Studies Show Significant Unmet Need in Severe Heart Attack Patients and Cost-Effectiveness of SSO2 Therapy

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Matt HoganZOLL Medical Corporation+1 (978) 805-6561[email protected]

Studies Show Significant Unmet Need in Severe Heart Attack Patients and Cost-Effectiveness of SSO₂ Therapy

October 29, 2024 - CHELMSFORD, Mass. - ZOLL^®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today the results of two important studies evaluating the economic burden of heart failure resulting from severe heart attack and the long-term cost-effectiveness of SuperSaturated Oxygen (SSO₂) Therapy for heart attack treatment. Results from these studies highlight the need for cost-effective therapies that improve quality of life and reduce the long-term economic burden of heart failure. SSO₂ Therapy, used immediately after primary percutaneous coronary intervention (PCI), is the only FDA-approved therapy shown to save damaged heart muscle following severe heart attack, defined clinically as an ST-segment elevation myocardial infarction (STEMI).¹

The Burden of Illness (BOI) Study, the first ever to evaluate adult STEMI survivors, was conducted in collaboration with IQVIA, Inc. and presented at the Academy of Managed Care Pharmacy Nexus 2024 meeting.² The study was a claims-based analysis to quantify the clinical and economic burden including those who develop heart failure. Additionally, ZOLL sponsored a second study in collaboration with the Cardiovascular Research Foundation (CRF), known as an incremental cost-effectiveness ratio (ICER), which evaluated the economic impact of reducing infarct size (damaged tissue) in adult anterior STEMI patients following treatment with SSO₂ Therapy as compared to standard of care. The ICER was presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 Congress.³

The BOI STEMI analysis evaluated healthcare claim forms for 3,236 STEMI survivors (ages 20-85), revealing that 34.4% of claims indicated a new diagnosis of heart failure on average within two months following STEMI.² In the heart failure group, all-cause total healthcare cost was 31% higher compared to other survivors.² These findings highlight the urgent need for improved, cost-effective therapies to improve STEMI survivors' quality of life and reduce the long-term economic burden of heart failure, which is currently projected to reach $70 billion by 2030.⁴ The ICER study, conducted by CRF, sought to evaluate the economic value of SSO₂ Therapy compared to the standard of care. Industry standards indicate that a highly cost-effective ICER is determined by a quality-adjusted life year (QALY) <$50,000.⁵ The QALY is the academic standard for assessing the value of a medical intervention, serving as a critical component of cost-effectiveness analyses for more than 30 years.⁶ The ICER for SSO₂ Therapy demonstrated a $12,926/quality-adjusted life year (QALY) gained, concluding that SSO₂ is highly cost-effective for anterior STEMI patients.³

"These results demonstrated that for patients with acute anterior STEMI undergoing primary PCI, the use of adjunctive SSO₂ Therapy on outcomes was highly cost-effective," said David Cohen, MD, Director of Academic Affairs at St. Francis Hospital, NY. "The SSO₂ ICER compares very favorably with many other therapies such as intravascular imaging for patients undergoing coronary stenting, microaxial flow pumps for patients undergoing high-risk PCI, and transcatheter mitral edge-to-edge repair for patients with severe functional mitral regurgitation."

"The results of this ICER study reinforce our robust clinical results, confirming the value of SSO₂ in combating the burden of illness associated with STEMI," remarked Matt Rochner, General Manager of ZOLL's TherOx business. "We know from our IC-HOT study that patients receiving SSO₂ Therapy had a greatly reduced chance of developing heart failure out to one year.⁷ ZOLL is proud to offer one of the most cost-effective therapies for STEMI patients, benefiting both healthcare and hospital systems."

SSO₂ Therapy is indicated for anterior STEMI heart attack patients who receive primary percutaneous coronary intervention (PCI) with stenting within six hours of symptom onset. Administered immediately following PCI, SSO₂ Therapy delivers high levels of dissolved oxygen (7-10x normal) 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,⁷ and it is the only therapy approved by the FDA to reduce infarct size.¹

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 businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to a 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, 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 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170027
² Veloz A, et al. Real-world clinical and economic burden among commercially-insured ST-segment elevation myocardial infarction survivors in the United States. Presented at Academy of Managed Care Pharmacy Nexus meeting. October 16, 2024.
³ Vilian K, et al. Cost-Effectiveness of Supersaturated Oxygen Delivery for Infarct Size Reduction in Patients with Anterior STEMI. Presented at the Transcatheter Cardiovascular Therapeutics Congress. October 29, 2024.
⁴ Wei C, et al. The economics of heart failure care. Prog Cardiovasc Dis. 2024 Jan-Feb;82:90-101.
⁵ Dubois RW. Cost-effectiveness thresholds in the USA: are they coming? Are they already here? Jour of Comparative Effectiveness Research. Vol 5; No 1. 21 Dec 2015.
⁶ Institute for Clinical and Economic Review (ICER). Cost-Effectiveness, the QALY, and the evLYG. 2024. https://icer.org/our-approach/methods-process/cost-effectiveness-the-qaly-and-the-evlyg/
⁷ 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.

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