Polarean Imaging: 30 days until big commercialisation decision from FDA
Today Polarean Imaging #POLX released its half year results for the 6 months ended 30th June 2022.
There are many points worth reading within the company's statement but there's only one investors are focusing on above all others. This is the response it is expecting from the United States Food and Drug Administration (FDA) on the 30th September, to Polarean's resubmission for their New Drug Application (NDA).
It's on this date when Polarean will learn whether it has received approval to commercially market its innovative investigational drug-device combination technology, which enables existing MRI systems to achieve an improved level of pulmonary function imaging.
It's with some trepidation that investors are looking forward to this date, as it was disappointed in early October 2021 to have received a Complete Response Letter from the FDA - rather than approval - in response to Polarean's initial NDA submission.
However, Polarean states: "The FDA processes are proceeding with question and answer and other interactions with the FDA as we approach our goal action date of 30 September 2022".
The hope is that this time round Polarean has satisfied any areas of concern the FDA threw up in its Complete Response Letter on October 6th 2021.
The Market
The market for Polarean's technology is big.
The burden of pulmonary disease in the USA is approximately US$150bn and is widespread and growing, affecting nearly 40 million Americans and 500 million worldwide, with post COVID patients comprising a new segment approaching the scale of asthma.
The Technology
Polarean's technology provides better images in a safe way to help advance the understanding of complex respiratory conditions. Given the limitations of existing methods of diagnosis and lung disease monitoring (plus some require patients to be exposed to radiation), there is a significant unmet need for safe, non-invasive, quantitative, and cost-effective image-based diagnosis technology.
Polarean (and many clinical research centres) believe that its unique medical drug-device combination offers the ideal solution for improving pulmonary disease diagnosis.
As of August 2021, there were 78 studies involving Hyperpolarized Xenon MRI listed at ClinicalTrials.gov. The company also announced in May 2022, that they have entered into a research collaboration with Oxford University Hospitals NHS Foundation Trust to study the long-term effects of COVID-19. Current technolgies are not able to detect long covid.
Cash to Commercialisation
Another positive point in Polarean's release today was its cash level. It pointed to net cash of US$22.7m as of 30 June 2022, which could finance the Company into 2024.
Valuation
At 59p, Polarean's market capitalisation is £125m but one could assume approval from the FDA could see the share price accelarate north as the potential of the company's technology is globally relevant and very scalable due to it being compatible with existing MRI systems.
Disclaimer & Declaration of Interest
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