SBIR Phase II: A medical device based treatment of onychomycosis

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to provide a safe and effective cure for fungal nail infections. In addition, the technology developed in this project could be utilized in other healthcare treatments such as skin and wound disinfection, decontamination of teeth and gums (oral hygiene), and the sterilization of medical instruments and implanted devices. Fungal nail infection rates are growing at an estimated 7% annually following both the general aging of the population and the rise in the incidence of diabetes. 50% of elderly over the age of 70 and 30% of all diabetics are affected. For many people, their infected nails are painful and embarrassing. Worst of all, diabetics with fungal nail infections are at increased risk for foot ulcerations, gangrene, and amputation. 38 million Americans suffer from nail fungal infections and spend over $3 billion dollars each year on treatments that are ineffective and sometimes unsafe. People suffering with nail fungal infections express widespread dissatisfaction with the limited success, side effects, high cost and inconvenience of current treatments. The proposed project will complete prototype development of a novel, safe, and effective treatment option for onychomycosis (nail fungal infection). The medical device will allow a doctor to fumigate the infected nail with gas because gas can penetrate the nail and kill the fungus where all other treatments cannot reach. The human toe nail lacks a blood supply to deliver optimal immune system protection to fight off fungal infections. This project will develop a device that converts the air above the surface of the toe nail into the same gases used by the immune system to fight infection. Hence, the gas treatment would safely mimic the normal blood supply of anti-microbial chemicals. This SBIR project will reduce technical development risks, improve the device usability by doctors, and establish the manufacturability of the device. Device prototypes will be validated in the laboratory and with users (Podiatrists). The clinical-ready prototypes developed during this project will be used in future clinical trials that will prove the efficacy and safety of the device needed to sell the product. The device promises to fulfill the unmet medical need for a safe and effective treatment option for the millions of Americans suffering with fungal infected nails.