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

Rhea-AI Summary

ONWARD Medical (ONWRY) reported strong Q1 2025 performance, successfully launching its ARC-EX System in the US with 10 systems sold and EUR 0.4M in revenue. The company is on track to meet its 1H 2025 target of 30 systems. Notable achievements include the first human implant of the ARC-IM Lumbar Lead and two successful ARC-BCI implants, reinforcing ONWARD's leadership in brain-computer interface technology. The company secured USD 2.5M in grants for Parkinson's disease research and established a Level 1 ADR program for US investors. Pathfinder2 study results showed continued functional improvements in SCI patients after one year of ARC-EX Therapy. The company ended Q1 with EUR 50.5M in net cash and expects FDA clearance for home use of ARC-EX System and CE Mark authorization for European marketing.

Positive

• Successfully sold 10 ARC-EX Systems in Q1 2025 US launch, on track for 30 systems target in 1H 2025
• Secured USD 2.5M in grants for Parkinson's disease research from MJFF and US Department of Defense
• Achieved 4th and 5th successful BCI implants and first human implant of ARC-IM Lumbar Lead
• Pathfinder2 study showed continued patient improvement after one year with no therapeutic plateau
• Strong cash position of EUR 50.5M at quarter end
• Established Level 1 ADR program to enhance US investor access

Negative

• Limited revenue generation of only EUR 0.4M in Q1 2025
• Still awaiting FDA clearance for home use and CE Mark authorization for European market
• Pending FDA IDE approval for Empower BP global pivotal study

EINDHOVEN, the Netherlands, June 17, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announces its Q1 2025 business update and year-to-date highlights:

• Commercial traction: Following FDA market authorization, the Company met its Q1 objective for the limited initial phase of its US launch of the ARC-EX^® System, hiring, training and deploying a field organization, establishing a sales and service process, building a roster of reference clinics, and selling ten systems.
  
• Technology advancement: The Company’s investigational ARC-IM^® and ARC-BCI^® platforms reached new milestones with the 4^th and 5^th successful BCI implants to restore thought-driven movement, and the first human implant of its investigational ARC-IM Lumbar Lead, which is designed to help restore mobility.
  
• Scientific leadership: Further expanding the body of clinical evidence supporting the ARC-EX System, Pathfinder2 study results published in Neuromodulation: Technology at Neural Interface showed that sustained access to ARC-EX Therapy can continue to drive functional improvements. Participants continued to make gains after one year of treatment.
  
• Financial highlights: The Company established a sponsored Level 1 American Depositary Receipt ("ADR") program to facilitate US investor trading and participation in its growth.
  

"Our Q1 achievements reflect ONWARD’s successful transition to a commercial organization that delivers breakthrough therapies to people with spinal cord injuries," said Dave Marver, Chief Executive Officer of ONWARD Medical. "The initial demand for our ARC-EX System and strong positive feedback we’ve received from users gives us confidence we can deliver against expectations in 2025.”

Commercial traction

ONWARD met its Q1 objective for the limited initial phase of its US launch of the ARC-EX System, hiring, training and deploying a field organization, establishing a sales and service process, building a roster of reference clinics, and selling ten systems.

Strong early demand and positive feedback from users suggest the Company expects to meet its 1H sales target of approximately 30 systems and deliver a strong 2025.

The Company also secured access to prominent US government online procurement platforms, enabling Veterans Affairs (VA) and other US government buyers to purchase the ARC-EX System.

Technology advancement

ARC-IM System

In the first quarter, ONWARD announced the first human implant of its ARC-IM Lumbar Lead. The new lead is designed for placement in the lumbar region of the spinal cord, the optimal location for therapies targeting restoration of standing, stepping, and lower limb mobility. The Company’s ARC-IM Thoracic Lead has been used in humans since early 2023.

The Company also announced two new grants to support early clinical feasibility studies using its ARC-IM System to help people with Parkinson's disease. The Michael J. Fox Foundation for Parkinson’s Research (MJFF) awarded the Company’s research partner .NeuroRestore a USD 1M grant to explore how the ARC-IM System can address mobility challenges in Parkinson’s disease. The US Department of Defense awarded a USD 1.5M grant to ONWARD and .NeuroRestore to support a clinical feasibility study to explore how the ARC-IM System can address blood pressure instability in Parkinson’s disease.

The Company continues to prepare for the initiation of Empower BP, a global pivotal study to assess the safety and efficacy of the ARC-IM System to address blood pressure instability after SCI. Commencement of the study is pending Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA).

ARC-BCI System

In June, ONWARD announced the 4^th and 5th successful implants of its ARC-BCI technology in two additional individuals. These achievements further reinforce ONWARD’s leadership in developing BCI-enabled movement solutions for people with SCI. Both procedures were performed at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, under the direction of Jocelyne Bloch, MD, Chief of Neurosurgery.

The Company’s innovations with BCI technology were featured on CBS 60 Minutes with Anderson Cooper, one of the most respected and longest-running US news programs. The segment highlighted the experience of study participants who received this breakthrough therapy. A companion segment, 60 Minutes Overtime, highlighted the Company’s other advancements in SCI and Parkinson’s disease.

Scientific leadership

In the first quarter, ONWARD announced the publication of positive results from the investigator-sponsored Pathfinder2 Study in Neuromodulation: Technology at Neural Interface. This peer-reviewed publication details findings from a one-year trial demonstrating that ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with SCI in community-based rehabilitation centers. Participants experienced gains in upper body strength, trunk control, and balance at one year of treatment, indicating no plateau in therapeutic benefit¹.

Financial highlights

As part of the phased launch of the ARC-EX System in the US, the Company reported EUR 0.4M in revenue. The quarter ended with net cash of EUR 50.5M, in line with expectations.

Facilitating greater access for US investors, in April the Company established a sponsored Level 1 American Depositary Receipt ("ADR") program through the Bank of New York Mellon ("BNY"). The ADRs trade on the OTCQX^® Best Market under the symbol: ONWRY.

Outlook

Strong early demand for the ARC-EX System and positive feedback from initial users suggest ONWARD expects to meet its 1H sales target of approximately 30 systems and deliver a strong 2025 in line with expectations.

The Company anticipates FDA clearance to market the ARC-EX System for home use. It also anticipates CE Mark authorization so it can begin marketing the device in Europe. The Company further expects to commence its Empower BP global pivotal study for the ARC-IM System. It also plans additional implants of its ARC-IM System and ARC-BCI to explore additional indications in SCI and Parkinson’s disease.

Webcast details

ONWARD will hold a webcast today at 2:00PM CET / 08:00AM EST, 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 injury (SCI) and other movement disabilities. Building on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA). The Company’s ARC-EX System is cleared for commercial sale in the US. In addition, the Company is developing an investigational implantable system called ARC-IM with and without an implanted brain-computer interface (BCI).

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, visit ONWD.com and connect with us on LinkedIn.

To be kept informed about the Company’s technologies, research studies, 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

Disclaimer

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 or 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.

¹ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

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

FAQ

What were ONWARD Medical's (ONWRY) Q1 2025 sales results for the ARC-EX System?

ONWARD Medical sold 10 ARC-EX Systems in Q1 2025, generating EUR 0.4M in revenue, and is on track to meet its target of approximately 30 systems in 1H 2025.

How much cash does ONWARD Medical have as of Q1 2025?

ONWARD Medical ended Q1 2025 with EUR 50.5M in net cash, which was in line with company expectations.

What are the latest developments in ONWARD's brain-computer interface technology?

ONWARD completed its 4th and 5th successful ARC-BCI implants in Q1 2025, performed at CHUV in Lausanne, Switzerland, reinforcing its leadership in BCI-enabled movement solutions for SCI patients.

What grants did ONWARD Medical receive for Parkinson's disease research?

ONWARD received two grants totaling USD 2.5M: USD 1M from The Michael J. Fox Foundation and USD 1.5M from the US Department of Defense for Parkinson's disease research.

What were the results of the Pathfinder2 study for the ARC-EX System?

The Pathfinder2 study showed that patients experienced continued functional improvements in upper body strength, trunk control, and balance after one year of ARC-EX Therapy, with no plateau in therapeutic benefit.