Infections by biofilm-forming microorganisms on indwelling medical devices such as catheters, prosthetic joints and internal fracture fixation devices pose a serious health threat. Overall, approximately 3% of all patients receiving such devices develop biofilm infections, with costs adding up to billions of Euro’s.Current strategies to combat biofilms are based on conventional antibiotics. They often fail because 1) biofilms are difficult to penetrate, 2) micro-organisms in biofilms are resistant to most conventional antibiotics, 3) antibiotics cause release of pro-inflammatory microbial compounds, and 4) the locally available concentrations are too low.The aim of BALI is to disrupt biofilm formation by a unique combination of Synthetic Antimicrobial Antibiofilm Peptides (SAAPs) with biofilm dispersing, microbicidal, and immune-orchestrating activity, incorporated in novel controlled release drug delivery formulations (PolyPid), for both prevention and treatment of biofilm infections. The recently developed SAAP OP-145, already tested in humans, will be the first candidate.PolyPid, a unique polymer-lipid-based drug delivery platform will be tailored for coatings allowing prolonged and pre-determined release rates of SAAPs, to ensure the required local concentrations over a desired period. The coatings will be optimized in vitro and subsequently in mice and rabbit studies to prevent and treat biofilm infection. Finally a phase 1 study in patients with bone fracture fixation devices will be performed.The novel SAAP-delivering PolyPid formulations can control biofilms and allows for treatment and management of infections, reducing infection rates of implanted medical devices. Patients relying on safe and effective medical devices thus will benefit strongly by reduction of infection frequencies. Besides improved health of EU citizens, the associated cost savings for hospitals and the economic benefits for the SMEs contribute to realization of EC policies