Polarean Imaging (POLX ) said it has successfully completed a significantly oversubscribed placing, subscription and Open Offer and raised gross proceeds of £25m at 60p.

The London-based medical imaging technology firm announced its plans to raise up to a minimum of £20m via a placing as well as an open offer of new shares yesterday afternoon.

The group told investors on Monday that at least £17.5m of this is to come via a share placing while diagnostic imaging provider and current 7.5% owner of Polarean’s existing issued ordinary share capital, Bracco Imaging S.p.A., will subscribe for a further £2.5m.

Polaran added that it is also providing the opportunity for shareholders to subscribe for an aggregate of around 3.3 million Open Offer Shares, to raise around £2.0m, before expenses.

The proceeds of the raise, together with Polarean’s existing cash resources are expected to extend its cash runway for at least the period of 18 months following the date of admission.

The net proceeds of the placing and subscription, which are estimated to be around £23.7m, will allow the group to prepare for the commercialisation and launch of its proprietary drug-device combination that utilises hyperpolarised xenon gas in MRI lung imaging.

The Company announced back in December 2020 that it had received confirmation of acceptance of its new drug application by the US FDA for the Group's drug-device combination using hyperpolarised xenon-129 gas to enhance MRI in pulmonary medicine. 

The FDA confirmed that the review will follow the standard review time frame with a target PDUFA action date of 5 October 2021. The Company said it plans to make full use of the intervening period to prepare for commercialisation and launch of the technology.

Specifically, the proceeds will enable the company to fund sales and marketing expenses, further build its commercial team and infrastructure and support ongoing clinical trials.

The funds will also cover regulatory and medical affairs costs and support the continued investment in R&D, as well as provide further working capital and for general purposes.

"This Fundraise represents a significant development for Polarean in the capital markets,” said Richard Hullihen, CEO of Polarean. He said, “The net proceeds of the Fundraise will allow us to prepare for commercialisation and launch post approval of our proprietary drug-device combination in the United States, the largest healthcare market globally,” 

He added, “Notably, we have also been able to attract considerable levels of interest and demand from new investors in this transaction, including US based investors, which will allow us to significantly broaden our shareholder register."

The fundraising will provide the company with funds ahead of its PDUFA date with the US FDA in October 2021, the deadline by which the FDA must decide whether to officially authorise the group’s drug-device combination which uses hyperpolarised xenon-129 gas.

If approved by the US FDA, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease. The annual burden of pulmonary disease, a type of lung disease, in the US alone is estimated to be over US$150 billion.

Shares in Polarean Imaging have increased by over 40% in value since the beginning of 2020 with the shares holding well above the placing price of 60p at 66.5p in early trading.

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Reasons to POLX

The Group and its wholly owned subsidiary, Polarean, Inc. are revenue generating, medical drug-device combination companies operating in the high-resolution medical imaging market.

Polarean’s equipment enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe).

The Group utilises the hyperpolarised Xenon gas (129Xe) as an imaging agent in order to visualise ventilation and gas exchange regionally in the smallest airways of the lungs, the tissue barrier between the lung and the bloodstream and in the pulmonary vasculature. 

Polarean operates in an area of significant unmet medical need and its technology aims to provide a diagnostic approach, offering a non-invasive and radiation-free functional imaging platform which is more accurate and less harmful to the patient than current methods. 

The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.

In December 2020, Polarean confirmed that the US FDA had accepted the Group’s new drug application (NDA) for its drug device combination product using hyperpolarised xenon-129 gas.The US regulator informed the Group that the NDA will follow a “standard time frame”.

This means that the target Prescription Drug User Fee Act or PDUFA date is now 5 October 2021 - this being the deadline by which the FDA must review all new drug applications.

Hullihen told investors, "FDA acceptance for the filing of Polarean's NDA represents another important step forward for the Company's platform. If approved, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease.”

Polarean told investors that following the achievement of this latest milestone, that it plans to make ‘full use of this time with regards to commercialisation and launch preparation.’

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