February 25, 2025GE Healthcare (GE HealthCare, Nasdaq: GEHC) announced that its newly FDA-approved positron emission tomography (PET) radiotracer Flyrcado™ (Flurpiridaz F 18) injection has been administered to the first group of patients at early adopter sites across the United States.This milestone event marks an important step forward for Flyrcado in advancing cardiac imaging technology.

Flyrcado, as a first-of-its-kind radiopharmaceutical, is a PET myocardial perfusion imaging (MPI) agent specifically used for detecting coronary artery disease (CAD).In patients with known or suspected CAD, Flyrcado has demonstrated higher diagnostic efficiency compared to the currently predominant single-photon emission computed tomography (SPECT) MPI used in nuclear cardiology. Flyrcado is provided in a ready-to-use unit dose format, an innovative design that significantly enhances the accessibility of PET MPI for both clinicians and patients. GE Healthcare anticipates that by the end of 2025, nearly all existing cardiac PET centers in the United States will be able to utilize Flyrcado.

Flyrcado has a half-life of 109 minutes, significantly longer than existing PET MPI tracers, which allows it to be distributed to a wide network of hospitals and imaging centers without the need for on-site tracer production or generator maintenance. GE Healthcare has partnered with Contract Manufacturing Organizations (CMOs) to expand Flyrcado's coverage across the United States, enhancing its regional accessibility.

Dr. Mouaz Al-Mallah (MD, MSc, FASNC), Director of Cardiac PET at Houston Methodist Hospital, highly praised the introduction of Flyrcado: "With its significantly longer half-life compared to existing PET MPI tracers, Flyrcado is opening new frontiers for cardiac PET. We are proud to be among the first institutions to use it in a cardiac PET lab."

A longer half-life eliminates the need for on-site tracer production, allowing Flyrcado to be ordered as a ready-to-use unit dose. Additionally, it provides clinicians with the flexibility to perform exercise stress tests, something no previous cardiac PET tracer has been able to achieve. We anticipate that Flyrcado will make PET MPI more accessible for both clinicians and patients, and enable more centers to offer this important imaging modality to suitable patients."

GE Healthcare has submitted a pass-through application for Flyrcado to the Centers for Medicare & Medicaid Services (CMS) in the United States to obtain surgical coding and reimbursement rates. This move will further enhance the accessibility of Flyrcado, allowing more patients to benefit from this advanced diagnostic technology. Flyrcado is expected to be fully commercialized by the second quarter of 2025.

GE Healthcare Pharmaceuticals Diagnostics (PDx) CEO Kevin O’Neill stated: "The first patient dosing of Flyrcado marks a significant milestone in the development journey of this product. With over a decade of development, we are thrilled to see it finally benefiting patients. These imaging centers are leaders in cardiac imaging, and we are pleased they recognize the impact of this diagnostic technology—referred to as a game-changer—for their clinicians and patients. We are committed to scaling up the manufacturing of Flyrcado to enhance accessibility for cardiac PET imaging centers across the United States."

CAD is the most common form of heart disease and the leading cause of death among men and women in the United States. In 2022, the reported number of deaths caused by CAD in the U.S. was 371,506. In the multicenter international AURORA Phase III trial, Flurpiradaz F 18 was compared with invasive coronary angiography as the gold standard for diagnosis, showing high diagnostic efficiency in detecting CAD. Additionally, Flyrcado provides the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD detection, making the most reliable assessment of patient ischemia possible.

GE Healthcare to Announce Commercial Launch of Flyrcado at ACC 2025 in Chicago from March 29-31. The company also anticipates obtaining CMS pass-through status shortly thereafter, enabling separate reimbursement for Flyrcado in the hospital outpatient setting. This will further enhance patient access and strengthen clinicians' diagnostic capabilities. GE Healthcare is also collaborating with commercial payers to ensure Flyrcado is recognized for its value and potential to improve patient outcomes, thereby becoming a covered benefit for in-network beneficiaries.

As a leading global innovator in medical technology and pharmaceutical diagnostics, GE Healthcare provides molecular imaging equipment and radiopharmaceuticals across cardiology, neurology, and oncology. The PDx division is a global leader in the field of imaging agents, supporting over 130 million patient exams in 2024, equivalent to completing four patient exams per second. The launch of Flyrcado once again demonstrates GE Healthcare's firm commitment to driving medical technology innovation and improving the quality of patient care.

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