ONWARD Medical (Euronext Amsterdam, Brussels, and Paris: ONWD) reported First Half 2026 results on 9 September 2026 with total revenue and other income of EUR 4.2 million against EUR 1.2 million in H1 2025, and cumulative participants in the ARC-BCI Therapy programme now at seven after two additional implants in the half. ARC-BCI is the platform ONWARD describes as “the world’s first and most advanced purpose-designed platform pairing a brain-computer interface (BCI) with an implantable spinal cord stimulation system.” The commercial engine underneath is ARC-EX, a non-invasive external spinal cord stimulator cleared by the FDA under De Novo classification in December 2024. ARC-EX revenue in H1 2026 was EUR 3.4 million, up 240 percent from EUR 1.0 million in H1 2025.
Commercial: ARC-EX at scale
ONWARD shipped 159 ARC-EX systems in the half, a 430 percent year-on-year unit increase. The device is available in more than 130 US clinics. Home use expanded through the US Veterans Affairs Healthcare System. International commercial availability now spans Netherlands, Switzerland, Germany, United Kingdom, France, Italy, Israel, and Spain. ARC-EX is a wearable transcutaneous system indicated for upper-extremity function in people with chronic spinal cord injury, positioned as the everyday-use therapy that funds ONWARD’s implantable and BCI-paired investigational pipeline.
ARC-IM implantable programmes
The Empower BP pivotal study is running the ARC-IM implantable spinal cord stimulator against blood pressure instability after spinal cord injury. The first participant was implanted at Craig Hospital in Denver, Colorado. Twenty-two participants are enrolled across 14 active sites in the US and Canada, with planned expansion to approximately 20 sites across US, Canada, France, Germany, Spain, and the UK. Empower BP is the near-term commercial gateway product for the ARC-IM platform.
Separately, the EIGER feasibility study, targeting mobility restoration in subacute and chronic spinal cord injury, has initiated at Schweizer Paraplegiker-Zentrum (SPZ) Nottwil and CHUV Lausanne with grant support from Innosuisse. A US Department of Defense Parkinson’s Research Program grant supports a parallel feasibility study of ARC-IM for blood pressure instability in Parkinson’s disease. ONWARD has guided to a first-in-human ARC-IM implant for bladder function in H2 2026, plus additional Parkinson’s and stroke feasibility implants.
ARC-BCI: seven participants, WIMAGINE inside
ARC-BCI is where the pipeline meets brain-computer interfaces directly. The platform pairs ARC-IM with the WIMAGINE cortical brain-computer interface developed by France’s CEA/Clinatec, a 64-electrode epidural implant with more than seven years of human safety data. ONWARD secured exclusive rights to WIMAGINE from CEA on 15 October 2024. That licence is what makes ARC-BCI a purpose-designed platform rather than an academic integration.
Two additional ARC-BCI implants in H1 2026 bring the cumulative programme total to seven participants. The clinical work runs at CHUV Lausanne under Jocelyne Bloch. Grant funders named in the release include the EU Horizon Europe programme and European Innovation Council, the Christopher and Dana Reeve Foundation, and the Swiss SERI. ARC-BCI remains investigational. No commercial timeline has been articulated.
ONWARD has been accepted into the FDA Total Product Life Cycle Advisory Program (TAP) for ARC-BCI. TAP is a relatively new FDA programme designed to compress medical-device regulatory timelines through structured early engagement, and ARC-BCI joins a small list of implantable BCI programmes accepted (alongside CorTec’s Brain Interchange, accepted for its stroke programme on 23 April 2026, per InsideBCI’s 1 September 2026 coverage).
The scientific ancestor of ARC-BCI is the STIMO-BSI brain-spine interface study run by NeuroRestore, the EPFL and CHUV joint programme co-directed by Grégoire Courtine and Jocelyne Bloch. The seminal paper is Lorach et al., “Walking naturally after spinal cord injury using a brain-spine interface,” Nature 618, 126-133, 24 May 2023. The first-in-human participant, Gert-Jan Oskam, is a Dutch cyclist with a cervical spinal cord injury from a 2011 accident. ONWARD’s own first-in-human implant of the productised ARC-IM stimulator paired with a wireless BCI was announced 30 August 2023 at CHUV for upper-limb function. ONWARD has since trademarked its brain-to-spinal-cord platform framing as DigitalBridge.
Financials and balance sheet
Total operating expenses in H1 2026 were EUR 26.3 million against EUR 20.9 million in H1 2025. Operating loss was EUR 23.3 million and net loss was EUR 24.7 million. Cash and equivalents at 30 June 2026 stood at EUR 81.5 million, up from EUR 68.1 million at 31 December 2025.
In April 2026 ONWARD raised EUR 40.6 million in an equity placement, including a EUR 25 million commitment from EQT Life Sciences. Alongside the equity raise, ONWARD entered into a new debt facility with BlackRock of up to EUR 50 million, with EUR 20 million drawn at closing. The BlackRock facility replaced ONWARD’s prior Runway Growth Capital LLC facility, which has been fully repaid. Armentum Partners acted as financial advisor.
Where ARC-BCI sits in the BCI operator landscape
ARC-BCI is not competing with Neuralink or Synchron for cursor control or communication. It is competing for the restoration of walking and upper-limb function in spinal cord injury, indications for which the BCI pairs a decoded motor signal from the cortex with targeted stimulation of the spinal cord below the injury. The nearest academic peers are the Louisville Kentucky Spinal Cord Injury Research Center work led by Susan Harkema and Claudia Angeli, and the Ohio State / Battelle / Feinstein Institute programme led historically by Chad Bouton. Both academic programmes pair BCI decoding with SCS but use general-purpose commercial SCS hardware (Medtronic and Abbott). ONWARD is the only operator running a co-designed BCI-plus-implantable-SCS platform at commercial-development stage.
Placed on the six-modality non-surgical and invasive BCI operator map that InsideBCI has been mapping through September (intracortical Neuralink / Paradromics / Blackrock / StairMed; cortical-surface Precision Neuroscience / ABILITY Neurotech / CorTec / Weiling Medical; endovascular Synchron; ultrasound Merge Labs / Gestala; non-invasive EEG Neurable / MindMaze; nanoparticle Subsense), ONWARD’s ARC-BCI sits inside the cortical-surface family via the WIMAGINE epidural implant, distinguished by its therapeutic pairing with an implantable spinal-cord stimulator rather than by novel neural decoding alone.
Not disclosed
Full-year 2026 revenue guidance is not disclosed. Cash runway guidance is not stated in the release. Named CFO, CMO, CRO, and CCO are not quoted in the release, with only CEO Dave Marver on the record. Named prescriber count, patient count treated under ARC-EX, and cumulative implants of ARC-IM (across Empower BP, EIGER, and the Parkinson’s feasibility work) are not disclosed as company-wide totals. The commercial timeline for ARC-BCI is not articulated. Whether ONWARD intends to seek FDA IDE and eventual PMA for ARC-BCI as a unified BCI-plus-SCS system, or to pursue ARC-IM and ARC-BCI as separate regulatory tracks, is not stated.
What to watch
The first ARC-IM bladder function implant, guided by ONWARD for H2 2026. That milestone would extend the ARC-IM indication set from mobility, blood pressure, and upper-extremity function into autonomic function, materially broadening the platform’s addressable indication base.
Empower BP first pivotal readout. Twenty-two participants are enrolled against a target site count of approximately 20. The first efficacy readout is the near-term regulatory-timeline anchor for the entire implantable programme.
ARC-BCI participant count on the H2 2026 full-year report. Two implants per half is the current pace. A step-up in cadence, or a first ARC-BCI implant at a site outside CHUV Lausanne, would be the first operational signal that WIMAGINE-plus-ARC-IM is scaling as a repeatable platform rather than a single-site clinical programme.
Any FDA TAP milestone disclosure from ONWARD on ARC-BCI. TAP participation is disclosed. Named TAP-driven milestones (advisory feedback dates, IDE pre-submission acceptance, IDE approval) would be the first hard regulatory signals for ARC-BCI.
Whether any other listed neurotech company acquires or partners around a purpose-designed BCI-plus-SCS platform in the coming quarters. ONWARD’s superlative claim to “world’s first and most advanced” holds today, in part because the market has not seen a competitor co-designed platform. A US-listed or Chinese operator entering the same therapeutic combination would move ARC-BCI from a monopoly configuration to a competitive category.