Press Releases

AMIHOT II Studied SuperOxygenation Therapy for Myocardial Salvage Intervention
Transcatheter Cardiovascular Therapeutics (TCT) Conference

IRVINE, Calif.--(BUSINESS WIRE)--TherOx, Inc. (THEROX), a privately held medical device company, announced that it has successfully completed enrollment in its pivotal trial, AMIHOT II (Acute Myocardial Infarction with Hyperoxemic Oxygen Therapy). The prospective, multi-center, randomized trial studied more than 300 STEMI (ST-segment Elevation Myocardial Infarction) patients for a new therapy developed by THEROX called SuperOxygenation Therapy, in a new treatment category the company is introducing called Myocardial Salvage Intervention (MSI).

SuperOxygenation Therapy is an adjunctive therapy performed immediately after Percutaneous Coronary Intervention (PCI) in Acute Myocardial Infarction (AMI) patients. Myocardial Salvage Intervention is a new treatment category for AMI patients that salvages the jeopardized myocardium and reduces infarct size.

AMIHOT II was derived from a subset of the original AMIHOT study population consisting of anterior AMI patients treated within 6 hours from symptom onset. AMIHOT II was designed to show superiority over the current AMI standard of care, including currently available drug regimens coupled with PCI. Effectiveness was assessed by infarct size reduction measured by SPECT at 14 days post event, and safety was determined by the 30-day MACE (Major Adverse Cardiac Events) rate. MACE comprised combined incidence of death, reinfarction, target vessel revascularization and stroke.

AMIHOT II trial results will be presented during a late-breaking session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington D.C. on October 23.

SuperOxygenation Therapy is intended to provide a solution for the 1.2 million Americans who have acute heart attacks each year. Over 500,000 of them may benefit from this therapy, providing interventional cardiologists with a new option in treating their patients who experience the most severe types of heart attacks. Reducing infarct size has been shown to improve heart function and outcomes post AMI.

“THEROX is pioneering a new therapy intended to provide interventional cardiologists with a treatment option addressing Myocardial Salvage Intervention for a significant group of heart attack patients,” said Kevin Larkin, President and Chief Executive Officer of THEROX. “SuperOxygenation Therapy is well-positioned to be the first entrant in the MSI category.”

“AMIHOT II was designed to show that SuperOxygenation Therapy when combined with PCI is superior to the current standard of care of PCI alone in this significant at-risk group of heart attack patients—SuperOxygenation Therapy has the potential to provide interventional cardiologists with another option following PCI to save heart muscle,” said Dr. Jack Martin, a principal investigator for the trial. “Myocardial Salvage Intervention is the next evolution in AMI care, just as PCI, when it was first introduced in the early 1990s. It promises to greatly advance AMI care.”

About THEROX
THEROX, a privately held medical device company based in Irvine, Calif., is focused on developing and commercializing its SuperOxygenation Therapy to save hearts, which ultimately saves lives. THEROX provides interventional cardiologists with the first treatment option that addresses Myocardial Salvage Intervention for acute heart attack patients. For more information, visit www.therox.com.

CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.