Studies Presented for Profusa's Lumee Oxygen Platform in PAD Patients
January 29, 2019—Profusa announced that clinical data from two studies evaluating the company's Lumee oxygen platform were presented at LINC, the Leipzig Interventional Course held January 22–25 in Leipzig, Germany. The company stated that the data indicate that the Lumee platform measures tissue oxygen level changes in both healthy volunteers and patients with critical limb ischemia (CLI).
The Lumee oxygen platform features a tiny, injectable tissue-integrated biosensor and an intelligent data platform intended for continuous, real-time monitoring of tissue oxygen levels. The device received European CE Mark approval in October 2016 for continuous monitoring of tissue oxygen. In the United States, it is an investigational device limited by federal law to investigational use.
Peter Schneider, MD, presented findings from a healthy volunteer feasibility study, which evaluated the performance of the Lumee oxygen platform in vivo to monitor changes in interstitial tissue oxygen compared to transcutaneous oximetry (TcPO2), demonstrating that the Lumee platform detected changes in tissue oxygen levels.
In the study, the Lumee biosensor was injected in the forearm of seven healthy volunteers. Investigators then performed vascular occlusion tests on the arms of enrolled volunteers and recorded simultaneous measurements of oxygen using both the Lumee platform and TcPO2. Repeated tests were performed 1 to 10 weeks after biosensor injection.
The investigators found that there was a high correlation between the results of the Lumee platform and TcPO2, with both technologies showing a statistically significant decrease in oxygen levels during occlusion by pressure cuff (P < .001 for each device). Additionally, the Lumee platform detected faster rates of oxygen changes during both the occlusion and recovery phases (P < .001, Wilcoxon signed-rank test) and detected reactive hyperemia in a higher percentage of tests (38% vs 4% occlusion tests).
In the company's press release, Dr. Schneider commented, "Measurements of regional tissue oxygen serve as a proxy to monitor local perfusion and have the potential to guide crucial therapeutic decisions in multiple clinical disciplines for peripheral artery disease, or PAD, and wound management, that are now made on the basis of clinical judgment and experience alone without guidance. These findings presented at LINC show promise that the Lumee oxygen platform can become a valuable tool for clinicians when they need to assess perfusion."
Marianne Brodmann, MD, presented an interim subset analysis from the first 30 patients enrolled in the OMNIA study of oxygen monitoring near ischemic areas. The ongoing multicenter trial is evaluating use cases of the Lumee oxygen platform.
Preliminary analysis assessed the relationship between oxygen levels, traditional hemodynamics, and wound healing in the affected limbs of patients with CLI before, during, and 1 day after revascularization using the Lumee platform, with follow-up visits at approximately 30, 90, 180, and 365 days. Enrolled patients received four injected Lumee biosensors: three in the foot and one as a reference sensor in the arm.
The findings demonstrated a positive correlation between increases in tissue oxygen level as measured with the Lumee platform during revascularization compared to changes in toe-brachial index (TBI), and tissue oxygen levels were significantly higher in patients who showed wound healing as compared to patients who did not.
Prof. Brodmann stated, "We are pleased to see that continuous monitoring of extravascular tissue oxygen using the Lumee oxygen platform showed a positive correlation to TBI, demonstrating that this technology could be useful to help guide clinical choices during CLI management. These data also validate previous research that showed increases in oxygen during revascularization may be a sensitive indicator of wound healing following the procedure."