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

描述（由申请人提供）： BioElectroMed正在开发一种名为NANOTOUCH的新医疗设备，该设备将利用纳秒脉冲电场消除良性和恶性皮肤病变。我们已经使用NANOTOUCH治疗了三种不同的小鼠恶性病变，恶性黑色素瘤、鳞状细胞癌和基底细胞癌。用总共300个持续时间为300 ns的电场脉冲，我们能够在所有这三种肿瘤类型中触发坏死和凋亡。我们已经完成了一项长期研究，其中在每只小鼠中治疗了一个黑素瘤。这种脉冲场疗法表现出100%的疗效，并导致17只动物在平均48天内完全消退，至少150天没有复发。使用NANOTOUCH治疗这些恶性皮肤病变，总电场暴露时间至多仅为120秒，可快速刺激肿瘤细胞内的固缩，减少流向肿瘤的血流，并在体内引发小鼠黑色素瘤肿瘤的坏死和凋亡。这导致两周内平均肿瘤大小消退90%。在我们获得FDA许可在人体临床试验中使用NANOTOUCH之前，我们必须开发一种新的电极设计，用于更厚的人类皮肤，然后必须在小鼠模型上证明这种新设计的有效性。我们将测试四种抽吸电极配置与人类皮肤的兼容性，然后确定哪种配置在消除具有人类基底细胞癌大部分特征的小鼠模型中的基底细胞癌方面最有效。我们还将开发可用于NANOTOUCH临床试验的脉冲输送系统。如果NANOTOUCH能够可靠地消除良性和恶性皮肤病变，它将提供一个受欢迎的，无疤痕的替代手术，可以提高成千上万的皮肤病患者的生活质量。 公共卫生相关性： 我们正在开发一种新的医疗设备，NANOTOUCH，用于治疗良性和恶性皮肤病变。NANOTOUCH使用超短电脉冲触发皮肤肿瘤自毁。它提供了一种无疤痕的手术替代方案，可以提高成千上万皮肤病患者的生活质量。

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.