FDA Slaps Clinical Hold On Miromatrix's For Bioengineered Liver Platform

  • The FDA has placed a clinical hold on Miromatrix Medical Inc's MIRO miroliverELAP Investigational New Drug (IND) application for acute liver failure.
  • The miroliverELAP IND application was submitted in mid-November. The FDA indicated they would provide an official clinical hold letter to Miromatrix within 30 days. 
  • Miromatrix plans to provide additional updates pending communication with the FDA.
  • Miromatrix Medical is a life sciences company that has developed a proprietary perfusion technology platform for bioengineering organs to address the shortage of available human organs. 
  • The Company's initial development focus is on human livers and kidneys.
  • Miromatrix is scaling to clinical-sized implants and recently successfully revascularized a decellularized porcine liver graft with human vascular cells and sustaining perfusion for 15 days post-transplantation. 
  • Price Action: MIRO shares closed 32.90% lower at $2.75 during premarket trading on Thursday.


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