ONWARD Medical's Groundbreaking ARC-EX Therapy Improves Lives
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 — ONWARD Medical N.V. (Euronext: ONWD), a pioneer in innovative spinal cord stimulation therapeutic solutions, has exciting news to share. The company recently published compelling results from the one-year Pathfinder2 Study, showcasing how sustained access to ARC-EX Therapy can significantly enhance functional outcomes for individuals living with spinal cord injuries (SCI) and other mobility challenges.
The paper, featured in the reputable journal Neuromodulation: Technology at Neural Interface, highlights the impressive findings from a trial that involved participants receiving ARC-EX Therapy alongside activity-based rehabilitation. This combination was administered in community rehabilitation environments, proving crucial for achieving remarkable enhancements in functionality.
CEO Dave Marver expressed confidence in the findings, stating, "The Pathfinder2 results published today in Neuromodulation demonstrate that individuals with SCI can continue to make progress with ongoing access to ARC-EX Therapy." He also recognized the contribution of Neurokinex, emphasizing how their work facilitates functional recovery without plateauing during the year-long treatment journey.
The study, independently conducted by Neurokinex in collaboration with UK-based Spinal Research, involved 10 participants with chronic cervical or thoracic SCI. Throughout the year, participants consistently developed improvements in upper body strength, trunk control, and overall balance. Notably, some also made gains in lower body movement and hand and arm strength, particularly in grip and dexterity.
Tara Stewart, Chair of Spinal Research, effectively summed up the breakthrough nature of these findings: "It's high time we shift our perspective regarding spinal cord injuries from 'incurable' to 'improvable.' This innovative device exemplifies how functional abilities can be restored. With appropriate investments in spinal cord research, we can significantly progress toward effective treatments for paralysis. The science shows potential, and we now need funding to drive this essential work forward."
Additionally, the research revealed substantial improvements for three participants in their American Spinal Injury Association Impairment Scale (AIS) classifications, with four achieving notable changes in their neurological levels of injury–including one individual shifting from a complete to an incomplete SCI classification. These outcomes demonstrate the long-term advantages of consistent access to ARC-EX Therapy and hint at the possibility of further advancements with prolonged treatment.
Lead Investigator Jenny Suggitt, MSc, OTR/L, reinforced the significance of these results, stating, "This peer-reviewed publication validates that ONWARD's ARC-EX Therapy can be safely and effectively administered within community settings. Significant improvements were evident across 120 treatment sessions over a year, suggesting promising opportunities for further recovery with ongoing treatment."
Harvey Sihota, founder and CEO of Neurokinex, expressed optimism for the future: "The positive results from the Pathfinder2 study are inspiring. I truly believe that ARC-EX Therapy will continue to yield even greater benefits for individuals with spinal cord injuries. It's undeniable that advancements in spinal stimulation technologies are set to revolutionize this rehabilitation space, leading to improved functional outcomes and greater independence for many people."
In late 2024, the ONWARD ARC-EX System received an important milestone with FDA approval for use in clinical settings. Anticipation for home use authorization is high, and the Company is actively pursuing CE Mark certification to bring the ARC-EX System to market in Europe in 2025.
ONWARD Medical's endeavors don't stop there; they are also developing a range of innovative technologies, including the investigational implantable ARC-IM System and its cutting-edge ARC-BCI System, which integrates brain-computer interface (BCI) technology powered by artificial intelligence (AI). The company is deeply committed to collaborating with the SCI community to create revolutionary solutions designed to restore movement, function, and independence post-injury.
Headquartered in the Netherlands, ONWARD Medical prides itself on its scientific and engineering excellence, with additional facilities located in Switzerland and Boston, Massachusetts. The company, listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD), continues to lead the charge in spinal injury rehabilitation innovations.
Frequently Asked Questions
What is ARC-EX Therapy?
ARC-EX Therapy is an advanced spinal cord stimulation technique that aims to restore movement and function in individuals with spinal cord injuries by combining electrical stimulation with rehabilitation.
What are the main findings of the Pathfinder2 Study?
The Pathfinder2 Study found that participants experienced significant functional improvements over a year, with continuous gains observed without a plateau in benefits.
Who conducted the Pathfinder2 Study?
The study was sponsored by Spinal Research and independently conducted by Neurokinex at their community-based rehabilitation centers.
What does the approval of the ARC-EX System mean?
FDA approval for the ONWARD ARC-EX System means it can now be utilized safely in clinical settings to help patients with spinal cord injuries rehabilitate effectively.
What is ONWARD Medical's future direction?
ONWARD Medical aims to further develop innovative spinal cord therapies, including ARC-IM and ARC-BCI systems, whilst seeking to improve the lives of individuals with spinal cord injuries through effective treatments.
