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

EINDHOVEN, the Netherlands, May 26, 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 announced its results for the first quarter of 2026:

• Commercial traction: The Company supplied 70 ARC-EX^® Systems for use in clinics and homes. ARC-EX was available in more than 100 clinics across the US and Europe by the end of the first quarter.
  
• Clinical milestones: The Company announced additional implants across its ARC-IM^® and ARC-BCI^® platforms, including the first participant enrollment and first successful implant in the Empower BP global pivotal study.
  
• Financial highlights: The Company reported EUR 2.0 million in revenue in Q1 and a cash balance of EUR 53.4 million, before raising over EUR 40 million in equity capital in April, extending its cash runway into Q1 2028.
  
  

“Launch of ARC-EX continues to be a resounding success, with strong initial home-use sales in the US and rapid traction within the Veteran Affairs community. We advanced our deep pipeline in Q1 with first enrollment and first implant in Empower BP, the global pivotal study to evaluate the investigational ARC-IM System to address blood pressure instability after spinal cord injury. 12 Empower BP sites have now been activated,” said Dave Marver, CEO of ONWARD Medical. “We were also proud to raise an additional EUR 40 million in equity capital, strengthening our balance sheet and fueling our ability to advance our commercial and clinical pursuits with speed and scale.”

Commercial traction

The Company supplied 70 ARC-EX Systems in the first quarter, demonstrating continued robust demand for its groundbreaking external spinal cord stimulation technology. This includes the first systems delivered to individuals for home use, including those in the US Veterans Affairs community. The expansion into home use meets the demand for broader and more convenient access to the first US FDA-cleared technology indicated to improve hand strength and sensation after SCI.

ARC-EX Therapy is now available in over 100 clinics across the US and Europe.

Clinical milestones

ARC-IM

The first participant enrollment and first successful implant in the Empower BP pivotal study occurred in the first quarter of 2026 at Craig Hospital in Denver, Colorado. Empower BP is the first global pivotal study designed to assess the safety and effectiveness of the implantable ARC-IM System to manage blood pressure instability in people with SCI. The randomized, double-blinded, sham-controlled study is expected to involve participants across approximately 20 leading neurorehabilitation and neurosurgical research centers in the US, Canada, France, Germany, Spain, and the UK. To date, 12 clinical sites across the US have been activated and are actively recruiting participants.

The Company also announced further pipeline progress with an additional individual receiving investigational ARC-IM Therapy as part of the ongoing early clinical feasibility study focused on addressing blood pressure instability associated with Parkinson’s disease.

ARC-BCI

The Company announced that two additional individuals living with spinal cord injuries have successfully received investigational ARC-BCI Therapy to restore movement of their own paralyzed limbs. ARC-BCI is the world’s first and most advanced purpose-designed platform pairing a brain-computer interface with an implantable spinal cord stimulation system.

Financial highlights

The Company reported EUR 2.0 million in total revenue for the quarter. Revenue from the sale of ARC-EX systems reached EUR 1.3 million in Q1.

As of March 31, 2026, the cash balance was EUR 53.4 million. In April, the Company successfully raised over EUR 40 million in equity capital supported by a EUR 25 million investment by EQT Life Sciences. The transaction was supported by strong demand from existing and new high-quality, long-only, and sector specialist investors. The net proceeds from the transaction are expected to provide the Company with cash runway into Q1 2028, assuming no draw down of the Company’s debt facility.

Webcast details

ONWARD Medical will hold a webcast today, May 26, 2026, at 2:00 PM CEST / 8:00 AM EDT, 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.