Pulse Biosciences Announces First Clinical Use Of The Proprietary Pulsetx Platform In A Pilot Study In Dermatology

PulseTx System Enters Clinic in First of Multiple Potential Applications

BURLINGAME, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc., (NASDAQ:PLSE), a medical technology company developing a proprietary therapeutic treatment platform based on Nano-Pulse Stimulation (NPS), today announced the treatment of the first patient using the company’s proprietary and first-of-its-kind PulseTx System in a pilot study in dermatology.

“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.”

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.

About Pulse Biosciences

Pulse Biosciences is a medical technology company developing a therapeutic tissue treatment platform based on Nano-Pulse Stimulation, a proprietary bioelectronics cell signaling technology. Published pre-clinical studies have shown that a single, brief exposure of Nano-Pulse Stimulation to target tissue stimulates a cascade of events within cells and in the surrounding microenvironment that results in apoptosis (cell death) and the priming of a durable adaptive immune response. Pulse Biosciences is pursuing a variety of applications for its technology that exploits the technology’s unique biologic effect in immuno-oncology, dermatology, aesthetics, and veterinary medicine. Clinical studies are being planned using the first commercial system designed to support a broad array of applicators for use in superficial, minimally-invasive and open surgical procedures. More information is available at www.pulsebiosciences.com.

Forward Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding or implying clinical studies and the anticipated benefits, products, applications for products and other similar statements about future events. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, changes in circumstances and other factors that are, in some cases, beyond our control and could cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Factors that could materially affect actual results can be found in our most recent filings with the Securities and Exchange Commission, including our most recent Registration Statement on Form S-1, as amended, and Quarterly Report on Form 10-Q, and include those listed under the caption “Risk Factors.” These forward-looking statements speak only as of the date hereof. Pulse Biosciences undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available.