#USA #Chicago #Atopic Dermatitis #Sibel Health #ADAM Sensor

Sibel Health's Groundbreaking Development

Sibel Health, a prominent name in the realm of wearable biosensing technology and digital health, has recently been granted $500,000 by the U.S. Food and Drug Administration (FDA). This funding is earmarked for the further development of its innovative clinical outcome assessment tool that targets scratching behaviors associated with atopic dermatitis (AD). This is a significant leap for Sibel Health as it enhances its ADAM™ sensor — a state-of-the-art, hand-mounted wearable device that employs AI algorithms to accurately monitor and measure scratching incidents during both active hours and sleep.

The challenges presented by atopic dermatitis cannot be overstated; the itching associated with this condition is often the most annoying symptom, drastically affecting patients' daily lives. Disrupted sleep and heightened discomfort can lead to increased skin damage and mental anguish. Historically, the assessment of itching has relied heavily on subjective patient-reported outcomes (PROs), which, while valuable, are fraught with potential biases. This includes recall biases where patients may misremember their scratching patterns or be influenced by placebo effects, especially prevalent among younger populations.

Dr. Steve Xu, MD, MSc, the CEO of Sibel Health, emphasizes the complexity of the patient experience. “While I strongly advocate for the value of PROs, we need more precise tools that can objectively capture patient experiences. That’s why we have developed the ADAM™ sensor — to provide a digital endpoint that helps pharmaceutical companies understand improvements in itch control through decreased scratching behaviors both day and night.” The FDA's award marks a pivotal moment in establishing scratching behaviors as a reliable and validated digital metric. With over 99% accuracy in detecting scratch duration and events, the new phase of development with the FDA's backing aims to refine the measurement processes using sensor fusion technology.

Enhancing Clinical Trials and Patient Care

Dylan Richards, Head of Data Science at Sibel Health, elaborates on the technology's capabilities. “Our advanced AI model will not only focus on detecting scratch events but aims to assess the intensity of scratching and the proportion of body areas affected. This funding will enable us to perform ongoing assessments using a singular wearable sensor, leading to more consistent and reliable clinical evaluations.”

Through collaborations with various companies in clinical trial phases, Sibel has continually utilized its technology to enhance the understanding of scratching behaviors in various conditions, particularly in atopic dermatitis and associated pruritic conditions.

This venture also signifies Sibel’s strong collaboration with Maruho Co., Ltd., a notable player in the Asian dermatology market. Earlier in 2025, findings from a joint study indicated that the biofeedback feature of the ADAM™ sensor could significantly reduce scratching incidents by half overnight in a group of AD patients. This emphasizes their commitment to revolutionizing the way dermatological conditions are measured and managed globally.

Broader Implications for Itch Management

While the focus remains on atopic dermatitis for this FDA-supported initiative, the implications extend to various other pruritic conditions. These include chronic kidney disease-related itching and other infectious disease-related pruritus, like scabies. The passive monitoring capabilities afforded by the ADAM™ sensor are expected to serve as a foundation for wider applications in clinical research and patient management protocols.

In Dr. Xu's words, “This project transcends mere technological advancements. It touches on the very real and painful experiences of patients. We are striving to create a consensus on a vital sign for itchiness that reflects real-life experiences rather than relying solely on recollections.” The drive towards implementing objective metrics in dermatology carries the potential to expedite the drug development process and enable quicker patient access to novel therapies.

With this grant, Sibel Health aims not only to enhance the tools available for measuring pruritus but also to substantiate the broader patient journey through the use of innovative digital solutions.