Clinical Overview

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Clinical Overview

TherOx is now enrolling patients in the IntraCoronary Hyperoxemic SuperSaturated Oxygen Therapy (IC-HOT) study, a confirmatory safety study of the second generation system that delivers SuperSaturated Oxygen (SSO2) Therapy for reduction of infarct size after an AMI. This 100-patient study is being conducted to support a PreMarket Approval submission to the FDA.

Previously, TherOx conducted the pivotal AMIHOT II trial to evaluate the safety and effectiveness of  SSO2 Therapy to treat Acute Myocardial Infarction (AMI) in anterior wall infarction patients treated with PCI and stenting within 6 hours of symptom onset. Investigational centers in the United States, Europe, and Canada participated in the FDA-sanctioned trial.

The goal of the AMIHOT II study was to validate the promising results from earlier studies in patients with anterior wall heart attacks treated with PCI within 6 hours of symptom onset. The AMIHOT II study included 301 patients. Find out more about the results of the AMIHOT II study.

TherOx had conducted prior clinical evaluations of  SSO2 Therapy to treat AMI, first in a Phase I feasibility study (29 subjects), and then in the randomized AMIHOT I study (269 subjects). The AMIHOT I study included all patients with inferior and anterior wall heart attacks within 24 hours of symptom onset. The results of these earlier studies suggested improvements in heart function and viability in subjects treated with  SSO2 Therapy, particularly those treated within 6 hours of symptom onset. Learn more about the results from the earlier studies.