PolyPid Ltd. announced that the first patient has been recruited and is scheduled for surgery in its revised SHIELD II Phase 3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The U.S. Food and Drug Administration (FDA) recently accepted the Company's revised protocol for SHIELD II, which is recruiting patients undergoing colorectal resection surgery with large incisions (> 20 cm). SHIELD II will enroll an estimated 550 additional patients beyond the 40 patients already recruited into the trial.

Total recruitment time into the trial is anticipated to be approximately 12 months and top-line results are expected in mid-2024. PolyPid also intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up.