Pulse Biosciences, a medical technology company developing a proprietary therapeutic treatment platform based on Nano-Pulse Stimulation (NPS), announced the treatment of the first patient using the PulseTx System in a pilot study in dermatology.
The PulseTx System is an NPS platform designed for broad application across many therapeutic tissue treatment indications, including in immuno-oncology, dermatology, general tissue treatment applications, and veterinary medicine.
The novel and highly versatile system is comprised of a tunable nanosecond pulse electrical generator capable of generating pulses of varying pulse duration, amplitude, frequency and number.
These are the fundamental parameters of NPS therapies and enable the PulseTx System to stimulate unique biological responses in cells, such as programmed cell death, or apoptosis, across a wide variety of tissue types.
The PulseTx System is designed with a tunable nanosecond pulse generator to utilize a suite of interchangeable tissue applicators customized to the tissue being treated and the manner in which that tissue may be accessed to enable treatments across a wide variety of applications.
This first treatment in dermatology utilizes applicators designed for the treatment of superficial skin lesions. Additional applicators are currently in design to enable the use of the PulseTx System in a number of pilot studies as Pulse pursues various vertical markets.
The PulseTx System is the first and only NPS system designed with the potential to be used across multiple applications for human medicine.
“We’ve worked closely with key opinion leaders during the development of the PulseTx System in preparation for entry into the clinic, and we are excited to have reached this important milestone of using the PulseTx System under an IRB approved protocol in dermatology,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences.
“This is an important step in our previously communicated strategy of developing a single NPS platform that can be used to pursue a number of pilot studies across different applications. The insights we gain from this first pilot study will enable us to move quickly into application specific studies both in dermatology, one of our key vertical markets, and in other markets.”
The five-patient, dose-response dermatology study will use the PulseTx System on abdominal skin that will later be resected during a standard abdominoplasty (“tummy tuck”). The objective of the study is to establish the response and recovery time of the skin to different NPS doses.
“We are proud to be the first center in the United States to have the opportunity to use this groundbreaking system in the study of a unique non-thermal treatment modality,” noted study principal investigator David Kaufman, MD.
“Preclinical research suggests that the PulseTx System has the potential to meet an important patient need, and the treatment of the first patient with this novel medical technology marks an important step toward improving therapeutic outcomes for a variety of dermatologic conditions.”
Pulse Biosciences has identified several potential opportunities to treat important dermatologic conditions, such as warts, seborrheic keratosis, actinic keratosis, squamous cell carcinoma, and basal cell carcinoma.
The data from its dermatology studies may also inform the company’s immuno-oncology clinical programs, which will likely focus on skin cancers.