Pulse Biosciences Updates on Regulatory Progress

December 18, 2019 |

4 min read

The Company expects to submit its final responses to the FDA following the meeting, and based on FDA feedback, anticipates the 510(k) review to be concluded by the end of January.

Dec. 18, 2019 14:00 UTC

HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company), a novel bioelectric medicine company bringing to market its proprietary CellFX™ System, today announced an update to its regulatory timeline with the Food and Drug Administration (FDA). In connection with the ongoing review of the Company’s 510(k) submission for its CellFX System in dermatology, the Company requested a face-to-face meeting with the FDA to discuss its proposed final responses. Due to holiday schedules within the FDA, the meeting is planned for the first half of January. The Company expects to submit its final responses to the FDA following the meeting, and based on FDA feedback, anticipates the 510(k) review to be concluded by the end of January.

“We look forward to meeting with the FDA and believe face-to-face meetings are an important part of the regulatory process and are consistent with our efforts to develop a long-term and collaborative relationship with the Agency,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “Though we hoped to have the meeting in December, we appreciate the FDA’s efforts to schedule the meeting as soon as resources were available, and for providing clarity on timing after we submit our final responses. We understand this timing is important to all our stakeholders and we will continue to provide updates as appropriate.”

About Pulse Biosciences

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that improves and potentially extends the lives of patients. The CellFX System is the first planned 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. NPS technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The cell-specific effects of NPS technology have been validated in a series of ongoing clinical trials. The CellFX System is a multi-application platform designed to address a broad range of dermatologic conditions. As part of the customer experience, the Company is offering a utilization-based revenue model and easy-access customer portal offering a suite of services. CellFX procedures offer customer value across an expanding spectrum of clinical applications. The initial commercial use will be in the clearance of common and difficult-to-treat skin lesions that share high demand among patients and practitioners for improved and durable aesthetic outcomes that lead to greater overall satisfaction.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the Company’s CellFX System, including the progress and timing of the FDA’s review of the Company’s 510(k) submission, the commercialization of the Company’s Cell FX System, and the results of clinical study plans. These forward-looking statements are based on current expectations and estimates and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested or implied by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including, but not limited to, the following: the impact of governmental regulatory agencies, including the FDA, and regulatory approvals, clearances and restrictions or any dispute that may occur with any regulatory body; risks inherent to the planning, design and execution of clinical studies; the timing and success of product development; and other risk factors under the heading “Risk Factors” in the Company’s most recently filed quarterly report on Form 10-Q and as periodically updated by the Company’s subsequent filings with the Securities and Exchange Commission. Statements using words such as “estimates,” “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” “targeted” and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Pulse Biosciences, Inc. undertakes no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation (NPS) technology are for investigational use only.