TherOx Submits IPO Prospectus Following FDA Approval of SSO2 Therapy, the First Adjunctive Treatment for PCI in Acute Myocardial Infarction

VCBeat (WeChat Official Account: vcbeat) has learned from foreign media that medical device company TherOx recently announced that its Supersaturated Oxygen (SSO₂) therapy has received FDA approval for the treatment of acute myocardial infarction (AMI). This therapy is also the first approved treatment for heart disease administered via percutaneous coronary intervention (PCI), and it can significantly reduce muscle damage in patients with heart disease.

TherOx (NASDAQ: THER), founded in 1994, is a private medical device company based in Irvine, California, USA. The company is dedicated to developing SSO₂ therapy for the broad population of patients with acute myocardial infarction (AMI), aiming to repair damaged heart tissue and save the lives of cardiac patients. SSO₂ therapy is a novel treatment for heart disease that works by administering supersaturated oxygen to patients, helping to restore blood flow to the heart and thereby reducing the extent of vascular occlusion.

Heart disease is typically caused by the obstruction of blood and oxygen flow to the heart, leading to swelling of the cardiac microcapillaries and further restricting coronary blood flow. If this obstruction is not rapidly resolved, it will cause irreversible damage to the heart. According to the American Heart Association, approximately 750,000 people in the United States suffer from heart disease each year. Although percutaneous coronary intervention (PCI) has been the standard treatment for acute myocardial infarction (AMI) for the past 25 years, more than 30% of AMI patients still develop heart failure after treatment, and 15% die within five years post-treatment.

PCI enables the placement of stents in coronary arteries to help restore occluded vessels to their original state. The SSO 2 therapy requires first opening the coronary arteries via PCI, followed by the immediate one-time infusion of the patient’s super-saturated oxygenated blood into the target ischemic region of the heart through a microcatheter, with an infusion duration of approximately 60 minutes. This super-saturated oxygenated blood helps reduce capillary swelling and restore blood flow to surrounding tissues, thereby reducing the area of myocardial infarction.

Following successful percutaneous coronary intervention (PCI) to restore coronary artery patency, SSO₂ therapy delivers high-pressure oxygen directly to the ischemic myocardium. This therapy is indicated for patients with severe cardiac disease, such as those presenting with ST-segment elevation myocardial infarction (STEMI) of the left anterior descending (LAD) artery. Patients with LAD STEMI require treatment within six hours of symptom onset; physicians must implant a medical stent into the affected vessel and immediately administer adjunctive SSO₂ therapy.

Currently, the efficacy of SSO 2 therapy has been validated in numerous clinical trials, demonstrating its ability to sustainably reduce infarct size in patients with acute myocardial infarction (AMI). Compared with primary percutaneous coronary intervention (PCI) alone, PCI combined with SSO 2 therapy further reduces infarct size by 26% and maintains left ventricular stability within 30 days post-treatment. Furthermore, SSO 2 therapy significantly lowers the incidence of AMI-related complications.

“Supersaturated oxygen is key to the implementation of SSO2 therapy,” said Gregg W. Stone, MD, of Columbia University. “Supersaturated oxygen can reduce infarct size in patients with large anterior myocardial infarction. Although PCI can restore blood flow in the infarct-related artery, this invasive procedure may still cause irreversible damage to the patient’s myocardium. SSO2 therapy aims to further prevent such harm.”

Kevin T. Larkin, President and CEO of TherOx, stated, “The FDA’s approval of this supersaturated oxygen therapy provides interventional cardiologists with a state-of-the-art, PCI-based treatment for myocardial infarction, preventing post-procedural heart failure and thereby saving patients’ lives.”

(Compiled by: Wang Chan)