As cardiopulmonary drug development increasingly demands earlier signals, better patient stratification, and more mechanism-aligned endpoints, advanced imaging is emerging as a critical enabler of precision clinical trials. Polarean’s Xenon MRI platform is opening a new window into the pulmonary microvasculature, long considered a “silent zone” in cardiopulmonary disease and reshaping how pharma sponsors evaluate therapeutic response. In this interview with MedTech Spectrum, Alexis Opp, Senior Manager, Product Marketing & Market Access at Polarean, discusses how Xenon MRI is positioning itself as a differentiated imaging biomarker platform for cardiopulmonary trials, the operational realities of scaling across multi-centre studies, and the implications for reducing development risk and cost.
What strategic opportunity does cardiopulmonary drug development represent for Polarean, and how does this study position Xenon MRI as a differentiated platform in pharma-sponsored clinical trials?
Cardiopulmonary drug development represents a natural and strategic extension of Polarean’s Xenon MRI platform. Many cardiopulmonary diseases are defined by regional, functional abnormalities of the microvasculature in the lung that are poorly captured by conventional tools such as spirometry (which is a blunt tool to gauge obstructive or restrictive disease, but doesn’t measure pulmonary vascular disease), CT (which measures larger vessels structure and blood volume), or echocardiography (which measures the heart). As a result, drug development in this space has historically faced challenges with patient selection, endpoint sensitivity, and early signal detection.
This multi-center PH-ILD study positions Xenon MRI as a unique imaging platform that can directly interrogate pulmonary gas exchange and hemodynamics at the capillary level. By providing quantitative, regional biomarkers that align closely with disease biology and therapeutic mechanism of action, Xenon MRI offers pharma sponsors a way to generate earlier and more informative readouts in clinical trials. That capability is increasingly valuable as sponsors look to de-risk programs earlier and make more confident go/no-go decisions.
Xenon MRI enables direct measurement of pulmonary capillary function, a historically “silent zone.” How significant is this capability for accelerating drug development timelines and improving trial decision-making?
The ability to directly measure pulmonary capillary function is highly significant. The pulmonary microvasculature has traditionally been a “silent zone” because it is difficult to assess noninvasively and regionally. Yet it is often central to disease progression and therapeutic response in conditions like PH-ILD. Right heart catheterization is invasive and is placed in the heart and very large upper branch of the pulmonary artery to calculate pressures. Conversely at the very smallest terminal branches of the cardio-pulmonary circuit, Xenon MRI, because it is an inhaled gas, can visualize gas transfer from alveoli into red blood cells, and can measure changes in capillary blood volume (which can be driven by reduced compliance [stiffness] of these vessels in caused by interstitial thickening. Xenon MRI provides mechanism-aligned biomarkers that can detect physiologic changes earlier than symptomatic changes in global measures of exercise capacity or respiratory function. This has the potential to shorten development timelines by enabling earlier proof-of-mechanism, reducing reliance on late-stage endpoints, and supporting smaller sample sizes in pilot proof-of-principle trials. For sponsors, that translates into faster learning cycles and better-informed development decisions.
From a commercial perspective, how do you see pharma adoption of imaging-derived biomarkers reshaping the role of advanced imaging in cardiopulmonary clinical development?
We are seeing a broader shift toward imaging-derived biomarkers as integral components of clinical development because they offer precision in a non-invasive way. In cardiopulmonary disease especially, advanced imaging can bridge the gap in pulmonary vascular disease between molecular mechanism and patient-level outcomes by providing spatially resolved, quantitative physiologic data.
As pharma adoption grows, advanced imaging will increasingly function as an advanced tool to support patient stratification, enrichment for success and a sensitive endpoint of treatment effect. Unlike CT, Xenon MRI can be used more frequently (hourly, daily, or monthly depending on the trial design) for acute pharmacodynamics or for longitudinal monitoring without concerns of radiation exposure to the patients. Platforms like Xenon MRI, which are noninvasive, radiation-free, and repeatable, are particularly well suited to this role and align with pharma’s push toward precision medicine and data-rich trial designs.
What operational and technical challenges were addressed to scale Xenon MRI across a multi-center U.S. study, and how does your partnership with VIDA Diagnostics strengthen execution?
Scaling Xenon MRI across multiple sites requires careful coordination across hardware, software, workflow, and training to ensure data consistency and reproducibility. This includes standardizing acquisition protocols, implementing centralized quality control, and consistent data processing.
Our partnership with VIDA Diagnostics is a key enabler of execution. VIDA brings deep expertise in quantitative imaging analytics, centralized image processing, and multi-center trial support. Together, we provide an end-to-end solution that allows sponsors to deploy Xenon MRI confidently across sites, with high-quality, analyzable data that meets the rigor expected in pharma-sponsored trials.
How does this platform support more precise patient stratification and endpoint sensitivity, and what implications does this have for reducing trial risk and development costs for pharma partners?
Xenon MRI has already shown that it can detect disease progression in ILD not visible by CT. Similarly in obstructive diseases, like asthma, cystic fibrosis, and COPD, Xenon MRI by reaching the “silent zone” of small airway disease, consistently outperforms spirometry in its sensitivity to predict mild/early disease, exacerbations, and hospitalizations. It is logical to extend this in cardiopulmonary disease, given that surrounding the airway “silent zone” is a pulmonary-vascular “silent zone” as well that Xenon reaches and can uniquely probe. In diseases like PH-ILD, this enables identification of patients whose pathology is driven by pulmonary vascular dysfunction versus parenchymal or left-heart contributions—an important distinction for therapeutic targeting.
In terms of endpoints, Xenon MRI biomarkers offer greater sensitivity to regional change, which can reduce variability and improve signal detection. For pharma partners, this can mean smaller sample sizes, fewer inconclusive trials, and reduced exposure to late-stage failure—ultimately lowering development risk and cost.
Looking ahead, how do you envision Xenon MRI evolving as a core infrastructure tool for cardiopulmonary precision medicine and future regulatory acceptance of imaging biomarkers?
We see Xenon MRI evolving into a foundational functional imaging platform for cardiopulmonary precision medicine—one that complements molecular and clinical data by providing spatially resolved physiologic insight. Given the amount of inhaled therapeutics that are being developed by pharma, having an inhaled signaling agent following the same route as the drug is delivered, it provides a unique tool to assess the actual effects that the inhaled therapeutic is having. In this new study, the ability of Xenon MRI to measure inhalation at the precise site of action with in minutes, will provide novel insights into systemic vs. inhaled drug delivery. As evidence continues to accumulate across disease areas and use cases, we expect growing alignment with regulatory expectations around validation, standardization, and clinical relevance of imaging biomarkers.
Over time, this positions Xenon MRI not only as a powerful research tool, but as a future component of clinical diagnostic infrastructure in cardiopulmonary disease, supporting clinical decision-making, payer discussions, and ultimately routine clinical care. Our focus is on building the evidence, partnerships, and operational maturity in the research space needed to support that trajectory.
