SBIR Phase II: Venous Valve Prosthesis as a Cure for Chronic Venous Insufficiency

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to develop a medical device for valve replacement treatment of chronic insufficiency of the veins (CVI). Currently, no definitive treatment option exists to address the underlying cause of the disease, valvular reflux, which leaves millions of patients with chronic venous ulcers, skin thickening, and pain for years to decades. When brought to market, the proposed novel prosthetic valve and delivery system will provide a viable curative therapy superior to current treatment options and mitigating complications associated with existing valve prostheses, such as thrombosis and valve incompetence. The proposed product will curtail substantial health care expenditures associated with CVI, such as wound care, hospitalizations for infections, and associated secondary procedures. Because implantation of this valve does not require the complex or invasive surgical interventions of existing technologies, its use also will avoid expenses associated with open surgical procedures and rehabilitative care. The commercialization of this innovation is expected to benefit CVI patients, while significantly reducing costs. This SBIR Phase II project aims to develop a novel, reliable, and marketable prosthetic valve and delivery system for the treatment of incompetent veins. In Phase I, a design was created for a device that exceeded laboratory and animal benchmarks. Phase II proposed development improves the design for broader deployment by demonstrating the the valve's ability to minimize thrombosis as well as the capability to be produced at scale. Phase II objectives are to: 1) Develop and produce the next generation valve for in vitro and animal testing; 2) Compare safety of valve designs in an in vitro study; 3) Demonstrate the safety and efficacy of the leading design in a chronic animal study; 4) Complete biocompatibility testing on the design to ensure it is appropriate for human testing; and 5) Establish manufacturability of the device. These steps will provide the foundation for future clinical trials to demonstrate safety and efficacy of the device in humans. 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.