Pulse Biosciences Updates on CellFX System Regulatory and Clinical Study Progress
Pulse Biosciences (Nasdaq: PLSE) announced significant regulatory progress for its CellFX System. The FDA has moved its 510(k) submission for a general dermatology indication to Interactive Review. The company successfully completed treatments in a pivotal comparison study for sebaceous hyperplasia, with a 510(k) submission expected soon. Additionally, an FDA Investigational Device Exemption has been granted for a study on cutaneous non-genital warts. The review for CE mark approval and Health Canada license is also on track, showcasing robust advancements despite prior challenges.
- FDA notification of advancement to Interactive Review for CellFX System.
- Completion of pivotal study for sebaceous hyperplasia with imminent 510(k) submission.
- FDA IDE approval for non-genital warts study with enrollment expected soon.
- Ongoing review for CE mark and Health Canada license indicates strong regulatory progress.
- None.
Pulse Biosciences, Inc. (Nasdaq: PLSE) (“Pulse Biosciences” or the “Company”), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced CellFX® System regulatory progress updates.
Recent CellFX System Highlights
- Received notification from the Food and Drug Administration (FDA) that the Company’s 510(k) submission for a general dermatology indication for the CellFX System has advanced from Substantive Review to Interactive Review.
- Completed all treatments in the Company’s previously announced pivotal comparison study to evaluate the treatment of sebaceous hyperplasia (SH) using the CellFX System, with the planned specific indication 510(k) submission as early as the end of the first quarter of 2021.
- Obtained FDA Investigational Device Exemption (IDE) approval of a pivotal comparison study to evaluate the treatment of cutaneous non-genital warts using the CellFX System, with enrollment expected to begin by the end of the first quarter of 2021.
- Continued review by the Notified Body of the CellFX System for CE mark approval and Health Canada for Medical Device License remains on track.
“We are very pleased with the progress our team made throughout a challenging 2020 in advancing the CellFX System and in interactions with regulatory authorities in the US, European Union and Canada,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “We continue to work with the regulatory authorities in each of these geographies and appreciate the collaborative and timely interactions we have had during these reviews.”
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. If cleared, the CellFX® System is the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology, such as the ability to non-thermally clear cells while sparing non-cellular tissue, to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy. Subject to regulatory approval, the initial commercial use of the CellFX System is to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. To learn more, please visit 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 considered 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, notified body, Health Canada and other regulatory body filings or approvals, and the ability of the Company to successfully complete a 510(k) submission for the CellFX System or for any specific indications, the ability of the Company to prepare and provide data to FDA, EU, Canadian 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 certain lesions, 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.
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