PolyPid to Present Its Positive Phase 3 SHIELD II Topline Results at the 2025 American College of Surgeons Clinical Congress

Core Insights - PolyPid Ltd. will present topline results from its Phase 3 SHIELD II trial at the 2025 American College of Surgeons Clinical Congress in Chicago [1][2] - The SHIELD II trial demonstrated significant efficacy of D-PLEX₁₀₀ in reducing surgical site infections and related complications [4] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through its proprietary PLEX technology, which allows for controlled, prolonged-release of therapeutics [5] - The company plans to submit a New Drug Application (NDA) for D-PLEX₁₀₀ in early 2026 following positive Phase 3 results [5] Trial Details - The SHIELD II trial was a multinational, randomized, double-blind study that met its primary and key secondary efficacy endpoints [4] - D-PLEX₁₀₀ achieved a 38% reduction in the combined endpoint of surgical site infections, reinterventions, or mortality compared to standard care alone, with a p-value of less than 0.005 [4] - The trial also showed a 58% reduction in the rate of surgical site infections in the treatment arm with D-PLEX₁₀₀, also with a p-value of less than 0.005 [4] Conference Information - The presentation will take place on October 5, 2025, at 11:30 AM CT during the high-impact clinical trials session [2][8] - PolyPid management will be available for meetings during the conference [3]