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 stroke
- Designation 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 onset
- Additionally, Revalesio is planning to advance RNS60 in P-III (RESTORE) trial to assess it in a broader population of stroke pts eligible for endovascular therapy
Ref: PRNewsWire | Image: Revalesio | Press Release
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