Sibel Health Awarded a $500,000 Drug Development Tools Research Grant by the FDA for a Novel AI-Enabled Wearable Sensor for Scratch Monitoring

CHICAGO, Dec. 9, 2025 /PRNewswire/ -- Sibel Health, a leader in wearable biosensing and digital health, today announced that it has been awarded a competitive grant from the U.S. Food and Drug Administration (FDA) to advance towards full qualification of a novel clinical outcome assessment for scratching behaviors in atopic dermatitis (AD) as a drug development tool.

The award supports the next phase of development for Sibel's ADAM™ sensor — a hand-mounted wearable device that objectively measures scratching during both sleep and daytime activities combined with an AI-enabled algorithm.

Itch is the defining symptom of atopic dermatitis and one of the most burdensome experiences for patients, disrupting sleep, impairing daily function, and contributing to skin damage. Despite its central importance in drug development, itch is still primarily measured using patient-reported outcomes (PROs), which can be subject to recall bias, placebo effects, and reduced reliability during sleep particularly in pediatric populations.

"As a dermatologist, I'm a huge believer in PROs. The patient experience trumps all and our sensor will never replace the value of PROs. But, the field also needs better tools to assess what patients are objectively going through. This is why we developed the ADAM™ sensor as a novel digital endpoint to help therapeutic makers understand how their drug is improving itch by reducing scratching day or night. We're proud to have deployed our technology with dozens of sponsors from Phase I to Phase IV trials to assess scratching in both AD and other pruritic conditions," says Steve Xu, MD, MSc, CEO of Sibel Health and PI of the grant.

This FDA award represents a critical step toward establishing scratching behavior as a validated, objective digital endpoint, bringing a new level of rigor to how itch is measured in clinical trials and real-world evidence generation. "We already have >99% accuracy in determining scratch duration and scratch events. Using Sibel Health's latest hardware innovations, we will be expanding upon our best in class scratch detection AI model using sensor fusion to estimate scratch intensity and the percentage of body surface area scratched. Clinical scoring of AD relies on the evaluation of body surface area involvement, and this grant will enable similar measurements to be generated continuously with a single wearable sensor," says Dylan Richards, Head of Data Science at Sibel Health and co-investigator. By advancing regulatory science in this area, novel digital endpoints have the ability to help accelerate the drug development process that enables patients to gain access to breakthrough therapies faster and at a lower cost.

Building on Global Partnerships

This milestone also reinforces Sibel's strategic partnership with Maruho Co., Ltd., a leading Japanese company specializing in dermatology for the Asian market. Earlier in 2025, a team that included both Sibel and Maruho investigators demonstrated that a bio-feedback enabled version of the ADAM™ sensor reduced scratch events by 50% overnight in a cohort of AD patients published in JAMA Dermatology. Together, Sibel and Maruho are advancing digital technologies in the space of dermatology globally. "Our partnership with Maruho reflects a shared commitment to redefining how dermatological conditions are measured, understood, and managed," added Dr. Xu. "Objective, high-resolution behavioral data like scratching has the potential to go beyond clinical trials and support the broader patient journey with digital-enhanced solutions."

Impact Beyond Atopic Dermatitis

While this FDA-supported work focuses on AD, the implications extend to a wide range of pruritic conditions, including chronic kidney disease–associated pruritus, cholestatic itch, prurigo nodularis, and infectious diseases like scabies. By enabling objective, passive monitoring during sleep, ADAM™ provides a scalable foundation for broader application in clinical development, decentralized trials, and longitudinal patient care.

"This is about more than technology," said Dr. Xu. "Itch is devastating. This is about giving patients, clinicians, and drug developers a common, objective vital sign for itch— one that reflects lived experience, not just recalled symptoms."

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SOURCE Sibel Health