Polarean Imaging prepares for commercial launch awaiting FDA approval
The medical-imaging technology company outlined that its efforts in FY21 had focused on preparation for this commercialisation, following the Company's October 2020 New Drug Application ("NDA") submission to the United States Food & Drug Administration ("FDA").
Despite a setback in October 2021 that meant the US FDA was unable to approve the NDA due to some technical or manufacturing-related issues, the company later resubmitted its application post-period end in March 2022 after addressing all the items raised by the FDA.
Polarean has established a user fee goal date of 30 September 2022 as it focuses its efforts on building our commercial organisation to support a successful launch upon FDA approval.
“Although the delay in FDA approval is disappointing, we are using this time to continue to explore potential future applications for our technology,” CEO, Richard Hullihen, outlined.
To fund these commercialisation efforts, in April 2021, Polarean completed an oversubscribed £27 million placing, subscription and open offer, thus placing it into “a strong financial position” and bringing in several new “top-tier investors” into the Polarean shareholder base, it stated.
By 31 December 2021 the Group's cash balance stood at US$28.9m, up from $6.3m in 2020 - a sum which, based on the Board’s strategic decisions, could finance the company into 2024.
The Company reported $1.18m of total revenue over the year, compared to $1.056m reported in FY20. In addition, Polarean reported $0.508m in gross profit as well as a net loss of $14m.
Research undertaken by Polarean’s medical affairs team with leaders in pulmonary disease, has acknowledged that there is “clear awareness, interest, and enthusiasm” building for the potential of hyperpolarised xenon MRI to improve the care of patients with pulmonary disease.
Polarean said its technology is also growing amongst several pharma companies that are seeking novel approaches to use quantitative, functional lung imaging in their own drugs.
The company said it has also been in close contact with reimbursement entities in the United States market, developing pathways to ensure that reimbursement for the use of Polarean's products is established, “and at a level that is acceptable to insurers and providers,” it said.
Polarean said its primary focus for FY22 is working with the FDA to obtain final approval for its drug-device combination product and continuing to plan and prepare for commercial launch.
In recent weeks, Polarean announced that it is advancing research in partnership with McMaster University in Ontario, Cincinnati Children's Medical Centre, as well as Oxford University Hospitals NHS Trust which is focusing on research in ‘long-COVID’ patients.
“We continue to identify exciting opportunities in the areas of COVID-19, cardiology and pulmonary vascular disease and these prospects should expand the use of the Company's technology in the future. Although the delay in FDA approval is disappointing, we are using this time to continue to explore potential future applications for our technology,” said Hullihen.
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Despite an unsuccessful first review cycle with the US FDA, Polarean is now back on track in regard to its commercialisation pathway for the company’s drug-device combination product.
Following a detailed discussion in the Type A meeting with the US FDA in 2021, the company confirmed upon its refiling that the issues spotted by the US regulator – which were identified as mostly “technical or manufacturing-related in nature” - had been appropriately addressed.
Polarean recently entered into a research collaboration with Oxford University Hospitals NHS Foundation Trust to study the long-term effects of patients suffering with long COVID-19.
WIth Polarean already operating in an area of significant unmet medical need, the upcoming EXPLAIN study will see the company address an area that remains largely misunderstood.
Long COVID is an umbrella term used to describe ongoing symptoms following COVID-19 infection after four weeks. Since the mechanisms driving the symptom of breathlessness remain unclear, new diagnostic modalities are crucial to advance the care of these patients.
Through novel analyses of gas-exchange images which will be conducted in the study, Polarean and OUH hope to better characterise long COVID and improve patient care.
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