ZOLL TherOx Receives CE Mark Approval for Supersaturated Oxygen Therapy

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Edna Kaplan

KOGS Communication, LLC on behalf of ZOLL Medical Corporation

ZOLL THEROX RECEIVES CE MARK APPROVAL FOR SUPERSATURATED OXYGEN THERAPY

May 4, 2020 — CHELMSFORD, MASS. — ZOLL^® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today it has received CE Mark approval to market and distribute its SuperSaturated Oxygen (SSO₂) Therapy System in Europe. SSO₂ Therapy provides interventional cardiologists with the first and only clinically proven treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in heart attack patients.¹

"SSO₂ Therapy will support clinicians in delivering the highest quality of care for their STEMI patients in Europe and other countries that accept CE Mark," said Neil Johnston, President, ZOLL Circulation.

SSO₂ Therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization via angioplasty and stenting of the blocked coronary artery. It is indicated for patients who suffer the most serious kind of heart attack, left anterior descending ST-elevation myocardial infarction (LAD STEMI) — also known as a "widowmaker" due to the high mortality rate — and are treated within six hours of symptom onset. SSO₂ Therapy is the first and only FDA-approved device beyond percutaneous coronary intervention (PCI) to reduce muscle damage in heart attack patients.²

"I am very happy to know that ZOLL received CE Mark approval for the TherOx^® System" said Antonio L. Bartorelli, MD, Interventional Cardiology Director at Centro Cardiologico Monzino, University of Milan. "We were among the first in Europe to observe the beneficial impact of SSO₂ Therapy on left ventricular recovery after primary coronary intervention in patients with LAD ST-elevation myocardial infarction³ and we look forward to being able to use this effective treatment again in our patients."

Historically, angioplasty and stenting have been the standard of care in treating heart attacks. Many patients do not achieve maximum clinical benefit and suffer from reduced heart function. More than 30% of severe heart attack patients develop heart failure,⁴ and of those, 50% will die within five years.⁴ SSO₂ Therapy has been shown in prospective clinical trials to safely reduce infarct size in widowmaker heart attack patients. Decades of research on heart attack patients has demonstrated that infarct size reduction is correlated with reduced mortality and heart failure, and better left ventricular function.⁵

SSO₂ Therapy was developed by Irvine, California-based TherOx, Inc., now part of ZOLL Medical Corporation. Additional information about SSO₂ Therapy is available at https://www.therox.com/sso2-therapy.

About ZOLL Medical Corporation

ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, supersaturated oxygen therapy, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com.

About Asahi Kasei

The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corporation, with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 40,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.

¹Stone GW, et al. Circ Cardiovasc Intervent 2009;2:5:366–375.
²Martin JL. Cardiac Interventions Today. 2019;13:4:28–30.
³Bartorelli AL. Am J Cardiovasc Drugs. 2003;3:253-63.
⁴Heart Failure Fact Sheet|Data & Statistics|DHDSP|CDC
⁵Stone, G.W. et al. J Am Coll Cardiol. 2016;67(14):1674–83.

Copyright © 2020 ZOLL Medical Corporation. All rights reserved. TherOx and ZOLL are trademarks and/or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

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