On April 12, 2018 Pulse Biosciences, Inc. (Nasdaq:PLSE) reported clinical efficacy results of its first multi-center study of Nano-Pulse Stimulation (NPS) technology for the treatment of seborrheic keratosis lesions (SKs) in humans (Press release, Pulse Biosciences, APR 12, 2018, View Source [SID1234525290]). The findings will be featured at the 2018 American Society for Laser Medicine and Surgery (ASLMS) Annual Conference to be held in Dallas on April 11-15, 2018. The company also will present data from the first-in-human clinical study of NPS dose-response effects. These definitive studies establish the foundation for future therapeutic applications of NPS across a range of benign and cancerous skin growths.
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"We were pleased that histology results and clinical findings from the dose response study were predictive of the high lesion clearance rates observed in our first controlled study of a seborrheic keratosis treatment"
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In the clinical trial of SK elimination using the novel, non-thermal NPS technology, seborrheic keratosis lesion reduction assessments of a single, localized SK treatment showed that 82% of 174 treated lesions were rated as clear or mostly clear after 106 days in 58 adult patients. An independent, blinded photographic review of lesion images scored 71% of lesions as clear or mostly clear. Patients rated 78% of lesion outcomes as satisfied or mostly satisfied, closely mirroring investigator ratings.
Thomas Rohrer, MD, a leading dermatologic and Mohs skin cancer surgeon in Boston, MA will present study results on Friday, April 13 at 4:37pm CST in a talk titled First Clinical Use of Non-Thermal Nano-Pulse Stimulation to Eliminate Seborrheic Keratosis Lesions. "These impressive results demonstrate the reliable removal of SK lesions with a single treatment using NPS technology," said Dr. Rohrer. "Pulse’s NPS technology has made a significant leap from very promising pre-clinical results to its first successful application in the removal of a common benign skin lesion with consistent results observed at each of the four top medical centers participating in the study. This unique mechanism of action of non-thermal NPS shows great potential for treating a range of benign and non-benign skin lesions."
In addition to Dr. Rohrer, other investigators in the SK trial included dermatologist George Hruza, MD, a Mohs skin cancer surgeon in St. Louis, MO; facial plastic surgeon James Newman, MD, Chief of Plastic Surgery at Premier Plastic Surgery Clinics in the San Francisco Bay Area, CA; and dermatologist Brian Zelickson, MD of Minneapolis, MN, who is widely recognized for his research in skin tissue effects related to energy-based devices.
The second publication of Pulse Biosciences research at the energy-based science and medicine conference was conferred the ASLMS Best of Basic Science and Translational Research Award. The winning paper is titled A Dose-Response Study of a Novel Non-Thermal Method of Selectively Modifying Cellular Structures in Skin with Low Energy Nanosecond Electrical Stimulation. Clinical results showed that NPS demonstrates a non-thermal mechanism for targeting cellular structures with very low-grade inflammation that does not affect the viability of the non-cellular dermal tissue across a wide range of energy levels as evaluated by clinical and histological responses observed in human skin. This research will be presented on Friday, April 13 at 10:05am CST.
According to dermatopathologist Dr. Mehregan, "Our dermatopathology lab analyzed over 200 biopsy samples from NPS-treated human skin and observed a pattern of unique cellular-effects that spared the non-cellular dermis at most energy doses. These basic tissue findings demonstrate real promise for clinical studies of multiple future clinical applications."
Publication co-authors included plastic surgeon David Kaufman, MD, Folsom, CA; Michelle Martinez, RN, BSN, of Kaufman Plastic Surgery in Folsom, CA; Brian Zelickson, MD; David Mehregan, MD, of Detroit and Monroe MI; and Pulse Biosciences contributors Richard Nuccitelli, PhD, Edward Ebbers, and Lauren Jauregui.
"We were pleased that histology results and clinical findings from the dose response study were predictive of the high lesion clearance rates observed in our first controlled study of a seborrheic keratosis treatment," said Ed Ebbers, Vice President and General Manager of Dermatology at Pulse Biosciences. "These impressive safety results and robust SK efficacy rates increase our confidence in future planned study treatments of other benign lesions, such as keloids and warts, and non-benign skin lesions."
"The presentation of our initial NPS clinical data at the prestigious ASLMS annual meeting is an important milestone for our dermatology program and Pulse Biosciences, as we continue to build the evidence in support of NPS as a unique and compelling treatment modality across a number of applications," added Darrin Uecker, President and CEO of Pulse Biosciences.
For more information: NPS study data presented at 2018 ASLMS Annual Meeting
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About the SK Study
Fifty-eight (58) adult subjects in four clinical centers were required to have at least four (4) off-face lesions within study criteria for size, and a clinical diagnosis of SK. A local anesthetic was injected prior to treatment with the NPS device. Three lesions were treated in a single session, and one lesion was left untreated as a control. Subjects returned five times over a 106-day period for physician assessment of SK lesions and the cosmetic appearance of treated areas.
About Seborrheic Keratoses
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. 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.