HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced positive results from its clinical efficacy study using proprietary Nano-Pulse Stimulation™ (NPS™) technology to treat patients with Sebaceous Hyperplasia (SH), a difficult-to-treat skin condition that typically presents on the face. Initial data indicate that 221 of 222 (99.5%) facial SH lesions treated with NPS energy were rated as clear or mostly clear by clinical investigators 60 days post treatment. NPS is a non-thermal technology that utilizes ultra-short, nanosecond energy pulses that directly interacts with the physical structure of cells without disrupting the integrity of non-cellular tissues.
This SH study builds upon previous study results showing the safety and clinically meaningful outcomes of NPS treatment to remove Seborrheic Keratosis lesions. Further, successful elimination of Sebaceous Hyperplasia lesions substantiates the unique ability of NPS to penetrate into the dermis and target deeper cellular structures, such as the sebaceous gland, without damaging the surrounding dermis. No adverse events were reported during the course of either the SH study or SK study.
The Sebaceous Hyperplasia clinical study enrolled 73 patients, over the course of two months, each with up to four facial lesions. Patients received one or two non-thermal NPS treatments per lesion at five prestigious centers in the U.S. The study’s primary success measurement was the degree of clearing of benign SH lesions as rated by the investigator at the final study visit. Since these lesions frequently appear on the face, another important outcome assessment was the return of the skin’s normal appearance after the lesion was removed.
99.5% of the treated lesions were assessed as clear or mostly clear by investigators at the 60-day post-treatment follow-up evaluation. Approximately 92% (n=203) of treated lesions were assessed as clear or mostly clear after a single NPS treatment. Patients rated 78% of lesion outcomes at study end as satisfied or mostly satisfied. In some cases, mild to moderate post-treatment hyperpigmentation was noted, particularly in patients with higher Fitzpatrick Skin Types.
“We are very excited about our NPS study findings and those of the other four centers because we see many patients in the clinic with Sebaceous Hyperplasia who opt out of treatment simply because current thermal-based modalities lack reliable efficacy and pose a high risk of damaged skin in the treated area,” said Gilly S. Munavalli, MD, a leading cosmetic and Mohs skin cancer surgeon in Charlotte, NC. “Based on our cumulative clinical experience, NPS represents a reliable and consistent treatment that not only successfully eliminates bothersome SH lesions, but also addresses the underlying cause of the condition by treating the sebaceous gland that resides in the dermis while sparing surrounding non-cellular skin tissue,” explained Dr. Munavalli, further noting that “this added benefit of NPS helps reduce oil or sebum production that can contribute to other skin problems like acne.”
In addition to Dr. Munavalli, other investigators in the SH study included laser and cosmetic skin surgeon Suzanne Kilmer, MD of Sacramento, CA; facial plastic surgeon James Newman, MD, Chief of Plastic Surgery at Premier Plastic Surgery Clinics in the San Francisco Bay Area, CA; Thomas Rohrer, MD, dermatologic and Mohs skin cancer surgeon in Boston, MA; and laser and cosmetic dermatologist Brian Zelickson, MD of Minneapolis, MN.
“We were delighted that the histology results and clinical findings from the Sebaceous Hyperplasia lesion study corroborated the high lesion clearance rates observed in our first controlled study of NPS treatment of Seborrheic Keratosis,” said Ed Ebbers, Vice President and General Manager of Dermatology at Pulse Biosciences. “These impressive safety results and solid efficacy rates for SH increase our confidence in pursuing other skin conditions such as cutaneous warts and acne where the ability to target undesirable cells both in the epidermis and dermis without collateral tissue damage offers a valuable competitive advantage and tremendous market opportunity.”
“We believe the results of this study represent an important development for physicians and their patients who are affected by Sebaceous Hyperplasia,” said Darrin Uecker, President and CEO of Pulse Biosciences. “It is the strength of our clinical data combined with growing physician recognition of NPS’ cellular mechanism of action that is building the momentum towards our planned commercial launch in 2019.”
About Sebaceous Hyperplasia
Sebaceous Hyperplasia (SH) is a common, benign skin condition caused by overactive sebaceous glands in adults of middle age or older. SH occurs when the sebaceous glands become enlarged, creating shiny, yellowish lesion or bumps, usually 2-4 millimeters in diameter and typically on the face. SH affects an estimated 4.3 million patients in the U.S. based on a 2018 Clinician Survey conducted by SERMO and sponsored by Pulse Biosciences.
About Pulse Biosciences
Pulse Biosciences is a novel medical therapy company bringing to market its proprietary CellFX™ Nano-Pulse Stimulation™ (NPS™) platform. The Company’s CellFX NPS system provides a precise, non-thermal delivery of novel nanosecond duration energy pulses that impact cells in treated tissue while sparing acellular tissue. NPS’s unique mechanism of action disrupts the functions of internal cell structures while maintaining the outer cell membrane, initiating a cascade of events within the cell that results in regulated cell death. The unique characteristics of the Company’s NPS mechanism of action has the potential to significantly benefit patients across multiple medical applications, including dermatology, the Company’s first planned commercial application. In pre-clinical studies, NPS has demonstrated an ability to induce immunogenic cell death in several cancer cell lines. The Company believes its NPS platform technology may play a role in immuno-oncology as a focal tumor treatment that can initiate an adaptive immune response. More information can be found 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’ 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.
CAUTION: Pulse Biosciences’ Nano-Pulse Stimulation (NPS) is an investigational use therapy.