In March, Polarean Imaging, a medical imaging technology company, raised $10.7M after seeing success with their Phase III trials in January.
Polarean said the two phase III clinical trials “validated the belief” that its technology allows doctors and surgeons to visualise aspects of lung function that have gone undetected using traditional magnetic resonances imaging (MRI) techniques.
The North Carolina-based company said the extra cash would strengthen its balance sheet while it prepares for the new drug application (NDA) for its hyperpolarised 129-Xenon gas MRI technique, which is planned for submission to the US Food & Drug Administration during the third quarter of the year.
Polarean designs and manufactures equipment for the production of hyperpolarized xenon or helium gas.
When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. By inhaling and holding a small amount of the gas for just a few seconds, the patient is able to create a much stronger MRI signal, providing doctors with multiple images of lung structure and function.
Current investigational uses include identifying early diagnoses of respiratory diseases as well as monitoring progression and therapeutic response. In addition, xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs.
Polarean said the new funds will be used to support the preparation and submission of the NDA, the initial preparation for commercial launch following submission of the NDA, and to provide additional working capital to build and sell additional polarisers.
Polarean’s Richard Hullihen said in June they’re targeting the third quarter of 2020 to submit an NDA for its drug-device combination.