DESCRIPTION (provided by applicant): BioElectroMed is developing a new medical device called the PulseCure System that utilizes nanosecond pulsed electric fields to eliminate both benign and malignant skin lesions. We have used the PulseCure to treat malignant melanoma and basal cell carcinoma in mice with very high efficacy. With a single, 6-minute treatment using 100 ns pulses, we can trigger complete remission of malignant melanomas without recurrence in nude mice. During this 6 minute treatment period the tumor is only exposed to the electric field for total of 200 5s yet this stimulates pyknosis, apoptosis, DNA fragmentation and reduces blood flow to the tumor. This results in a mean tumor size regression of 90% within two weeks and complete remission within 1 month. We have developed a new suction electrode design for use on much thicker human skin and have demonstrated the efficacy of this new design on the mouse model. We also developed a microprocessor-controlled pulse delivery system for easy use in the clinical trials of the PulseCure. Here we propose to optimize the pulse parameters using the most effective suction electrode configuration to minimize treatment time and make several improvements to the PulseCure system necessary for human trials. These improvements include reducing electromagnetic interference, implementing safety features required by the ANSI/AAMI ES60601-1 and ES60601-2 standards, fabricating an adjustable arm to facilitate electrode placement on humans, developing a computer interface to record both patient and treatment data and automation of matching resistor selection and spark gap spacing. We will then conduct a feasibility study treating human skin scheduled for removal from patients during a plastic surgery procedure as well as Basal Cell Carcinomas on volunteers with Basal Cell Nevus Syndrome. Next we will conduct a Pilot Clinical Trial treating 30 basal cell carcinomas on 10 patients with Basal Cell Nevus Syndrome. If the PulseCure can reliably eliminate malignant skin lesions, it would offer a welcome, non-surgical and perhaps 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 PulseCure, for treating both benign and malignant skin lesions. The PulseCure uses ultrashort electrical pulses to trigger skin tumors to self- destruct. It offers a non-surgical therapy that may be a scar-free and could improve the quality of life for tens of thousands of dermatology patients.

Project Narrative: We are developing a new medical device, the PulseCure, for treating both benign and malignant skin lesions. The PulseCure uses ultrashort electrical pulses to trigger skin tumors to self- destruct. It offers a non-surgical therapy that may be a scar-free and could improve the quality of life for tens of thousands of dermatology patients.