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D-PLEX100 is a novel drug-device combination designed to provide local, prolonged, and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (SSIs). It utilizes PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology to pair active pharmaceutical ingredients with a polymer-lipid matrix. This enables the sustained release of the broad-spectrum antibiotic doxycycline at high local concentrations for up to 30 days post-surgery. The product is intended for use in conjunction with standard systemic antibiotics and targets both typical and antibiotic-resistant bacteria. D-PLEX100 has received Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations from the FDA for prevention of SSIs in patients undergoing abdominal colorectal surgery. It is currently being evaluated in Phase 3 clinical trials for prevention of incisional infections following abdominal colorectal surgery with large incisions and has also been studied for sternal wound infection post-cardiac surgery[1][4][5][8].
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