First Patient Enrolled in AMIHOT III Trial Investigating ZOLL’s Supersaturated Oxygen Therapy in Heart Attack Patients

CONTACT:

Matt Hogan

ZOLL Medical Corporation

FIRST PATIENT ENROLLED IN AMIHOT III TRIAL INVESTIGATING ZOLL'S SUPERSATURATED OXYGEN THERAPY IN HEART ATTACK PATIENTS

Study Evaluates the Effectiveness of TherOx Supersaturated Oxygen (SSO₂) Therapy in Patients Presenting with Acute Anterior Myocardial Infarction with Successful Reperfusion Compared to Standard Therapy

September 7, 2022 — CHELMSFORD, MASS. — ZOLL^® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the first patient has enrolled in the AMIHOT III post-approval study further evaluating TherOx^® SuperSaturated Oxygen (SSO₂) Therapy for the treatment of the most severe form of heart attack, left anterior descending (LAD) ST-Elevation Myocardial Infarction (STEMI). The patient, treated at WakeMed Health & Hospitals in North Carolina, received SSO₂ Therapy, the first FDA-approved therapy shown to significantly reduce the size of damaged tissue (infarct) following percutaneous coronary intervention (PCI).

Multiple clinical trials have demonstrated the efficacy of SSO₂ Therapy in reducing infarct size in LAD STEMI^1,2,3 by delivering a high concentration of dissolved oxygen (7–10x normal) directly to damaged heart muscle immediately after stenting.. TherOx SSO₂ Therapy is currently indicated for patients who suffer LAD STEMI — heart attacks with a high mortality rate — treated within six hours of symptom onset. SSO₂ Therapy has been shown to reduce relative infarct size — damage to the heart muscle — by 26% over standard of care. One year follow-up data on patients treated with SSO₂ Therapy showed reductions in heart failure hospitalization and mortality.⁴

AMIHOT III is a randomized, post-approval evaluation that will further validate the benefits of SSO₂ Therapy over current standard of care alone and provide insight into the mechanisms that lead to improved outcomes for LAD STEMI patients. Besides demonstrating the safety and effectiveness of SSO₂ Therapy, additional endpoints include incidence of microvascular obstruction (MVO), and outcomes measures such as heart failure readmissions and quality-of-life measures. The study will randomize 434 patients across sites in the U.S. and Europe. The study’s Principal Investigator is James Blankenship, MD, MHCM, MSCAI (University of New Mexico, Albuquerque, NM).

“WakeMed strives to be on the cutting edge of cardiovascular care, and I am excited that our team has enrolled the first AMIHOT III patient in this study to further confirm SSO₂ Therapy's benefits over standard of care in the treatment of severe heart attacks,” said Frances Wood, MD, interventional cardiologist at WakeMed. “Based on our experience with the IC-HOT trial that helped SSO₂ achieve FDA approval, we believe this therapy will have a strong impact in improving outcomes and reducing mortality for heart attack patients.”⁵

“With SSO₂ Therapy, ZOLL is expanding care for LAD STEMI patients,” added Christopher Barnabas, President of ZOLL Circulation. “Previous data serve as a strong indication that we will observe short- and long-term outcome improvements such as reduced incidence of heart failure and mortality in these high-risk patients.”^1,2,3,4

About ZOLL

ZOLL, an Asahi Kasei 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 cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. 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. For more information, visit www.asahi-kasei.com.

Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability.

About WakeMed Health & Hospitals

Serving the community since 1961, WakeMed is a not-for-profit health care system founded and based in Raleigh, N.C. WakeMed exists to improve the health and well-being of our community by providing outstanding and compassionate care to all. WakeMed’s 970-bed system comprises a network of facilities throughout the Triangle area, including three full-service hospitals, seven emergency departments, a dedicated Children’s Hospital and Rehabilitation Hospital, more than 80 physician offices and Wake County’s only Level I and Level III Trauma Centers. WakeMed’s mission-driven team includes more than 10,300 employees, 1,000 volunteers and 1,300 affiliated physicians, along with the more than 700 physicians and providers with WakeMed Physician Practices – all representing the best minds and the biggest hearts and the finest quality in health care and community health. For more information, visit www.wakemed.org or follow WakeMed on Facebook, Twitter and Instagram.

¹ Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75
² O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405.
³ David SW, et al. Catheter Cardiovasc Interv. 2018;1–9.
⁴ Chen, et al. Catheter Cardiovasc Interv. 2020;1–7.
⁵ David SW, et al. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2018;1–9. https://onlinelibrary.wiley.com/doi/abs/10.1002/ccd.27905

Copyright © 2022 ZOLL Medical Corporation. All rights reserved. TherOx and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation and/or its subsidiaries 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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