and costly to deliver. Reimbursement pathways, training of multidisciplinary surgical and rehabilitation teams, and equitable access across European health systems will influence how many patients can realistically receive these therapies. Exclusive licensing raises additional questions about pricing, spinouts in the research community and the ability of other groups to build on Clinatec's work.

Safety, ethics and data privacy considerations

BCIs record neural data that can be highly personal. Product development must address data security, user consent, and governance of how neural signals are stored and used. There are also ethical questions about long-term implantation, informed consent for patients with severe disability, and how to manage expectations given the life changing hopes tied to mobility restoration. Regulators and clinical teams will need clear frameworks for monitoring adverse events and for transparent reporting of outcomes.

Implications for the EU innovation agenda

The deal illustrates how public research organisations, national research centres and EU innovation funding can catalyse technology transfer into the private sector. The European Innovation Council's Transition funding is intended to derisk projects and push promising lab results toward market readiness. Licensing of public sector-developed devices to industry is a normal pathway to scale but does not eliminate the need for independent validation. Policymakers and funders should watch how exclusivity, pricing and access evolve as more medical neurotechnology projects mature in Europe.

Next steps and what to watch for

Key milestones to monitor include the outcome of ongoing human implant studies, the design and results of any pivotal trials for the combined implantable ARC-BCI, formal regulatory submissions to the FDA and EU authorities, and announcements on manufacturing and reimbursement strategies. Independent publications of safety and efficacy data will be important to corroborate company statements and to assess long-term impact.

Bottom line

The exclusive licence for WIMAGINE gives ONWARD a clearer commercial pathway to develop an integrated brain-spine interface aimed at restoring movement after spinal cord injury. Early human work and regulatory designations are encouraging but remain preliminary. Delivering a safe, effective and widely accessible implantable BCI system will require larger controlled studies, robust regulatory review, careful handling of ethical and data privacy issues, and planning for costs and health system adoption.