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


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  • The FDA has placed a clinical hold on Miromatrix Medical Inc's (NASDAQ: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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New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


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