Getting new treatments approved by medicines regulators can be an arduous progress that takes many years with no guarantee of success. But the pain can be worth it, as Polarean Imaging (POLX) has demonstrated this year.
It’s 2022 numbers were hit by the delayed approval of its XenoView technology, relating to information related to the manufacturing practices at the partner's facility. But it ended the year with a higher-than-expected $16.5m in the bank and, having received clearance from the US Food and Drug Administration on the eve of Christmas, is now fully focused on commercialising the ground-breaking lung-imaging technology.
XenoView is a hyperpolarised contrast agent for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adult and paediatric patients aged 12 years and above. It enables visualisation of lung ventilation without exposing patients to ionising radiation and its associated risks. The Polarean HPX Hyperpolarisation System creates a dose of XenoView that is administered in a single 10 to 15 second breath hold MRI procedure.
Last week, the company revealed the first successful use of the newly approved technology, with a 19-year-old male with cystic fibrosis the first patient to be scanned at the Cincinnati Children's Hospital Medical Center in the US. Cincinnati expects to conduct more scans imminently, while Polarean plans to sell 15 to 20 polariser systems and 75 to 100 cylinders of XenoView by the end of 2024.
To help drive sales, Polarean is employing several approaches, including reimbursement codes that would enable hospitals to be reimbursed for using XenoView and related procedures, improving hospitals’ return on investment, and also partnering.
It aims to collaborate with the pharmaceutical industry to reduce the size, time, and costs of pulmonary drug clinical trials by providing image-based data. It also sees opportunities to partner with MRI manufacturers and pulmonary disease organizations to expand the use of XenoView in diagnosis and treatment.
Looking ahead, the company believes that ongoing clinical trials and investigations in areas such as long COVID and cardiopulmonary vascular disease could expand the market for their technology. Chronic lung diseases, such as emphysema, chronic bronchitis, and asthma affect more than 30 million people in the US alone. Apart from the considerable impact on human health, these pulmonary conditions also impose a significant economic burden, surpassing $150 billion annually in the US.
Brokers expect sales to climb from £1m in 2022 to £3m next year and £8m in 2024.