By Sabela Ojea


Shares of Pulse Biosciences jumped on Tuesday after the company said that it submitted a Food and Drug Administration premarket application for its CellFX nsPFA percutaneous electrode.

Shares were recently up 15% at $7.19. The stock has surged 315% in the past twelve months.

Once the 510(k) application has been accepted, the FDA will conduct its review and may request additional information from the company based on that review, the immuno-oncology company developing an oncolytic electroceutical therapy said.

The FDA's guidance suggests the goal is to complete the 510(k) substantive review within 90 calendar days, Pulse Biosciences said.

"We look forward to collaborating with the FDA throughout the review process," Chief Executive Kevin Danahy said.

The 510(k) program accounts for most new medical devices the FDA reviews to reasonably assure their safety and effectiveness, according to the FDA's website.

CellFX nsPFA is designed for non-cardiac applications.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix


(END) Dow Jones Newswires

11-21-23 1214ET