CMI Inc. and Life Molecular Imaging Announce Reimbursement of Neuraceq® Diagnostic Amyloid-PET Test (florbetaben 18F) in Japan

First amyloid PET diagnostic tool reimbursed in Japan

TOKYO And BERLIN, November 22, 2023 /PRNewswire/ — CMI Inc. and Life Molecular Imaging (LMI) are pleased to announce that Neuraceq Amyloid PET Diagnostic® (florbetaben 18F injection) has been approved by the Ministry of Health, Labor and Welfare for reimbursement by government health insurance. With this C2 route approval, Neuraceq®-PET is the first amyloid PET diagnostic tool currently reimbursed in Japan. Neuraceq® is available in Japan of the approved medical device 放射性医薬品自動合成装置Synthera+ (PMDA Medical Device License No. 30100BZX0016900) and is currently accessible at Keio University Hospital, TokyoKoseikai Takeda Hospital, Kyoto and Uozumi Clinic, Kumamoto. CMI Inc. plans to create Neuraceq® production on other hospital radiopharmacy sites.

With reimbursement for this diagnostic tool, Japanese doctors can use this cutting-edge imaging technology to accurately assess their patients with cognitive decline. Amyloid plaque density can be assessed to improve earlier diagnosis and to further guide patient treatment and management.

Following the recent approval of Eisai’s Alzheimer’s disease (AD)-modifying drug LEQEMBI® In Japan, an accurate and reliable diagnosis of AD is essential to access this new therapy. Amyloid PET, also including Neuraceq®, has played a central role in the recent positive results of clinical studies of new anti-amyloid drugs by making possible the selective inclusion of patients with confirmed amyloid pathology in the brain in the trials. Additionally, amyloid clearance was accurately measured with amyloid PET.

“Obtain reimbursement for amyloid PET thanks to Neuraceq® In Japan is an important step. We are pleased that our amyloid PET tracer, a very important and reliable diagnostic imaging agent, is now available to more Japanese patients,” said Dr Ludger Dinkelborg, Managing Director of Life Molecular Imaging.

“LMI Committed to Expanding Neuraceq’s Global Market Access®. We will continue to work with our partner CMI in Japan to improve the diagnosis of patients evaluated for mild cognitive impairment (MCI) and Alzheimer’s disease, and to develop Neuraceq® accessible to a greater number of referring doctors across the country,” said Colleen RubyCOO, Americas and APAC at Life Molecular Imaging.

“CMI works intensively for PET installations in Japan and we encourage them to administer PET-amyloid using Neuraceq® to patients with possible Alzheimer’s disease so that they can have the opportunity to access advanced therapeutic drugs,” said Yasuhisa FujibayashiChief Technology Officer, CMI Inc.

For more information in Japanese, please read the CMI press release:
https://www.cmi-jpn.co.jp/wp-content/uploads/20231122PR.pdf

About Neuraceq Synthera+ automated synthesizer® (florbetaben 18F)

Indication approved in the Japan

Neuraceq® is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging of the brain to estimate the density of β-amyloid neuritic plaques in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease. Alzheimer’s (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates few or no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative test 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 showed that this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurological disorders as well as in older adults with normal cognition. Neuraceq is a complement to other diagnostic assessments.

Usage Limits

  • A positive Neuraceq® the analysis does not establish the diagnosis of AD or any other cognitive disorder.
  • Safety and effectiveness of Neuraceq® have not been established to (i) predict the development of dementia or other neurological disorders, or (ii) monitor responses to therapies.

Important Safety Information (as approved in Japan)

Risk of image interpretation and other errors
Errors may occur in the Neuraceq estimate of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. Errors can also occur in cases of severe brain atrophy that limits the ability to distinguish gray matter from white matter on the Neuraceq scanner. Errors can also occur due to motion artifacts leading to image distortion. The results of the Neuraceq analysis indicate the presence of cerebral senile β-amyloid plaques only at the time of image acquisition and a negative analysis result does not exclude the development of cerebral senile β-amyloid plaques at the time of image acquisition. ‘future.

Radiation risk
Neuraceq, like other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Cumulative long-term radiation exposure is associated with increased cancer risk. Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure.

Common side effects
The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. Adverse reactions occurring with a frequency greater than 1% include injection/application site erythema, injection site irritation, and injection site pain.

For more information, please visit: https://neuraceq.com

About molecular imaging of life (IMT)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was established in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Life Healthcare Group. By developing new PET tracers for molecular imaging, LMI is focusing on a key area of ​​modern medicine. The organization strives to be a leader in the field of molecular imaging by developing innovative products that improve the early detection and characterization of chronic and life-threatening diseases, thereby leading to improved therapeutic outcomes and better quality of life. Please visit https://life-mi.com.

About CMI inc.
CMI Inc imports and sells the highest quality products such as cyclotron system, PET automatic drug synthesizer, automatic dispensing system, etc. CMI also supports the planning, development and operation of clinical and research facilities for positron emission tomography (PET) and contributes to the progress and expansion of Japan’s medical field. Learn more about https://www.cmi-jpn.co.jp

About Life Healthcare Group
Life Healthcare is a diversified, people-focused global healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years of experience in the private healthcare sector in South Africa and currently operates 64 healthcare facilities across Southern Africa. Africa. Services include acute hospital care, acute physical rehabilitation services, acute mental health care, kidney dialysis services, oncology, imaging and occupational health and wellness services. The Group also owns Life Molecular Imaging, a molecular imaging R&D business of innovative PET tracers aimed at reducing the burden of disease through improved early detection. Learn more about https://www.lifehealthcare.co.za/

For media queries
Brittany Hahn | Marketing Communications Manager | Molecular imaging of life
Tel: +1.484.735.2840 |

SOURCE Molecular Imaging of Life


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