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With regard to the substantial clinical improvement criterion, the applicant asserted that CYTALUX represents a substantial clinical improvement over existing technologies because CYTALUX enables the surgeon to identify cancer intraoperatively in real time that otherwise would have been missed, enabling the surgeon to achieve more complete resection in cytoreductive surgery for ovarian cancer

The resulting vascular leakage allows plasma proteins and interstitial fluid to flood the tumor stroma, raising intratumoral pressure and disorganizing blood flow

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These differences may have resulted in a relative reduction in effect sizes when pooling cross-sectional estimates obtained in the main analyses and those from 6-year follow-up analyses