- Pre-registration underway for upcoming contracts with US clients currently under discussion... Expecting significant expansion with US clients.
- FDA approval procedures for miLab solutions are progressing smoothly... “We aim to become a global leader in blood and cancer diagnostics through successful entry into the US market.”
November 28, 2024 – Noul Co., Ltd. (CEO David Lim, hereinafter ‘Noul’) announced that it has completed establishment registration and device listing for four of its medical device products (miLab™ Platform, miLab™ Cartridge MAL, miLab™ Cartridge BCM, SafeFix™) with the U.S. Food and Drug Administration (FDA).
Currently, Noul is smoothly progressing through each stage of the FDA approval process for its miLab solutions as part of its full-scale entry into the US market.
David Lim, CEO of Noul, stated, “This registration was completed in advance for upcoming contracts with US clients currently under discussion. We are very pleased to have taken the first step towards our US market entry by completing the first FDA registration for the miLab platform, which forms the foundation of all our diagnostic products.” He added, “We will accelerate the FDA approval process for all Noul products, successfully leading our entry into the US market, and further expand globally to become a world-leading company specializing in blood and cancer diagnostics.”
This registration is an important step in proving that Noul’s products meet the stringent quality control and safety standards set by the US FDA, and it holds great significance as it marks the official commencement of Noul’s entry into the US market. Through this registration, Noul has fulfilled the legal requirements for the distribution and use of its products in the US, further enhancing its product competitiveness and credibility in the global market.
The listed products include Noul’s automated diagnostic device, the ‘miLab™ Platform’, which incorporates solid staining and imaging technologies, along with two diagnostic cartridges for malaria and blood analysis (miLab™ Cartridge MAL and miLab™ Cartridge BCM), and the fixation solution (SafeFix™). These products form the core platform that underpins Noul’s diagnostic solutions, with analysis software for applications such as malaria, blood analysis, and cervical cancer added to further enhance their diagnostic capabilities.
The U.S. in vitro diagnostics market is expected to grow at a compound annual growth rate (CAGR) of 7.7%, from approximately $36.35 billion in 2023 to $61.13 billion by 2030. The market is growing faster than expected, driven by factors such as the aging population, increased prevalence of chronic diseases, and heightened awareness of early disease diagnosis. In line with this market growth, Noul plans to accelerate its entry into the U.S. market.
Meanwhile, Noul recently supplied its AI-based blood analysis solution ‘miLab™ BCM’ to major hospitals and screening centers in Italy, marking its first sales of miLab™ BCM in European countries. This supply came as a result of additional purchases following the earlier delivery of the malaria diagnostic solution ‘miLab™ MAL’ to Italy earlier this year. The excellent performance and reliability of the previously supplied products played a crucial role in this additional purchase.