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Polarean celebrates a landmark year

09:36, 28th June 2024
John Hughman
Vox Newswire
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Results from medical imaging specialised Polarean (POLX)Follow | POLX highlighted a year of substantial progress that saw a major strategic shift under the leadership of newly arrived chief executive Christopher von Jako following the retirement of Richard Hullihen in xx. 

Polarean Imaging has made significant commercial strides in advancing its XENOVIEW™ (Xenon Xe 129 hyperpolarised) technology, notably the receipt of a new reimbursement C-code from CMS, with a payment range of $1,201 to $1,300, enhancing the technology's economic viability for hospitals. The company received its first de novo polariser order from a prestigious academic medical centre in the northeastern U.S. and secured an order for a Xenon gas blend cylinder from Cincinnati Children's Hospital Medical Center, enabling the first clinical scan using this technology in the U.S. 

Additionally, the University of Missouri Health Care upgraded its polariser system to a clinical configuration, further demonstrating the technology's growing adoption. A strategic collaboration with Philips to advance hyperpolarised Xenon MRI adds further commercial potential, while the submission of a post-marketing commitment plan to the FDA could lower the minimum age for XENOVIEW MRI from twelve to six years and further expand the market.

The FDA has already granted XENOVIEW a New Chemical Entity designation, providing a five-year market exclusivity period, and issued 510(k) clearance for a specialised MRI chest coil compatible with Philips 3.0T MRI scanners. 

Polarean held a formal Type B meeting with the FDA to discuss expanding XENOVIEW indications to include gas exchange and microvascular haemodynamics for pulmonary and cardio-pulmonary diseases. Furthermore, the company partnered with VIDA Diagnostics to accelerate the clinical and research use of its Xenon 129 MRI platform.

The company narrowed its pre-tax loss from $13.9m in 2022 to $11.9m in the year to December 2023 and ended the year with net cash of $6.2m. However. it successfully completed a $12.6m fundraising after the period end through existing strategic partners NUKEM Isotopes and Bracco Imaging, highlighting continued support for Polarean’s industry leading technology. That extends the company’s cash runway until at least Q1 2026.

CEO Christopher von Jako commented: “The fundraise will enable us to substantially progress implementation of our five-pillar growth strategy in pursuit of its mission to revolutionise pulmonary medicine.”

Since the period end the company has hit further milestones, receiving its first de novo XENOVIEW (Xenon Xe 129 hyperpolarised) polariser order from the University of Alabama at Birmingham, the grant of a U.S. patent for dynamic cardiopulmonary blood flow imaging using Xenon MRI, and the receipt of an order from Cincinnati Children's Hospital Medical Center for a new polariser to enhance its research system.

 

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Polarean Imaging's five-pillar strategy focuses on driving utilization, expanding the user base, securing reimbursement coverage, broadening the market, and fostering key partnerships, and is already delivering noteworthy results. 

Revenues of US$2-3m are expected this year, compared to less than US$1m in 2023. If take up continues its current trajectory, by end of 2025 Polarean’s total installed clinical base should be 12-14 systems with scans performing 5-6 scans/week and revenues of US$5-6m. Profitability would then be expected by 2027 provided the FDA approves the gas exchange application for XENOVIEW, which is highly likely.

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