Life Molecular Imaging

Making the
Invisible

Visible

Molecular imaging provides unique insights into the human body, enabling physicians to provide an improved diagnosis and personalize patient care

Life Molecular Imaging

Making the
Invisible

Visible

Molecular imaging provides unique insights into the human body, enabling physicians to provide an improved diagnosis and personalize patient care

about life molecular imaging

Your Partner for
Molecular Imaging

Our mission is to develop novel PET tracers in the field of molecular imaging that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life.

our specialties

We offer a wide
range of imaging tools

 

Life Molecular Imaging is developing a product portfolio of innovative molecular imaging tracers that address major clinical needs in neurology and cardiology.

Providing an opportunity to directly visualize and measure brain function and to depict pathophysiological processes of neurodegenerative diseases

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Neuro Imaging

Neuro Imaging

Molecular imaging also has potential diagnostic applications in cardio- and cerebro-vascular diseases.

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Cardiovascular Imaging

Cardiovascular Imaging
Neuraceq®

Knowing can help you
plan the path ahead

Our lead product Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.
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ACTIVE PRODUCTION SITES WORLD WIDE
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Major drug development trials using Neuraceq®
RESEARCH & DEVELOPMENT

Research & Development Focus Areas

Our research and development portfolio focuses on neurodegenerative and cardiovascular diagnostics, including a next-generation Tau tracer for Alzheimer’s disease and progressive supranuclear palsy.
Neuraceq<sup>®</sup> <br> Beta Amyloid Imaging
Neuraceq®
Beta Amyloid Imaging
Neurodegeneration
18F-PI-2620 <br> Tau Imaging
18F-PI-2620
Tau Imaging
Neurodegeneration
18F-DED <br> MAO-B Imaging
18F-DED
MAO-B Imaging
Neurodegeneration
18F-GP1<br>Thrombus Imaging
18F-GP1
Thrombus Imaging
Cardiovascular
Florbetaben<br>Cardiac Amyloid Imaging
Florbetaben
Cardiac Amyloid Imaging
Cardiovascular
Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, 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 protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq 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 florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq 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 Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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