Supplied ARC-EX systems jump 120% to 88 in third quarter of 2026
Key Facts
Onward Medical said sales or supply of ARC-EX systems through paid evaluations reached 88 systems in the third quarter of 2026, up 120% year over year. The company reported the figure during its quarterly results call, as carried by Investing.com. Quarterly revenue was 2.5 million euros, including 2 million euros in product revenue, according to the call. That put product revenue at the forefront of reported revenue for the period, alongside the system’s expanding use in clinics and homes. The company said most systems supplied during the quarter were intended for home use.
Product revenue was 2 million euros out of total quarterly revenue of 2.5 million euros, according to management’s remarks on the call. Management said cash burn during the period was 8.1 million euros, while cash stood at 73.4 million euros at quarter-end. The chief financial officer said cash burn included the impact of refinancing secured notes. This provides a picture of revenue and cash flows during the period, alongside the balance the company held at its end. The company’s press release did not report a cash-burn figure, while the figure appeared in the results call transcript.
On commercial expansion, ARC-EX therapy was available at more than 170 clinics worldwide, including more than 150 U.S. Department of Veterans Affairs clinics and facilities, management said. The company added that most systems supplied in the quarter were for home use. In the United States, home-use adoption channels included self-pay and paid 90-day evaluations within the Department of Veterans Affairs system and its procurement. These channels describe pathways for patients to access the system, alongside its availability through the clinic network. The chief executive said the full U.S. launch had been underway for about five quarters, while expansion in Europe began about two quarters ago, according to the call.
In clinical development, about 31 participants had been enrolled in the Empower BP study as of 3 November 2026, while 16 clinical sites were recruiting participants in the United States, Canada and Germany, according to the company. The randomized, double-blind, sham-controlled study is testing the safety and efficacy of the investigational ARC-IM system for managing blood pressure instability in people with spinal cord injury. The company said the study includes leading neurorehabilitation and neurosurgery research centers in North America and Europe. The study adds a clinical pathway to the commercial expansion the company reported for the quarter, while ARC-IM remains in clinical testing. Management is expected to consider in an interim analysis in spring 2027 whether the final sample size can stop at 60 participants or needs to reach 112 participants.
On reimbursement, the company said the U.S. Centers for Medicare & Medicaid Services confirmed during the quarter the device’s classification as durable medical equipment and assigned it a miscellaneous code under the Healthcare Common Procedure Coding System. Management said the code allows it to pursue reimbursement on a case-by-case basis under the Medicare program. The company’s statement does not mean that a uniform reimbursement rate has been approved; it allows the company to pursue reimbursement requests case by case. On financing, Onward Medical said it signed an agreement during the quarter of up to 50 million euros with funds and accounts managed by BlackRock. It drew 20 million euros at the agreement’s closing to repay previous financing, according to the company’s statement.