BURLINGAME, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq:PLSE), a medical technology company developing a therapeutic tissue treatment platform based on its proprietary Nano-Pulse Stimulation (NPS) technology, today announced treatment of the first patient in the Company's multi-center study evaluating the safety and efficacy of the NPS technology for the treatment of seborrheic keratosis (SK). SK is one of the most common types of skin lesions, impacting over 80 million patients in the United States.
"We are excited to announce the first patient treatment in this important study of our NPS technology for a common skin lesion, one of many types of skin lesions for which NPS's non-thermal cellular mechanism is uniquely well suited," stated Ed Ebbers, Vice President and General Manager of Dermatology at Pulse Biosciences.
The recently initiated study is expected to include treatment of at least 45 adult patients with four or more non-facial SK lesions. The presence or absence of lesions will be evaluated over the course of the 106-day period following NPS treatment. Pulse Biosciences expects the study to be completed by the end of 2017.
"As an investigator on this study, I am excited to be involved in evaluating this novel approach for treating SK lesions. I believe that Nano-Pulse Stimulation has the potential to provide patients with a unique option that is quick and easy to perform with a potentially favorable cosmetic outcome when compared to current treatment options, such as cryotherapy or electrodessication" said James Newman, MD, FACS, the Stanford University-trained Chief of Plastic Surgery at Premier Plastic Surgery Clinics in San Mateo and Palo Alto, CA. "I frequently see patients who are looking for an effective, cosmetically appealing and patient-friendly treatment option for these lesions."
In addition to Dr. Newman, principal investigators in the multi-center study include dermatologists George Hruza, MD, in St. Louis, MO, Thomas Rohrer, MD, in Boston, MA, and Brian Zelickson, MD, in Edina, MN. David Kaufman, MD, a plastic surgeon in Folsom, CA, and the principal investigator in the Company's previous dose-response study, will also be enrolling patients for the study.
"We continue to make excellent progress towards demonstrating the benefits of NPS across a number of compelling application areas," said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. "The first patient treatment in this seborrheic keratosis study is an important milestone for Pulse Biosciences and our dermatology program. We believe NPS offers a unique and compelling treatment profile for both benign and non-benign skin lesions."
About Seborrheic Keratosis
Seborrheic keratosis (SK) typically appears as a raised skin lesion with a waxy, scaly texture that can vary in color from light tan to dark brown or black. It affects more than 80 million people in the United States, and is often associated with aging skin. A recently published study in the Journal of Clinical and Aesthetic Dermatology found that 61% of patients took action to hide, disguise, or distract attention from their SK lesions. The published study also noted that 86% of SK sufferers were somewhat or extremely interested in a removal treatment in a dermatologist's office and willing to pay a reasonable out-of-pocket fee.
The treatment of the first patient in the Company's SK study announced today represents Pulse Biosciences' first endeavor into the self-paying aesthetic and medical dermatology markets, which are expected to grow to $12 billion and $29 billion, respectively, by 2020, according to data obtained from MarketsandMarkets and GBI Research. The selection of SK as the initial dermatology target application for NPS builds upon the data derived from the Company's earlier clinical data in dermatology suggesting the unique cellular response from NPS provides a favorable profile for successfully treating SK, in addition to other dermatological conditions. Leading clinicians generally agree that the effective treatment of SK lesions with a non-surgical and nonthermal procedure represents a highly desired alternative to patient inaction due to limitations of existing treatments.
Pulse Biosciences' NPS treatment is expected to offer clinicians and patients an efficient, patient-friendly treatment alternative that takes advantage of NPS's unique treatment characteristics. Specifically, NPS's non-thermal destruction of undesired skin lesions results in a minimal inflammatory response while maintaining healthy structures of the treated tissue, thereby resulting in a favorable healing profile and positive cosmetic result. Current treatments are often invasive, painful, or carry a significant risk of undesired cosmetic results such as scarring or pigment changes. Over two-thirds of SK lesion removal procedures currently entail cryosurgery, which uses the extreme cold of liquid nitrogen (-320 degrees Fahrenheit) to destroy lesions. Other less frequently used methods include extreme heat (high energy lasers or radio frequency energy) to burn off SK lesions or the scraping/shaving of SK lesions using a surgical tool called a curette. Sometimes multiple methods are required to remove thicker lesions.
About Nano-Pulse Stimulation
Nano-Pulse Stimulation (NPS) is a non-thermal, energy-based technology that can stimulate unique behaviors in cells by applying ultra-short nanosecond duration electrical pulses that affect the cell membrane and intracellular structures. NPS can be used for lesion removal by inducing cell death in targeted tissue cells with minimal inflammatory response, which improves healing and supports the replacement of treated tissue cells with healthy tissue cells.
About Pulse Biosciences
Pulse Biosciences is a medical technology company developing a therapeutic tissue treatment platform based on Nano-Pulse Stimulation, a proprietary cell signaling technology. Nano-Pulse Stimulation is a non-thermal, precise, focal drug-free tissue treatment technology that directly affects the cell membrane and intracellular structures to stimulate unique behaviors in cells. NPS can initiate a cell death process that allows for the treatment of tissue cells with minimal inflammatory response which improves healing outcomes and supports the replacement of treated tissue cells with healthy tissue cells. In cancerous lesions, NPS has been shown in preclinical models to induce immunogenic cell death (ICD) exposing the unique antigens of the treated cells to the immune system, resulting in the generation of cytotoxic T-cells and the mounting of an adaptive immune response targeted against those cells. Pulse Biosciences is investigating a variety of applications for its technology that exploits the technology's unique biologic effect, including immuno-oncology, dermatology, and veterinary medicine. More information is available at www.pulsebiosciences.com.
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences' current and planned future clinical studies, the timing and outcomes of such trials, expectations regarding regulatory clearance and the timing of FDA filings or approvals, the mechanism of action of NPS treatments, and other matters related to commercialization of and size and growth of markets for its pipeline of product candidates and other future events. These statements are not historical facts but rather are based on Pulse Biosciences' current expectations, estimates, and projections regarding Pulse Biosciences' business, operations and other similar or related factors. Words such as "may," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expects," "intends," "plans," "projects," "believes," "estimates," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences' control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences' filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.