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Mount Sinai and EnLiSense: Pioneering Real-Time Biomarker Monitoring through Groundbreaking Studies

February 15, 2024

EnLiSense’s device offers the first groundbreaking solution for continuous, non-invasive monitoring of inflammatory bowel disease through innovative sweat-sensing technology.

DALLAS--(BUSINESS WIRE)--EnLiSense CCM, a pioneer in non-invasive sweat-sensor technology for real-time health monitoring, is thrilled to announce a groundbreaking advancement in the world of Inflammatory Bowel Disease (IBD) management. Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.

“There's a crucial need for a proactive real-time ability to frequently monitor chronic diseases in order to improve their management”

EnLiSense's journey reaches a significant milestone with over half a million human biomarker readings, underscoring the extensive validation of our technology. These readings provide crucial data points, enhancing the precision and trustworthiness of inflammatory biomarker monitoring. This development represents a major leap forward in comprehending chronic diseases such as IBD, a condition involving chronic inflammation of the gastrointestinal tract, which includes Crohn’s disease and ulcerative colitis, affecting nearly 1 in 100 Americans.

In collaboration with the Icahn School of Medicine at Mount Sinai and funded by the Crohn’s & Colitis Foundation, these two pivotal studies highlight the potential of IBD Aware, our sweat sensing wearable device. “Longitudinal Assessment Of Sweat‑Based TNF‑Alpha In Inflammatory Bowel Disease Using A Wearable Device,” was published in Nature Scientific Reports, and “Longitudinal Monitoring Of IL-6 And CRP In Inflammatory Bowel Disease Using IBD-AWARE” was published in Biosensors and Bioelectronics.

The studies involved measuring inflammation markers CRP, TNF-α, and IL-6 in subjects' blood and sweat continuously in subjects with and without IBD. Researchers found a correlation between sweat and blood markers, demonstrating the device's potential for monitoring inflammatory diseases. Additionally, the device accurately distinguished between individuals with and without inflammation. Sweat measurements in both studies revealed significantly higher IBD biomarker levels in patient groups, with TNF-α levels being twice as high in patients compared to non-patients.

In an effort to closely align technology with patient care, EnLiSense has launched a study-matching program that welcomes eligible patients to engage in ongoing research. By using the IBD Aware device, participants not only aid in the technology's validation but also help pave the way for proactive, personalized healthcare, where treatments can be customized using real-time, data-driven insights.

“These validation studies mark a crucial first step in introducing this transformative biosensor technology to the IBD community, reflecting our unwavering commitment to bridging the gap between pioneering research and tangible impact,” said Andres Hurtado-Lorenzo, PhD, Senior Vice President, Translational Research & IBD Ventures at the Crohn’s & Colitis Foundation. “The importance of continuous monitoring of inflammatory markers relevant for IBD in sweat cannot be overstated, as it has the potential to decrease the invasiveness of endoscopy and the need for fecal sample collection. This novel biosensor offers a minimally invasive means to monitor inflammatory markers in real-time, which has never been possible in IBD. This groundbreaking research started with the vision we had for our Novel Technologies initiative focused on biosensors. We are proud to have enabled this novel biosensor research in IBD and to have created a path that advances this bioengineering research from academia to industry, to develop innovative products that will revolutionize IBD management.”

"There's a crucial need for a proactive real-time ability to frequently monitor chronic diseases in order to improve their management,” says first author Robert P. Hirten, MD, a gastroenterologist and the Clinical Director of the Hasso Plattner Institute for Digital Health at Mount Sinai. “Sweat is easily accessible and can be sampled nearly continuously and noninvasively. Many substances in the blood can be found in sweat, making it an ideal monitoring source. Our goal was to study a sweat-sensing wearable device capable of nearly continuous measurement of key markers for chronic inflammatory diseases.”

“This clinical validation is a testament to over a decade of pioneering research in non-invasive sweat-sensor technology by EnLiSense. The IBD Aware device represents a major leap forward, offering clinicians and patients unprecedented insights into disease state, treatment timing and effectiveness, symptom management, and dietary adjustments – aspects previously inaccessible in real-time,” says Dr. Shalini Prasad, PhD, Professor and Department Head, Bioengineering at the University of Texas at Dallas and Co-founder of EnLiSense. Dr. Prasad continues, “This technology lays the groundwork for a dynamic data and AI platform specialized in analyzing inflammatory conditions, serving as a pivotal decision-support tool for clinicians. It not only can enhance predictive analysis for disease flare-ups but also has the potential to significantly improve the quality of life for those with chronic illnesses, marking a new era in personalized and effective treatment strategies.”

With optimism for the future, the research team anticipates that EnLiSense's technology will significantly alter the chronic disease management landscape. Plans for an expansive multicenter study are already underway, aiming to broaden the scope of biomarker analysis and solidify the device's role in personalized healthcare.

These studies were funded by a grant from the Crohn’s & Colitis Foundation (Novel Technologies Initiative Award ID 695759 and 611587, PI: Shalini Prasad) and by a grant from National Institute of Health (Award ID K23DK129835, PI: Robert P Hirten).

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