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Milestone supports strategy to advance evidence-based applications of fluorescence imaging in liver cancer<\/p>\n\n\n\n
Singapore, 15 October 2026 \u2014 UltraGreen.ai Limited (SGX: ULG) (\u201cUltraGreen\u201d or the \u201cCompany\u201d), together with its Diagnostic Green business, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to IC-GREEN\u00ae (indocyanine green for injection), for use as a diagnostic for the management of hepatocellular carcinoma (HCC). HCC is the most common form of primary liver cancer.
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The designation represents an important milestone in UltraGreen\u2019s strategy to advance the clinical applications of IC-GREEN through further research and regulatory development, with a focus on areas where fluorescence imaging could provide additional information to support clinical decisions. The FDA orphan drug designation programme encourages the development of medicines and diagnostic agents for rare diseases and conditions, with designated products potentially qualifying for regulatory and financial incentives.
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A particular area of clinical interest is patients with HCC who are candidates for surgical resection. For these patients, identifying tumour tissue and understanding the extent of disease are important considerations in planning and performing surgery. The development programme aims to evaluate how ICG fluorescence imaging may provide surgeons with additional visual information to help identify tumour tissue during surgery, complementing established imaging techniques and surgical assessment.
UltraGreen is continuing work on further clinical studies to build the evidence supporting this proposed diagnostic use. This forms part of the Company\u2019s broader strategy to expand the applications of our ICG through clinical collaboration, evidence generation and additional regulatory submissions.
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Ravinder Sajwan, Chief Executive Officer of UltraGreen.ai, said: \u201cThis designation marks an important milestone in our strategy to advance the use of IC-GREEN in areas of clinical need. While the designation relates specifically to hepatocellular carcinoma, it reflects our commitment to building robust clinical evidence and pursuing new indications where fluorescence imaging can provide additional value to physicians and patients. We believe the long-term opportunity lies not only in our ICG products, but in expanding the range of clinical settings where fluorescence imaging can support decision-making and improve patient management.\u201d <\/p>\n\n\n\n
Under the FDA\u2019s orphan drug designation programme, designated products may qualify for incentives including tax credits for qualified clinical testing and exemptions from certain FDA application fees. Subject to subsequent FDA approval and eligibility requirements, the designated use may also qualify for seven years of orphan drug exclusivity in the United States. <\/p>\n\n\n\n
Orphan drug designation does not constitute FDA approval for the HCC indication or establish safety or effectiveness for that use. Approval remains subject to the necessary clinical evidence and FDA review. Any orphan drug exclusivity would relate to the approved orphan indication rather than all uses of indocyanine green.<\/p>\n\n\n\n