HAYWARD, Calif.–(Business WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE) (“Pulse Biosciences” or the “Company”), a novel bioelectric drugs business progressing Nano-Pulse Stimulation™ (NPS™) engineering, right now declared CellFX® Program regulatory development updates.
Modern CellFX Technique Highlights
- Obtained notification from the Food stuff and Drug Administration (Fda) that the Company’s 510(k) submission for a basic dermatology indication for the CellFX Technique has innovative from Substantive Evaluation to Interactive Evaluation.
- Finished all treatment plans in the Company’s formerly announced pivotal comparison research to appraise the therapy of sebaceous hyperplasia (SH) working with the CellFX System, with the planned distinct indication 510(k) submission as early as the stop of the 1st quarter of 2021.
- Acquired Fda Investigational Device Exemption (IDE) acceptance of a pivotal comparison research to assess the treatment of cutaneous non-genital warts applying the CellFX Method, with enrollment envisioned to start out by the conclude of the to start with