10159116GLP In-Vivo Preclinical Safety and Pharmacokinetic Study of a Novel Dual-Drug Coated Balloon FormulationActiveLaunchpadInnovate UKCAD symptoms can include chest pain and shortness of breath. A complete blockage of blood flow can lead to a heart attack. CAD and PAD are estimated to affect over 500m and 200m people around the world, respectively, and these numbers are increasing continuously. Traditional treatments for CAD and PAD have included endovascular interventions such as bypass grafting, balloon angioplasty to widen vessels, stenting -- originally without drugs but now with anti-restenotic drugs. More advanced, modern treatments include bioresorbable stents and drug-coated balloons, with the intention to leave no permanent implant behind, an approach which may have better long-term safety outcomes. Advantages of DCB over stenting include: 1.Avoiding a permanent implant 2.Shorter medications 3.Avoiding additional/multiple stent layers. The primary drug of choice for DCBs is the anti-cancer drug paclitaxel. While this has been supplanted for DES by sirolimus -- a drug with a more favourable safety profile and lower dose requirements, paclitaxel still dominates the DCB marker, with a small number of manufacturers developing sirolimus DCBs. Sirolimus offers advantageous drug delivery, but a tailored excipient is required due to the poor native retention of the drug in the tissue. Arterius has developed and patented a unique polymer excipient to transport and retain sirolimus in the tissue, combined with the antithrombotic drug dipyridamole to simultaneously inhibit restenosis and vessel thrombosis. Arterius has completed feasibility studies and demonstrated drug transfer and retention in vitro, in ex vivo bioreactor model and in a small animal pharmacokinetic study. The prototype Arterius DCB, with significant market opportunity as the first dual-drug DCB, now requires further in vivo and bench testing studies to demonstrate safety and efficacy.