Noul has secured Korean government funding to support global clinical trials and regulatory filings for its AI-based blood analysis platform, as the company pushes to expand into overseas diagnostics markets.
The company said Wednesday it was selected for an overseas clinical trial support project under Korea’s multi-ministerial advanced medical device R&D program. Noul will receive 2.2 billion won ($1.6 million) over three years to conduct multinational pivotal studies for its blood diagnostics system, miLab BCM, and advance efforts to secure FDA and European CE-IVDR approvals.
Noul’s miLab BCM, a fully automated blood analysis solution integrating complete blood count (CBC) (Courtesy of Noul)
The project is intended to generate clinical performance data needed for regulatory clearance and commercialization. Noul plans multicenter studies in Korea, the U.S., Europe and Latin America to evaluate the system across different ethnic populations and healthcare environments.
The company said it aims to obtain FDA 510(k) clearance and CE-IVDR certification while expanding into 10 overseas markets.
David Lim, CEO of Noul, said the government selection validates both the company’s AI blood diagnostics technology and the commercial potential of miLab BCM. He said the funding would strengthen Noul’s existing FDA and CE approval strategy and help accelerate overseas commercialization efforts.
Noul plans to begin pivotal trials in adult and pediatric patients at Asan Medical Center (AMC) and Kyung Hee University Hospital at Gangdong.
At AMC, the company will compare complete blood count (CBC) and five-part white blood cell differential (WBC 5-diff) testing performance against conventional laboratory analyzers in adults. At Kyung Hee, researchers will assess diagnostic equivalence between capillary and venous blood samples in children.
The pediatric study is aimed at demonstrating the platform’s usefulness in ultra-low-volume blood sampling settings, an area where conventional large-scale analyzers can face limitations.
Noul also plans to expand clinical trials overseas. In the U.S., the company said it intends to conduct FDA submission studies at more than three institutions. In Europe, it plans to evaluate the system in both central laboratory and point-of-care settings to support CE-IVDR certification.
Additional studies are planned in Indonesia and Latin America to assess diagnostic consistency across diverse populations and support regional market entry.
According to the company, miLab BCM uses AI-based image cytometry technology to analyze cell morphology directly. Unlike conventional blood analyzers that often require additional microscopic review when abnormalities are detected, the platform integrates CBC testing and blood cell morphology analysis into a single system using on-device AI and NGSI solid staining technology.
The system also simplifies the testing process into a five-step automated workflow and can perform analysis using 5 microliters of capillary blood, which Noul says could make it useful in infant and pediatric testing environments.
Kim Ji-hye
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