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. (PLSE) is a pioneering clinical-stage electroceutical company focused on the commercial application of its proprietary Nano-Pulse Stimulation (NPS) technology. Headquartered in Hayward, CA, the company's core mission is to leverage this novel technology to improve and extend patient lives, addressing the distinct needs of patients and physicians alike.
Nano-Pulse Stimulation Technology
NPS is a cutting-edge, non-thermal, drug-free energy-based technology that utilizes ultra-short nanosecond electrical pulses to impact cell membranes and intracellular structures. This method promotes unique cellular behaviors and can induce specific immune responses, opening up a myriad of therapeutic possibilities. Unlike conventional treatments, NPS delivers electrical pulses in billionths of a second, providing targeted effects without damaging surrounding tissues.
Applications and Innovations
Pulse Biosciences is actively exploring the potential of its NPS technology across various medical fields. Key areas of investigation include immuno-oncology, where NPS may be used to treat cancer by modulating the immune system's response, and dermatology, for treatments that require precise, non-invasive interventions. The technology's unique biologic effects position it as a promising solution for conditions lacking optimal treatments.
Recent Achievements and Projects
The company has made significant strides in both preclinical and clinical studies, demonstrating the safety and efficacy of NPS technology. Recent projects have focused on refining device capabilities, enhancing treatment protocols, and expanding the scope of applications. Partnerships with leading medical institutions and ongoing collaborations with researchers underscore Pulse Biosciences' commitment to innovation.
Financial Condition
Pulse Biosciences generates substantial revenue primarily from the sale of its systems in North America. The company continues to invest in research and development to further advance its technology and explore new market opportunities.
For those looking to stay updated on the latest developments, performance, and news related to Pulse Biosciences, Inc., StockTitan provides a comprehensive and timely resource.
Pulse Biosciences (PLSE) announced positive preliminary results from its first-in-human feasibility study using Nanosecond Pulsed Field Ablation (nano-PFA) for treating benign thyroid nodules. The study, presented at the 2024 American Thyroid Association Annual Meeting, showed that nano-PFA treatment reduced nodule sizes by over 50% and provided symptomatic relief within the first month. The company's Percutaneous Electrode System demonstrated effectiveness without residual fibrosis or scarring. The 30-patient clinical trial (NCT06117085) is being conducted in Naples, Italy, with plans for a pivotal trial in mid-2025 to support U.S. commercialization.
Pulse Biosciences (PLSE) reported Q3 2024 financial results and business updates. The company placed nsPFA Percutaneous Electrode Systems at seven U.S. sites and treated 9 patients in their atrial fibrillation study. They also treated over 50 patients with their nano-PFA 360° Cardiac Catheter. Financial highlights include GAAP costs of $13.7M (up from $11.3M YoY), GAAP net loss of $12.7M (vs $10.6M YoY), and cash position of $79.0M as of September 30, 2024. The company raised $60M through a rights offering in July 2024, with potential for additional $66M through warrant exercises.
Pulse Biosciences (PLSE) has appointed Dr. David Kenigsberg as Chief Medical Officer of Electrophysiology and added Dr. Andrea Natale as a medical advisor. Dr. Kenigsberg, founder of Florida Heart Rhythm Specialists, joins to support the development of the company's nano-PFA 360 Cardiac Catheter. Dr. Natale, Executive Medical Director of Texas Cardiac Arrhythmia Institute, will join existing advisors Dr. Vivek Reddy and Dr. Jacob Koruth to advance the clinical development of the catheter technology for treating atrial fibrillation.
Pulse Biosciences (Nasdaq: PLSE), a company specializing in Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, has announced its plans to release third quarter 2024 financial results on Wednesday, October 30, 2024, after the market closes. The company will host a conference call at 1:30pm PT / 4:30pm ET on the same day to discuss the results.
Investors can participate in the call by dialing 1-877-407-0752 (domestic) or 1-201-389-0912 (international). Additionally, a live and recorded webcast of the event will be available on the company's investor relations website at http://investors.pulsebiosciences.com/.
Pulse Biosciences (Nasdaq: PLSE) reported business updates and preliminary Q2 2024 financial results. Key highlights include:
1. Completed first soft tissue ablation procedures in the US using the Percutaneous Electrode System.
2. Performed initial epicardial ablations for atrial fibrillation treatment in Europe.
3. Expanded enrollment for the endocardial ablation study.
4. Raised $60 million through a rights offering.
5. Q2 2024 financials: $11.7 million in GAAP costs and expenses, $9.4 million in non-GAAP costs and expenses, and $26.2 million in cash and equivalents as of June 30, 2024.
6. Granted inducement options to new employees totaling 215,000 shares.
Pulse Biosciences (Nasdaq: PLSE) has appointed Paul A. LaViolette to its Board of Directors as Co-Chairman alongside Robert W. Duggan. LaViolette brings 40 years of medical technology development, operating, and leadership expertise to the company, which specializes in Nanosecond Pulsed Field Ablation™ (nsPFA™) technology. His extensive experience includes roles as Chief Operating Officer at Boston Scientific and current positions as Managing Partner at SV Health Investors and director for Edwards Lifesciences. LaViolette's appointment is expected to provide valuable insights and expertise to help Pulse Biosciences develop transformational treatments and maximize the potential of its proprietary technology across various therapeutic categories.
Pulse Biosciences (NASDAQ: PLSE) has announced the successful treatment of the first two patients in a first-in-human feasibility study using its novel Cardiac Surgery System for atrial fibrillation. The procedure, performed at St. Antonius Hospital in the Netherlands, utilized the company's proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology. The study will include up to 30 patients and aims to demonstrate the device's safety, effectiveness, and durability.
Key highlights:
- The system received FDA Breakthrough Device Designation in July 2024
- It was recently enrolled in the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP)
- Pulse Biosciences plans to pursue FDA premarket approval (PMA) for commercialization
- A pivotal clinical study is expected to begin in early 2025
Pulse Biosciences (Nasdaq: PLSE), a company specializing in Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, has announced its participation in two upcoming investor conferences. The company will attend the 9th Annual Needham MedTech & Diagnostics 1x1 Conference virtually on August 13, 2024, hosting one-on-one meetings without a formal presentation. Additionally, Pulse Biosciences management will present at the Canaccord Genuity Annual Growth Conference in Boston on August 14, 2024, at 8:00am ET. A live and recorded webcast of the Canaccord presentation will be available on the company's investor relations website.
Pulse Biosciences (Nasdaq: PLSE), a company specializing in Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, has announced its plans to release second quarter 2024 financial results on Monday, August 12, 2024, after the market closes. The company will host a conference call at 1:30pm PT / 4:30pm ET on the same day to discuss the results. Investors can join the call by dialing 1-877-704-4453 (domestic) or 1-201-389-0920 (international). A live and recorded webcast of the event will also be available on the company's investor relations website.
Pulse Biosciences has received FDA Breakthrough Device Designation for its CellFX® nsPFA Cardiac Surgery System, intended for treating atrial fibrillation (AF). The system uses proprietary nanosecond Pulsed Field Ablation™ technology, featuring a surgical clamp that delivers rapid, consistent ablation lesions during cardiac procedures. This approach is significantly faster and potentially safer than current thermal ablation methods, minimizing risk to surrounding tissues.
The designation facilitates expedited development and review processes by the FDA. Pulse Biosciences plans to pursue Premarket Approval (PMA) for commercialization in the U.S. and expects to start its pivotal clinical trial in 2025, with initial human procedures slated for later this year in the Netherlands.
This milestone underscores the technology's promise as a safer and more effective AF treatment, aiming for faster market introduction and improved patient outcomes.
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