ONWARD Medical has secured significant funding to explore new applications of its innovative spinal cord stimulation technology for Parkinson's disease. The Netherlands-based medical technology company announced two major grants totaling approximately $2.5 million to conduct clinical feasibility studies using its investigational ARC-IM System.
The Michael J. Fox Foundation for Parkinson's Research (MJFF) has awarded $1 million to researchers Jocelyne Bloch, MD and Grégoire Courtine, PhD of NeuroRestore. This funding will support a clinical feasibility study with six participants to investigate whether the ONWARD ARC-IM System can effectively address mobility challenges in Parkinson's disease. The study has already begun, with the first participant implanted in late 2024.
Additionally, the US Department of Defense Parkinson's Research Program has granted approximately $1.5 million to ONWARD and NeuroRestore. This funding will enable a separate clinical feasibility study with five participants to explore the system's potential to address blood pressure instability in Parkinson's disease. This study is expected to commence in the first half of 2025.
Addressing Critical Unmet Needs in Parkinson's Disease
Mobility and balance issues represent significant challenges for Parkinson's patients. More than 90% of people living with Parkinson's experience walking and balance dysfunction, and approximately 60% experience annual falls. These motor impairments severely impact quality of life, often leading to loss of independence and increased risk of injury.
"Mobility issues are seldom sufficiently addressed with prevailing treatments, underscoring the urgent need for more effective therapies in Parkinson's," explained Dave Marver, CEO of ONWARD Medical. "There are 10 million people worldwide living with Parkinson's, and we are hopeful the ARC-IM System may offer them new and powerful therapeutic options."
The mobility study will build on promising findings previously published by Courtine and Bloch in Nature Medicine in November 2023. In that study, ARC-IM Therapy demonstrated improvements in mobility and balance, and reduced freezing-of-gait after Parkinson's.
Blood pressure instability represents another significant challenge, affecting approximately 800,000 people with Parkinson's in the US and Europe. ONWARD has previous experience in this area, having received a grant from the US Defense Advanced Research Projects Agency (DARPA) to support development of its ARC-IM System to address blood pressure instability in spinal cord injury.
The ARC-IM System Technology
The ARC-IM System is designed to deliver targeted, personalized spinal cord stimulation to restore function and movement after spinal cord injury and other movement disabilities. The system consists of an implantable neurostimulator that generates precise electrical stimulation delivered by a lead placed on the spinal cord.
Together, these components deliver ARC Therapy to the area of the spinal cord responsible for movement or restoration of autonomic function. The technology has already shown promise in spinal cord injury applications, with the company's ARC-EX System now cleared for commercial sale in the US.
Expanding Beyond Spinal Cord Injury
These new studies represent an important expansion of ONWARD's technology beyond its initial focus on spinal cord injury.
"The versatility and promise of the ONWARD ARC-IM System has been validated by grants from these distinguished organizations, supporting research to determine if our technology can be leveraged beyond spinal cord injury," said Marver.
ONWARD Medical has built its reputation 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).
Headquartered in the Netherlands with additional facilities in Switzerland and Boston, Massachusetts, ONWARD Medical is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD). The company continues to advance its mission of creating therapies to restore movement, function, and independence in people with spinal cord injury and other movement disabilities.
Clinical Significance and Future Outlook
If successful, these studies could open new therapeutic avenues for Parkinson's patients who currently have limited options for addressing mobility challenges and blood pressure instability. The ARC-IM System's targeted approach to spinal cord stimulation offers potential advantages over existing treatments.
The enrollment of the first participant in the mobility study marks an important milestone in this research program. As both studies progress, they will provide valuable insights into whether spinal cord stimulation technology can effectively address some of the most debilitating symptoms of Parkinson's disease.
For the millions of people worldwide living with Parkinson's disease, these studies represent hope for new therapeutic options that could significantly improve quality of life and independence.
