Pulse Biosciences, Inc. (Nasdaq:PLSE) has begun a clinical study to evaluate nano-pulse stimulation (NPS) platform in a common skin cancer, basal cell carcinoma (BCC).
NPS is a non-thermal therapy that uses ultra-short, nanosecond-pulsed electric fields that directly affect and disrupt intracellular structures. It has been shown to induce immunogenic cell death in pre-clinical cancer models, according to the company.
Study participants will be treated with NPS prior to resection of the BCC lesion, which is the standard of care for such lesions. Post-resection tissue samples will be assessed for the elimination of the lesion in the NPS treatment zone and for biomarkers indicating an immune response to the NPS-treated lesions.
The Hayward, Calif. startup withdrew the FDA 510(k) application for its PulseTx NPS system on September 11, 2017, saying it failed to meet a deadline for submitting requested information to the agency. The company has said it intends to refile.