MEDICAL DEVICES
patch that adheres to the skin. The patch, in turn, transmits the data wirelessly to a mobile device, which displays real-time, clinical-grade data using a custom app. Profusa’s first clinical offer, the Lumee Oxygen
Platform and the next-generation Wireless Lumee Oxygen Platform, are CE-marked for use in the EU for patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring (in the US, the Lumee Oxygen Platform is an investigational device limited by federal law to investigational use).
Putting sensors to work in clinical trials In the not-too-distant future, we will see biosensors like ours being used in clinical studies to measure glucose, lactase, pH, alcohols, CO2
Shorter study timing: if we monitored subjects with biosensors, then we could shorten study timing because the ‘visits’ may not be monthly, for example, but occur in real time. Whenever the biochemistry changes, we could capture that.
and elements
such as potassium and sodium. They could be incorporated into any study where these biochemistries offer a direct view into the primary or secondary end points. This approach offers several advantages:
A critical limb ischemia case study We’ve already seen some of these advantages in critical limb ischemia (CLI). Tracking tissue oxygen levels is vital in the care of patients with peripheral artery disease, which affects more than 200 million people worldwide and is caused by the narrowing of blood vessels, and reduced blood flow to the lower limbs. This lack of efficient delivery of oxygen and other nutrients to the tissues in the extremities leads to the development of sores and wounds that do not heal. CLI is a severe form of peripheral artery disease characterised by constant resting pain, tissue loss and, in more advanced cases, gangrene, and often leads to amputation.
Ease of recruitment and retention: instead of bringing the subject into a particular clinic and drawing blood, the data is collected remotely once the sensors are injected. Subjects are no longer limited to those living in areas near the clinical site. They don’t need to make frequent visits to clinics, which can interfere with work, home and care-giving duties, and be seen as burdensome. Since data acquisition is remote and continuous, the subject can live his or her life without the need to attend to clinical study protocol, which has the benefit of increasing compliance.
Better data: when we can examine data continuously, rather than just by a handful of points over time, we can expand the available end points we’re measuring. Instead of looking at how biomarkers change between doctor’s visits, continuous measurements enable us to analyse not just how they change in absolute terms, but how they change relative to a specific time, and the shape of the curve could potentially be important. This view expands the potential knowledge the studies can provide.
Lower costs: bringing subjects into a clinic for follow-up measurements, as opposed to allowing them to stay at home and gathering measurements remotely, would allow us to obtain many more data points at a much lower cost.
“In the not-too-distant future, we will see biosensors like ours being used in clinical studies to measure glucose, lactase, pH,
alcohols, CO2 and elements such as potassium and sodium.”
The Profusa biosensor has been tested in
trials with CLI patients undergoing endovascular revascularisation treatment (EVT), in which surgeons clear blocked arteries in the limbs. Data from the study OMNIA (oxygen monitoring near ischemic areas), found that continuously measuring tissue oxygen prior, during and after surgical procedure enables greater prediction of wound healing than current modalities. Specifically, increases in tissue oxygen before, during and after an EVT were significantly higher in patients who experienced wound healing than in those who did not. In addition, tissue oxygen levels during revascularisation were a better predictor of wound healing than traditional clinical measures, such as ankle-brachial index or toe-brachial index. Findings also showed that oxygen changes
between discrete time points, specifically at the start and end of an EVT, may not be predictive
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