ONWARD Medical implants first device in EIGER study for spinal cord injury treatment

ONWARD Medical has successfully implanted the first device in its new EIGER study, a critical step toward evaluating the safety and early effectiveness of the company's ARC-IM System in restoring mobility for individuals with spinal cord injuries (SCI). This study, which is the first of its kind to include participants with subacute SCI, marks a significant advancement in the company’s mission to develop innovative therapies for mobility restoration.

The EIGER study, conducted at the Schweizer Paraplegiker-Zentrum (SPZ) in Nottwil and the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, aims to assess the ARC-IM System’s ability to support recovery of standing and walking in both subacute and chronic SCI patients. Subacute SCI refers to injuries sustained within six weeks of enrollment, while chronic SCI involves injuries more than a year old.

“Today’s milestone is an important step in our journey to restore mobility for people living with spinal cord injuries,” said Dave Marver, CEO of ONWARD Medical. “The EIGER study will provide invaluable data that will inform the design of a pivotal study, enabling us to bring this crucial new therapy to market.”

The ARC-IM System, a neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation, comprises the ONWARD Neurostimulator (IPG) and the ARC-IM Lumbar Lead. This technology is aimed at precisely activating spinal circuits involved in lower-limb and trunk movement to facilitate motor function recovery.

The study will enroll up to 12 participants across two cohorts: individuals with subacute SCI, who sustained their injuries less than six weeks before enrollment, and those with chronic SCI, who sustained their injuries more than a year ago. The first implant was performed at CHUV under the direction of Dr. Jocelyne Bloch, Chief of Neurosurgery at CHUV.

The EIGER study is supported by a grant from Innosuisse, a Swiss innovation agency. This financial support underscores the significance of the study and its potential impact on the field of spinal cord injury treatment.

ONWARD Medical, headquartered in the Netherlands, has a strong track record in developing therapies to restore movement, function, and independence in people with SCI and other movement disabilities. The company’s proprietary ARC Therapy has received 10 Breakthrough Device Designations from the FDA and is currently being evaluated in the Empower BP global pivotal study for addressing blood pressure instability after SCI.

The company’s commitment to innovation and patient care is evident in its ongoing research and development efforts. “The EIGER study is a pivotal step in our efforts to bring new hope to those living with spinal cord injuries,” Marver added.

ONWARD Medical’s focus on cutting-edge neurotechnology and its extensive research partnerships place it at the forefront of spinal cord injury treatment. The company’s Science and Engineering Center in Switzerland and its US office in Boston, Massachusetts, support its global mission to develop and deploy advanced therapies for spinal cord injury patients.