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Polarean Imaging Seeks FDA Approval for Expanded Use of XENOVIEW®

Story Highlights
  • Polarean Imaging submits a Phase III trial protocol to the FDA for XENOVIEW expansion.
  • The expansion aims to enhance lung function assessment, impacting pulmonary disease diagnosis.
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Polarean Imaging Seeks FDA Approval for Expanded Use of XENOVIEW®

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The latest announcement is out from Polarean Imaging ( (GB:POLX) ).

Polarean Imaging plc has submitted a new Phase III clinical trial protocol to the FDA to expand the indication of its XENOVIEW® contrast agent to include quantitative gas-exchange imaging. This expansion aims to enhance the clinical utility of XENOVIEW by enabling comprehensive lung function assessment, which could significantly impact the diagnosis and treatment of various pulmonary diseases. The FDA’s review of this protocol is expected to conclude by Q4 2025, marking a critical milestone in Polarean’s growth strategy and its mission to transform pulmonary imaging.

The most recent analyst rating on (GB:POLX) stock is a Buy with a £8.00 price target. To see the full list of analyst forecasts on Polarean Imaging stock, see the GB:POLX Stock Forecast page.

Spark’s Take on GB:POLX Stock

According to Spark, TipRanks’ AI Analyst, GB:POLX is a Neutral.

Polarean Imaging’s overall stock score is primarily impacted by its challenging financial performance and weak technical indicators. Positive corporate events provide some support, but the negative valuation and lack of earnings call guidance weigh heavily on the score.

To see Spark’s full report on GB:POLX stock, click here.

More about Polarean Imaging

Polarean Imaging plc is a revenue-generating medical imaging technology company focused on revolutionizing pulmonary medicine through MRI technology. The company specializes in the development of hyperpolarized Xenon MRI inhaled contrast agents, with its flagship product, XENOVIEW™, being FDA-approved for lung ventilation imaging. Polarean aims to address the global unmet medical needs of over 500 million patients suffering from chronic respiratory diseases by providing non-invasive and radiation-free imaging solutions.

Average Trading Volume: 2,475,820

Technical Sentiment Signal: Sell

Current Market Cap: £11.47M

Learn more about POLX stock on TipRanks’ Stock Analysis page.

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