Flurpiridaz F 18

CVAUSA, the largest network of private cardiology groups in the U.S., plans to broadly adopt Flyrcado in line with its mission to deliver the highest quality cardiovascular care for patients. CVAUSA currently performs approximately 85,000 cardiac positron emission tomography (PET) procedures annually, highlighting the potential opportunity for Flyrcado as adoption grows. GE HealthCare remains committed to driving innovation and collaborating with leading cardiology groups to advance PET myocardial perfusion imaging (MPI) technology. ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that Cardiovascular Associates of America (CVAUSA), the largest network of private cardiology groups in the U.S., plans to broaden its adoption of GE HealthCare’s FDA-approved cardiac positron emission tomography (PET) radiotracer Flyrcado™ (flurpiridaz F 18) injection, across approximately 25 sites following a successful pilot at Cardiovascular Medicine in Davenport, Iowa. This planned rollout marks a significant milestone for advancing PET myocardial perfusion imaging (MPI) in community cardiology settings and reflects growing confidence in Flyrcado’s role in shaping the future of cardiac imaging. The pilot at Cardiovascular Medicine provided cardiologists with an opportunity to evaluate Flyrcado in real-world workflows. “The pilot demonstrated that Flyrcado can be seamlessly integrated into a high-volume cardiac PET practice,” said Dr. Edmund Coyne, former President of Cardiovascular Medicine. “In our Davenport location, we routinely perform 12+ cardiac PET scans a day, and during our two-week, 21 patient pilot, we found that Flyrcado fits smoothly into that workflow without disruption. We saw firsthand the benefits in diagnostic confidence and efficiency, as well as excellent image quality, and we look forward to seeing these advantages scaled across CVAUSA’s network.” “Our mission is to deliver the highest quality cardiovascular care, and expanding the use of advanced cardiac PET imaging is a key part of that,” said Tim Attebery, Chief Executive Officer of CVAUSA. “We perform approximately 85,000 cardiac PET procedures annually across our network, and following a successful pilot with Flyrcado, we’re excited to bring this technology to more of our sites—helping our partner cardiologists make more informed decisions for patients with known or suspected coronary artery disease.” “We are encouraged by the adoption of Flyrcado in a variety of real-world settings—including large academic institutions, integrated delivery networks (IDNs), mobile PET/CT settings, and customers transitioning from SPECT to PET MPI,” said Eric Ruedinger, Vice President and General Manager of GE HealthCare’s Pharmaceutical Diagnostics division for the U.S. and Canada. “The accumulating real-world evidence shows Flyrcado’s versatility and efficacy across diverse clinical environments, laying the foundation for continued growth and confidence in this game-changing tracer.” Recent milestones underscore the growing importance of Flyrcado in clinical practice. GE HealthCare announced a distribution and services agreement with CDL Nuclear Technologies to support implementation across multiple sites of care, including private cardiology practices. In addition, Flurpiridaz F 18 is now featured in a new international procedure standard co‑published by leading societies—SNMMI, ASNC, EANM, and ACNM—in The Journal of Nuclear Medicine1 and Journal of Nuclear Cardiology. These guidelines highlight Flurpiridaz F 18 high myocardial uptake, almost linear extraction fraction relationship, and superior spatial resolution compared to SPECT and outline best practices for patient selection, rest/stress protocols, and workflow integration—further validating the tracer’s role in delivering high‑quality, safe, and effective cardiac PET imaging. GE HealthCare’s Pharmaceutical Diagnostics division is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information. Forward-Looking Statements This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as “will,” “expect,” “may,” “would,” “could,” “plan,” “believe,” “anticipate,” “intend,” “potential,” and similar expressions. These forward-looking statements may include, but are not limited to, statements about Flyrcado and GE HealthCare Technologies Inc.’s (the “Company’s”) performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, uncertainties regarding the commercial success of Flyrcado, the Company’s ability to receive pass-through status from the US Centers for Medicaid and Medicare, and decisions by regulatory authorities impacting labeling, manufacturing processes, safety, or other matters that could affect the availability or commercial potential of Flyrcado. Other factors that may cause such a difference also include those discussed in the "Risk Factors" section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation. Important Safety Information and Usage of Flyrcado™ (flurpiridaz F 18) injection FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information Indications and Usage FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. Contraindications None Warnings and Precautions Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information. Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void. Adverse Reactions Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. Use in Specific Populations Pregnancy There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. Lactation Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Pediatric Use Safety and effectiveness of FLYRCADO in pediatric patients have not been established. Safety and effectiveness of FLYRCADO in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or www.fda.gov/medwatch For full prescribing information, click here. For important safety information, please click here. 1 Packard, R. R. S., Maddahi, J., Pelletier-Galarneau, M., Al-Mallah, M. H., Coelho, M., Dorbala, S., Galt, J., Hyun, M., Menon, N., Miller, E. J., Shetty, M., & Saraste, A. (2025). SNMMI/EANM/ASNC/ACNM procedure standard/practice guideline for 18F-flurpiridaz PET myocardial perfusion imaging and blood flow quantitation. Journal of Nuclear Medicine and Journal of Nuclear Cardiology. https://doi.org/10.2967/jnumed.125.270873