ONWARD Medical Launches Empower BP Study on its ARC-IM System
ONWARD Medical announces the enrollment of the first participant in Empower BP, a pivotal global clinical study evaluating the safety and efficacy of its implanted ARC-IM system for treating blood pressure instability following spinal cord injury. This study marks the company's first global scale trial for this spinal stimulation system.
Empower BP is a randomized, double-blind, sham-controlled study involving about 20 neurorehabilitation and neurosurgery centers across the USA, Canada, France, Germany, Spain, and the UK. The study targets individuals with spinal cord injuries at levels C2-T6 with AIS severity grades A-D. The first participant was enrolled at Craig Hospital in Denver, Colorado. Blood pressure instability is identified as a key medical need following spinal cord injury, characterized by chronic orthostatic hypotension and episodes of autonomic dysreflexia.
ARC-IM System Components and Preliminary Results
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The ARC-IM system consists of the implanted ONWARD neurostimulator and the thoracic ARC-IM electrode, designed for precise stimulation of the thoracic region of the spinal cord that regulates blood pressure. Clinical feasibility study results, published in September 2025 in Nature Medicine, report an immediate and robust increase in blood pressure among treated participants, a reduction in the frequency and severity of hypotensive symptoms, as well as an improvement in quality of life and greater engagement in rehabilitation activities and daily life. Additional benefits included reduced fatigue, improved bowel management, and increased tolerance of upright postures, with some participants reducing or stopping traditional treatments.
“We continued to deliver strong commercial execution in Q3, and we achieved several meaningful scientific and regulatory milestones across our technology platforms.”
Commercial traction forte avec 40 systèmes ARC-EX vendus en Q3 et disponibilité dans plus de 60 cliniques US; CE Mark pour l'UE et clearance FDA pour usage à domicile élargissent l'opportunité commerciale; IDE approuvé pour ARC-IM permettant le lancement de l'étude pivot Empower BP; publications scientifiques majeures renforcent le dossier clinique.
Risks mentioned
retards dans les autorisations réglementaires
variations de la demande commerciale
concurrence technologique et concurrentielle
incertitudes liées aux études cliniques et résultats futurs
Opportunities identified
FDA clearance for home use expands US market opportunity
CE Mark enables commercialization in EU and facilitates entry to UK and Switzerland
IDE approval for ARC-IM enables initiation of Empower BP pivotal study
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