Welcome to our dedicated page for Pulse Biosciences news (Ticker: PLSE), a resource for investors and traders seeking the latest updates and insights on Pulse Biosciences stock.
Pulse Biosciences develops bioelectric medicine technology based on its proprietary nPulse platform, which uses nanosecond pulsed field ablation energy to deliver nanosecond electrical pulses for non-thermal cell clearing. Company news commonly centers on the nPulse Cardiac Catheter System for atrial fibrillation, clinical study disclosures, feasibility data, and presentations at electrophysiology and healthcare conferences.
Recurring updates also cover the company's work in selected applications such as surgical soft tissue ablation, investor presentations and analyst events, executive leadership changes, operating and financial results, governance matters, and capital-structure disclosures related to its common stock and financing programs.
Pulse Biosciences (Nasdaq: PLSE) announced positive clinical results from its Nano-Pulse Stimulation (NPS) technology at the ASDS virtual annual meeting held from October 9-11, 2020. The studies demonstrated effective treatment for sebaceous hyperplasia lesions, warts, and basal cell carcinoma using the CellFX System. Key findings included high clearance rates and improved patient satisfaction. The company has initiated a multicenter clinical study comparing NPS technology to RF electrodessication for sebaceous hyperplasia lesions, showcasing its commitment to dermatologic innovations.
Pulse Biosciences (Nasdaq: PLSE) announced FDA Investigational Device Exemption (IDE) approval for a pivotal study aimed at treating sebaceous hyperplasia (SH) lesions with its CellFX® System. This multicenter comparative study will enroll 60 patients to evaluate the safety and efficacy of the CellFX System against electrodessication. The first procedure took place on September 28, 2020. Results from this study will support a 510(k) submission to expand the CellFX indication for SH. The company aims to conclude the study by Q1 2021 and submit the 510(k) soon after.
Pulse Biosciences (Nasdaq: PLSE) has received Medical Device Single Audit Program (MDSAP) certification, which streamlines regulatory oversight for medical device manufacturers. This certification is crucial for the commercial launch of the CellFX® System, utilizing Nano-Pulse Stimulation™ (NPS™) technology to treat dermatologic conditions. CEO Darrin Uecker emphasized this achievement as a commitment to quality assurance and a necessary step towards obtaining Health Canada approval, expected in the first half of 2021.