I-Corps: Translation Potential of a Tailored Drug Delivery Device for Peripheral Artery Disease

The broader impact/commercial potential of this I-Corps project is the development of a drug-coated balloon to treat arterial diseases. Currently, patients with below-the-knee peripheral artery disease face a 25% mortality rate within five years, and many ultimately require amputations. Cerebrovascular disease, the leading cause of brain injury and the fifth most common cause of death, also lacks adequate treatment options. Treating areas with small-diameter vasculature, such as below-the-knee arteries and the brain, is difficult with existing technologies including drug-eluting stents and drug-coated balloons. The proposed technology is designed to deliver more effective treatment in these challenging areas by dissolving drugs in a delivery matrix that is used to coat a balloon. This may reduce the risk and improve the treatment and the outcomes for patients. This I-Corps project utilizes experiential learning coupled with first-hand investigation of the industry ecosystem to assess the translation potential of a drug delivery formulation aimed at coating angioplasty balloons for the treatment of peripheral and cerebrovascular artery diseases. In the proposed technology, the drug is dissolved within an excipient matrix, which makes it non-crystalline and highly bioavailable to treat the diseased tissue. In addition, the amorphous form of the drug dissolves quickly, making it less likely to shed emboli-forming particles compared to its crystalline counterparts. Pilot studies have shown that the formulation can deliver therapeutically relevant drug levels for up to 30 days. Notably, a single balloon can administer the drug to multiple locations, allowing the treatment of long, diffuse arterial lesions in one procedure. This may reduce the need for additional surgeries and lower the risk of surgical side effects. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.