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 significant regulatory progress for its CellFX System. The FDA has moved its 510(k) submission for a general dermatology indication to Interactive Review. The company successfully completed treatments in a pivotal comparison study for sebaceous hyperplasia, with a 510(k) submission expected soon. Additionally, an FDA Investigational Device Exemption has been granted for a study on cutaneous non-genital warts. The review for CE mark approval and Health Canada license is also on track, showcasing robust advancements despite prior challenges.
Pulse Biosciences announced a notice of redemption for all outstanding warrants to purchase shares of the Company’s common stock, effective February 5, 2021. The redemption price is set at $0.01 per warrant. The warrants were issued as part of a rights offering that occurred in June 2020, which raised $30 million. The conditions for redemption were met as the average stock price exceeded $14.02 for ten consecutive trading days prior to December 31, 2020. If all warrants are exercised, the Company could receive an additional $4.5 million.
Pulse Biosciences (Nasdaq: PLSE) announced the grant of non-qualified stock options for 40,250 shares to recently hired non-executive employees on December 15, 2020. The options are priced at $18.40 per share, matching the closing stock price on the grant date, and will vest annually at 25% starting from the first anniversary of each recipient's start date. This grant is part of the 2017 Inducement Equity Incentive Plan, designed to attract new talent in accordance with Nasdaq rules.
Pulse Biosciences (NASDAQ:PLSE) is advancing its Nano-Pulse Stimulation™ (NPS™) technology, aimed at treating difficult skin lesions. A scientific update on NPS will feature at the upcoming Controversies and Conversations in Lasers & Cosmetic Surgery Symposium. Dr. Suzanne Kilmer will present clinical results demonstrating the safety and effectiveness of this technology. Over 700 patients and 3,600 lesions have been treated using NPS technology via the CellFX System. The company anticipates potential regulatory clearances in the U.S., EU, and Canada by Q1 2021, enhancing the prospects for commercialization.
Pulse Biosciences, Inc. (Nasdaq: PLSE) announces plans to participate in three upcoming virtual investor conferences. Management will present at the Stifel Healthcare Conference on November 17, 2020, and at the Stephens Annual Investment Conference on November 19, 2020. Additionally, they will engage in one-on-one meetings at the Piper Sandler Healthcare Conference on December 1, 2020, with a presentation webcast available on November 23, 2020. Interested parties can access webcasts from all conferences via the Company’s website, showcasing their innovative Nano-Pulse Stimulation™ technology.
Pulse Biosciences, Inc. (Nasdaq: PLSE) has announced it will release its third-quarter 2020 financial results on November 9, 2020, after market close. This announcement comes ahead of a scheduled conference call with management at 1:30 PM PT to discuss the results. The company is advancing its Nano-Pulse Stimulation™ (NPS™) technology, with the CellFX® System awaiting regulatory approval for commercial use in treating various dermatologic conditions. The technology aims to provide innovative solutions for patient care while offering a utilization-based revenue model.
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.