SBIR Phase I: Intravascular Drug Delivery Using Microneedle Arrays

This Small Business Innovation Research (SBIR) Phase I research project will determine the feasibility of using microneedles for localized drug delivery to treat various diseases, particularly cardiovascular disease. Percutaneous transluminal coronary angioplasty (PTCA) has become established as a viable approach for coronary revascularization in the treatment of coronary artery disease. Restenosis occurs when the treated vessel becomes blocked again due to the vessels self-healing reaction to damage caused by the PTCA procedure. Recent animal studies have shown that local delivery of therapy into the coronary arterial wall significantly reduces restenosis following stent injury. This projects solution for restenosis prevention is to use silicon microneedle arrays mounted onto special balloon catheters for delivery of drug directly into the vessel wall. The proposed microneedles are fabricated using MEMS (microelectromechanical systems) technology and arrayed in a unique pattern for intracoronary usage. Commercially, the application is to use novel microneedles and balloon catheter system as a method for prevention of restenosis. The balloon angioplasty procedure is used to treat blocked arteries in over 600,000 patients annually in the United States and restenosis usually occurs within 6 months after the initial procedure. Since MEMS microneedles are batch fabricated, low manufacturing costs are realized. Thus, use of microneedles could displace expensive drug-eluting stents, the current gold standard for restenosis prevention, resulting in an order of magnitude reduction in health care costs. Furthermore, microneedles could be used to treat vulnerable plaques, which are the leading cause of heart attacks. Estimates place the vulnerable plaque market in the $10B range. Other applications for the microneedle platform technology include treatment of diabetes and cancerous tumors.