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, Inc. (Nasdaq: PLSE) generates frequent news as it advances its proprietary nPulse nanosecond pulsed field ablation (nsPFA) technology across cardiac and soft tissue applications. The company’s updates focus on clinical trial progress, regulatory milestones, scientific data presentations and early commercial activity for its nsPFA-based systems.
Investors and clinicians following PLSE news will see announcements on key atrial fibrillation programs, including the nPulse Cardiac Surgical System and the nPulse Cardiac Catheter Ablation System. Company releases describe IDE approvals from the U.S. Food and Drug Administration, enrollment of patients in the NANOCLAMP AF and NANOPULSE-AF studies, and feasibility results from European centers using surgical and catheter-based nsPFA devices. Late-breaking data presentations at major cardiology and cardiothoracic surgery meetings are also highlighted.
News flow also covers soft tissue ablation initiatives, such as the nPulse Vybrance Percutaneous Electrode System for benign thyroid nodules and research collaborations with academic centers on benign and malignant thyroid tumors. Pulse Biosciences reports publication of first-in-human thyroid data, IDE approvals for thyroid studies, and progress in multi-center trials like PRECISE-BTN.
In addition, PLSE news includes quarterly business updates and financial results, inducement equity grants under Nasdaq rules, and participation in healthcare investor conferences. These items provide context on the company’s operating plans, clinical strategy and capital markets activity. For readers tracking the development of nsPFA technology in atrial fibrillation and thyroid or other soft tissue indications, the Pulse Biosciences news page offers a consolidated view of company disclosures, clinical milestones and corporate events over time.
Pulse Biosciences (Nasdaq: PLSE) presented an ePoster at the American Academy of Dermatology's Virtual Annual Meeting on April 23-25, 2021. The research, conducted by Collective Acumen, surveyed 405 aesthetic patients regarding their motivations for clearing benign skin lesions. Results revealed that 76% of respondents valued the new CellFX procedure more highly than popular aesthetic treatments like botulinum toxin or fillers. CEO Darrin Uecker emphasized the demand for effective, aesthetically appealing solutions. The company also launched CellFX.com for additional resources.
Pulse Biosciences, Inc. (Nasdaq: PLSE) has announced its participation in two upcoming virtual investor conferences. On March 10, 2021, management will engage in one-on-one meetings at the H.C. Wainwright Global Life Sciences Conference, with a presentation webcast available on March 9, 2021. Additionally, on March 17, 2021, the company will participate in an aesthetic dermatology panel discussion at the Maxim Emerging Growth Virtual Conference, featuring a live webcast at 2:00pm ET. Interested parties can access on-demand webcasts via the company’s website.
Pulse Biosciences (Nasdaq: PLSE) reported its fourth quarter and full-year financial results for 2020. The company secured FDA clearance and CE mark approval for its CellFX® System, enhancing its market position in aesthetic dermatology. As of December 31, 2020, cash and investments totaled $20.5 million, a decrease from $29.6 million in Q3 2020. Despite a net loss of $13.8 million for Q4 2020, the company maintained operational focus, with minimal pandemic impact on its processes. The launch of its Controlled Launch program for the CellFX System is expected to drive long-term growth.
Pulse Biosciences (Nasdaq: PLSE) has successfully completed the first CellFX procedures in the European Union, marking a critical milestone in its controlled launch program. The CellFX System, which utilizes Nano-Pulse Stimulation™ technology, is designed to non-thermally treat common benign lesions, enhancing patient satisfaction. A survey highlighted that patients prioritize treatment for skin lesions, with an average of 200 cases per month per aesthetic dermatologist. The company aims to establish best practices with leading specialists across Europe, while concurrently launching in the U.S.
Pulse Biosciences (Nasdaq: PLSE) has initiated the controlled launch of its CellFX® System, marking its first commercial use. This innovative technology utilizes Nano-Pulse Stimulation™ (NPS™) to treat skin conditions non-thermally, preserving healthy tissue. The launch is supported by positive clinical data and has received interest from leading dermatology professionals in the U.S. and Europe. Medical Director Dr. Munavalli reports a high demand for improved treatment options among patients, affirming the CellFX System's versatility in dermatological applications.
Pulse Biosciences, Inc. (Nasdaq: PLSE) will report financial results for Q4 and full year 2020 after market close on February 22, 2021. A conference call is scheduled for 1:30 PM PT, allowing investors to hear management discuss the results. The company is known for its innovative Nano-Pulse Stimulation™ (NPS™) technology, which powers its CellFX® System, aimed at improving dermatologic outcomes while sparing non-cellular tissue. This system represents a multi-application platform with a utilization-based revenue model.
Pulse Biosciences (Nasdaq: PLSE) has filed a prospectus supplement with the SEC for an offering of common stock totaling up to $60 million. The funds will be used for working capital, including further investment in clinical studies for its Nano-Pulse Stimulation technology and the development of its CellFX System. Shares will be sold through Stifel, Nicolaus & Company as the sales agent. Investors are advised to read the complete prospectus and the risks associated with the offering.
Pulse Biosciences (Nasdaq: PLSE) has received FDA clearance for its CellFX® System, designed for dermatologic procedures that require skin ablation and resurfacing. This marks a significant step in the company’s regulatory strategy, following its recent CE mark acquisition. The CellFX System utilizes innovative Nano-Pulse Stimulation™ (NPS™) technology, which non-thermally clears unwanted cellular structures while preserving surrounding tissue. A controlled commercial launch will commence shortly with selected Key Opinion Leaders in the U.S., aiming for long-term commercial success.
Pulse Biosciences (Nasdaq: PLSE) has received CE mark approval for its CellFX® System, validating its Nano-Pulse Stimulation™ (NPS™) technology for treating dermatologic conditions like sebaceous hyperplasia and seborrheic keratosis in the EU. This marks the system's first commercial regulatory clearance, enabling a controlled launch in top aesthetic centers across Europe. The technology offers a unique approach to removing lesions without damaging adjacent tissue, presenting a significant advancement in aesthetic dermatology. The commercial launch is set to occur this quarter.
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.