Pulse Biosciences gives updates on CellFX System regulatory progress

Pulse Biosciences announced CellFX System regulatory progress updates. Received notification from the Food and Drug Administration, FDA that the Company's 510k 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( 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."