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**HIEstem** is a regenerative cellular therapy developed by Medinno, consisting of thrombin pre-conditioned Wharton's jelly-derived mesenchymal stem cells (MSCs) from umbilical cord, designed to treat neonatal hypoxic ischemic encephalopathy (HIE) and intraventricular hemorrhage (IVH). It exerts neuroprotective, anti-inflammatory, and anti-gliosis effects to mitigate brain injury from oxygen deprivation or hemorrhage in newborns, addressing unmet needs where standard hypothermia therapy shows limited efficacy and high mortality (up to 60% for HIE and 50-80% for IVH). HIEstem has completed Phase 1 trials, received Orphan Drug Designation in South Korea and Rare Pediatric Disease Designation in the US, and is preparing for global Phase 2 trials; Cytonus Therapeutics holds exclusive rights for North America and MENA markets.[1][3][5]
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