ONWARD Medical: Sharp Increase in Sales, But a Loss of €40.9M in 2025
The biotech specializing in mobility restoration after spinal cord injury shows a dramatic acceleration in its U.S. sales, with 117 ARC-EX systems sold in 2025 and a market penetration of 25% in rehabilitation clinics. However, this commercial traction comes with an operational loss of EUR 40.9M and a significantly deteriorated operating cash flow, raising questions about the path to profitability.
Impressive Market Entry in the United States
ONWARD Medical launched its ARC-EX system in the United States in 2025, showcasing impressive marketing results. The company sold 117 systems during the year, establishing a presence in over 80 specialized rehabilitation clinics, which represents about 25% of this fragmented market. The system received FDA approval for home use in November, significantly expanding the potential of the American market. Concurrently, the company secured access to U.S. government supply platforms, notably with the Department of Veterans Affairs (VA). In Europe, ONWARD began a gradual launch in the fourth quarter of 2025, delivering the first systems in the Netherlands, Switzerland, Germany, and the United Kingdom. The company's total revenue reached EUR 5.4M in 2025, with EUR 3.7M generated from ARC-EX system sales (up from EUR 0.08M in 2024), a more than 46-fold increase in one year.
Significant Increase in Operational Expenses
The commercial traction is accompanied by a considerable rise in operational expenses. ONWARD recorded an operational loss of EUR 40.9M in 2025, as the company heavily invested to support its commercial expansion. Marketing and market access expenses jumped 142% to EUR 8.1M, reflecting investments in personnel and commercial infrastructure deployed in the United States and other key areas. General and administrative expenses increased by 33% to EUR 16.8M, accompanying the maturation of the operational structure. Research and development expenses decreased by 11% to EUR 12.3M due to reduced external costs, while clinical and regulatory expenses rose by 21% to EUR 5.7M. In terms of cash flow, ONWARD consumed EUR 39.1M in operating cash flow in 2025 (up from previous periods), reflecting ongoing investment in personnel and infrastructure. However, the company still maintains a net cash position of EUR 68.1M, bolstered by a capital raise of over EUR 50M in October 2025.
Anticipating Steady Execution of Commercial and Innovation Strategy in 2026
ONWARD anticipates a stable and consistent execution of its commercial and innovation strategy in 2026, driven by two new growth engines: the commercialization of the ARC-EX system for home use and expansion in Europe and other geographical areas. The company is also preparing for the execution of the Empower BP study, a large-scale global clinical trial aimed at evaluating the safety and efficacy of the ARC-IM system in treating blood pressure instability after spinal cord injury. The first recruitment and implantation of the first patient in this study took place in the first quarter of 2026 at Craig Hospital in Denver (Colorado), with 10 clinical sites already activated. The company is considering an IPO on NASDAQ within the next 12 to 18 months, subject to favorable market conditions. For investors, the main challenge is the company's ability to transform this early commercial traction into a viable economic model before the depletion of its cash reserves, currently estimated to provide visibility until the first quarter of 2027.
