Onward Medical Granted FDA Approval for Home Use of Its ARC-EX System
Onward Medical has received FDA 510(k) clearance to expand the use of the ARC-EX system for home use in the United States, according to the press release.
Onward Medical's ARC-EX system, designed to enhance hand strength and sensation for individuals with spinal cord injuries, has been acquired by over 60 American clinics this year. While no specific financial figures were disclosed in this release, the deployment of the system across these clinics indicates a growing market adoption.
Expanded Use Authorization
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According to Onward Medical, the FDA's authorization now allows the ARC-EX system to be used in conjunction with functional practices in clinics and with home exercises. The non-invasive transcutaneous spinal cord electrical stimulation system is intended for use by rehabilitation professionals in medical centers as well as at home by patients, or with the assistance of others if necessary.
Significant Access Expansion
The FDA's decision represents a significant expansion of access to the ARC-EX system, which is already available in over 60 American clinics. The company reports that a study, Up-LIFT, showed that 90% of participants noticed an improvement in strength or function, with benefits observed up to 34 years post-injury. The results of the latest study, LIFT Home, suggest that continued use of the ARC-EX system at home is effective in maintaining and extending gains achieved in clinical settings.
“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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