In a call hosted today, June 9, 2025, PolyPid Ltd. unveiled highly successful topline results from its SHIELD II Phase 3 trial of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal colorectal surgery patients with large incisions.

The double-blind trial of 798 patients achieved statistical significance across all endpoints, demonstrating a 38% reduction in the primary composite endpoint and a remarkable 58% reduction in SSI rates from 9.5% to 3.8% compared to standard care alone.

These results position D-PLEX100 among the most effective prophylactic interventions for this indication, addressing a significant unmet medical need that costs the U.S. healthcare system up to $10 billion annually.

With FDA Fast Track, Breakthrough Therapy, and QIDP designations already secured, PolyPid plans a pre-NDA meeting by end-2025 followed by NDA submission in early 2026, while these compelling Phase 3 results are expected to accelerate ongoing global partnership discussions for commercialization.