Posted by Michael Wonder on 22 May 2019
PolyPid receives a second QIDP designation for D-PLEX100 in abdominal surgery
21 May 2019 - PolyPid Ltd announced today that the United States FDA has granted a second qualified infectious disease product designation to D-PLEX100 for the prevention of post-abdominal surgery incisional infection.
D-PLEX100, PolyPid's lead product candidate, had previously received both QIDP designation and fast track status from the FDA for the prevention of sternal wound infection post cardiac surgery, one of the most devastating complications with a mortality rate of up to 40 percent when deep sternal infection occurs.
Plans are currently underway for PolyPid to commence their Phase 3 clinical trial in cardiac surgery in the second half of 2019.
