The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Shots:The US FDA has granted FTD to RNS60 (oxygen-enriched saline) for the treatment of acute ischemic strokeDesignation was based on extensive preclinical data & P-II (RESCUE) trial, which showed reduced brain tissue loss, improved functional outcomes, & shorter hospital stays in pts treated within 24 hours of stroke onsetAdditionally, Revalesio is planning…

ByRidhi RastogiAugust 4, 2025

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Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

Shots:The RESTORE trial assessed the ReActiv8 Restorative Neurostimulation therapy (n=99) vs SoC (n=104) for 1yr. to treat intractable chronic low back pain in patients (N=203) The data showed a mean improvement in ODI score (1EP; -19.7 ± 1.4 vs -2.9 ± 1.4), back pain measured by 11-pts. NRS (2EPs; -3.6 ± 0.2 vs…

BySenior EditorJanuary 16, 2025

The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

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