polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company") 

Appointment of Dan Brague as consultant

Strategic counsel to the commercial team, refining XENOVIEWTM sales plan

Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces the appointment of Mr. Daniel ("Dan") Brague, currently a Non-Executive Director of Polarean, as a consultant to the Company with immediate effect.

Dan Brague will provide strategic advice to the Polarean commercial team to help refine its marketing and sales plans for the Company's drug device combination product, XENOVIEWTM (xenon Xe 129 hyperpolarised).

Dan is a highly accomplished executive leader with a background focused on enterprise growth and value creation, who joined the Board of Polarean as a Non-Executive Director in May 2022. He has spent more than 25 years in the healthcare sector with over 20 years in diagnostic imaging, and a proven track record across sales & marketing, product innovation, finance and business strategy. His most recent executive role was as CEO of Curium North America, a leading global manufacturer of radiopharmaceuticals, specifically including inhaled gas radioisotopes. 

Dan will retain his position on the Board as a Non-Executive Director and Chairman of the Remuneration Committee.

Under the terms of the consultancy contract, Polarean will pay Dan an hourly fee of US$300. This fee is capped at US$100,000 in total.

The consultancy agreement with Dan amounts to a related party transaction within the meaning of the AIM Rules for Companies (the "AIM Rules"). The Directors who are independent of the related party transaction (being all the Directors other than Mr. Dan Brague) having consulted with Stifel, the Company's nominated adviser, consider the terms of the consultancy agreement to be fair and reasonable insofar as the shareholders of the Company are concerned.

Richard Hullihen, CEO of Polarean Imaging plc said: "Dan brings significant experience in the commercialisation of innovative medical imaging products worldwide, including pulmonary diagnostics. His specific background in the US healthcare environment, reimbursement, and market development will be invaluable as we look to execute our commercialisation strategy for XENOVIEWTM."

Commenting on his appointment, Dan Brague said: "Having served on the Polarean Board since May 2022, I am a strong believer in the potential of XENOVIEWTM to meet the clinical need for a non-invasive diagnostic technology for the over 30 million Americans that suffer from a chronic lung disease. I am pleased to be able to use my experience to support the Polarean team in its commercialisation activities."

Enquiries: 

About Polarean (www.polarean.com)

The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, medical imaging technology companies operating in the high-resolution medical imaging space. Polarean aspires to revolutionize pulmonary medicine by bringing the power and safety of MRI to the respiratory healthcare community in need of new solutions to evaluate lung function, diagnose disease, characterize disease progression, and monitor response to treatment. By researching, developing, and commercializing novel imaging solutions with a non-invasive and radiation-free functional imaging platform, Polarean's vision is to help address the global unmet medical needs of more than 500 million patients worldwide suffering with chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized MRI contrast agent to be approved in the United States. On December 23, 2022, the FDA granted approval for Polarean's first drug device combination product, XENOVIEWTM (xenon Xe 129 hyperpolarized). 129Xe MRI is also currently being studied for visualization and quantification of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue membrane, and into the pulmonary bloodstream for future clinical indications.

About Xenoview

Indication

Xenoview, prepared from the xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent for use with magnetic imaging (MRI) for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older.

Limitations of Use

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

Important Safety Information

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 saturation 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 Patients: In published literature in paediatric patients aged 6 to 18 years, the following transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of paediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate were reported following hyperpolarised xenon Xe 129 administration. XENOVIEW is not approved for use in paediatric patients less than 12 years of age.

See full U.S. Prescribing Information at www.xenoview.net

XENOVIEW has received marketing approval in the United States and not in other countries.

XENOVIEWTM is a trademark of Polarean, Inc.