Polarean Imaging (POLX) , UK-based medical imaging technology company, issued a 2024 strategy update detailing progress toward the implementation of the 5-pillar growth plan outlined in its half-year report.
Polarean said it has been visiting its initial two clinical sites - Cincinnati Children's Hospital Medical Center and University of Missouri Health Care - in order to educate pulmonologists and radiologists on the benefits of its XENOVIEW MRI technology and boost utilisation. As a result, the number of scans at the 2 sites has been steadily increasing.
POLX has also been engaging new sites to introduce its pulmonary functional MRI technology as a solution to their unmet diagnostic needs, citing obstacles around long hospital capital acquisition timelines and transitioning research to clinical sites. Still, POLX reported increased awareness of its technology across the industry in the US.
These efforts were further helped by the Centers for Medicare & Medicaid Services' issuance of a reimbursement code for XENOVIEW scans and associated rate of $1,200-1,300 in October 2023. Polarean confirmed that its initial clinical sites have attained reimbursement by both private insurers and Medicaid, and said it is working to broaden reimbursement coverage.
In order to expand its total addressable market, Polarean is working to meet FDA requirements to expand the approved patient age range for XENOVIEW from 12 to 6 years old. Additionally, POLX is trying to secure approvals of new indications for XENOVIEW to include gas exchange and cardiopulmonary applications, with an associated clinical trial expected soon.
Polarean's partners Philips and NUKEM Isotopes remain actively involved in promoting the XENOVIEW MRI technology, and POLX is actively engaging more pharma and medtech companies. NUKEM recently increased its stake in POLX to over 10%, making it the largest shareholder in the company. To help protect its IP and consolidate its market position, POLX recently secured 2 new patents in the US and Japan with over 15 applications pending.
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A good update from Polarean, detailing progress in expanding the footprint of its disruptive XENOVIEW MRI technology across the US, with strong momentum into 2024. On the financial front, POLX has followed strict cost control measures since August 2023 that have yielded a cash balance of US6.1m, extending its cash runway into October 2024.
To achieve its commercial targets, POLX said it will need further capital of at least US$10m, seeking to initiate financing options in Q2. So far, NUKEM Isotopes - the largest shareholder in POLX - has stated its intention to commit US$2.5m, and Bracco has said it would commit US$2.0 to a prospective future fundraise. Furthermore, POLX has obtained advanced assurance from HMRC to confirm £2.5m (US$3.1m) of Enterprise Investment Scheme availability.
The extra US$10m would allow POLX to expand its sales team to achieve its intended commercial traction, finalise the FDA plan for the aforementioned gas exchange trial, develop further partnerships, and fund the company until Q1 2026. Under these conditions, profitability is expected by H2 2027.
While markets may not be thrilled about the need to raise more capital, the upcoming fundraise should be seen as growing pains given the progress and milestones Polarean is expected to achieve this year. By end of 2024, POLX should have a total installed clinical base of 5-7 systems with sites performing 3-4 scans/week, enabling them to earn a positive ROI on the Polarean technology.
Furthermore, revenues between US$2m and US3m are expected this year, compared to less than US$1m in 2023. If takeup continues its current trajectory, by end of 2025 POLX's total installed clinical base should be 12-14 systems with scans performing 5-6 scans/week with revenues of US$5-6m. As mentioned, profitability is expected by 2027 provided the FDA approves the gas exchange application for XENOVIEW, which is highly likely.
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