Polarean Imaging plc.

The Company and its wholly owned subsidiary, Polarean, Inc. (together the “Group”) are revenue-generating, investigational drug-device combination companies operating in the high-resolution medical imaging research space. The Group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specializes in the use of hyperpolarized xenon gas (129Xe) as an imaging agent to visualize ventilation. 129Xe gas is currently being studied for visualization of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue barrier, and into the pulmonary bloodstream. In October 2020, the Group submitted a New Drug Application (“NDA”) to the FDA for hyperpolarized 129Xe used to evaluate pulmonary function and to visualize the lung using MRI. The Group received a complete response letter on 5 October 2021.