SBIR-STTR Award

This Small Business Innovation Research Phase I Project aims to design and develop a process for applying nanocomposite coatings of multiple components to the surfaces of small parts with intricate geometry using a novel electronanospray process. Electronanospray generates monodisperse streams of highly uniform nanoparticles. The primary objectives of this proposal are to define key process conditions that are needed to coat drug-eluting coronary artery stents. Specifically, it will determine the impact of particle size (nanoscale 20 to 500 nm range) and the composition and number of spray stream components (2 or more) on coating thickness and uniformity, and nanocomposite composition and surface qualities. The process can coat biodegradable polymers, drugs and biotherapeutics on surfaces with intricate geometry. Advantages of this coating technology include a high transfer efficiency uniformity, non-line-of-sight coating, and the ability to combine multiple active agents in a single coating operation. Commercially this technology has application not only for coating medical devices but also modifying the surface of other small intricate parts where the nanocomposite coating enables new functionality. The drug-eluting (coated) stent market is growing rapidly and is predicted to exceed $6 billion by 2008. A novel coating process would capture a significant revenue stream if it could provide higher yield, greater quality and thereby lower costs, while at the same time offering improved therapeutic potential and improved human health by eliminating the need for high risk surgery. For example, improved coatings could enable longer-term activity of the implants with one or more therapeutic agents or diminish late side effects, such as thrombosis or scarring, that are now beginning to appear with current generation implants. The commercial value extends beyond the medical device implant market (e.g. aerospace applications, sensing technologies) if it can be demonstrated that this coating process can be used for applying other nanocomposite, multi-functional coatings to very small surfaces

This Small Business Innovation Research (SBIR) Phase II project is focused on designing, prototyping, and fully qualifying a proprietary manufacturing apparatus capable of applying a range of next-generation coronary stent coatings. First generation drug-eluting coronary stents have significantly improved clinical outcomes for heart patients, while concurrently highlighting the potential for substantial improvements. Next-generation methods are needed for improving the way drugs and other biologics are applied to the stent, as well as for active-agent release from the stent. The company successfully demonstrated in Phase I that its proprietary ElectroNanospray process could reproducibly apply nanocomposite drug/polymer coatings onto the intricate architecture of a coronary stent and could consistently meet preliminary specifications provided by a potential commercial partner. This Phase II project will extend that R&D by producing a manufacturing
Apparatus designed to significantly improve process control features and throughput. Rigorous step-wise hardware-qualification experiments will generate test lots of coated stents for further characterization and validation by the same partner. Feedback will guide design iterations needed to optimize this unique manufacturing capability, with the goal of producing an apparatus that coats stents with a broad range of novel nanocomposite coatings and drug-release properties for preclinical testing and meets the stringent performance requirements for commercial manufacturing in a regulated environment.


Commercially, sales of drug-eluting coronary stents will exceed $6 billion in 2006. With the first products entering the market in 2003, this represents the fastest market introduction in medical device history. The drug-eluting stent showed that the body's inflammatory and scarring response to the implanted bare metal stent, which resulted in re-blockage of the artery, could be overcome by applying thin layers of drug-releasing polymers to the stent surface. The broader implications are that coatings that enable site-specific delivery of biologically active compounds could improve the clinical performance of a wide variety of medical device implants, not only for cardiovascular indications, but also for use in orthopedic, neurology and tissue engineering applications. In addition, using the drug-eluting stent as an example, they offer the possibility of bringing about the same or improved clinical outcomes as existing therapies, while reducing cost, hospital length of stay, and loss of productivity by the patient. The novel manufacturing apparatus proposed in this research will have the ability to create and apply engineered nanocomposite coatings to device implants that incorporate novel active agents and controlled-release properties not possible with today's conventional coating processes, thereby offering the possibility of improved clinical outcomes for a wide variety of diseases