October 30, 2007) – TherOx Inc., a privately held medical device company, announced it has met its endpoints for its pivotal trial, AMIHOT II (Acute Myocardial Infarction with Hyperoxemic Oxygen Therapy), which studied SuperOxygenation Therapy for Acute Myocardial Infarction (AMI) patients.
The data will be submitted shortly to the FDA as part of the company’s Premarket Approval (PMA) application. AMIHOT II showed superiority of the adjunctive administration of SuperOxygenation Therapy over the current AMI standard of care alone – available drug regimens coupled with urgent Percutaneous Coronary Intervention (PCI) – by demonstrating a significant reduction in infarct size for patients treated within six hours from symptom onset for anterior AMI. The prospective, multi-center, randomized trial studied more than 300 STEMI (ST-segment Elevation Myocardial Infarction) patients for a new therapy called SuperOxygenation Therapy, in a new treatment category called Myocardial Salvage Intervention (MSI).
SuperOxygenation Therapy, an adjunctive therapy performed immediately after PCI, is the first and only treatment option post-PCI that has shown promise to reduce infarct size and thus preserve heart muscle during an acute heart attack. Myocardial Salvage Intervention is a new treatment category for AMI patients that salvages the jeopardized myocardium and reduces infarct size.
“AMIHOT II demonstrated a significant reduction in infarct size with SuperOxygenation Therapy compared to the current standard of care for anterior AMI patients treated by angioplasty within six hours of symptom onset,” said the study’s principal investigator, Dr. Gregg W. Stone from Columbia University Medical Center and the Cardiovascular Research Foundation in New York. “The positive results shown in AMIHOT II significantly expand AMI treatment options for interventional cardiologists and their patients affected by large heart attacks.”
SuperOxygenation Therapy intends to provide a solution for many of the 1.2 million Americans who have acute heart attacks each year.
“With the positive results of our clinical trial, we have made a significant step towards providing a treatment option that addresses Myocardial Salvage Intervention for a large group of heart attack patients,” said Kevin Larkin, president and CEO of TherOx. “SuperOxygenation Therapy is poised to have a major impact on the industry. Reducing infarct size has been shown to improve heart function and patient outcomes including mortality and quality of life.”
For more information: www.therox.com