ONWARD Medical starts EIGER implant study for spinal cord injury
ONWARD Medical has completed the first surgical implant in its EIGER clinical feasibility study, marking the opening of a new trial evaluating its investigational ARC-IM System for restoring mobility after spinal cord injury (SCI). The procedure was carried out at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, under the direction of Jocelyne Bloch, chief of neurosurgery at the centre.
The EIGER study will enrol up to 12 participants divided between two cohorts: individuals with subacute SCI, defined as injuries sustained within six weeks of enrolment, and those with chronic SCI, defined as injuries more than one year old. A second Swiss site, the Schweizer Paraplegiker-Zentrum in Nottwil, will also participate. The study is part-funded by Innosuisse, the Swiss innovation agency.
The system and its scope
The ARC-IM System consists of an implanted neurostimulator and a lumbar lead designed to activate spinal circuits involved in lower-limb and trunk movement. ONWARD describes the platform as capable of delivering targeted, personalised spinal cord stimulation. The company says it intends EIGER to inform the design of a subsequent pivotal study, which would be the regulatory gateway to a commercial launch.
Chief executive Dave Marver said: "We intend for this study to inform the design of a pivotal study that will enable us to bring this important new therapy to market for the benefit of those with SCI and other movement disabilities."
EIGER is notable for including the subacute SCI population, a group absent from ONWARD's earlier mobility trials. The rationale is clinically significant: intervention earlier after injury, when spinal circuits retain greater plasticity, may yield stronger functional recovery than treatment in the chronic phase. Whether this hypothesis holds in a human implant setting is precisely what the feasibility data will test.
Market and competitive context
Implanted spinal cord stimulation for movement restoration sits at the intersection of the neuromodulation and medical device sectors, a space that has attracted increasing research and commercial interest over the past decade. Several academic groups, as well as device companies, are pursuing epidural and intradural stimulation approaches for SCI rehabilitation. ONWARD's commercial position is underpinned by ten FDA Breakthrough Device Designations, and its external ARC-EX system already holds market clearance in the US and Europe, giving the company a commercial foothold from which to prosecute the implanted programme.
In parallel, ONWARD is running the Empower BP global pivotal study, which evaluates ARC-IM's first targeted indication: blood pressure instability after SCI. That study provides a nearer-term regulatory readout and will contribute safety and usability data relevant to the broader ARC-IM platform. The company is also developing a variant of ARC-IM that pairs with a brain-computer interface and AI-driven algorithms to support thought-driven movement, extending the platform's potential addressable population beyond SCI into adjacent movement disorders including Parkinson's disease.
Investors will be watching the EIGER enrolment pace and early safety signals closely, given that the study's primary purpose is to de-risk the eventual pivotal design rather than generate pivotal-grade efficacy evidence.