PolyPid's D-PLEX₁₀₀ Receives the US FDA's Breakthrough Therapy Designation for the Prevention of Surgical Site Infections in Colorectal Surgery
Shots:
- The BTD is based on a P-II trial evaluating D-PLEX100 vs SOC alone in 201 patients for the prevention of SSIs in abdominal colorectal surgery
- The results demonstrated a significant decrease in SSIs of 59 % in the ITT population and a decrease of 69% in the Per Protocol population
- The ongoing P-III studies in abdominal surgery- SHIELD I and SHIELD II are on track. D-PLEX100 has received two FDA’s FTD for the prevention of post-abdominal surgery incisional infections and for the prevention of sternal wound infections post-cardiac surgery- as well as two QIDP's in the same indications
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