Florbetaben (18F) Injection (Neuraceq®) Set to Launch at St. Teresa's Hospital in Hong Kong in March 2025
Innovative Imaging Solution to Enhance Alzheimer's Disease Diagnosis and Patient Care in the Region
BOSTON, March 14, 2025 /PRNewswire/ -- Life Molecular Imaging (LMI) and St. Teresa's Hospital are pleased to announce that Florbetaben (18F) Injection (brand name: Neuraceq®) will be available in Hong Kong from St. Teresa's Hospital by March 2025.
Neuraceq® is expected to play a significant role in the early and accurate diagnosis of Alzheimer's disease (AD) and bring greater awareness of AD in Hong Kong. This marks an important step in LMI's mission to expand global access to Neuraceq®, ensuring that more patients and healthcare providers worldwide have the tools needed for early and accurate diagnosis of AD.
Neuraceq® is an FDA-approved radioactive diagnostic agent for the detection of amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful diagnostic tool for the appropriate characterization of patients assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases.
Neuraceq® will facilitate the management of patients suffering from AD, including those interested in novel disease-modifying monoclonal antibody treatments recently introduced at St. Teresa's Hospital. With the availability of Neuraceq®, St. Teresa's Hospital now provides comprehensive care for AD patients from state-of-the-art diagnosis to targeted anti-amyloid therapy.
"LMI remains dedicated to expanding global access to Neuraceq®. We are pleased to partner with St. Teresa's Hospital in Hong Kong to enhance the diagnosis of patients undergoing evaluation for mild cognitive impairment (MCI) and Alzheimer's disease, while ensuring Neuraceq® remains easily accessible to physicians in the region," said Ludger Dinkelborg, Ph.D., Managing Director at LMI.
About Neuraceq (florbetaben 18F) - US Package Insert
Indication
Neuraceq® is a radioactive diagnostic agent 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 of Use
- A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
- Safety and effectiveness of Neuraceq have not been established for:
- Predicting development of dementia or other neurologic conditions
- Monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. 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.
Common Adverse Reactions
The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%).
For more information please visit: neuraceq.com
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global people-centred, diversified healthcare organisation listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercialising innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/ | https://life-mi.com/
About St. Teresa's Hospital
St. Teresa's Hospital (STH), established in 1940 by the Congregation of the Sisters of St. Paul de Chartres, is a Catholic institution dedicated to providing competent and quality healthcare services to the sick and needy through the Christian spirit of Faith, Hope, and Love. With over 85 years of continuous development and unwavering dedication, STH has grown into one of Hong Kong's most respected and well-established private hospitals. The hospital currently offers approximately 1,000 beds, staffed by over 50 resident medical officers, offering extensive general and specialist outpatient and inpatient care services. STH is equipped with state-of-the-art healthcare facilities designed to meet the highest medical standards. A notable feature of the hospital is the Cyclotron Pharmaceutical Centre, which supports its Scanning Department in offering advanced PET scan services for accurate imaging diagnoses. This capability enhances diagnostic precision and ensures comprehensive care for patients. To address the evolving needs of the community, STH remains steadfast in its commitment to continuous improvement and the delivery of high-quality medical services. These commitments guide the hospital to provide not only advanced medical treatment but also a compassionate and holistic approach to healthcare.
For more information, please visit https://www.sth.org.hk | https://www.sthscan.com/hk/
For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]
SOURCE Life Molecular Imaging
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