CMI Inc. and Life Molecular Imaging (LMI) are pleased to announce that the amyloid-PET diagnostic  Neuraceq^® (florbetaben ¹⁸F injection) has been approved from the Ministry of Health, Labor, and Welfare to be reimbursed by governmental health insurance. With this C2 path approval, Neuraceq^®-PET is the first amyloid PET diagnostic tool currently reimbursed in Japan. Neuraceq® is available in Japan from 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, Tokyo, Koseikai Takeda Hospital, Kyoto and Uozumi Clinic, Kumamoto. CMI Inc. plans to set up Neuraceq^® production at further hospital radiopharmacy sites.

With the reimbursement of this diagnostic tool, Japanese physicians can use this state-of-the-art imaging technology to accurately evaluate their patients with cognitive decline. The density of amyloid plaques can be assessed to improve an earlier diagnosis, and to further guide therapy and patient management.

After the recent approval of Eisai's Alzheimer's disease (AD) modifying drug LEQEMBI^® in Japan, an accurate and reliable diagnosis of AD is critical to access this new therapy. Amyloid PET, including also Neuraceq^®, had a pivotal role in the recent positive clinical study outcomes of new anti-amyloid drugs by making selective inclusion of patients with confirmed amyloid pathology in the brain in the trials feasible. Moreover, amyloid clearance was precisely measured with amyloid PET.

"Achieving reimbursement for amyloid PET using Neuraceq^® in Japan is an important milestone. We are pleased that our amyloid PET tracer, a very important and reliable diagnostic imaging agent, is now available for more Japanese patients," said Dr. Ludger Dinkelborg, Managing Director of Life Molecular Imaging.

"LMI is committed to expanding global market access of Neuraceq^®. We will continue to work with our partner CMI in Japan to improve the diagnosis of patients being evaluated for mild cognitive impairment (MCI) and Alzheimer's disease, and to making Neuraceq^® available to more referring physicians across the country," said Colleen Ruby, Chief Operating Officer, Americas and APAC at Life Molecular Imaging.

"CMI is intensively working for PET facilities in Japan and we are encouraging them to deliver amyloid-PET using Neuraceq^® to patients with possible Alzheimer's disease so that they may have an opportunity to reach advanced therapeutic drugs," said Yasuhisa Fujibayashi, Chief Technology Officer, CMI Inc.