SBIR-STTR Award

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

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Project narrative:
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.

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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.

Thesaurus Terms:
Abscission;Apoptosis;Apoptosis Pathway;Aspiration, Mechanical;Athymic Nude Mouse;Automation;Bcc;Basal Cell Nevus Syndrome;Basal Cell Carcinoma;Basiloma;Benign;Blood Flow;Carcinoma, Basal Cell, Pigmented;Cell Death, Programmed;Cicatrix;Clinical;Clinical Trials;Clinical Trials, Unspecified;Computer Interface;Dna Fragmentation;Data;Dermatology;Development;Devices;Disease Remission;Documentation;Drainage, Suction;Electrodes;Electromagnetic;Electromagnetics;Epithelioma, Basal Cell;Ethics Committees, Research;Excision;Extirpation;Feasibility Studies;Fifth Phacomatosis;Gorlin Syndrome;Gorlin Syndrome 2;Gorlin-Goltz Syndrome;Heating;Human;Human, General;Hypersensitivity Skin Testing;Irbs;Institutional Review Boards;Lesion;Malignant;Malignant - Descriptor;Malignant Melanoma;Malignant Skin Neoplasm;Malignant Tumor Of The Skin;Mammals, Mice;Man (Taxonomy);Man, Modern;Medical Device;Melanoma And Non-Melanoma Skin Cancer;Mice;Mice, Athymic;Mice, Nude;Microprocessor;Monitor;Murine;Mus;Nevoid Basal Cell Carcinoma Syndrome;Noise;Nude Mice;Operation;Operative Procedures;Operative Surgical Procedures;Patients;Physiologic Pulse;Plastic Surgery Procedure;Plastic Surgical Procedures;Procedures;Protocol;Protocols Documentation;Pulse;Qol;Quality Of Life;Rmsn;Recurrence;Recurrent;Remission;Removal;Research Ethics Committees;Sched;Safety;Scars;Schedule;Skin;Skin Basal Cell Carcinoma;Skin Cancer;Skin Cancer, Including Melanoma;Skin Neoplasms;Skin Tests;Suction;Surgical;Surgical Interventions;Surgical Procedure;Surgical Removal;Syndrome;System;System, Loinc Axis 4;Testing;Thick;Thickness;Time;Treatment Efficacy;Treatment Period;Tumor Of The Skin;Ulcer, Rodent;Work;Arm;Basal-Cell Nevus Syndrome (Bcns);Clinical Investigation;Design;Designing;Electric Field;Hereditary Cutaneomandibular Polyoncosis;Hypersensitivity Test;Immunologic Skin Test;Improved;Jaw Cysts-Basal Cell Tumors-Skeletal Anomalies Syndrome;Melanoma;Mouse Model;Multiple Basal-Cell Carcinoma Syndrome Multiple Basal-Cell Nevus Syndrome;Multiple Hereditary Cutaneomandibular Polyoncosis;Multiple Nevoid Basal-Cell Carcinoma Syndrome;Multiple Nevoid Basal-Cell Carcinoma Syndrome (Mnbccs);Multiple Nevoid Basal-Cell Epithelioma-Jaw Cysts-Bifid Rib Syndrome;Nano Second;Nanosecond;Nevoid Basal-Cell Carcinoma (Nbcc) Syndrome (Nbccs, Nbs);Nevoid Basal-Cell Carcinoma Syndrome;Nevoid Basal-Cell Epithelioma-Jaw Cysts-Bifid Rib Syndrome;Odontogenic Keratocytosis-Skeletal Anomalies Syndrome;Pilot Trial;Plastic Surgery;Prototype;Public Health Relevance;Resection;Response;Skin Lesion;Surgery;Therapeutic Efficacy;Therapeutically Effective;Treatment Days;Treatment Duration;Tumor;Volunteer