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• Overview
• Early Studies
• AMIHOT II Pivotal Trial
• Publications

Early Studies

Feasibility Study
TherOx conducted an FDA-approved Phase I feasibility study of SSO₂ Therapy subsequent to PCI and stenting for acute myocardial infarction (AMI). This study demonstrated the promise of SSO₂ Therapy in the treatment of AMI and provided a foundation for the AMIHOT I and AMIHOT II studies.

Learn more about the Phase I feasibility study (PDF).

OYSTER-AMI Study
The OYSTER-AMI study was conducted at Centro Cardiologico Monzino in Milan, Italy under the guidance of Dr. Antonio Bartorelli. This study demonstrated the promise of  SSO₂ Therapy in the treatment of heart attack and provided an additional foundation for the AMIHOT and AMIHOT II trials.

Get further information about the OYSTER-AMI study (PDF).

AMIHOT I
The AMIHOT (Acute Myocardial Infarction with Hyperoxemic Oxygen Therapy) I study was an FDA-sanctioned, multi-center randomized study to evaluate the safety and effectiveness of  SSO₂ Therapy for the treatment of AMI. 289 subjects were enrolled in the study, including 269 randomized patients and 20 non-randomized run-in patients. Three co-primary surrogate endpoints were evaluated: ST segment resolution measured through total ischemic area under the curve, infarct size at 14 days (using Tc-99m SPECT imaging), and regional wall motion score index (RWMSI) improvement over 3 months.

Results demonstrated comparability in major adverse cardiac events (MACE) at 30 days, but did not show statistically significant improvement in the three surrogate endpoints of myocardial function and recovery in the overall patient population, which included a 24 hour inclusion window for both inferior and anterior wall AMI. However, in a subset of anterior AMI subjects treated within six hours of symptom onset, significant improvements were observed in all three surrogate endpoints. This population formed the basis for the AMIHOT II trial.

Download further information about the AMIHOT I trial (PDF).

DISCLAIMER

Europe: The TherOx^® DownStream^® System, the TherOx^® DownStream^® Cartridge, and the TherOx^® AO Catheter bear the CE Mark and are available for sale in Europe.   

United States: In the United States, the TherOx^® DownStream^® System, the MI-Cath^® Infusion Catheter, and the DownStream^® AO Cartridge, are investigational devices. They are limited by United States law to investigational use. They are not for sale or distribution in the United States.