TherOx®, a privately held medical device company focused on improving treatment of acute myocardial infarction (AMI), today announced completion of a debt financing for an undisclosed amount led by existing investor ZOLL® Medical Corporation, an Asahi Kasei Group Company. The proceeds will be used to support the U.S. market introduction and commercialization of its SuperSaturated Oxygen (SSO2) Therapy system upon receipt of Food and Drug Administration (FDA) premarket approval (PMA).
“We appreciate the ongoing support from our existing investor, ZOLL Medical Corporation, as our positive discussions with the FDA continue and our PMA appears to be in the final phase of review,” said Kevin T. Larkin, president and chief executive officer of TherOx. “We look forward to the time when we can provide this important new therapy to physicians and their patients who experience typically debilitating large anterior AMIs.”
The financing follows the announcement of TherOx’s IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study results confirming the safety and effectiveness of SSO2 Therapy in treatment of anterior AMI patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms. These confirmatory results build on the successful outcome of the AMIHOT II controlled, randomized pivotal trial that studied the first-generation SSO2 Therapy system.
SSO2 Therapy is intended to reduce infarct size by boosting oxygen delivery to the heart muscle immediately after the coronary artery has been opened by PCI. The TherOx SSO2 Therapy system delivers a one-time, 60-minute infusion of superoxygenated blood to the coronary arteries after standard-of-care treatment for heart attack has been completed.
SSO2 Therapy is intended to provide interventional cardiologists with the first treatment option beyond PCI to salvage heart muscle in heart attack patients. Although PCI is the standard of care in treating AMI, for many patients it doesn’t sufficiently reduce infarct size to achieve maximum clinical benefit. Adjunctive to PCI, SSO2 Therapy is intended to salvage heart muscle and reduce infarct size.