ONWARD Medical Begins EIGER Study to Assess ARC-IM System for Spinal Cord Injury Mobility Restoration — ONWARD Medical N.V.

Event summary

ONWARD Medical has initiated the EIGER clinical feasibility study to evaluate the ARC-IM System for restoring mobility in individuals with subacute or chronic spinal cord injury (SCI).
The study will enroll up to 12 participants across two cohorts: individuals with subacute SCI (injury sustained within 6 weeks of enrollment) and individuals with chronic SCI (injury sustained more than one year before enrollment).
The first implant was performed at CHUV in Lausanne under the direction of Jocelyne Bloch, MD, Chief of Neurosurgery.
The EIGER study is supported by a grant from Innosuisse and is being conducted at SPZ in Nottwil and CHUV in Lausanne.

The big picture

ONWARD Medical's EIGER study represents a strategic push into restoring mobility for both subacute and chronic spinal cord injury patients, a segment with significant unmet needs. The study's success could position the ARC-IM System as a leading neuromodulation platform, potentially expanding its applications beyond SCI to other movement disorders. The company's ability to secure grants and partnerships, such as the Innosuisse support, underscores the growing interest in neurotechnology solutions for mobility restoration.

What we're watching

Clinical Progress: The pace at which the EIGER study enrolls participants and yields preliminary data will determine the timeline for a potential pivotal study.
Regulatory Pathway: Whether the ARC-IM System can secure additional Breakthrough Device Designations from the FDA will be crucial for its market approval.
Market Expansion: How ONWARD Medical leverages the ARC-IM platform across multiple indications, including Parkinson's disease, will impact its long-term growth strategy.