STATEMENT: New indication approved for Verdye for mapping of the breast sentinel lymph node

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STATEMENT: New indication approved for Verdye for mapping of the breast sentinel lymph node

(Information sent by the signatory company)

New Approved Indication for Verdye (Injectable Indocyanine Green, ICG) for Mammary Sentinel Lymph Node Mapping

ATHLONE, Ireland, February 5, 2024 /PRNewswire/ -- Diagnostic Green Plc (Diagnostic Green) is pleased to announce the approval of Verdye (ICG) for the intraoperative identification of sentinel lymph nodes and visualization pathways in breast cancer in Spain .

The presence of lymphatic metastases is an important prognostic factor for breast cancer survival. Sentinel lymph node biopsy (SLNB) remains a critical component of early detection of breast cancer and is the current standard of care to help determine whether cancer has spread to the lymph nodes.

With the approval of ICG for breast SLNB, surgeons now have an alternative to using technetium (99mTc) radiolabeled colloids with blue dyes (BD) to visualize lymph nodes. The use of 99mTc places a significant burden on both patients and hospitals, including logistical challenges associated with pre-procedural administration, the risk of exposure to ionizing radiation for professionals, and all the requirements associated with handling radiopharmaceuticals. Additionally, blue dyes may pose significant potential risks, including soft tissue necrosis and metabolic and hematologic side effects, so they are infrequently used for routine surgical care.

Discussing the approval, Declan Cassells, CEO of Diagnostic Green, said: "This is a major advance for the detection of breast SLN, as it takes advantage of the real-time imaging capabilities of the ICG. The intraoperative use of the ICG not only equals or exceeds the accuracy of current methods, but also significantly improves the patient experience, offering a safer and less invasive alternative to traditional methods that use technetium and blue dyes for SLN detection."

The approval was supported by multiple meta-analysis studies that concluded that:

Verdye (indocyanine green, ICG) is available throughout EMEA and is sold through a network of distributors or directly through Diagnostic Green. For information on how to order Verdye (indocyanine green) in specific territories, see or contact Diagnostic Green at

Diagnostic Green Ltd is a wholly owned subsidiary of Renew Health Ltd. Based in Ireland, Diagnostic Green is the leading supplier of indocyanine green worldwide. The product is sold as Verdye in EMEA and Latin America, and as Green Indocyanine for Injection, USP in the United States and Canada. Diagnostic Green was established to provide high-quality fluorescence imaging products to physicians around the world. Our vision is to ensure that fluorescence imaging becomes the standard in tissue visualization for clinicians in every OR/OR around the world.

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