Medtech company Onward, listed on Euronext Brussels, has published its half-year report: losses remain substantial, as U.S. sales of the ARC-EX are still in their early stages, while ongoing trials and the build-out of the commercial infrastructure continue to absorb significant resources. But according to CEO Dave Marver, sales are set to accelerate strongly in the second half of the year, with several regulatory approvals expected before year-end. In our conversation following the results, Marver sounded determined and highly optimistic.
Second phase of commercialization
The company reported its first-half results. While the detailed figures are not yet of prime importance, the €1.2 million revenue illustrates that ARC-EX sales are underway. Net loss reached €21.2 million, compared to €18.3 million a year earlier, reflecting the rising costs of building a commercial team in the U.S.
To recap, ARC-EX is a unique, non-invasive device that improves hand strength and sensation in people with spinal cord injury. Approved by the FDA in December 2024, the system stimulates the spinal cord externally using electrodes that deliver small electrical pulses. Even modest improvements in hand function can bring a dramatic boost in independence and quality of life.
Crucially, Onward confirmed it sold 30 ARC-EX systems in the U.S. during the first half of the year, meeting its stated target. “We deliberately kept sales limited while we built our commercial team and ensured the rollout would go smoothly,” said Marver, who added that interest has been stronger than expected. “More than 300 clinics—out of a total market of roughly 450—have already contacted us in the first half to learn more and evaluate the device. This shows the therapy has captured the attention of the entire sector, and in the second half our sales will accelerate significantly. By year-end, we expect to have sold into at least 100 clinics.”
Strategy and upcoming approvals
The acceleration is enabled by the expansion of the U.S. team, which Marver says should not be seen as mere sales reps. “The team consists of 12 clinicians, physical therapists, and occupational therapists. They are trained not only to explain the device but also to assist with implementation. Their work involves training, optimization, and ongoing support to ensure clinics can integrate the therapy seamlessly.” The opportunity is all the greater as no other treatment options currently exist for these patients.
And this is just the beginning. “Each clinic introduces ARC-EX to an average of 15 patients and their caregivers, effectively preparing the market for our next milestone: home use. We filed our FDA submission for home use in June, and we expect approval in the fourth quarter. The impact could be significant, as patients will be able to continue therapy in their daily lives.”
While the U.S. remains the top priority, Europe is also set to gain importance. Onward has applied for CE marking, with approval also expected in the fourth quarter. “Unlike in the U.S., where approvals are split between clinical and home use, the European approval would cover both indications from the start. This would open immediate access to a broader patient base, both in clinics and at home.” The company plans a phased European rollout, starting with Germany and a handful of other countries. In several markets, local management teams are already being assembled.
From R&D to a commercial company
Is the shift to a more commercial profile a challenge for CEO Dave Marver? “I joined Onward five years ago, when the company had no revenue but the conviction that this technology would one day reach the market. For me, this transition to commercialization is more than welcome. With a background in sales and marketing at Medtronic, in both the U.S. and Europe, I have many years of experience bringing medtech products to market. Today, Onward has grown into a multifunctional organization, with teams in research, clinical trials, regulatory affairs, and now also sales and marketing. And the profound impact we are already seeing on the lives of people with spinal cord injuries is the true reward for our work.”
On the development side, momentum is also strong. Onward is advancing ARC-IM, an implanted brain-computer interface platform that offers unprecedented control to patients with severe neurological disorders. “Applications go well beyond spinal cord injury, covering Parkinson’s disease, stroke, blood pressure instability, and mobility challenges. Following FDA approval, we have launched a global study to evaluate the safety and efficacy of this technology in treating blood pressure instability after spinal cord injury.”
Market reaction and financial position
Despite these advances, the market has been slow to reward Onward: the share price is flat compared to the beginning of the year. “European medtech investors have become more cautious following several high-profile failures in the sector,” Marver noted. “But I’m not concerned. I’m focused on execution, not short-term volatility. Investors will ultimately respond to revenue growth and market traction. Within Onward, we are confident about the coming quarters.”
Marver also highlighted the company’s ADR listing on Wall Street, launched in partnership with Bank of New York. “It gives U.S. investors easier access to our shares and allows us to maintain close relationships with American bankers, analysts, and institutions. Longer term, a dual Nasdaq listing remains a strategic goal.”
For now, investors need not worry about cash levels. As of June 2025, Onward held €40.9 million in cash. “For a medtech company at this stage, our financials are relatively strong. With funding secured through 2026, we can focus our resources on key priorities: commercializing ARC-EX and advancing the pivotal Empower BP trial for ARC-IM.”
One of Onward’s most important backers is Ottobock, the world’s largest prosthetics company. “Ottobock’s planned IPO later this year will generate substantial capital and broaden its reach, making it an invaluable partner,” Marver concluded.
