SENTIS Enrollment Completed to Study CoAxia’s NeuroFlo Therapy

February 12, 2010—CoAxia, Inc. (Maple Grove, MN) announced the completion of enrollment in its SENTIS (Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke) randomized, controlled, pivotal trial of the company's NeuroFlo perfusion augmentation therapy as an acute interventional treatment for ischemic stroke. The SENTIS trial is being performed in the United States and Europe under a US Food and Drug Administration (FDA) investigational device exemption. The company plans to complete data collection and analysis of results in the third quarter of 2010, and if warranted, submit a premarket approval application to the FDA.

According to the company, the SENTIS trial includes ischemic stroke patients treated within 14 hours of the onset of symptoms. It is a 1:1 randomized, controlled study with a neurological improvement endpoint measured at 90 days after symptom onset. The outcome measure is the Stroke Global Score as defined by the National Institute of Neurological Disease and Stroke. With 515 patients enrolled at over 50 stroke centers in 10 countries, CoAxia believes that it will have sufficient patients and site diversity to accurately measure safety and efficacy of the NeuroFlo technology in a broad segment of ischemic stroke patients. The company also believes that if the NeuroFlo treatment proves to be safe and effective, as many as 50% of stroke patients may become eligible for treatment compared to approximately 5% of ischemic stroke patients who currently are treated acutely in the United States. Professor Ashfaq Shuaib, MD, is the principal investigator of the SENTIS trial.