HoneyNaps Registers as CRO to Expand AI-Powered Sleep Analytics Across Global Pharmaceutical and Medical Device Trials

• HoneyNaps, a South Korea- and U.S.-based AI sleep medicine company, has officially registered as a Contract Research Organization with the Korea National Enterprise for Clinical Trials (KoNECT), marking its formal entry into the CRO sector and underpinning the commercial expansion of SOMNUM Clinical — its AI-powered polysomnography analytics service backed by two U.S. FDA clearances.

• SOMNUM Clinical automates polysomnography data analysis in line with American Academy of Sleep Medicine guidelines, reducing analysis time by more than 90% while delivering standardized, reproducible sleep metrics across multicenter global trials — targeting a global clinical sleep health market projected to grow from $22.8 billion in 2025 to $36.9 billion by 2034.

HoneyNaps, an AI-powered sleep medicine company headquartered in South Korea with U.S. operations in Cambridge, Massachusetts, announced on July 27, 2026, that it has officially registered as a Contract Research Organization with the Korea National Enterprise for Clinical Trials. The registration formalizes HoneyNaps’ entry into the CRO sector and accelerates the commercial expansion of SOMNUM Clinical, its AI-powered clinical trial analytics service built on the company’s FDA-cleared SOMNUM AI sleep analysis platform.

SOMNUM Clinical automates the analysis of polysomnography data — the gold-standard sleep study used across a broad range of clinical research applications — delivering quantitative assessment of key sleep parameters including sleep stages, apnea-hypopnea index, arousal events, and other clinically relevant metrics. The platform applies standardized scoring criteria aligned with American Academy of Sleep Medicine guidelines, enabling objective, reproducible, and consistent analysis across multiple study sites. For CRO clients and sponsors running multicenter global trials, the operational impact is significant: SOMNUM Clinical reduces PSG analysis time by more than 90%, directly compressing study timelines and reducing the inter-site and inter-scorer variability that has historically been a data quality challenge in sleep research.

HoneyNaps brings established clinical research credentials to its CRO registration. The company has supported clinical studies involving more than 10,000 participants and has managed nationwide multicenter and multidisciplinary clinical trials — experience that underpins its ability to deliver not only AI analytics but also comprehensive operational trial support for global programs. The SOMNUM AI platform underlying SOMNUM Clinical has received two U.S. FDA 510(k) clearances, most recently for SOMNUM V3.0 for AI-based sleep-disordered breathing analysis, providing a regulatory credibility foundation that distinguishes HoneyNaps from analytics-only software vendors entering the clinical trial services market.

The CRO registration positions HoneyNaps to address growing demand for sleep as a clinical endpoint and digital biomarker across therapeutic areas well beyond traditional sleep disorders. Sleep is increasingly recognized as a clinically meaningful readout in obesity, cardiovascular disease, neurodegenerative disorders, mental health, and digital therapeutics programs — broadening the addressable market for sleep-specialized CRO analytics services. The global clinical sleep health market is projected to grow from approximately $22.8 billion in 2025 to $36.9 billion by 2034, driven in part by the integration of sleep as both a primary endpoint and a secondary biomarker in a growing number of pharmaceutical, medical device, and digital health trials.

“Sleep medicine is rapidly emerging as an important digital biomarker across a wide range of therapeutic areas, increasing the need for objective and standardized analysis in clinical research. With our CRO registration and AI-powered analytics platform, we are expanding beyond sleep disorder studies to support clinical trials involving pharmaceuticals, wearable devices, digital therapeutics, obesity, neurological diseases, and many other healthcare innovations.”

Sean Ha (Tae Kyoung Ha), President, HoneyNaps USA