polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

Company Update

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced magnetic resonance imaging ("MRI") of the lungs, announces that it has received its first de novo order for a new XENOVIEW? polariser, and provides a comprehensive update against the five growth initiatives set out at its interim results.

First de novo order and system sales to high priority institutions

The Company has received its first de novo polariser order from a top-tier U.S. academic medical centre located in the northeast. Polarean continues to have positive meetings and is in active negotiations with additional top-tier academic medical centres. Though there is never certainty as to the timing or outcome from such negotiations, nor as to the speed of utilisation, management is optimistic that these negotiations will lead to the XENOVIEW MRI technology being more widely available in medical centres throughout the United States.

Driving utilisation at newly established clinical sites

Both the University of Cincinnati Children's Hospital Medical Center and the University of Missouri Health Care ("MU Health Care") continue their efforts to increase clinical utilisation of their polariser systems in patients with chronic lung disease. Both centres have undertaken multiple clinical scans and Polarean continues to work closely with these sites to ensure increased and consistent utilisation. As with any new technology introduction, radiology departments move carefully through the initial clinical scans to ensure that the entire process comprising ordering, scheduling, acquisition, image processing/reporting and billing runs efficiently and integrates smoothly into their clinical pathways, before promoting systemwide availability.

MU Health Care recently published an article and video detailing its first clinical scan, to increase awareness of the XENOVIEW MRI technology for its patient population.

In addition, Polarean is working closely with several medical centres and their clinicians who are anticipated to be coming online in 2024 to ensure a smooth integration of XENOVIEW MRI into their infrastructure including their clinical and reimbursement operations as they embark on establishing a successful novel advanced imaging programme.

Establishing reimbursement coverage and payment

The new reimbursement APC-code (C9791) issued by the US Centers for Medicare & Medicaid Services ("CMS") in August 2023 for the XENOVIEW MRI technology corresponds to a payment range of between US$1,201 to US$1,300.

The new code, along with additional existing codes for the XENOVIEW MRI process, enables the hospitals to request a total reimbursement of approximately $2,500, representing a significantly improved economic incentive for the hospital. All seven United States Medicare Administrative Contractors (MACs), who are responsible for processing Medicare claims, are covering the code as of 1 October 2023 based on medical necessity.

Building on the new code from CMS, work is beginning at Polarean's clinical sites to further expand the reimbursement for private U.S. health insurers to enable further utilisation of XENOVIEW.

Developing key industry partnerships

The Company's collaboration with Philips continues to progress. Polarean held a training session on the Company's technology in October 2023 for the Philips US MRI sales force. Philips continues to work with Polarean to introduce XENOVIEW MRI to its customer base.

Polarean has signed contracts to sponsor a new clinical trial in patients with COPD (chronic obstructive pulmonary disease) in collaboration with a leading nebuliser device manufacturer. The pilot study will explore the use of XENOVIEW MRI as the primary outcome measure in the evaluation of different aerosol drug delivery technologies of albuterol, a bronchodilator. Investigators at the University of Virginia Health will be assessing differences in lung ventilation, including quantification of hyperpolarised xenon distribution pre- and post-bronchodilation, utilising the proprietary Polarean XENOVIEW VDP software. The pilot study will initially comprise of six patients; if this generates the expected results, it could lead to a larger trial that would be similarly cost-shared between Polarean and the industry partner. Patient enrolment is expected to begin in early 2024.

The Company recently attended the Radiological Society of North America ("RSNA") Annual Meeting in Chicago, IL, from 26-30 November, where management held several key meetings with both existing and potential customers, suppliers, and strategic partners. Several presentations were made at the RSNA Annual Meeting on the use of Xenon MRI. Dr Cody Thornburg from MU Health Care presented their early experience in using the XENOVIEW MRI technology; the presentation included the discussion of their first clinical case where a patient was admitted into the hospital with exacerbation due to cystic fibrosis. XENOVIEW MRI uncovered surprising ventilation defects that were not detected in the patient's chest radiographs, which prompted a specific change in management for the patient.

Expansion of current FDA labelling

The Company continues to make excellent progress on its post-marketing requirement plan to seek US FDA approval to expand the minimum current age of XENOVIEW MRI in children from twelve down to six years old.

The Company had a productive discussion with the FDA in its formal Type B meeting held in October, which provided additional guidance on the path to expand the XENOVIEW indication to include regional visualisation and quantitative assessment of gas exchange and microvascular haemodynamics for both pulmonary and cardio-pulmonary diseases. Management plans for the clinical trial to begin in late-2024, with approval possible by the beginning of 2027.

Financing

The Company's current cash runway is expected to last into Q3-2024. Management is continuing to evaluate all options for further financing and will update the market further when appropriate to do so.

Christopher von Jako, Ph.D., CEO of Polarean, said: "We are delighted to have received our first de novo polariser order from a top-tier academic medical centre, and we look forward to working closely with them to establish the use of XENOVIEW for their patients living with lung disease. As previously stated, establishing orders for new imaging technologies often takes time, even when clinicians are highly motivated to adopt the technology. We continue to have positive meetings with other high priority centres as they work through their budget cycle and value analysis processes, as well our already converted centres and those we expect to convert in 2024, to encourage increased utilisation of the technology in clinic.

"We have made strong progress in all other areas of the growth initiatives established at the interim results, and I believe that we are setting the correct foundations to enable the XENOVIEW technology to be a commercial success. While we are assessing various financing options, I am confident that we will be able to finance the Company for the medium term, and would like to extend my thanks to our strategic investors for their continued strong support."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018.

Enquiries:

About Polarean (www.polarean.com)

The Company and its wholly-owned U.S. subsidiary, Polarean, Inc. are revenue-generating, medical imaging technology companies. The Company aspires to revolutionise pulmonary medicine by bringing the power and safety of MRI to the respiratory healthcare community which is desperately in need of new modern solutions to evaluate lung function. Polarean is dedicated to researching, developing, and commercialising these novel imaging solutions with their non-invasive and radiation-free functional MRI platform. The Company strives to address the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarisation science and has successfully developed the first and only hyperpolarised Xenon MRI contrast agent (XENOVIEW?) to be FDA-approved in the United States. The Company also commercialises the systems, software, and accessories to support fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit www.polarean.com.

XENOVIEW IMPORTANT SAFETY INFORMATION

Indication

XENOVIEW?, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

Limitations of Use

XENOVIEW has not been evaluated for use with lung perfusion imaging.

CONTRAINDICATIONS

None.

Warnings and Precautions

Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold.

Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated.

Adverse Reactions

Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.

Please see full prescribing information at www.xenoview.net

PLC-RNS-2325