ONWARD® Medical Seeks FDA Approval for ARC-EX® System via De Novo Application

Tuesday, April 02, 2024

ONWARD Medical N.V., listed on Euronext as ONWD, a leading medical technology company specializing in innovative therapies for spinal cord stimulation, has announced the submission of its De Novo application to the US Food and Drug Administration (FDA). This application aims to gain FDA approval for its groundbreaking ARC-EX System, designed to restore function to the upper extremities following spinal cord injury (SCI). This milestone represents a significant step forward in ONWARD's mission to enhance mobility and independence for individuals with SCI.

Upon FDA clearance, the ARC-EX System will mark a historic achievement as the first spinal cord stimulation therapy capable of restoring hand and arm function post-SCI, and it will serve as ONWARD Medical's inaugural commercial product. The decision to prioritize upper limb function for the ARC-EX System was influenced by feedback from the SCI community, emphasizing the importance of arm, hand, and finger functionality in promoting independence post-injury. This therapy holds immense potential to improve the lives of individuals living with paralysis, offering newfound freedom and positively impacting their caregivers and loved ones.

The De Novo application follows the completion of the Up-LIFT global pivotal study, the largest of its kind focusing on transcutaneous spinal cord stimulation. Conducted at 14 leading SCI neurorehabilitation centers across the United States, Canada, the United Kingdom, and the Netherlands, the study evaluated the safety and efficacy of ARC-EX Therapy in enhancing upper limb strength and function in 65 participants with chronic tetraplegia. The results of the Up-LIFT trial signify a significant advancement in neuromodulation for individuals with spinal cord injury.

The ONWARD ARC-EX System delivers targeted electrical stimulation, known as ARC-EX Therapy™, transcutaneously to the spinal cord, promoting increased strength, movement, and function in the upper limbs post-SCI. Previously awarded FDA Breakthrough Device Designation (BDD) for upper limb function, the ARC-EX System underwent prioritized FDA review and benefited from interactions with FDA experts, offering the potential for additional reimbursement.

With an estimated 200,000 individuals in the US and Europe experiencing impaired upper extremity function following spinal cord injury, the ARC-EX System represents a critical advancement in restoring independence and quality of life for this population.






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