Using Targeted, Controlled High Frequency Energy for Treatment of Onychomycosis

Onychomycosis is a painful, debilitating fungal infection of the nail that afflicts over 5% of the global population and accounts for 50% of all nail disorders. In the United States alone, $1.6B is spent annually on minimally effective drug-based treatments, some of which have significant side effects, including liver failure. A newly emerging problem is resistance of fungi that cause onychomycosis to the drugs that have long been used to treat them. Risk factors for developing onychomycosis include diabetes mellitus, advanced age, obesity, smoking, nail trauma, and genetic predisposition. When patients with diabetes get onychomycosis, they are at increased risk of serious problems, such as foot ulcers, secondary infections, and amputation. 80-90% of onychomycosis is caused by a group of fungi called dermatophytes, specifically, Trichophyton rubrum. It is now known that the same dermatophytes that cause onychomycosis can rarely cause deep and disseminated infection in immunocompromised patients. A drug-free method for treating onychomycosis will help to preserve the effectiveness of antifungal agents for when they are needed to treat deep and disseminated infections in these vulnerable patients. Therefore, there is a significant unmet public health need for a safe, effective drug-free treatment for onychomycosis. Accure Medical is developing the TherawaveTM 100 that will specifically address all the limitations of current treatment options by delivering precise amounts of High Frequency Energy (HFE) to the location of the infection which resides within the patient’s nail plate and within the keratinized surface of the nail matrix and bed. The HFE source integrates with a custom applicator that attaches to the patient’s digit to deliver a brief, safe and effective treatment precisely to the target zone using custom algorithms. A novel, non-invasive approach to measuring, monitoring, and precisely controlling treatment temperature is incorporated into the device to deliver the energy at safe temperatures. Accure’s SBIR Phase II direct will focus on four Aims: (1) Proving reproducibility of reflective temperature measurement for patient applicator, (2) Designing HFE amplifiers and creating a multiple-applicator system to distribute power from a single unit to treat multiple patient digits, (3) Design of custom patient applicators for evenly disbursing the energy across a patient’s nail to increase the treatment efficacy, and lastly, (4) Optimizing system ergonomics for attachment of applicator to patient digits capable of accommodating variability of different patient nail sizes, nail topographies, and nail thicknesses. Achievement of these Aims will enable the development and commercialization of a highly effective treatment device that can be easily used in a hospital or outpatient clinic environment. Accure is targeting a clinical cure rate of >80% for onychomycosis. The prevalence of onychomycosis globally is ~5.5%, or ~430M people. The current global treatment market is over $4 billion.