US based medtech company seeks AIM IPO
26 March 2018
Polarean aims to improve pulmonary disease diagnosis with non-invasive, quantitative, image-based technology
Polarean Imaging plc, a revenue generating medical technology company with a late-stage proprietary drug-device combination for the magnetic resonance imaging (MRI) market, announces that it is seeking a listing on the AIM Market of the London Stock Exchange ("Admission").
Polarean's technology enables existing MRI systems to achieve an improved level of pulmonary (lung) function imaging to aid early diagnosis of pulmonary disease which currently affects hundreds of millions of people globally, including approximately 174 million people who suffer chronic obstructive pulmonary disease (COPD), which is responsible for 6% of all deaths worldwide each year.
The Company proposes to raise gross proceeds of £3 million by way of a conditional placing through its nominated adviser and broker, Northland Capital Partners Limited (the "Placing") and a conditional subscription (the "Subscription" and together with the Placing, the "Fundraise"). It is expected that Admission will become effective at 8am on or around 29 March 2018 and shares will trade under the AIM symbol 'POLX'. Polarean is expected to have a market capitalisation on admission of at least £11 million.
About Polarean - http://polarean.com/
The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are medical drug-device combination companies operating in the high resolution medical imaging market. The Group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe) as an imaging agent 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. Xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs.
Polarean operates in an area of significant unmet medical need and the Group's technology provides a novel 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.
The Group expects to achieve a number of key milestones following Admission. The US Food and Drug Administration (FDA) has accepted the Group's Phase III trial design for testing the Group's drug-device combination, so the most important near-term milestone will be the successful completion of the FDA Phase III clinical trial in the US. The trial is expected to commence early in the second quarter of 2018 and to last for approximately 18 months, which includes the time required to prepare the New Drug Application for submission to the FDA.
Polarean also develops and manufactures high performance MRI radiofrequency (RF) coils which are a required component for imaging 129Xe in the MRI system. The development of these coils by the Company facilitates the adoption of the Xenon technology by providing application-specific RF coils which optimise the imaging of 129Xe in MRI equipment for use as a medical diagnostic as well as a method of monitoring the efficacy of therapeutic intervention.
The net proceeds of the Fundraise, along with additional funds raised from a convertible loan note the Company had previously issued, will be used to fund:
- Preparations of FDA required documentation and the initial production run of polarisers for FDA clearance to market trials;
- FDA required clinical trials to gain clearance to market for 129Xe as a contrast agent and the polariser as a device; and
- Working capital.
Richard Hullihen, CEO of Polarean, commented: "We would like to thank our existing shareholders and our new institutional investors for providing us with the support to take the business to the next stage of its development through our admission to AIM. This is an exciting time for the Group as we believe we have established a technology that targets a huge unmet medical need to aid the diagnosis of pulmonary diseases and are well positioned to achieve the key milestones we have set out, including for the execution of our Phase III clinical trial in the US. The additional funding from the Fundraise will enable us to continue the implementation of our growth strategy and development pipeline. We look forward to providing our shareholders with further updates as we progress."
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