Market Overview

TherOx Completes Enrollment in Study of Next-Generation Therapy System Designed to Improve AMI Outcomes


, a privately held medical device company focused on improved
treatment of Acute Myocardial Infarction (AMI), announced that it
completed enrollment in the IC-HOT (Evaluation of Intracoronary
Hyperoxemic Oxygen
Therapy) study. IC-HOT is a confirmatory
study of the second-generation TherOx system that delivers
Supersaturated Oxygen (SSO2) Therapy for reduction of infarct
size after an AMI.

The IC-HOT study enrolled 100 patients and is being conducted to support
a PreMarket Approval submission to the U.S. Food and Drug Administration
(FDA). The primary study objective is to collect confirmatory data
supporting 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.

"Since the advent of angioplasty and stenting to treat heart attack we
haven't seen any new treatment options to reduce infarct size in this
vulnerable population, and SSO2 Therapy appears to fulfill
this unmet need," said Nainesh Patel, MD, interventional cardiologist at
Lehigh Valley Health Network and an investigator for the study.

According to the American Heart Association, every year nearly one
million people in the U.S. have heart attacks. Although PCI is the
standard of care in treating AMI, for many patients it doesn't do enough
to reduce infarct size and achieve maximum clinical benefit.

"SSO2 Therapy treats patients who have experienced the
most serious large anterior wall heart attacks - patients who often have
poor outcomes even after successful intervention," said Frances Wood,
MD, interventional cardiologist at WakeMed Heart and Vascular -
Structural Heart and study investigator. "This therapy is a promising
new tool to reduce infarct size and thus improve outcomes for these
higher risk patients."

SSO2 Therapy is intended to provide interventional
cardiologists with the first treatment option beyond PCI to salvage
heart muscle in heart attack patients. In SSO2 Therapy, the
patient's blood is supersaturated with oxygen and then returned directly
to the targeted ischemic area of the heart through a small catheter.
Adjunctive to PCI, SSO2 Therapy is intended to salvage the
jeopardized myocardium and thus reduce infarct size. Multiple
peer-reviewed studies have demonstrated the infarct size reduction
achieved by SSO2 Therapy was clinically significant compared
to PCI alone.

"Completing enrollment in our IC-HOT study significantly advances us
closer to our goal of improving treatment options in the U.S. for
physicians and their heart attack patients," said Kevin T. Larkin,
president and chief executive officer of TherOx.

About SSO2 Therapy

A heart attack is typically caused when blood and oxygen flow to the
heart is blocked or reduced. If not quickly restored, irreversible
damage to the heart muscle, or infarction, will occur. SSO2
Therapy is designed to reduce infarct size by boosting oxygen delivery
to the heart muscle immediately after the coronary artery has been
opened by PCI. The TherOx system creates

SSO2 Therapy by mixing highly oxygenated saline with the
patient's blood and delivers it through a catheter directly to the
targeted ischemic area of the heart.

The first generation system to deliver SSO2 Therapy received
the CE Mark and was successful in meeting the safety and effectiveness
endpoints in the AMIHOT II trial. Statistical results from the AMIHOT II
trial of SSO2 Therapy, together with PCI and stenting,
demonstrated a relative reduction of 26% in infarct size compared to PCI
and stenting alone.

This second-generation system being studied in IC-HOT builds on the
success of AMIHOT II and includes the additional benefits of shortening
the treatment time to 60 minutes and expanding the myocardial treatment
area to the entire left coronary system so that no ischemic area goes
untreated. (
identifier #NCT02603835)

SSO2 Therapy supports the current guidelines for
interventional cardiology procedures.

About TherOx, Inc.

TherOx is a privately held medical device company based in Irvine,
Calif., focused on developing and commercializing SSO2
Therapy for this sizeable patient population to save hearts, improving
and ultimately saving lives. For more information about TherOx, visit

In the United States, SSO2
Therapy is delivered by an investigational device. It is limited by
United States law to investigational use.
is not for sale or distribution in the United States

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