The study is a prospective, controlled, randomized, single-blind, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will be 1:1 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters:
1. National Institute of Health Stroke Scale (NIHSS) at baseline (stratify \<10, 11-18)
2. Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify \<5 hrs, or ≥5 hrs).