January 25, 2019 — Profusa announced promising clinical data from two studies evaluating the company's Lumee Oxygen Platform, an injectable tissue-integrated biosensor and an intelligent data platform intended for continuous, real-time monitoring of tissue oxygen levels. The data, presented at the Leipzig Interventional Course (LINC), Jan. 22-25 in Leipzig, Germany, indicate the Lumee platform measures tissue oxygen level changes in both healthy volunteers and patients with critical limb ischemia (CLI).
The device received CE Mark in October 2016 for continuous monitoring of tissue oxygen and is CE Marked for sale in the EU for monitoring tissue-oxygen perfusion as a general indication. In the U.S., it is limited by federal law to investigational use.
Peter Schneider, M.D., vascular surgeon and clinical researcher in limb salvage vascular procedures from Honolulu, Hawaii, presented findings from a healthy volunteer feasibility study. The study 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.
"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 judgement and experience alone without guidance," said Schneider. "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."
In the study, after the Lumee biosensor was injected in the forearm of seven healthy volunteers, vascular occlusion tests were performed on the arms of enrolled volunteers. Simultaneous measurements of oxygen were recorded using both the Lumee platform and tcpO2, (a commonly used noninvasive technique that measures the oxygen level of tissue below the skin), with repeated tests occurring one to 10 weeks after biosensor injection. Results revealed that the Lumee platform and tcpO2 were highly correlated, with both technologies showing a statistically significant decrease in oxygen levels during occlusion (p<0.001 for each device). Data also revealed the Lumee platform detected faster rates of oxygen change during both the occlusion and recovery phases (p<0.001, Wilcoxon signed-rank test) and detected reactive hyperemia in a higher percentage of tests (38 percent versus 4 percent occlusion tests).
Marianne Brodmann, M.D., interim head of the clinical division of angiology, department of internal medicine at Medical University in Graz, Austria presented findings from an interim analysis of the first 30 patients enrolled in the Oxygen Monitoring Near Ischemic Areas Study (OMNIA). The findings demonstrate that in patients with critical limb ischemia (CLI), tissue oxygen level increases measured with the Lumee platform during revascularization were positively correlated with changes compared to toe brachial index (TBI), a common vascular test used to measure arterial insufficiency. Tissue oxygen levels were also significantly higher in patients who showed wound healing as compared to patients that did not.
"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," said Brodmann. "These data also validate previous research that showed increases in oxygen during revascularization may be a sensitive indicator of wound healing following the procedure."
The OMNIA Study is an ongoing multicenter trial evaluating use cases of the Lumee Oxygen Platform. Preliminary analysis assesses the relationship between oxygen levels, traditional hemodynamics and wound healing in the affected limbs of patients with CLI before, during and one day after revascularization using the Lumee platform. Follow-up visits are conducted around 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.
For more information: www.profusa.com