ONWARD Medical doubles revenue as ARC-EX unit sales surge 430%
ONWARD Medical has reported a sharp acceleration in commercial traction for the first half of 2026, selling or supplying 159 ARC-EX Systems via paid evaluation, a 430% year-on-year increase in units. Total revenue reached EUR 4.2 million, with ARC-EX product revenue alone rising 240% to EUR 3.4 million compared with EUR 1.0 million in the same period last year.
The Euronext-listed neurotechnology company also raised EUR 40.6 million in equity capital during the period, anchored by a EUR 25 million investment from EQT Life Sciences, and secured a new debt facility of up to EUR 50 million from BlackRock. It ended June with a cash position of EUR 81.5 million, up from EUR 68.1 million at year-end 2025. The company simultaneously retired its existing loan from Runway Growth Capital, replacing it with the more flexible BlackRock arrangement.
Commercial and clinical progress
ARC-EX, which holds US FDA clearance for improving hand strength and sensation in people with incomplete spinal cord injuries, is now available across more than 130 clinics in the United States, including expanded home-use access through the Veterans Affairs Healthcare System. The first systems have also been sold directly to individuals for home use, a distribution step that ONWARD frames as central to broadening reach beyond specialist rehabilitation centres. International commercial availability has extended to clinics across the Netherlands, Switzerland, Germany, the UK, France, Italy, Israel, and Spain.
On the investigational side, ONWARD enrolled its first participants in the Empower BP global pivotal study, which is evaluating the implantable ARC-IM System for managing blood pressure instability after spinal cord injury. The randomised, double-blinded, sham-controlled study has now enrolled 22 participants across 14 actively recruiting sites in the US and Canada, with an eventual target of approximately 20 neurorehabilitation and neurosurgical centres also spanning France, Germany, Spain, and the UK.
The company also initiated the EIGER feasibility study at two Swiss centres to assess ARC-IM's potential for restoring standing and walking after subacute and chronic spinal cord injury, and reported two additional implants of its ARC-BCI brain-computer interface platform, bringing the total to seven study participants.
Market context and regulatory path
ONWARD operates in an emerging segment of active implantable neurostimulation for spinal cord injury, a space that has attracted growing academic and commercial interest following high-profile published research from groups at EPFL and the University of Louisville. Direct competitors at a commercial scale remain limited, but several university-spinout programmes and established neuromodulation players are developing spinal stimulation approaches. ONWARD's portfolio of ten FDA Breakthrough Device Designations provides meaningful regulatory leverage, accelerating its dialogue with the agency ahead of anticipated pivotal data readouts.
The operating loss widened to EUR 23.3 million in H1 2026, from EUR 20.0 million a year earlier, reflecting stepped-up investment in commercialisation, regulatory affairs, and clinical execution. With EUR 81.5 million in cash and access to the undrawn tranches of the BlackRock facility, the company appears adequately funded through the Empower BP readout window, though the timeline to that milestone has not been disclosed.
Looking to the second half of 2026, ONWARD said it expects to initiate a first-in-human feasibility study exploring ARC-IM's potential to restore bladder function after spinal cord injury, and to pursue additional implants in Parkinson's disease and stroke programmes. Chief executive Dave Marver described the company as "well positioned to broaden access to ARC-EX and advance ARC-IM toward regulatory approval," a target that will depend heavily on the Empower BP dataset when it matures.