ONWARD Medical® Initiates Global Pivotal Study for ARC-IM System in Spinal Cord Injury Patients

## ONWARD Medical Initiates Global Pivotal Study for ARC-IM System, Targeting Blood Pressure Instability in Spinal Cord Injury Patients

**Toronto, ON –** ONWARD Medical, a pioneer in neuromodulation technologies, has announced the enrollment of the first participant in its global pivotal study. This landmark trial is set to evaluate the efficacy of the company’s ARC-IM system, a groundbreaking implantable device designed to address blood pressure instability, a common and often life-threatening complication following spinal cord injury (SCI).

The ARC-IM system represents a significant advancement in the management of autonomic dysreflexia (AD) and orthostatic hypotension (OH), two severe forms of blood pressure dysregulation that profoundly impact the quality of life and long-term health outcomes for individuals with SCI. AD is characterized by sudden, dangerous spikes in blood pressure, while OH leads to a precipitous drop, often resulting in fainting and an increased risk of falls and further injury. Current management strategies are often reactive, relying on medications or manual interventions that can be cumbersome and may not fully restore physiological stability.

This pivotal study, conducted across multiple international sites, aims to rigorously assess the ARC-IM system’s ability to restore autonomic regulation. The device functions by delivering targeted electrical stimulation to the spinal cord, aiming to re-establish communication pathways between the brain and the body’s autonomic nervous system. By modulating neural activity, the ARC-IM system seeks to proactively manage blood pressure fluctuations, offering a more consistent and reliable solution than existing methods.

“The enrollment of our first participant marks a critical milestone in the development of the ARC-IM system,” stated ONWARD Medical’s Chief Medical Officer. “Blood pressure instability after spinal cord injury is a debilitating condition that significantly limits independence and can lead to severe medical emergencies. We believe the ARC-IM system has the potential to fundamentally change how we manage these autonomic challenges, offering renewed hope for improved health and enhanced quality of life for individuals living with SCI.”

The study’s design is expected to provide robust clinical data on the system’s safety and effectiveness. Participants will undergo a comprehensive evaluation process, with the ARC-IM system implanted and then activated. Researchers will meticulously track key physiological parameters, including blood pressure variability, frequency and severity of AD and OH episodes, and overall patient-reported outcomes. The technological innovation behind ARC-IM lies in its sophisticated sensing and stimulation capabilities, allowing for personalized therapeutic adjustments and a more adaptive response to the individual’s physiological needs.

The commercialization pathway for such advanced neuromodulation devices is often complex, requiring extensive clinical validation and regulatory approval. Success in this pivotal study would position ONWARD Medical to pursue regulatory submissions with major health authorities, potentially paving the way for broader patient access to this innovative therapy. The implications for the neuro-rehabilitation market are substantial, as it could establish a new standard of care for autonomic dysfunction in SCI populations and potentially extend to other neurological conditions where autonomic control is compromised.

The ongoing development of the ARC-IM system underscores the growing role of implantable neurostimulation in addressing complex neurological deficits. As technology advances, the ability to precisely target and modulate neural circuits offers a promising frontier for treating conditions that have historically presented significant unmet medical needs. ONWARD Medical’s commitment to advancing this field through rigorous scientific inquiry and patient-centric innovation is evident in their pursuit of this global pivotal study.