Key Milestone toward Bringing SSO2 Therapy
to the U.S. Market
IRVINE, Calif.–(BUSINESS WIRE)–TherOx,
Inc., a privately held medical device company focused on improved
treatment of Acute Myocardial Infarction (AMI), announced that the first
patient has been enrolled in an Investigational Device Exemption (IDE)
confirmatory study of its second generation system that delivers
Supersaturated Oxygen (SSO2) Therapy for reduction of infarct
size after an AMI. This study is being conducted to support a PreMarket
Approval submission to the FDA.
“Many heart attack patients suffer from large anterior infarcts after
angioplasty and stenting, which carry a poorer prognosis in terms of
mortality and the potential for future heart failure,” said Shukri
David, MD, FACC, Physician Chair of the Heart & Vascular Center of
Excellence at St. John Providence Health System near Detroit, MI, and an
investigator for this study. “This important study of SSO2 Therapy
may provide physicians with an additional intervention that further
improves outcomes for our heart attack patients.”
Called the IC-HOT (Evaluation of Intracoronary
Therapy) study, it will enroll 100 subjects
at up to 15 investigational centers in the United States. The primary
objective of the study 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. (Clinicaltrials.gov
According to the American Heart Association, every year nearly one
million people in the U.S. have heart attacks. Although percutaneous
coronary intervention (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 is intended to provide interventional
cardiologists with the first treatment option beyond PCI to salvage
heart muscle in heart attack patients. SSO2 Therapy,
adjunctive to PCI, is a solution of highly oxygenated saline mixed with
the patient’s blood delivered through a catheter to the targeted
ischemic area of the heart. 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.
“This study moves us another step closer to our goal of improving
treatment options in the U.S. for physicians to provide to 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 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. 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 http://www.therox.com.
In the United States, SSO2
Therapy is delivered by an investigational device. It is limited by
United States law to investigational use. It
is not for sale or distribution in the United States.
Betsy Merryman, 310-560-8176