This article first appeared on GuruFocus .
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Revenue:EUR4.2 million in H1 2026, up 250% year-over-year; EUR3.4 million from product revenues.
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Gross Profit:EUR2.9 million, approximately 70% gross margin.
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Operating Expenses:EUR26.3 million, up from EUR21 million in H1 2025.
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Operating Loss:EUR23.3 million, in line with expectations.
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Net Loss:EUR24.7 million for the period.
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Cash Position:EUR81.5 million at end of June 2026, up from EUR68.1 million at start of year.
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Cash Burn:EUR26 million in H1 2026.
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Equity Raised:Over EUR40 million in new equity capital, including EUR25 million from EQT Life Sciences.
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Debt Facility:Up to EUR50 million facility from BlackRock replacing existing loan; EUR20 million drawn at closing.
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Cash Runway:Extends into Q1 2028.
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ARC-EX Systems:159 systems sold or supplied via paid evaluation in H1 2026, more than 5x increase year-over-year; 89 units sold in Q2 2026.
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ARC-EX Clinic Footprint:Over 130 US clinics and 150 clinics worldwide in H1 2026; estimated 35%40% of US facilities managing spinal cord injury.
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ARC-EX Europe:Sales into seven countries since end of 2025.
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EMPOWER-BP Trial:22 participants enrolled; 14 clinical sites active.
Release Date: September 09, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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ARC-EX systems sold or supplied via paid evaluation reached 159 in H1 2026, a more than 5x increase year-over-year, with 89 units sold in Q2 alone, nearly matching all of 2025.
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Revenue for H1 2026 was EUR4.2 million, a 250% year-over-year increase, driven by strong product sales and expanding commercial footprint.
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Cash balance at end of H1 2026 was EUR81.5 million, up from EUR68.1 million at start of year, with runway extending into Q1 2028, following over EUR40 million in new equity capital raised, including EUR25 million from EQT Life Sciences.
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ARC-EX is now available in over 150 clinics worldwide, including over 130 in the US, covering an estimated 35-40% of US facilities that manage spinal cord injury patients, with 50% penetration in VA SCI hubs.
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Clinical progress on ARC-IM: EMPOWER-BP pivotal study enrolled 22 participants across 14 active sites, with interim analysis expected by end of Q1/early Q2 2027; EIGER feasibility study for mobility initiated; additional implants in Parkinson's and BCI studies.
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High conversion rate: over 90% of VA patients who undergo paid evaluation convert to actual purchase, indicating strong demand and acceptance.
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Reimbursement progress: completed CMS coding submission, expecting decision in Q4 2026; launched program to assist patients with case-by-case insurance reimbursement.
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Strong commercial execution: built sustainable commercial engine, expanded into 7 European countries, and entered one additional market outside US and Europe.
Negative Points
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Operating expenses increased to EUR26.3 million in H1 2026 from EUR21 million in H1 2025, driven by commercialization and clinical trial costs, leading to an operating loss of EUR23.3 million and net loss of EUR24.7 million.
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Cash burn for H1 2026 was EUR26 million, and the company remains in investment mode with no clear timeline for cash flow breakeven.
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No revenue guidance provided for H2 2026, and management cautioned that the strong growth rate may not continue at the same pace, with potential seasonality in capital equipment sales.
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Reimbursement outside VA is still limited; broad insurance coverage awaits CMS coding decision and payer engagement, which may take time.
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Nasdaq listing is on hold due to unfavorable market conditions, particularly weak large-cap med tech performance, delaying potential US capital access.
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Pipeline indications (e.g., urinary incontinence, stroke) are in early feasibility stages with no solid timelines for pivotal studies or commercialization, as they depend on grant funding and partner-driven enrollment.
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Spoke penetration in VA is low (only 4 spokes), and expansion is complex due to varying decision-making structures between hubs and spokes.
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Home use conversion may be hindered by patient access barriers such as insurance coverage or ability to pay, and need for caregiver support.
Q & A Highlights
Q: What percentage of ARC-EX units supplied to VA patients convert from paid evaluation to actual purchase, and what are the expectations for RTX sales in the second half? A: CEO Dave Marver explained that the VA pays for a three-month evaluation, after which the device is purchased and the evaluation fee is netted out. He noted that over 90% of patients convert to actual purchases. Regarding H2 sales, he declined to issue guidance due to the early stage of commercialization but warned not to assume the current growth rate will continue, noting potential seasonality typical of capital equipment with a stronger Q4.
Q: When do you expect the first decision on codes from US insurance to cover costs for ARC-EX? A: Chief Commercial Officer Sean Sciara stated that veterans can access the device today without broader insurance decisions. For the non-VA market, the company has completed its submission to the CMS group that assigns coding and expects to hear back in Q4. In the meantime, they launched a program in July to help clinics and patients engage insurers for case-by-case reimbursement.
Q: Can you provide an update on the EMPOWER-BP pivotal study enrollment and the timeline for the interim analysis? A: Chief Clinical, Regulatory and Quality Officer Shari O'Quinn reported that over 22 participants are enrolled and 14 clinical sites are active. She confirmed the goal is to reach the required enrollment number for the interim analysis by the end of this year, with the analysis expected to be conducted in early next year (Q1/early Q2). The company remains on track for regulatory approval by the end of 2028 and commercial launch in early 2029.
Q: What is the rationale for including subacute patients in the EIGER feasibility study for mobility? A: CEO Dave Marver explained that the inclusion of subacute patients (injured for 6 weeks or less) is mainly driven by the hypothesis of greater efficacy. The thesis is that intervening early, before muscle atrophy and loss of coordination occur, will make the mobility therapy more effective. While it slightly enlarges the population, the primary goal is to identify the best patient population to inform the design of the eventual pivotal study.
Q: What are the major hurdles for expanding ARC-EX into markets outside of the US and Europe? A: CCO Sean Sciara stated that the company has launched in one country outside the US and Europe and is evaluating others. The main challenges are twofold: finding an appropriate distribution partner to commercialize a new therapy and managing the operational work required for regulatory filings and product entry into new countries.
Q: What are the dynamics that inform a clinic's proclivity to prescribe ARC-EX for home use versus clinic use? A: CCO Sean Sciara noted that uptake is less about clinic size and more about human nature, with early adopters leaning in quicker. He identified the biggest barriers to home use as ensuring the patient would benefit, can use it at home, and has a caregiver to help. He emphasized that the transition to home use is largely dependent on access, either through insurance or ability to pay.
Q: What is the status of the Nasdaq listing and the company's cash flow breakeven timeline? A: CEO Dave Marver stated the company is "poised and ready" for a Nasdaq listing but market conditions are not conducive due to the rocky performance of large-cap med tech. CFO Ali Kiboro added that the company has not guided on when it will achieve cash flow breakeven, as it is a function of growth and future investments. The company is in investment mode but aims to be disciplined with capital.
Q: Are you collaborating with Neuralink or similar companies for research or innovation? A: CEO Dave Marver highlighted that Onward has its own safe BCI with over eight years of human safety data. However, the ARC-IM spinal cord stimulator has a flexible architecture that can communicate wirelessly with other BCIs. He confirmed the company is in regular discussions with leading BCI companies but noted that few are ready for human clinical research, so Onward is "poised and ready" to collaborate when they catch up.
Q: What is the amount of committed capital needed for indication expansion around ARC-EX, and how would this evolve? A: CEO Dave Marver explained that while they cannot promote off-label use, there is interest in the technology for other recovery targets. The company is supporting investigator-initiated research projects. He noted that as a Class II breakthrough device, the pathway for new indications should be relatively efficient and low-cost compared to the Class III PMA device (ARC-IM), potentially relying on investigator-initiated data or multisite studies, though discussions with the FDA are ongoing.
Q: How much did you spend on the EMPOWER-BP study in the first half of 2026? A: CFO Ali Kiboro stated that while specific costs were not broken out, it is fair to assume that the majority of the year-over-year increase in operating expenses was driven by the EMPOWER-BP study, along with spending on registrations into new geographies.
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
