EINDHOVEN, the Netherlands, Nov. 03, 2026 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announces its results for the third quarter of 2026 with a comprehensive business update:

Financial highlights: The Company reported EUR 2.5M in Q3 revenue and a cash balance of EUR 73.4M as of September 30, 2026.
Commercial traction: 88 ARC-EX^® Systems were sold or supplied via paid evaluation in Q3, a 120% year-over-year growth in units. At the end of the quarter, ARC-EX was available in more than 170 clinics worldwide, including 150 rehabilitation clinics and Veterans Affairs (VA) facilities in the US.
Empower BP global pivotal study: The Company continued to advance the Empower BP study, with 31 participants enrolled to date and 16 clinical sites actively recruiting across the US, Canada, and Germany.
Clinical milestones: The Company advanced several clinical feasibility studies exploring future indications for investigational ARC-IM^® Therapy. Key milestones included the first subacute implant in the EIGER clinical feasibility study evaluating ARC-IM Therapy to restore mobility after SCI; the first-in-human use of ARC-IM Therapy to restore bladder control after SCI; and two additional implants in an ongoing feasibility study addressing blood pressure instability in Parkinson's disease.

“We continue to drive strong execution across our commercial and clinical priorities while maintaining financial discipline. Access to ARC-EX is expanding worldwide, helping more people with spinal cord injury improve hand strength and sensation. We are also advancing our therapy pipeline through Empower BP, the first global pivotal study of our ARC-IM platform, and meaningful progress across our clinical feasibility programs,” said Dave Marver, CEO of ONWARD Medical. “Building on three quarters of strong execution and a healthy balance sheet, we are well positioned to advance our strategic priorities through the remainder of the year.”

Commercial traction

In Q3, the Company sold or supplied via paid evaluation 88 ARC-EX Systems for use in clinics and homes. Quarterly unit volumes more than doubled year over year. ARC-EX Therapy is now available in more than 170 clinics worldwide, including 150 US rehabilitation clinics and US Veterans Affairs facilities. A growing number of rehabilitation clinics outside the US also offer ARC-EX, including in the Netherlands, Switzerland, Germany, UK, France, Israel, Italy, and Spain.

The majority of ARC-EX systems supplied in Q3 were intended for home use. Expansion into the home addresses the demand for broader and more convenient access to ONWARD’s groundbreaking technology, which is indicated to improve hand strength and sensation after SCI. In the US, home use adoption was driven by self-pay, 90-day paid evaluations within the VA, VA purchases, and individuals who pursued reimbursement from private insurers on a case-by-case basis.

Empower BP global pivotal study

The Company continues to make steady progress in the execution of Empower BP, the first global pivotal study designed to assess the safety and effectiveness of the investigational ARC-IM System to manage blood pressure instability in people with SCI.

The randomized, double-blind, sham-controlled study involves leading neurorehabilitation and neurosurgical research centers across North America and Europe. To date, 31 participants have been enrolled in Empower BP, with 16 clinical sites actively recruiting across the US, Canada, and Germany.

Pipeline advancement

Following the initiation of the EIGER clinical feasibility study to evaluate the investigational ARC-IM System for restoring mobility after spinal cord injury, the Company reported first implants in both the chronic and subacute cohorts. EIGER is the first ONWARD mobility study to include individuals with subacute SCI, defined as injuries sustained within six weeks of enrollment. The study is being conducted in Switzerland at the Schweizer Paraplegiker-Zentrum (SPZ) in Nottwil and the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, with the support of a grant from Innosuisse.

The Company also achieved the first-in-human use of investigational ARC-IM Therapy to explore its potential to restore bladder control after SCI as part of ReeVoid, a new clinical feasibility study. ReeVoid is designed to evaluate the safety and preliminary effectiveness of targeted spinal cord stimulation to improve bladder emptying and urinary continence after SCI. The study is being conducted at CHUV in Lausanne and is supported by a grant from the Christopher and Dana Reeve Foundation.

The Company made further pipeline progress with two additional participants receiving investigational ARC-IM Therapy as part of an ongoing early clinical feasibility study focused on addressing blood pressure instability associated with Parkinson's disease. This study is supported by a grant from the US Department of Defense Parkinson’s Research Program.

Financial highlights

The Company reported EUR 2.5M in total revenue for the quarter. Revenue from the sale and supply of ARC-EX systems was EUR 2.0M. As of September 30, 2026, the cash balance was EUR 73.4M, in line with expectations.

In Q3, the Company secured a financing agreement for up to EUR 50M with funds and accounts managed by BlackRock. An initial EUR 20M was drawn at closing to fully repay all outstanding amounts and retire the Company’s former financing agreement with Runway Growth Capital LLC.

Corporate governance

In October, the Company announced the appointment of Fouad Azzam, a Partner in the EQT Life Sciences team, as a non-executive member of its Board of Directors.

Webcast details

ONWARD Medical will hold a webcast today, November 3, 2026, at 2:00 p.m. CET / 8:00 a.m. ET, hosted by CEO Dave Marver. To join the session, please register using this link.

About ONWARD Medical

ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries and other movement disabilities. Building on decades of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy. It has subsequently been awarded 10 Breakthrough Device Designations from the FDA. The Company’s ARC-EX^® System is cleared for commercial sale in the US and Europe. The Company is also developing an investigational implantable system called ARC-IM^®, designed to address several unmet needs, including blood pressure instability after spinal cord injury. It can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement.

Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, please visit ONWD.com.

To stay informed about ONWARD’s research studies, technologies, and the availability of therapies in your area, please complete this webform.

For Media Inquiries:
Sébastien Cros, VP Communications
media@onwd.com

For Investor Inquiries:
investors@onwd.com

Forward-Looking Statements

Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors, including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers nor representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors, nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.

ARC-EX Indication for Use: The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, nonprogressive neurological deficits resulting from an incomplete spinal cord injury (C2-C8 inclusive). The ARC-EX System is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients, as needed.

Other Investigational Products: All other ONWARD Medical devices and therapies, including ARC-IM and ARC-BCI, are investigational and not available for commercial use.

This item of content is a press release from a third party provider who make no warranties or representations in connection with this content and therefore PA can make no warranties in respect of its use.

Tags

More Like This

ONWARD Medical Reports First Quarter 2026 Results with Strong Commercial Momentum and Key Clinical Milestones

ONWARD Medical Reports Full Year 2025 Financial and Operating Results, Highlighting Strong US Commercial Performance and Major Pipeline Milestones

ONWARD Medical Reports First Half 2026 Results with Strong Product Revenue Growth and Continued Progress across ARC Therapy Pipeline

ONWARD Medical Provides Preliminary Q3 2025 Update Highlighting Accelerating ARC-EX Adoption in the United States

ONWARD Medical Drives Strong US ARC-EX Adoption and Achieves Important Scientific and Regulatory Milestones in Q3 2025

ONWARD Medical Demonstrates Commercial Traction and Advances Pipeline in the First Half of 2025

ONWARD Medical Builds Commercial Momentum for the ARC-EX System and Reinforces its Brain-Computer Interface Leadership in Q1 2025

ONWARD Medical Reports Full Year 2024 Financial and Operating Results and Shares 2025 Year-to-Date Highlights