Completes First Procedures in CellFX System Specific Indication Study
Following IDE approval, several patients have been enrolled, with the first patient procedure completed on
“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
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, 88% of these aesthetic dermatology specialists reported a clear interest in a new procedure to address SH lesions. Previously published clinical data by the Company demonstrated that over 90% of SH lesions were cleared or mostly cleared by 60 days post-NPS treatment.
1 2019 Physician (n=304) and Patient (n=405) surveys conducted by third-party market research firm on behalf of
About Pulse Biosciences®
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.
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
Nadine D. Tosk