HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company bringing to market its proprietary CellFX™ System harnessing Nano-Pulse Stimulation™ (NPS™) technology, today announced that it will present results of three clinical studies demonstrating high clearance rates across its benign skin lesion portfolio during the upcoming American Society for Dermatologic Surgery (“ASDS”) annual meeting on October 24-27, in Chicago. The data will span the company’s CellFX procedure using NPS non-thermal energy in clearing Sebaceous Hyperplasia lesions, non-genital warts and back acne. The cellular-specific NPS technology was also selected to be featured at the opening Plenary Session, which highlights cutting-edge science and emerging therapies in dermatologic surgery.
“The breadth and depth of the clinical data we are presenting at ASDS points to the tremendous progress we are making collaboratively to advance our CellFX System across a broad range of benign lesions,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “These results reflect the ongoing commitment needed to introduce the CellFX System into the clinic to improve clinical outcomes and quality of life for patients.”
In prior studies, investigator assessments concluded that the NPS procedure met efficacy endpoints in 99.5% of Sebaceous Hyperplasia lesions and 82% of Seborrheic Keratosis lesions along with normal and expected skin recovery periods. NPS technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent healthy, non-cellular tissue.
Dr. Tom Rohrer, a dermatologic surgeon in private practice at SkinCare Physicians in Boston, MA, and former president of the ASDS, will spotlight NPS technology in his lecture at the “Emerging Therapies” plenary of the Society’s annual meeting.
“I am excited to share the science and clinical data on NPS technology because it is a first-of-its-kind bioelectric technology that is genuinely different from existing energy-based devices,” said Thomas Rohrer, MD. “In our clinical experience, as well as in peer-reviewed published studies, the cellular mechanism of NPS energy points to a rapidly evolving and dynamic new technology with a tremendous amount of upside for our patients.”
ORAL PRESENTATIONS:
Abstracts |
Lead Authors |
Key Findings |
Schedule |
First Clinical Use of Non-Thermal Nano-Pulse Stimulation Technology for Treating Cutaneous, Non-Genital Warts [Feasibility Study]
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E. Victor Ross, MD,
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The high rate of wart size reduction suggests the utility of the unique NPS cellular mechanism for the treatment of non-genital, cutaneous warts. In two instances, the control wart showed 100% reduction in size, suggesting there may be an immune response. Based on these initial results, a larger pivotal study is warranted and will be conducted in the future.
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Thursday,
General
Oral Abstracts
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A Feasibility Study for the Treatment of Moderate to Severe Acne Vulgaris of the Back Using Nano-Pulse Stimulation Energy
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Mark S. Nestor, MD,
Brian Berman, MD,
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Initial data of two male patients suggests the positive effect of treating back acne with NPS energy. A larger study is needed to validate these promising early results and to focus on achieving similar acne lesion reduction efficacy while minimizing the rate and extent of hyperpigmentation. |
Thursday
General Dermatology
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Emerging Therapies in Dermatologic Surgery
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Thomas Rohrer, MD |
An overview of the science, mechanism and clinical uses of Nano-Pulse Stimulation technology for clearing benign and malignant skin lesions. |
Thursday,
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A Multicenter, Pivotal Study Using the Nano-Pulse Stimulation Procedure to Treat Sebaceous Hyperplasia Lesions [Optimization Study] |
Girish Munavalli, MD
Brian Zelickson, MD,
Elizabeth Tanzi, MD
|
This second study of SH lesions evaluated the use of lower energy levels for relative efficacy and recovery periods, as well as lower side effect profiles.
The data reaffirms that NPS technology is an effective method for safely clearing SH lesions. The reduced energy levels utilized in this study demonstrated similar levels of efficacy as in the previous study, while reducing the time of normal skin recovery and decreasing the rate and duration of residual skin effects, such as hyperpigmentation and volume loss.
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Thursday,
Cosmetic Derm
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About Pulse Biosciences
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that improves and potentially extends the lives of patients. The CellFX System is the first planned commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation (NPS) technology to treat a variety of applications for which an optimal solution remains unfulfilled. NPS technology delivers nano-second pulses of high amplitude electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The cell-specific effects of NPS technology have been validated in a series of ongoing clinical trials. The CellFX System is preparing to launch in 2019 as a multi-application platform designed to address a broad range of dermatologic conditions. As part of the customer experience, the Company is offering a utilization-based revenue model and easy-access customer portal offering a suite of services. CellFX procedures offer customer value across an expanding spectrum of clinical applications. The initial commercial use will be in the clearance of common and difficult to treat skin lesions that share high demand among patients and practitioners for improved and durable aesthetic outcomes that lead to greater overall satisfaction.
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding regulatory clearance and the timing of FDA filings or approvals, the mechanism of action of NPS treatments, current and planned future clinical studies, other matters related to its pipeline of product candidates, future financial performance 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.
