Periodic Reporting for period 3 - CytoTrack (Wearable diagnostic for inflammation tracking for personalized patient care among at-risk patients)
Periodo di rendicontazione: 2022-10-01 al 2024-03-31
The healthcare industry is moving fast towards personalized and precision healthcare, so each patient can receive the right treatment at the right time and at the right dose. However, how can this be done if there is no tool today that can track our health in real-time? How can we find the right window of action if we only get snapshots at given intervals with conventional blood tests? Current available wearables typically track physical information continuously with the use of sensors such as accelerometers and gyroscopes to count the number of steps and measure movements and heart rate monitors. They do not collect biochemical data to measure how the health status of individuals truly evolves over time.
With healthcare costs skyrocketing in many countries, governments have no choice but turn to preventive health. This has opened up a huge market opportunity for screening and monitoring technologies that allow patients to be monitored remotely before and after a procedure, and during a treatment. A wearable health device can extend a care strategy at home, provide the means for medical professionals to react more promptly to relapses, generate continuous and objective cohort data, and monitor treatment adherence.
Pressure to develop simple and minimally-invasive alternatives to blood testing is pushing many companies to innovate. Among the biofluids available on the body, the interstitial fluid (ISF) is considered to be a very promising candidate, because it can be tracked repeatedly over day and night, without intruding on an individual’s life. Continuous glucose monitoring – which is done in ISF – has emerged as the fast-growing alternative to the finger prick traditional measurements, with a continuous, minimally-invasive solution for real-time feedback. Continuous glucose monitoring devices (CGMs) have normalized the wearing of a wearable, connected patch for patients, paving the way for solutions that go beyond glucose.
With healthcare costs skyrocketing in many countries, governments have no choice but turn to preventive health. This has opened up a huge market opportunity for screening and monitoring technologies that allow patients to be monitored remotely before and after a procedure, and during a treatment. A wearable health device can extend a care strategy at home, provide the means for medical professionals to react more promptly to relapses, generate continuous and objective cohort data, and monitor treatment adherence.
Pressure to develop simple and minimally-invasive alternatives to blood testing is pushing many companies to innovate. Among the biofluids available on the body, the interstitial fluid (ISF) is considered to be a very promising candidate, because it can be tracked repeatedly over day and night, without intruding on an individual’s life. Continuous glucose monitoring – which is done in ISF – has emerged as the fast-growing alternative to the finger prick traditional measurements, with a continuous, minimally-invasive solution for real-time feedback. Continuous glucose monitoring devices (CGMs) have normalized the wearing of a wearable, connected patch for patients, paving the way for solutions that go beyond glucose.
During the CytoTrack project, Xsensio advanced the development of a breakthrough product aimed at the on- body tracking of inflammatory markers, and developed unique health insight into a novel biofluid composition on healthy volunteers (HREC No: 038-2023) thanks to the fabrication of a proprietary biofluid collector that rigorously followed quality management system, and for which Xsensio obtained ISO 13485 Certificate No. Q5 119322 001 from Notified Body TÜV SÜD in 2024.
At the core of Xsensio’s wearable innovation lies our proprietary Lab-on-Skin© technology that leverages cutting-edge nanotechnology and biochemistry to continuously or repeatedly measure the components inside the biofluids at the surface of the skin, and repeatedly analyze its biochemical composition to detect changes in real time that reflect an individual’s physiological state. High miniaturization allows us to include a range of sensors on the chip, each functionalized to target a specific biomarker of interest, for a rich multiparametric analysis. The underlying electrical sensing technology is the same, except the top coating that differs, rendering the technology scalable and applicable to a wide range of health applications. To achieve this Lab-on-Skin© vision, sensors are individually functionalized with a specific chemical layer (e.g. enzymes, aptamers, antibodies, nanobodies etc) in order to selectively detect each targeted analyte with limited cross-sensitivity or screening parasitic from other chemical species. Xsensio successfully achieved the detection of lactate and CRP and is expanding to other inflammation-related and cardiac-related proteins, and to a range of hormones.
The company is now ready to start an ambitious new phase. Indeed, following the work in Cytotrack Xsensio has secured national Innosuisse funding for a 2025 clinical observational study (111.128 IP- LS) on 140 shock and pre-shock patients in the intensive care unit at the CHUV, a leading European hospital, with the sensing device that forms our first family of medtech industrial products. This upcoming clinical study is a pivotal next step, designed to validate the functionality and reliability of our newly developed hardware in a real-world setting. We are confident that the clinical results will demonstrate the potential of our wearable biosensing technology in improving patient outcomes in the intensive care environment.
The company is now ready to start an ambitious new phase. Indeed, following the work in Cytotrack Xsensio has secured national Innosuisse funding for a 2025 clinical observational study (111.128 IP- LS) on 140 shock and pre-shock patients in the intensive care unit at the CHUV, a leading European hospital, with the sensing device that forms our first family of medtech industrial products. This upcoming clinical study is a pivotal next step, designed to validate the functionality and reliability of our newly developed hardware in a real-world setting. We are confident that the clinical results will demonstrate the potential of our wearable biosensing technology in improving patient outcomes in the intensive care environment.