XingImaging is committed to the production of radiotracers to support clinical trials in China. XingImaging's PET capabilities will help enable AD patients in China to access and participate in clinical trials testing novel AD investigational therapeutics.
XingImaging, LLC is a clinical PET imaging service company anchored in China and specializing in Radiotracer Production through Positron Emission Tomography (PET) acquisition to evaluate, and support development of treatments for neurodegenerative disorders including Alzheimer and Parkinson disease, Oncology and other disease pathologies. XingImaging believes that quality is an integral part of the PET radiopharmaceutical process and essential to good business practices. Since it is not possible to analyze every chemical, biochemical or physical entity in the radiopharmaceutical process, quality assurance measures are strategically applied to ensure that the final product is fit for its intended purpose.
XingImaging is unique in that it has established a network of radiopharmaceutical tracer production, and imaging centers for PET acquisition and image analysis utilizing the most advanced neuroimaging tracer compounds available to be used in China and Asia. Supported by experienced, well-established study teams in China, Europe and the US, XingImaging provides the capability for PET radiotracer production and PET acquisition. These services support multi-center trials in China and Asia which require PET for study eligibility, disease evaluation, and treatment efficacy.
PET production facilities in the XingImaging Network are located at Class-4 Hospitals in China and XingImaging is currently expanding to other regions in Asia. Class-4 hospitals are hospitals certified by the Nation Medical Products Administration (NMPA), formerly known as CFDA, to manufacture and use novel PET tracers in clinical imaging studies (likened to the US FDA Radioactive Drug Research Committee). For hospitals with this status, injection and PET imaging must occur within the same facility/site as the radiotracer production; distribution of the PET tracer to other facilities including other Class-4 hospitals is not allowed.
XingImaging LLC, a research company (the “Applicant”), is filing a Certificate of Need application pursuant to Section 19a-638 of the Connecticut General Statutes for the acquisition of (1) a Siemens PET/CT (2) a United Imaging PET/CT, and (3) a Siemens SPECT/CT (collectively, the “Imaging Equipment”). The Imaging Equipment will be located at 55 Church Street, New Haven, CT 06510 and will be used exclusively for research purposes. The Imaging Equipment will not be used for the provision of any medical services. The total capital expenditure in connection with this project will be approximately $6,700,000.
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