PolyPid is an Israeli clinical-stage biopharmaceutical company focused on controlled-release drug delivery. Its lead product candidate, D-PLEX100, is a prophylactic treatment designed to prevent surgical site infections (SSIs). D-PLEX100 is applied as a sterile powder directly to the surgical wound just before closure, releasing doxycycline, a broad-spectrum antibiotic, continuously at the site for 30 days. This bypasses a core limitation of systemic antibiotics — disrupted blood flow at the surgical site limits local drug concentration — by delivering the antibiotic directly where it's needed. The pivotal Phase 3 SHIELD II trial showed D-PLEX100 reduced a combined primary endpoint of SSIs, all-cause mortality, and surgical reinterventions by 40% versus standard of care, and reduced SSI rates specifically by 60%. PolyPid plans to file a rolling NDA beginning Q1 2026, targeting the abdominal colorectal surgery indication, with label expansion to broader surgical indications planned thereafter. D-PLEX100 is built on PolyPid's proprietary PLEX technology, a matrix of alternating polymer and lipid layers that releases a drug in a controlled, linear manner as body moisture gradually disintegrates the layers. PolyPid plans to commercialize D-PLEX100 through partnerships rather than its own sales force — it has an existing agreement with Advanz Pharma for Europe, and is seeking a U.S. partner with hospital sales infrastructure. PolyPid manufactures D-PLEX100 at its own facility in Israel and intends to retain manufacturing as a core competency. Beyond D-PLEX100, PolyPid has early-stage programs applying its platform to long-acting GLP-1 delivery and intratumoral oncology, both intended for out-licensing.