Study shows significant functional improvements after one year of ARC-EX Therapy

Improvements were observed throughout one-year treatment period with no plateau

Results demonstrate the importance of sustained access to ARC-EX Therapy

EINDHOVEN, the Netherlands, Feb. 25, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announces the publication of positive results from the investigator-sponsored Pathfinder2 Study in Neuromodulation: Technology at Neural Interface.

The peer-reviewed paper details findings from a one-year trial demonstrating that ONWARD ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with SCI in community-based rehabilitation centers.

"The Pathfinder2 results published today in Neuromodulation demonstrate people with SCI can make continued gains with sustained access to ARC-EX Therapy," said Dave Marver, CEO ONWARD Medical. "Congratulations to the team at Neurokinex for showing ARC-EX Therapy can help people with SCI drive functional recovery without plateau during a one-year treatment period."

The study, sponsored by UK-based Spinal Research, and independently conducted by Neurokinex at its network of community-based rehabilitation centers, enrolled 10 participants with chronic cervical or thoracic SCI. Participants experienced gains in upper body strength, trunk control, and balance, without any indication of plateau in therapeutic benefit after one year of treatment. Some participants also improved lower body movement and enhanced hand and arm strength, especially in grip and dexterity.*

"It's now time to stop talking about spinal cord injury as being incurable and to start talking about it as improvable," said Tara Stewart, Chair Spinal Research. "This breakthrough device demonstrates that function can be restored. With proper investment in spinal cord research, we can accelerate progress toward meaningful treatments for paralysis. The science shows promise - what we need now is the funding to advance this critical work."

Additionally, 3 participants improved their American Spinal Injury Association Impairment Scale (AIS) classification, and 4 demonstrated changes in their neurological level of injury, including a participant who moved from complete to incomplete SCI. These findings reinforce the long-term benefits of continued access to ARC-EX Therapy and suggest further gains may be achievable with extended treatment.

"This peer-reviewed publication validates that ONWARD ARC-EX Therapy combined with activity-based rehabilitation can be safely and effectively delivered in community settings," said Jenny Suggitt, MSc, OTR/L, Lead Investigator of Pathfinder2. "Most importantly, participants continued to show improvements throughout 120 treatment sessions over a one-year period, suggesting there is potential for further recovery with extended treatment."

"I’m hugely encouraged by the positive outcomes of the Pathfinder2 study and believe ARC-EX Therapy will enable us to deliver even greater gains for people living with a spinal cord injury,” said Harvey Sihota, founder and CEO of Neurokinex. "There is no doubt that spinal stimulation technologies will take spinal cord injury rehab and outcomes to the next level bringing even more meaningful functional improvements that offer people greater independence."

In December 2024, the ONWARD ARC-EX System^® was approved by the US FDA for use in clinic settings. Home use authorization is anticipated later this year. The Company plans to seek CE Mark certification to commercialize the ARC-EX System in Europe in 2025.

ONWARD Medical is developing a pipeline of technologies, including its investigational implantable ARC-IM System and its investigational ARC-BCI System, an implanted platform that uses a brain-computer interface (BCI) powered by artificial intelligence (AI). To learn more about ONWARD Medical's commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.

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

About ONWARD Medical

ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with 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). In addition to the ARC-EX System, which is now cleared for commercial sale in the US, the Company is developing an 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).

For more information, visit ONWD.com and connect with us on LinkedIn and YouTube.

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:
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.

*ARC-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.

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.

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.

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