TherOx secures financing to support US market introduction of AMI Therapy system

Medical device company TherOx has received an undisclosed amount of financing from existing investor ZOLL Medical, a subsidiary of Asahi Kasei Group, to support the launch of SuperSaturated Oxygen (SSO2) Therapy system in the US.

The medical device-maker is focused on improving treatment for acute myocardial infarction (AMI).

TherOx will use the proceeds to support the US market introduction and commercialization of its SuperSaturated Oxygen (SSO2) Therapy system after receiving premarket approval (PMA) from the US Food and Drug Administration.

TherOx president and CEO Kevin Larkin said: “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.

“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.”

TherOx stated that the financing follows the announcement of its Evaluation of Intracoronary Hyperoxemic Oxygen Therapy (IC-HOT) study results that confirm the safety and effectiveness of SSO₂ Therapy for treating anterior AMI patients who have undergone percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.

The results build on the outcome of the Acute Myocardial Infarction With HyperOxemic Therapy II (AMIHOT II) controlled, randomized pivotal trial that studied the first-generation SSO₂ Therapy system.

SSO₂ Therapy is intended to reduce infarct size by increasing oxygen delivery to the heart muscle immediately after the coronary artery has been opened by PCI.

The TherOx SSO₂ Therapy system claims to deliver a one-time, 60-minute infusion of superoxygenated blood to the coronary arteries after standard-of-care treatment for heart attack has been administered.

SSO₂ Therapy is expected to provide interventional cardiologists with the first treatment option beyond PCI to salvage heart muscle in heart attack patients.

TherOx stated that though PCI is the standard of care in treating AMI, for many patients it may not sufficiently reduce infract size to achieve maximum clinical benefit. The intention of using SSO₂ Therapy is to complement PCI, to save heart muscle and to reduce infract size.