Pulse Biosciences Announces FDA IDE Approval and Initiation of Sebaceous Hyperplasia Study
Pulse Biosciences (Nasdaq: PLSE) announced FDA Investigational Device Exemption (IDE) approval for a pivotal study aimed at treating sebaceous hyperplasia (SH) lesions with its CellFX® System. This multicenter comparative study will enroll 60 patients to evaluate the safety and efficacy of the CellFX System against electrodessication. The first procedure took place on September 28, 2020. Results from this study will support a 510(k) submission to expand the CellFX indication for SH. The company aims to conclude the study by Q1 2021 and submit the 510(k) soon after.
- FDA IDE approval received.
- Initiation of pivotal study to treat SH lesions.
- First patient procedure completed ahead of schedule.
- Strong market demand for treatments addressing SH lesions.
- None.
HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced FDA Investigational Device Exemption (IDE) approval and initiation of a pivotal study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX® System. The data generated from this study is intended to support a 510(k) submission to expand the indication for use of the CellFX System specifically to treat SH lesions.
Following IDE approval, several patients have been enrolled, with the first patient procedure completed on September 28, 2020. The multicenter prospective comparative study is intended to evaluate the safety and efficacy of procedures to clear facial SH lesions performed with the CellFX System versus those performed by electrodessication in a comparator group. Enrollment of 60 patients across five study sites is expected to be completed in approximately three months. All subjects will have up to two treatments and will be evaluated through the primary safety and efficacy endpoints at 60-days following their last treatment. The ClinicalTrials.gov Identifier for the study is NCT04539886.
“We are pleased to have received FDA IDE approval and to have begun this important SH comparative study slightly ahead of the fourth quarter start we had previously communicated. Understanding the COVID-19 pandemic has increased the demand on FDA resources, we appreciate their attention throughout the IDE process. Barring delays in enrollment, we expect to conclude the study in the first quarter of 2021 and plan to quickly follow with a 510(k) submission for the corresponding specific indication. We have long viewed SH as a top addressable market priority for the CellFX System based on patient demand in clinics today and the CellFX System’s early demonstration of procedure effectiveness,” said Darrin Uecker, President and CEO of Pulse Biosciences. “As we have communicated previously, in parallel we are completing our GLP preclinical study in support of the initial CellFX System 510(k) submission for a general dermatologic indication. We remain on track to submit this 510(k) in the next several weeks.”
About Sebaceous Hyperplasia
Sebaceous hyperplasia (SH) is a very common skin condition that presents as shiny, yellowish or white raised bumps, or lesions, that most frequently occur on the face and are often oily in appearance. SH lesions form on the skin surface when the sebaceous glands, which are located in the deeper layer of the skin, become enlarged and form bumps between 2 and 4 millimeters wide on the facial skin surface. These deeper sebaceous glands that cause the SH lesion are difficult to treat with current thermal technologies without damaging the skin surface.
Based on a 2019 survey1, dermatologists who specialize in aesthetic procedures see an average of over 40 patients per week with SH lesions and their surveyed aesthetic patients diagnosed with this common problem are highly motivated to seek treatment as a cash-paying procedure to improve the appearance of their facial skin. Yet the majority of these patients diagnosed with SH are untreated, likely due to limitations of existing treatments that either cannot reach the sebaceous gland or that damage the skin surface, making the skin appearance worse than prior to treatment. Given the profile of NPS technology as a new option to reach these sebaceous glands with more desirable cosmetic effects, in the same survey,
1 2019 Physician (n=304) and Patient (n=405) surveys conducted by third-party market research firm on behalf of Pulse Biosciences, Inc.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. If cleared, the CellFX® System will be the first 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. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. Subject to regulatory approval, the initial commercial use of the CellFX System is expected to address a broad range of dermatologic conditions that share high demand among patients and practitioners for improved and durable aesthetic outcomes. Designed as a multi-application platform, the CellFX System is intended to offer customer value with a utilization-based revenue model across an expanding spectrum of clinical applications. To learn more please visit www.pulsebiosciences.com.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.
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 and other regulatory filings or approvals, including meetings with FDA and the ability of the Company to successfully complete a 510(k) submission for the CellFX System or for a specific indication for the treatment of sebaceous hyperplasia (SH) lesions, the ability of the Company to prepare and provide data to FDA and other regulatory bodies, NPS technology including the effectiveness of such technology and the effectiveness of related clinical studies in predicting outcomes resulting from the use of NPS technology, the CellFX System including the benefits of the CellFX System and commercialization of the CellFX System, current and planned future clinical studies and the ability of the Company to execute such studies and results of any such studies, other matters related to its pipeline of product candidates, the Company’s market opportunity and commercialization plans, including the market for the treatment of SH, future financial performance, the impact of COVID-19 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.
