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.
Launch of ARC-EX continues to be a resounding success...
Risks mentioned
Retard dans les approbations réglementaires pouvant affecter les délais.
Concurrence accrue dans le secteur de la neurotechnologie.
Opportunities identified
Lancement du système ARC-EX avec succès aux États-Unis.
Récupération de la demande soutenue pour la technologie de stimulation.
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