Development of a nanosecond pulsed electric field system to treat skin cancer

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DESCRIPTION (provided by applicant): BioElectroMed is developing a new medical device called the NANOTOUCH that will utilize nanosecond pulsed electric fields to eliminate both benign and malignant skin lesions. We have used the NANOTOUCH to treat three different malignant lesions in mice, malignant melanoma, squamous cell carcinoma and basal cell carcinoma. With a total of 300 electric field pulses 300 ns in duration we are able to trigger both necrosis and apoptosis in all three of these tumor types. We have completed a long-term study in which a single melanoma was treated in each mouse. This pulsed field therapy exhibited 100% efficacy and resulted in complete regression within an average of 48 days in the 17 animals treated without recurrence for at least 150 days. Treating these malignant skin lesions with a total electric field exposure time of at most only 120 <s with the NANOTOUCH rapidly stimulates pyknosis within the tumor cells, reduces blood flow to the tumor and triggers both necrosis and apoptosis in murine melanoma tumors in vivo. This results in a mean tumor size regression of 90% within two weeks. Before we can obtain permission from the FDA to use the NANOTOUCH in human clinical trials, we must develop a new electrode design for use on much thicker human skin and then must demonstrate the efficacy of this new design on a mouse model. We will test four suction electrode configurations for compatibility with human skin and will then determine which of these is the most effective at eliminating basal cell carcinomas in a mouse model that has most of the characteristics of human basal cell carcinoma. We will also develop a pulse delivery system that can be used in the clinical trials of the NANOTOUCH. If the NANOTOUCH can reliably eliminate benign and malignant skin lesions, it would offer a welcome, scar-free alternative to surgery that could improve the quality of life for tens of thousands of dermatology patients. PUBLIC HEALTH RELEVANCE: We are developing a new medical device, the NANOTOUCH, for treating both benign and malignant skin lesions. The NANOTOUCH uses ultrashort electrical pulses to trigger skin tumors to self-destruct. It offers a scar-free alternative to surgery that could improve the quality of life for tens of thousands of dermatology patients.