NEWS BRIEF

Pharmaceutical Diagnostics today
GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment develops and manufactures pharmaceutical imaging agents used to support over 130 million procedures per year globally - equivalent to four patient procedures every second—across all major care pathways. With over 5,000 employees globally and seven current Good Manufacturing Practice manufacturing sites, PDx products are used in 100+ countries. This year’s news announcements focused on driving resiliency, security of supply and choice in contrast media, as well as shaping the future of radiopharmaceuticals to enable precision care.

GE HealthCare announces Flyrcado milestone: Strong pilot results drive broader rollout at CVAUSA
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.

Lantheus and GE HealthCare announce exclusive licensing agreement for prostate cancer imaging agent PYLARIFY® (Piflufolastat F 18) in Japan
Lantheus Holdings, Inc. (NASDAQ: LNTH) and GE HealthCare (NASDAQ: GEHC) announced an exclusive licensing agreement for GE HealthCare to develop, manufacture, and commercialize Lantheus’ piflufolastat F18 (PYLARIFY® in U.S. market) in Japan for prostate cancer diagnostics and companion diagnostic use. PYLARIFY is used for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. The agreement included the transfer of regulatory dossiers, manufacturing competencies and technical support to enable GE HealthCare to drive clinical development in Japan towards potential regulatory submissions and commercial launch.

GE HealthCare enters an agreement to distribute Flyrcado through CDL Nuclear Technologies Group, a leading provider of cardiac PET imaging equipment and services in the U.S.
GE HealthCare (Nasdaq: GEHC) announced a Distribution and Services Agreement (DSA) with CardioNavix, a part of the CDL Nuclear Technologies services group that provides end-to-end cardiac positron emission tomography (PET) imaging solutions to hospitals and outpatient practices throughout the U.S. Through this agreement, GE HealthCare aims to bring Flyrcado™ (flurpiridaz F18) injection—its novel cardiac PET imaging agent—to patients nationwide, including private cardiology practices and office and hospital imaging settings, expanding the reach of cardiac PET for the evaluation of known or suspected coronary artery disease. Through their nearly 225 U.S. customers, CDL and CardioNavix support more than 220,000 cardiac PET procedures annually. This agreement builds the capabilities needed to support Flyrcado’s growth in outpatient cardiac PET imaging by pairing CardioNavix’s comprehensive program setup, workflow, and clinical and operations support with GE HealthCare’s contract manufacturing organization (CMO) network to accelerate site enablement.

FDA approves expanded indications for GE HealthCare’s Vizamyl PET imaging agent for beta amyloid detection, enabling more precise care for Alzheimer’s patients
GE HealthCare (Nasdaq: GEHC) announced that the U.S. Food and Drug Administration (FDA) approved an updated label for its positron emission tomography (PET) imaging agent VizamylTM (flutemetamol F 18 injection) for beta-amyloid detection. The revised label, effective immediately, expands the indications for use, enables quantitative analysis of Vizamyl scans, and removes significant previous limitations such as monitoring patient response to anti-amyloid therapy. The updated label enables enhanced decision making, and more confident diagnosis and monitoring of Alzheimer’s disease, helping patients and their families access timely, precision care.

Updated NCCN Clinical Practice Guidelines in oncology (NCCN Guidelines®) recommend use of FES PET imaging for lobular breast cancer
GE HealthCare (Nasdaq: GEHC) announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for clinicians now recommend considering fluoroestradiol (FES) positron emission tomography (PET) for systemic staging in patients with recurrent or metastatic lobular breast cancer. GE HealthCare’s Cerianna™ (fluoroestradiol F18) injection, available in the United States, is the only FDA-approved imaging agent for the detection of estrogen receptor positive (ER+) breast cancer metastases, including lobular breast cancer. The updated NCCN Guidelines® expanded the recommendation for the use of FES PET imaging in ER+ disease. In 2023, FES PET was included in the NCCN Guidelines for systemic staging of recurrent/stage IV ER+ breast cancer.

GE HealthCare announces FDA approval of pediatric indication for Optison ultrasound enhancing agent
GE HealthCare (Nasdaq: GEHC) announced the U.S. Food and Drug Administration (FDA) approved a pediatric indication for the company’s Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) ultrasound enhancing agent (UEA). This approval will help improve the clarity and diagnostic accuracy of echocardiograms in pediatric patients, giving cardiologists a fuller picture of ventricular function when assessing possible heart abnormalities or disease. Optison is the only polyethylene glycol (PEG)-free ultrasound enhancing agent available in the U.S.

GE HealthCare completes acquisition of Nihon Medi-Physics (NMP), a leading radiopharmaceutical company in Japan
GE HealthCare Technologies Inc. (GE HealthCare or the Company) (Nasdaq: GEHC) completed its acquisition of the remaining 50% stake in Nihon Medi-Physics Co., Ltd (NMP), from Sumitomo Chemical, giving it full ownership. As part of GE HealthCare, NMP can further build on its expertise in developing and manufacturing proprietary and in-licensed radiopharmaceuticals used in single photon emission computed tomography (SPECT) and positron emission tomography (PET) molecular imaging procedures to detect and diagnose disease. As part of GE HealthCare, NMP—already a leading radiopharmaceutical company in Japan—is positioned to enhance patient access to next-generation radiopharmaceuticals that enable detection and diagnosis of disease.

ACC 2025: GE HealthCare announces the U.S. launch of pivotal innovations that will help transform the cardiology care pathway
GE HealthCare (Nasdaq: GEHC) announced the U.S. launch of Flyrcado™ (flurpiridaz F 18) injection at the 2025 American College of Cardiology (ACC) Annual Scientific Session & Expo, which took place March 29-31 in Chicago. Additionally, the company showcased its new AI-powered innovations, reflecting its strategy to leverage AI to help increase efficiency and enable seamless integration of data across the cardiology care pathway. GE HealthCare has been investing in AI for years and has topped the FDA list of AI-enabled device authorizations for three years in a row with 85 authorizations. The much-anticipated Flyrcado™ (flurpiridaz F 18) injection, a first-of-its-kind unit dose positron emission tomography myocardial perfusion imaging agent for the detection of coronary artery disease, is now available in select U.S. markets and has been granted traditional pass-through payment status by the U.S. Centers for Medicare and Medicaid.

Patients in the US undergo first doses of GE HealthCare's new PET radiotracer, Flyrcado (flurpiridaz F 18) injection
GE HealthCare (Nasdaq: GEHC) has delivered the first patient doses of Flyrcado™ (flurpiridaz F 18) injection, a first-of-its-kind unit dose positron emission tomography myocardial perfusion imaging (PET MPI) agent for the detection of coronary artery disease (CAD), at early adopter imaging centers in the US. This milestone followed the recent FDA approval of Flyrcado, which is indicated for patients with known or suspected CAD, and delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. Available as a ready-to-use unit dose, Flyrcado can expand clinician and patient access to PET MPI and is expected to be available to nearly all of the existing cardiac PET centers in the US by the end of 2025.

GE HealthCare invests $138 million in Cork, Ireland manufacturing facility to address increasing contrast media demand
GE HealthCare (Nasdaq: GEHC) announced a $138 million investment to expand its Carrigtohill, Cork contrast media fill and finish manufacturing site in Ireland. A new state-of-the-art facility on the grounds of the existing site will enable 25 million more patient doses per year of contrast media by the end of 2027. Demand for CT and X-Ray contrast media—used to enhance medical imaging procedures globally—is estimated to double in the next 10 years. This investment will create additional capacity to cater for growing demand while offering increased flexibility and resiliency for security of supply.

GE HealthCare to acquire remaining 50% stake in Nihon Medi-Physics (NMP), a leading radiopharmaceutical company in Japan, from Sumitomo Chemical
GE HealthCare (Nasdaq: GEHC) agreed to acquire full ownership of Nihon Medi-Physics Co., Ltd (NMP), by purchasing from Sumitomo Chemical (TYO: 4005) the 50% stake it does not already own. As part of GE HealthCare, NMP can build on its expertise developing and manufacturing proprietary and in-licensed radiopharmaceuticals used in single photon emission computed tomography (SPECT) and positron emission tomography (PET) molecular imaging procedures to detect and diagnose disease. Sumitomo and GE HealthCare expect the agreement to close in early 2025, subject to regulatory approvals. This transaction bolsters GE HealthCare’s Pharmaceutical Diagnostics segment and demonstrates its commitment to shaping the future of Molecular Imaging.

Media contact
Emmy Elguizaoui
Pharmaceutical Diagnostics
emmy.elguizaoui@gehealthcare.com
M: +1 978 243 7503

INDICATIONS AND USAGE OF CERIANNA™

Indications and Usage
CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

Limitations of Use
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).

Contraindications
None.

Adverse Reactions
In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare Company at 800.654.0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For full Prescribing Information click here.

INDICATIONS AND USAGE OF FLYRCADO™

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.

For full prescribing information, click here. For important safety information, please click here.

INDICATIONS AND USAGE OF OPTISON™

Indications and Usage
OPTISON is an ultrasound contrast agent indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricle to improve the delineation of the left ventricle endocardial borders.

Contraindications
OPTISON is contraindicated in patients with known or suspected hypersensitivity to perflutren or albumin.

Warnings and Precautions

• Serious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).
• Serious anaphylactic reactions have been observed during or shortly following perflutren-containing microsphere administration, including shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema have occurred in patients with no prior exposure to perflutren-containing microsphere products.
• When administering OPTISON to patients with a cardiac shunt, microspheres can bypass filtering of the lungs and enter the arterial circulation. Assess patients with shunts for embolic phenomena following OPTISON administration. OPTISON is only for intravenous administration; do not administer OPTISON by intra-arterial injection.
• High ultrasound mechanical index values may cause microsphere rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. OPTISON is not recommended for use at mechanical indices greater than 0.8.

Adverse Reactions
Common adverse reactions (incidence > 0.5%) were: headache, nausea and/or vomiting, warm sensation or flushing, dizziness, dysgeusia, chills or fever, flu-like symptoms, malaise/weakness/fatigue, chest pain, dyspnea, injection site discomfort, and erythema. Cardiac arrests and other serious but nonfatal adverse reactions were uncommonly reported in post-approval use. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions. Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients.

Use in Specific Populations

Pregnancy and Lactation
There are no data with OPTISON use in pregnant woman to inform any drug-associated risks. There are no data on the presence of perflutren protein-type A microspheres in human milk, the effects on the breastfed infant or the effects on milk production.

Pediatric Use
Safety and efficacy of OPTISON in pediatric patients is supported by evidence from adequate and well-controlled studies in adults and additional efficacy and safety data from a clinical study in 37 pediatric patients aged 9-17 years.

Geriatric Use
No overall differences in safety or effectiveness were observed in patients 65 years and over but a greater sensitivity to OPTISON in older individuals cannot be ruled out.

Please see the full Prescribing Information, including Boxed Warning for additional important safety information.

INDICATIONS AND USAGE OF VIZAMYL™

Indications and Usage
VIZAMYL™ (flutemetamol F 18 injection) is indicated for positron-emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline.
Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing of information of the therapeutic products.

Contraindications
VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80.

Warnings and Precautions

• Anaphylaxis and Other Serious Hypersensitivity Reactions: Serious hypersensitivity reactions including anaphylaxis, presenting with flushing, dyspnea, and hypotension have been observed within minutes following administration and may occur in patients with no history of exposure to VIZAMYL. Obtain a history of allergy or hypersensitivity reactions. Always have resuscitation equipment and trained personnel immediately available at the time of VIZAMYL administration. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. VIZAMYL is contraindicated in patients with a history of hypersensitivity to VIZAMYL or polysorbate 80.
• Risk of Image Misinterpretation and Other Errors: Errors may occur in the estimation of amyloid beta neuritic plaque density during VIZAMYL image interpretation. The use of clinical information in the interpretation of VIZAMYL images has not been evaluation and may lead to an inaccurate assessment. Extensive brain atrophy and motion artifacts that distort the image may limit the ability to distinguish gray and white matter on a VIZAMYL scan. Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal or examine the striatum for VIZAMYL signal as it is less affected by atrophy.
• Radiation Risk: VIZAMYL contributes to a patient’s long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most commonly reported adverse reactions in clinical trials were flushing (2 %), increased blood pressure (2 %), headache (1 %), nausea and dizziness (1 %). Postmarketing experience included anaphylactic reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Use in Specific Populations

Pregnancy
There are no available data on VIZAMYL in pregnant woman to evaluate drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. All radiopharmaceuticals, including VIZAMYL, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose. If considering VIZAMYL administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.

Lactation
There are no data on the presence of flutemetamol F 18 or metabolites in human milk or its effects on the breastfed infant or milk production. Exposure of VIZAMYL to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIZAMYL and any potential adverse effects on the breastfed child from VIZAMYL or from the underlying maternal condition.

Pediatric Use
The safety and effectiveness of VIZAMYL have not been established pediatric patients.

Geriatric Use
No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.

Overdosage
The major risks of overdosage relate predominantly to increased radiation exposure, with long-term risk for neoplasia. In the event of administration of a radiation overdose with VIZAMYL, hydration and frequent urination should be encouraged to minimize radiation exposure to the subject. It is unknown whether or not the flutemetamol is dialyzable.

Prior to VIZAMYL administration, please read the full Prescribing Information for additional Important Safety Information.

INDICATIONS AND USAGE OF PYLARIFY®

Indications and Usage
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information.

Contraindications
None.

Warnings and Precautions

• Risk of Image Misinterpretation: Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
• Hypersensitivity Reactions: Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.
• Radiation Risks: Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

Please read the accompanying full Prescribing Information also available at PYLARIFY.com.