This proposal continues the development and testing of a novel, safe, and effective treatment device for onychomycosis (nail fungal infection). Onychomycosis is a common infectious disease with potentially serious consequences. The infected nail is a persistent reservoir for microbes that can lead to significant medical problems including cellulitis, skin ulceration, and gangrene. Over 38 million Americans suffer from onychomycosis, which carries a direct cost of over $4 billion in the US healthcare system. Unlike current oral treatments that may cause liver damage, or topical creams and lasers that have low or unproven efficacy, the device under development in this grant offers patients and doctors a reliable, convenient method to treat nail fungal infections without toxic side effects. I this project, we will test our patent-pending technology on human patients to prove the clinical feasibility of treating fungal infections with our medical device prototype. Our critical success metric for this Phase II project is mycological cure (i.e., 100% fungal killing) and clear nail growth in onychomycosis patients. This is a necessary step to reduce technical risk in the ultimate development of an FDA-approved medical device for curing onychomycosis. In support of our product goal, we propose to answer four critical questions related to the utility of this novel device: 1)Do the three clinical instruments pass validations testing to show consistent and similar performance?; 2)Is the instrument functional in a clinical setting as related to user instructions, user interface and human factor analysis?; 3) Can performing a three treatment protocol over a week result in mycological cure for the patient?; 4) Will the treatment result in clear nail growth for the patient over a 6-month interval?

Public Health Relevance

This project will perform human feasibility testing with a robust technology that can act as a therapeutic cure for onychomycosis (fungal nail). The public health significance of this product is a cure that improves the quality of life for the 38 million infected Americans. The use of a medical device to topically treat fungal nail infection would supply a safe and effective tool to the medical practitioner for treatment of onychomycosis and possibly other skin diseases. However, it also addresses issues of importance to microbial resistance. A central hypothesis in our application is that the reactive oxygen and nitrogen species (RONS) created in nonthermal plasmas sterilize the infecting microbes in ways that are similar to the actions of the human immune system. RONS ability to target many essential processes of microbial pathogens results in broad antimicrobial activity that is difficult for micr-organisms to completely circumvent and could result in a sustainable antimicrobial strategy. If the core platform technology is able to produce a broad spectrum kill of microbes, it would also have uses in wound disinfection, decontamination of teeth and gums (oral hygiene), and the sterilization of medical instruments and implanted devices. The current studies in this application will establish a knowledge base to support future work to more extensively examine issues of treatment efficacy and safety on humans.

National Institute of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1)
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Cole, Alison E
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Devicefarm, Inc.
United States
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