Seven people with spinal cord injuries can now move their own paralyzed limbs again using a brain-spine interface implanted by a single European company. ONWARD Medical reported its Q1 2026 results on 26 May 2026 with two additional ARC-BCI participants brought into the programme over the quarter, taking the total to seven. The same release detailed the first commercial revenue line for the company’s non-invasive ARC-EX system (EUR 1.3 million across 100+ clinics with the first home-use shipments to US VA patients) and the first participant enrollment plus first successful implant in the Empower BP global pivotal study for blood-pressure instability after SCI, conducted at Craig Hospital in Denver with 12 sites now activated.

The Q1 numbers

ONWARD booked EUR 2.0 million in total Q1 2026 revenue. The core ARC-EX commercial system (a non-invasive transcutaneous spinal cord stimulator for restoring upper-limb function in chronic spinal cord injury patients) accounted for EUR 1.3 million. The company supplied 70 ARC-EX systems for use in clinics and homes during the quarter, with the product now available in more than 100 clinics across the US and Europe. The first home-use shipments went to US Department of Veterans Affairs patients following the FDA 510(k) clearance expansion in November 2025.

Cash position at end of Q1 was EUR 53.4 million. The April 2026 equity raise of more than EUR 40 million (covered in Inside BCI’s 20 April piece) extends the runway into Q1 2028. The combined commercial + capital position gives the company roughly two years of runway to convert ARC-EX commercial traction into the implantable pipeline milestones the business case has been built around.

ARC-BCI cadence

ARC-BCI is ONWARD’s brain-spine interface platform, pairing a brain-computer interface implant on the motor cortex with a spinal cord stimulator below the injury site. The intent decoded from the cortex triggers stimulation that activates surviving spinal cord neurons distal to the injury, restoring voluntary movement in lower limbs. The architecture is the commercial expression of the Grégoire Courtine and Jocelyne Bloch research published in Nature in 2023 and earlier (see Inside BCI’s 26 May EPFL cluster piece).

The Q1 update brings the total ARC-BCI implant count to seven, with two additional participants added over the quarter. At the time of the April 20 ARC-EX raise piece, the count was three. The cadence is approximately four implants per six weeks, which is consistent with the company’s communicated 2026 trajectory rather than ahead of it. The investor framing now needs the implant count to keep tracking that cadence through the remainder of the year for the implantable narrative to hold against the funded runway window.

Empower BP pivotal opens

The Empower BP global pivotal study evaluates the ARC-IM implantable platform for blood-pressure instability after spinal cord injury, a different therapeutic indication from the motor-restoration use case ARC-BCI addresses. Q1 brought the first participant enrolled and the first successful implant in the study at Craig Hospital in Denver, with 12 sites now activated.

Blood-pressure instability (orthostatic hypotension and related autonomic dysreflexia) is a common and debilitating secondary complication of high-level SCI, with limited pharmacological options. The Empower BP indication is therefore a structurally different commercial story than ARC-BCI’s motor-restoration positioning: it addresses a sub-population of the SCI patient base whose primary clinical problem is autonomic, not motor. If the pivotal reads out positively, ONWARD adds a second indication to the ARC implantable platform without requiring fundamentally new device hardware.

Where ONWARD sits in the brain-spine cohort

ONWARD’s ARC-BCI is one of two clinically-active brain-spine interface programmes in the world. The Lausanne / EPFL / CHUV academic programme led by Grégoire Courtine and Jocelyne Bloch has continued publishing in Nature and Lancet and is the academic source from which ONWARD spun out. The other active clinical-stage brain-spine programme is the Xuanwu Hospital + Beinao-1 combined surgery in China, with a single patient at one-year follow-up showing ASIA Grade A to C conversion.

The contrast between the two programmes is structurally illustrative. ONWARD is the European publicly-listed company with seven implants and a commercial revenue line. The Xuanwu / Beinao-1 programme is one patient, one-year follow-up, conducted at a state-affiliated Chinese clinical centre with the cortical-side device built by the China Institute for Brain Research-affiliated NeuCyber NeuroTech. The Western press tracks ONWARD’s cadence; the Chinese press tracks the Xuanwu / Beinao-1 milestone. Both are real, structurally different, and serving the same therapeutic indication.

What to watch

The next ONWARD-specific signal is the August Q2 2026 earnings call, which will confirm whether the ARC-BCI implant cadence is holding at four per six weeks and whether the Empower BP enrollment is scaling beyond Craig Hospital across the 12 activated sites. The second signal is ARC-EX home-use commercial traction, particularly the rate at which the VA channel scales versus the broader clinical channel. The third signal is whether ONWARD discloses any update on its FDA implantable pathway for ARC-IM in the US following the European pivotal start.

Sources

• ONWARD Medical Reports First Quarter 2026 Results (Yahoo Finance / Globe Newswire, 26 May 2026)
• ONWARD Medical Reports First Quarter 2026 Results (Manila Times / Globe Newswire mirror)
• ONWARD Medical Investor Relations
• ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM (Globe Newswire, 4 February 2026)
• ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use (Globe Newswire, November 2025)