TransMedics falls after FDA clears competitor liver transplant device

TransMedics (TMDX) shares are moving lower after Bridge to Life announced that the Food and Drug Administration has granted De Novo clearance for its VitaSmart Hypothermic Oxygenated Perfusion System. The clearance establishes a “new regulatory classification for hypothermic oxygenated perfusion in liver transplantation in the United States,” the privately held company said in a statement. The FDA clearance enables the commercial use of VitaSmart for hypothermic oxygenated perfusion of donor livers following static cold storage and prior to transplantation. Shares of TransMedics are down 5%, or $7.38, to $134.55 following the news. TransMedics’ OCS Liver is an FDA approved device for donation after circulatory death and donation after brain death donor livers.