The National Institutes of Health (NIH) has recently granted Profusa Inc $1.75 million to support fast-tracked Phase I and Phase II studies of its Lumee biosensors, designed for continuous oxygen monitoring in peripheral artery disease patients.
Phase I of the grant will fund safety studies of the Lumee technology, and Phase II will fund a clinical study of the technology at the University of California San Francisco, according to a media release from South San Francisco-headquartered Profusa.
“Our goal is to further demonstrate the functionality of Profusa’s novel Lumee oxygen biosensor technology in patients with PAD, and to determine its ability to predict surgical outcomes and to guide additional therapies to avoid amputation,” explains Natalie Wisniewski, PhD, a co-principal investigator of the studies and Profusa’s co-founder and chief technology officer, in the release.
“Profusa’s oxygen-sensing technology may allow doctors for the first time to know the tissue oxygen levels in the ischemic limb before, during, and after treatment,” explains Christopher Owens, MD, MSc, a co-principal investigator who will conduct the 50-patient clinical trial in Phase II.
“We’ll be able to more accurately select patients who will need a revascularization procedure to heal their wounds, and we will be able to monitor the change in tissue oxygen during and after the procedure in order to guide our treatment and know when it is complete. The upside for our patients will be less pain and disability, improved function, and fewer amputations,” adds Owens—associate professor of Surgery, Division of Vascular and Endovascular Surgery at the University of California San Francisco—in the release.
For more information, visit Profusa Inc.
[Source(s): Profusa Inc, PR Newswire]