Pulse Biosciences, Inc. (NASDAQ: PLSE) reported Q1 EPS of ($0.49), $0.05 worse than the analyst estimate of ($0.44).
Recent Corporate Developments
- Pre-market Notification (510(k)) submitted to the U.S. Food and Drug Administration (FDA) for its proprietary CellFX System seeking clearance for commercial use in common dermatologic procedures to remove general benign lesions including Sebaceous Hyperplasia, a common but difficult-to-treat facial lesion and Seborrheic Keratosis, a common benign pigmented lesion. This afternoon we received an additional information (“AI”) letter request from FDA, and the FDA among other things is questioning the adequacy of the predicate device provided in the 510(k). Responding to this request will add time and require additional testing, inclusive of clinical trials. In consideration of the above we are presently evaluating an alternative approach, the De Novo process approach, which would also likely require additional time, testing and clinical studies. At the end of the day the De Novo approach may be in the best interest of Pulse Biosciences. We will update on this important matter no later than the upcoming Annual Meeting of Stockholders scheduled for May 16, 2019.
- Mitchell Levinson, a well-seasoned entrepreneur and executive in the aesthetic procedure market, appointed to the Board of Directors.
- Podium presentations by key opinion leaders in aesthetic dermatology speaking to the novel mechanism of action of the CellFX System and the positive results from our clinical studies in Sebaceous Hyperplasia and Common Warts at the American Academy of Dermatology Annual Meeting and the American Society for Laser Medicine and Surgery Annual Conference.
- Continued progress in active feasibility studies including Common Warts, Back Acne and Basal Cell Carcinoma.
“At Pulse Biosciences we remain focused on commercializing our CellFX System in aesthetic dermatology and we are pleased with our progress towards this goal in Q1,” said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer.
