The management of vascular stenosis (narrowing of the arteries and veins) has undergone major advances over the past decades, yet challenges remain. Bare metal stents (BMS) were plagued by unacceptably high rates of in-stent restenosis (ISR). Although drug-eluting stents (DES) were developed primarily to reduce neointimal hyperplasia, rates of ISR remain at least 5-15%. Furthermore, the use of stents remains controversial in certain situations, including within vessels with small diameters, long lesions, bifurcations, repeated ISR, and in segments of peripheral artery disease (PAD). It is estimated that 8.5 million people in the U.S. alone have PAD, which can lead to further morbidities including lifestyle limiting claudication, amputation, and stroke. In certain locations in the legs, stents carry a significant risk of stent fracture. Stent fracture rates can approach 37%, often resulting in restenosis or total vessel occlusion. The use of drug-coated balloons (DCB) has emerged as an attractive alternative to treat both PAD and ISR lesions without leaving behind a permanent stent prosthesis. DCBs are angioplasty balloons coated with an anti-proliferative drug to prevent restenosis. Endomimetics, LLC has developed a novel dual-action coating for drug-coated balloons that could reduce neointimal hyperplasia and restenosis and enhance re-endothelialization and vascular healing in patients that have PAD. The global drug-coated balloons (DCBs) market is expected to reach above USD 1.5 billion by 2025 with a high double-digit growth rate of around 15% over the forecast period.
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