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Clinical Data from UChicago Supports Novel Continuous Calprotectin Monitoring Wearable for IBD Management

April 8, 2024

EnLiSense's IBD Aware device offers a pioneering solution for managing inflammatory bowel disease by continuously monitoring calprotectin levels non-invasively through innovative passive-perspiration sensor technology.

DALLAS--(BUSINESS WIRE)--EnLiSense unveils their latest study further validating the efficacy of their IBD Aware platform that is designed to transform the lives of patients with inflammatory bowel disease (IBD). With support from the Crohn’s & Colitis Foundation, the IBD Aware technology demonstrates the transformative potential of remote monitoring for inflammatory diseases, and offers progress in the effort to manage IBD and other chronic conditions proactively, passively, and minimally invasively. The study showcases the IBD Aware device's ability to non-invasively monitor calprotectin levels in both active and remission phases of IBD. The validation of real-time, accurate biomarker tracking paves the way for EnLiSense's next steps as the company works to advance data and AI analytics and support clinicians with decision-support tools.

“Our patient-centric vision for the Foundation’s Novel Technologies Initiative was to enable for the first time the development of wearable biosensors that can detect biomarkers like calprotectin in a minimally invasive and in real-time manner”

In collaboration with the University of Chicago and funded by the Crohn’s & Colitis Foundation, the study, titled “Continuous Monitoring of CRP, IL-6, and Calprotectin in Inflammatory Bowel Disease Using a Perspiration-Based Wearable Device,” was recently published in Inflammatory Bowel Diseases Journal. The study successfully “demonstrated the clinical utility of perspiration as a noninvasive, continuous marker of gut inflammation.” This research not only reinforces the IBD Aware device's potential role in the future of inflammation monitoring but also lays the groundwork for novel approaches to predicting and proactively managing IBD flares, leveraging extensive datasets of inflammatory biomarkers like calprotectin directly from the patient.

Dr. David T. Rubin, MD, Joseph B. Kirsner Professor of Medicine and Director of the IBD Center at the University of Chicago, and study co-investigator, emphasizes the progress this technology represents. "The ability to continuously and accurately monitor calprotectin levels via perspiration and using a wearable technology is an important milestone for our field. The continuous monitoring of calprotectin provides critical insights into the nuances of disease relapse and progression and can enable the timely identification of disease activity and subsequent disease interception through adjustments in treatments."

The study included 33 participants demonstrating the effectiveness of the IBD Aware device to monitor essential inflammatory biomarkers like calprotectin using sweat sensors. Notably, the device detected significantly higher calprotectin levels in individuals with active IBD compared to those in remission (P < .05), highlighting its capacity for real-time monitoring. A significant correlation was found between perspiration and serum calprotectin levels (R² = 0.7195) and C-reactive protein (R² = 0.615), demonstrating the precise measurements taken by the device. These results not only affirm the accuracy of the IBD Aware device, but demonstrate its utility in the shifting paradigm of proactive IBD management that emphasizes continuous, data-driven decision-making. The promising results of this study have given way to broader and more comprehensive studies, including those at the University of Chicago, to delve deeper into the potential of this wearable device to transform IBD care, enabling disease monitoring strategies that are increasingly personalized and proactive.

Dr. Andrés Hurtado-Lorenzo, PhD, Senior Vice President, Translational Research & IBD Ventures at the Crohn's & Foundation, views this advancement as a pivotal moment for IBD management innovation. “Our patient-centric vision for the Foundation’s Novel Technologies Initiative was to enable for the first time the development of wearable biosensors that can detect biomarkers like calprotectin in a minimally invasive and in real-time manner,” he explains. Dr. Prasad and the EnLiSense team have successfully achieved that. IBD Aware will transform IBD care by allowing clinicians to remotely monitor inflammation markers, leading to more precise and proactive care and a better understanding of the disease's progression. “The IBD Aware device exemplifies our dedication to empowering healthcare professionals and enhancing patient outcomes through remote and continuous monitoring."

Dr. Shalini Prasad, PhD, Professor and Department Head of Bioengineering at the University of Texas at Dallas and co-founder of EnLiSense, underscored the study's importance, “This clinical validation not only confirms our wearable's crucial role in utilizing calprotectin for managing inflammatory conditions but also signifies the beginning of a new era in disease management, enhanced by AI. Beyond illustrating our device's capability to monitor a range of IBD biomarkers, it propels us towards a future where personalized care is the norm, not the exception. We are committed to continuous innovation and collaboration to further refine our technologies, empowering both patients and healthcare providers with deeper, actionable insights."

EnLiSense is pioneering work to build a future where proactive, personalized, and precision remote patient monitoring becomes the standard in chronic disease management. As they advance to the next phase with a multicenter study designed to sharpen biomarker analysis, they will solidify their commitment to refining healthcare solutions that are as unique as the patients they serve. In this journey, they continue to pursue strategic collaborations with partners who share their vision of deeply integrating continuous inflammatory biomarker sensor technologies into the fabric of chronic disease management. Their goal is to both enhance the application of current biomarkers as well as discover new ones that could redefine care for conditions like IBD and beyond.

These studies were funded by a grant from the Crohn’s & Colitis Foundation (Novel Technologies Initiative Award ID 695759 and 611587, PI: Shalini Prasad).

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