Polarean delivers key milestones in H1, extends cash runway to Q2 2024
Polarean () , a UK-based medical imaging technology company, issued an interim update for the 6 months ended 30 June 2023.
Polarean secured its first order for a xenon gas blend cylinder for the production of its novel XENOVIEW (xenon Xe 129 hyperpolarised) product from Cincinnati Children's Hospital Medical Center. The company also entered a collaboration with Philips to advance the field of hyperpolarised Xenon MRI.
XENOVIEW is Polarean's proprietary technology that enables visualisation of lung ventilation without exposing patients to ionising radiation and 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.
During the period, Polarean submitted a commitment plan to the US FDA to seek approval prior to 30 June 2024 to expand the minimum current age of XENOVIEW MRI in children from 12 to 6 years. The FDA has so far granted "New Chemical Entity" designation for XENOVIEW with a 5-year market exclusivity period.
Post-period, Polarean upgraded the University of Missouri Health Care polariser system to a clinical configuration accompanied by the sale of an initial xenon gas blend cylinder for the production of XENOVIEW.
Net cash at 30 June 2023 was US$9.9m, enough to keep Polarean funded until end of Q2 2024.
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Several significant milestones for Polarean in H1 as the company's disruptive imaging technology begins to gain momentum. Polarean received FDA approval in December 2022, enabling it to start selling its products to the US clinical market.
While early takeup has been slower than expected, the company's efficient cash management should keep it funded through to early commercialisation. In our view, XENOVIEW has the potential to revolutionise diagnosis and monitoring in the fields of pulmonary and cardio-pulmonary medicine. However, as it withdraw its early commercial targets, investors sold on today's report.
There is good reason to believe in XENOVIEW's long-term success, however. The recent approval of a new C-code from US Medicare, corresponding to a payment range of US$1,201 to US$1,300, represents a significant achievement by the company, establishing a solid foundation for reimbursement endeavors within its targeted fields. Commercial efforts have just begun as Polarean's focus in H1 was on preparing legacy research sites for conversion to clinical scanning and obtaining required state drug licenses.
Polarean's near-term roadmap is based on 5 growth initiatives: Driving utilisation at newly established clinical sites, expanding to highest priority targeted clinical sites, developing key industry partnerships, establishing reimbursement coverage and payment, and expanding current FDA indication to include higher-value lung and pulmonary vascular diseases. The company's new CEO is optimistic about meeting these goals, setting up the company for a potential value inflation point in the near term.
Polarean's ongoing cost reduction measures should keep it funded until Q2 2024 when its expansion and utilisation initiatives should begin to pay off on the back of existing operational and permitting progress.
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