First Patient Enrolled in REAL SSO2 Study to Evaluate Clinical Utility and Economic Value of ZOLL TherOx SSO2 Therapy

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January 17, 2023 — CHELMSFORD, MASS. — ZOLL®, an Asahi Kasei company, announced today that the first patient has enrolled in the REAL SSO2 post-market observational study to assess the clinical utility and cost-effectiveness of TherOx SuperSaturated Oxygen (SSO2) Therapy compared to PCI alone in standard of care treatment for ST-elevation myocardial infarction (STEMI) patients. The first patient was enrolled by the interventional cardiology team at St. Mary's Medical Center in West Virginia, led by site investigator Mehiar El-Hamdani, MD and study coordinator Cheryl Kane, RN.

SSO2 Therapy is used immediately after stenting is performed for left-anterior descending (LAD) STEMI heart attacks — the most severe type — and within six hours of symptom onset. SSO2 delivers high levels of dissolved oxygen directly to the heart to recover damaged tissue. Data have shown that SSO2 Therapy is associated with lower rates of heart failure and death within one year,1 and it is the only therapy approved by the FDA to reduce infarct size. 2

The REAL SSO2 study is a prospective, real-world multi-center, post-market observational study enrolling 750 patients, including both SSO2-treated and control subjects. The study is intended to further demonstrate the clinical and economic value of SSO2 Therapy and evaluate post-event interventions, rehospitalization, and quality of life measures. The real-world data will be collected from the site enrollments in addition to case data from the American College of Cardiology (ACC) CathPCI patient registry. A complete overview of the study can be found on ClinicalTrials.gov.

"SSO2 Therapy is the newest treatment modality in improving care for STEMI patients, and we are thrilled to be leading this study aimed at demonstrating value beyond the acute clinical benefits," said Robert Yeh, MD, co-principal investigator and interventional cardiologist at Beth Israel Deaconess Medical Center. "Given the significant reduction in infarct size already demonstrated through previous clinical studies,1 we expect to see longer-term improvements in this patient population as compared to primary percutaneous intervention (PCI) alone." In addition to Dr. Yeh, the study's co-principal investigator is David Cohen, MD, Director of Clinical Outcomes & Research at Cardiovascular Research Foundation in New York, NY.

"The REAL SSO2 study is an important step towards positioning SSO2 Therapy as a standard of care," said Christopher Barnabas, President of ZOLL Circulation. "ZOLL is pleased to partner with top institutions and the ACC on this research, and we believe the study outcomes will further demonstrate the positive impact SSO2 Therapy can have for patients who suffer severe heart attacks."

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.

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.

1 Stone GW, et al. Circ Cardiovasc Interv; 2; 366-375. Sep 2009.2 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170027

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