ONWARD® ARC Therapy™ Highlighted at 2024 Annual Meeting of the North American Neuromodulation Society (NANS)

Clinical experience with investigational ARC-EX® Therapy showcased on the main stage and in clinical abstracts during the 2024 NANS Annual Meeting EINDHOVEN, the Netherlands — January 25, 2024 — ONWARD Medical N.V. ( Euronext : ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced that clinical experience, results, and therapy programming strategies from clinical studies, including the Up-LIFT pivotal study, were presented during the NANS 2024 meeting in Las Vegas, Nevada, USA. The Up-LIFT pivotal study investigated non-invasive neuromodulation to improve upper extremity strength and function after SCI; ARC-EX Therapy met all primary safety and effectiveness endpoints and demonstrated a 72% responder rate1.

During the Neuromodulation for Spinal Cord Injury (SCI) main stage presentation, Dr. David Darrow, Neurosurgeon and Assistant Professor at the University of Minnesota, Dr. Claudia Angeli PhD, Assistant Director of Kessler Foundation, and Dr. James Guest, Neurosurgeon and Professor of Neurological Surgery at the University of Miami and the Miami Project to Cure Paralysis, discussed SCI-targeted innovations. While bringing awareness to spinal cord injury during a meeting traditionally focused on chronic pain and movement disorders, Dr. Guest presented clinical results and his experience from the Up-LIFT pivotal study.

Neurosurgeon Dr. James Guest discusses investigational ARC-EX Therapy for functional recovery of upper extremities after SCI on the main stage at NANS 2024

The ARC-EX System, which received Breakthrough Device Designation from the US Food & Drug Administration in 2017 for improved upper limb function, is designed to non-invasively deliver electrical stimulation to the spinal cord.

“We are pleased to see our innovative therapies garner attention on the main stage at NANS, an important society and stakeholder group whose membership will drive access and adoption for ARC Therapy in North America,” said Dave Marver, ONWARD CEO. “We are preparing to submit a De Novo application for ARC-EX Therapy to FDA in the near future, leveraging the positive clinical results from the Up-LIFT pivotal study.”

The Company’s ARC-EX Therapy was also highlighted in two abstracts accepted by the NANS scientific board, including Transcutaneous Spinal Cord Stimulation Facilitates Upper Extremity Functional Recovery in Spinal Cord Injury: Results From The Up-LIFT Pivotal Trial (James Guest MD, PhD, Edelle C Field-Fote PT, PhD, Candace Tefertiller DPT, PhD, et al.) and Transcutaneous Spinal Cord Stimulation Parameters and Programming Strategies for Effective Upper Extremity Rehabilitation Following Tetraplegia (Chet Moritz PhD, Edelle C Field-Fote PT, PhD, Ilse van Nes MD, PhD, et al.).

All ONWARD devices and therapies, including but not limited to ARC-IM®, ARC-EX, and ARC Therapy™, alone or in combination with BCI, are investigational and not available for commercial use.

1Responder defined as a participant who met or exceeded the minimally important difference criteria for at least one outcome of the strength domain and at least one outcome of the functional performance domain.