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More than two months after reaching a settlement with state health regulators, XingImaging LLC announced Monday it is opening a new research facility in New Haven.
XingImaging LLC, a subsidiary of Mitro, is a developer of biomarker imaging and will use 24,000 square feet on three floors at 55 Church St., for its laboratory, clinic and U.S. headquarters.
The facility will include a clinic to recruit and evaluate participants for clinical research studies, cGMP radiochemistry laboratories, 2 PET-CT and 1 SPECT-CT scanners and image analysis capabilities.
XingImaging had applied to the state Office of Health Strategy (OHS) in June 2024 for a certificate of need (CON) application to acquire its scanners, which combined cost nearly $6.8 million.
Under the settlement reached with OHS on Oct. 30, 2024, XingImaging agreed to use its scanning equipment only for research purposes. The settlement adds that “no clinical use on patients,” such as for preventing, diagnosing, treating or following-up of clinical conditions “will be permitted.”
The settlement adds that if XingImaging later were to decide to begin operating as a healthcare facility, and/or use its equipment for clinical purposes, it would be required to file a CON application with OHS for approval.
XingImaging also must maintain appropriate licenses and registrations, including from the U.S. Nuclear Regulatory Commission permitting it to possess and handle radioactive material for imaging and radiochemistry development, and from the state Department of Energy and Environmental Protection (DEEP) for radioactive material and industrial X-ray devices.
The New Haven facility will offer a range of services, including clinical trial services, advanced imaging services, imaging analysis and radiotracer manufacturing.
Founded in 2012, Mitro Biotech Co. Ltd. was the first company in China to provide pre-clinical and clinical contract research services by applying molecular imaging technologies. Mitro and XingImaging merged in Oct. 2023.
Mitro and XingImaging CEO Gilles Tamagnan said the company is proud to open the facility in New Haven, which he called a “hub for research and healthcare innovation."
"The new facility represents a significant leap forward in our mission to deliver high-quality imaging solutions and accelerate the development of life-saving treatments,” Tamagnan said.
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