Live-Nachrichten • May 20
Pulse Biosciences Advances nPulse Cardiac Platform as US Trial Enrollment Begins and CEO Increases Stake Pulse Biosciences is concentrating its resources on its nanosecond pulsed field ablation (nsPFA) platform, with the nPulse Cardiac Catheter System as the lead program for atrial fibrillation treatment.
European feasibility studies of the nPulse catheter reported 100% procedural success at six months and a 1.7% serious adverse event rate across 177 patients, and the company has started enrollment in the pivotal U.S. NANOPULSE-AF IDE trial targeted for completion by early Q4 2026.
The company reported Q1 2026 revenue of US$401,000 and a net loss of US$18.6m, increased R&D spending on cardiac and soft tissue programs, raised about US$12.9m through an at-the-market offering to its majority stockholder, and recorded an insider purchase of 15,000 shares by CEO Paul LaViolette.
The focus on nsPFA cardiology and progress into a pivotal U.S. trial indicate that the company is in a clinically intensive phase where trial outcomes and regulatory decisions are likely to be key drivers of sentiment.
Investors may want to weigh the company’s ongoing losses and funding needs against the potential value of regulatory milestones such as FDA IDE approvals and a CE mark submission planned for 2026. Ankündigung • May 12
Pulse Biosciences, Inc., Annual General Meeting, Jun 11, 2026 Pulse Biosciences, Inc., Annual General Meeting, Jun 11, 2026. Ankündigung • Apr 26
Pulse Biosciences Presents Positive Outcomes in Late-Breaking Updated Data from nPulse Cardiac Catheter System At Heart Rhythm 2026 Pulse Biosciences, Inc. announced late-breaking positive clinical data from its nPulse Cardiac Catheter System first-in-human feasibility study at the Heart Rhythm 2026 meeting. The late-breaking presentation included incremental participant follow up data. Building upon the previously reported data set presented at the AF Symposium meeting in February of 2026, the expanded 6-month follow-up participant cohort increased to 95 subjects from 75 and the expanded 12-month follow-up participant cohort increased to 53 subjects from 47. Key study findings on the 5 second ablation cohort include: Sustained 100% procedural success of evaluable patients by holter at 6 months (95/95), Sustained 96% procedural success of evaluable patients by holter at one year (51/53), Sustained 90% Kaplan-Meier estimate of freedom from AF/AFL/AT at one year. Consistently efficient procedural performance, including: Left atrial dwell time: 18.6 ± 13.0 minutes, Total procedure time: 60.2 ± 27.7 minutes, Fluoroscopy time: 9.4 ± 5.9 minutes, Average applications per-patient for PVI: 12.3 ± 2.6, Safety profile across total cohort: maintained low serious adverse event rate, with 1.7% (3/177) of subjects experiencing a SAE related to the primary safety endpoint. The results from the study demonstrate durable pulmonary vein isolation and consistent procedural performance using a non-thermal nsPFA energy approach across multiple investigator sites was sustained with increased subject follow up. The data was presented by Dr. Vivek Reddy during a late-breaking clinical session on April 25, and included incremental follow-up results from the first-in-human feasibility study in patients with atrial fibrillation. The ongoing feasibility study is assessing the initial safety and efficacy of the nPulse Cardiac Catheter System for the treatment of AF (NCT06696170). To date, a total of 177 patients have been treated by 7 investigators in Europe, including the Na Homolce Hospital in Prague led by Dr. Vivek Reddy and Prof. Petr Neuzil, Jessa Hospital in Hasselt led by Dr. Johan Vijgen, and Tor Vergata Hospital in Rome, led by Dr. Andrea Natale. The initial cohort of treated patients has been evaluated by remapping at ~3 months and for rhythm control completed at 6 and 12 months post ablation procedure. Ankündigung • Apr 09
Pulse Biosciences, Inc. Announces Management Appointments Pulse Biosciences, Inc. announced the strengthening of its executive leadership team with the appointment of Liane Teplitsky as Chief Operating Officer and expanded role of Dr. David Kenigsberg as full-time Chief Medical Officer. Both the appointment of Liane Teplitsky as Chief Operating Officer and Dr. David Kenigsberg’s agreement to serve as the Company’s Chief Medical Officer on a full-time basis further enhance the Company’s strategic alignment to prioritize and accelerate the development and future commercialization of its nPulse Cardiac Catheter Ablation System. As COO, Ms. Teplitsky will oversee the Company’s Clinical, Regulatory, Quality, and Commercial functions. Ms. Teplitsky brings twenty years of experience leading and scaling innovative medical technology businesses, with a particular focus on electrophysiology, cardiovascular, and digital health technologies. She most recently served as Chief Executive Officer of Artedrone, where she led the strategy and development of an autonomous robotic technology for stroke treatment. Previously, Ms. Teplitsky held senior marketing and commercial leadership roles at Abbott Laboratories and St. Jude Medical, contributing to the development, clinical validation, and global commercialization of cardiovascular and EP therapies. She also served as President of Robotics, Technology and Data Solutions at Zimmer Biomet, where she led global strategy and commercialization for robotics and digital health technologies. Ms. Teplitsky holds a Master of Science in Biomedical Engineering from Duke University and Bachelor of Science degrees in Electrical Engineering and Physiology from the University of Saskatchewan. Ms. Teplitsky currently serves as Chairman of the Board of Carvolix (Paris-EUR) and will remain in this role as she joins Pulse Biosciences. The Company also announced that David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences, will expand his role, while maintaining his active routine clinical practice. His increased leadership capacity will benefit the Company as it advances its IDE pivotal clinical study evaluating the nPulse™ Cardiac Catheter System for the treatment of atrial fibrillation. Dr. Kenigsberg has extensive experience leading clinical trials in the field of electrophysiology and is a recognized key opinion leader in pulsed field ablation. Ankündigung • Apr 08
Pulse Biosciences Inc Enrolls First Patients in NANOPULSE-AF Ide Pivotal Clinical Study Evaluating nsPFA Cardiac Catheter System for Atrial Fibrillation Pulse Biosciences, Inc. developer of nPulse technology using proprietary nanosecond pulsed field ablation (nsPFA) energy, announced enrollment of the first patients in its NANOPULSE-AF study, a prospective, multicenter, IDE pivotal clinical investigation currently evaluating the nPulse Cardiac Catheter System for treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF). The first seven patients in this study were treated at St. Bernards Medical Center in Jonesboro, Arkansas. The performance of the nPulse System, combined with integrated catheter mapping using the investigational EnSite X software from Abbott, provides a very user-friendly experience and supports an efficient, reproducible and streamlined workflow. This milestone builds on Pulse Biosciences’ first-in-human feasibility study, which showed 96% procedural success at 12 months and 100% acute success, exceeding expectations in a field where 20-25% recurrence is typical. Outcomes were reproducible across operators and achieved without anti-arrhythmic drugs. The nPulse Cardiac Catheter System delivers energy in billionths of a second — nanoseconds — compared with conventional, slower microsecond-based systems. This ultra-fast, non-thermal energy is designed to create precise, durable PVI while minimizing impact to surrounding cardiac structures. Key design features of the System include: Precise Lesion Formation: Creates deep, circumferential lesions without stacking applications or rotating the catheter. Efficient Workflow: Isolates pulmonary veins with minimal applications and ultra-fast delivery (~5 seconds per application). Procedure Efficiency: Prior feasibility study showed median left atrial dwell time of 21 minutes and total procedure time of approximately 65 minutes. Enhanced Visualization: Integrated magnetic EP mapping with catheter-embedded sensors compatible with Abbott’s EnSite X system for real-time 3D electroanatomical visualization to provide a stable location reference, constructing anatomical shells, and standardizing electrophysiological maps to guide therapy. The NANOPULSE-AF Study is a prospective, multicenter, non-randomized IDE pivotal clinical investigation designed to evaluate the safety and effectiveness of the CellFX nsPFA Cardiac Catheter System in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. The Study plans to enroll approximately 215 participants across multiple clinical sites, with the first patients treated at St. Bernards Medical Center in Jonesboro, Arkansas. Primary endpoints will be assessed at 6 and 12 months post-ablation to measure procedural success and safety outcomes, supporting the broader clinical development of the nPulse system. Ankündigung • Mar 17
Pulse Biosciences Announces Strategic Alignment to Accelerate Cardiac Catheter Program Pulse Biosciences, Inc. announced a new strategic alignment to prioritize and accelerate the development and future commercialization of its nPulse Cardiac Catheter Ablation System. This initiative follows the announcement of groundbreaking clinical outcomes from the Company’s 150-patient European feasibility study, which demonstrated that nsPFA delivers a unique combination of speed, safety, and long-term durable efficacy in treating Atrial Fibrillation (AFib). The decision to centralize resources on the Cardiac Catheter program is backed by data recently presented at the 31st Annual AF Symposium, which positions nPulse as a best-in-class solution: 100% Procedural Success at 6 Months: 75/75 evaluable patients achieved acute Pulmonary Vein Isolation (PVI) success. 96% Sustained Success at 12 Months: Long-term follow-up (45/47 patients) confirmed highly durable Pulmonary Vein Isolation (PVI), exceeding traditional expectations in a field where approximately 20-25% recurrence is common. Industry-Leading Procedural Efficiency: Left Atrial Dwell Time:21.0 ± 13.3 minutes, this would reduce the time spent inside the heart. Total Procedure Time: Averaged 65 minutes, including only 9.8 minutes of fluoroscopy. Ease of Use: Success was achieved with an average of 16.1 applications per procedure. Safety Profile: A low 1.3% rate of Serious Adverse Events (SAEs) related to the primary safety endpoint. To capitalize on these groundbreaking results, Pulse Biosciences is modifying its capital allocation to prioritize the Electrophysiology (EP) market development program: Primary Focus: The majority of R&D and clinical investment is now dedicated to the nPulse Cardiac Catheter program’s upcoming pivotal IDE study in the United States and Europe and corresponding regulatory submission. Surgical Program Calibration: While the Company remains committed to the Surgical Clamp IDE enrollment, it will reduce short term market development investments in cardiac surgery. Soft-Tissue Ablation Optimization: Operations for the percutaneous soft-tissue ablation system have been streamlined to reduce spend on sales and marketing and focusing on market development by progressing the Vybrance Percutaneous Electrode System towards an on-label indication for the treatment of benign thyroid nodules, driving real-world utilization data, and validating reimbursement rates, thereby allowing for a reduction in investment that can be redirected to the catheter program. Late breaking clinical data on the treatment of AFib using the nPulse Cardiac Catheter System has been accepted for presentation at Heart Rhythm 2026, in Chicago, IL. A late-breaking data presentation by Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY, will include additional 12-month follow-up data from the nPulse Cardiac Catheter first-in-human feasibility study. Ankündigung • Mar 12
Pulse Biosciences, Inc. Announces First Enrollments in Feasibility Study for the Treatment of Malignant Thyroid Tumors with Npulse Vybrance Percutaneous Electrode System Pulse Biosciences, Inc, developer of the novel nPulse technology using its proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, announced first patient enrollments in the multi-center first-in-human feasibility study of the Company’s nPulse Vybrance Percutaneous Electrode System for treatment of T1N0M0 papillary thyroid microcarcinoma (PTM), a small, slow-growing, and most common form of thyroid cancer. The initial procedures were successfully completed at Sarasota Memorial Health Care System in Sarasota, Florida, and The University of Texas MD Anderson Cancer Center in Houston, Texas. The multicenter, prospective feasibility study is designed to evaluate the safety and effectiveness of the nPulse Vybrance Percutaneous Electrode System in treating papillary thyroid cancer tumors less than 1.5 cm in size. A total of 30 patients are planned for enrollment between two study sites. The first patient was enrolled and treated by Ralph P. Tufano, MD, Director of the Multidisciplinary Thyroid and Parathyroid Center at Sarasota Memorial, while two subsequent cases were completed by Principal Investigator, Dr. Victoria Banuchi, Associate Professor of Head & Neck Surgery at UT MD Anderson. The system previously received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ablation of soft tissue and is now being evaluated under an Investigational Device Exemption (IDE) specifically for thyroid cancer applications. The Company’s nPulse Vybrance Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary nPulse Console. The novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. This proprietary system is designed for non-cardiac applications. Ankündigung • Mar 10
Pulse Biosciences Announces Clinical Data From nPulse Vybrance System First-In-Human Clinical Durability Study Of Benign Thyroid Nodule Ablation Pulse Biosciences, Inc. had announced clinical data on outcomes durability from the nPulse Vybrance Percutaneous Electrode System First-in-Human ablation study of benign thyroid nodules using nsPFA energy. The long-term follow-up from this study demonstrates significant and sustained volume reduction of treated benign thyroid nodules at 15-22 months, with no tissue regrowth and no serious adverse events. Key study findings include: Durable 15-22 month results with an average of 74% volume reduction of treated benign thyroid nodules with overwhelming patient satisfaction reported; Continued volume reduction improvements from 1 month through 22 months; No regrowth of nodules at 15-22 months; Patient-reported Cosmetic Satisfaction: 100% were Highly Satisfied at final follow-up; Patient-reported Overall Satisfaction: 95% were Highly Satisfied at final follow-up; No serious adverse events; No intranodular fibrosis detected on ultrasounds at 15-22 months; Potential for clinical durability of benign thyroid ablation. These long-term benefits manifest the uniqueness of nsPFA as differentiated from all other present forms of Pulse Field Energy Ablation, namely the speed of particle flow as well as the absolute voltage pressure per unit of time. This study is an extension of the initial feasibility study conducted at Ospedale del Mare in Naples, Italy, which evaluated nsPFA energy for the treatment of benign thyroid nodules. The study was extended to allow for long-term follow-up of a subset of the patients included in the initial study. A total of 21 patients were subsequently monitored between 15 and 22 months to evaluate volume reduction trends over time. These data on initial feasibility and clinical durability demonstrated significant progress in the development of clinical evidence for the use of nsPFA energy for the ablation of benign thyroid nodules. While the work to establish clinical outcomes of nPulse Vybrance for benign thyroid nodules is early, these data provide the first long-term results of sustained tissue responses. Evidence of sustainable volume reduction and high patient satisfaction, added to the inherent procedural safety and soft tissue response of nsPFA ablation, provide promising signals to pursue in future market development work. Breakeven Date Change • Feb 22
No longer forecast to breakeven The 2 analysts covering Pulse Biosciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$32.4m in 2027. New consensus forecast suggests the company will make a loss of US$81.0m in 2028. Recent Insider Transactions Derivative • Feb 10
Chief Commercial Officer notifies of intention to sell stock Kevin Danahy intends to sell 75k shares in the next 90 days after lodging an Intent To Sell Form on the 9th of February. If the sale is conducted around the recent share price of US$20.75, it would amount to US$1.6m. Since March 2025, Kevin's direct individual holding has increased from 43.30k shares to 43.36k. Company insiders have collectively sold US$1.1m more than they bought, via options and on-market transactions in the last 12 months. New Risk • Feb 07
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m (US$86k revenue). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$82m net loss in 3 years). Ankündigung • Feb 06
Pulse Biosciences, Inc. Presents Late-Breaking Data from nPulse™? Cardiac Catheter System First-In-Human Feasibility Study at the AF Symposium Pulse Biosciences, Inc. announced late-breaking clinical data from the nPulse Cardiac Catheter first-in-human feasibility study. The study demonstrates successful treatment of atrial fibrillation in 150 patients with rapid procedure times and minimal adverse effects. The data were presented at the 31st Annual AF Symposium 2026 meeting, taking place February 5-7, 2026, in Boston, MA. Key study findings include: 100% procedural success of evaluable patients at 6 months (75/75); 96% procedural success of evaluable patient at one year (45/47); Average number of applications were 16.1 +- 5.2 per procedure; Total procedure and fluoroscopy times were 65 +- 28 and 9.8 +- 5.8 minutes, respectively; Left atrial dwell time was 21.0 +- 13.3 minutes; Safety profile: 1.3% (2/150) subjects had an SAE related to the primary safety endpoint. The ongoing feasibility study is assessing the initial safety and efficacy of the nPulse Cardiac catheter System for the treatment of AF (NCT06696170). The initial cohort of treated patients has been evaluated by remapping at 3 months and for rhythm control completed at 6 and 12 months post ablation procedure. Ankündigung • Feb 05
Pulse Biosciences, Inc. to Report Q4, 2025 Results on Feb 19, 2026 Pulse Biosciences, Inc. announced that they will report Q4, 2025 results After-Market on Feb 19, 2026 Breakeven Date Change • Feb 02
No longer forecast to breakeven The 2 analysts covering Pulse Biosciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$32.4m in 2027. New consensus forecast suggests the company will make a loss of US$84.3m in 2027. Ankündigung • Jan 09
Pulse Biosciences, Inc. Appoints Maria Sainz to Its Board of Directors, Effective January 9, 2026 Pulse Biosciences, Inc. announced the appointment of Maria Sainz to its Board of Directors effective as of January 9, 2026. Maria Sainz brings over three decades of experience in healthcare technology, including 18 years in CEO roles leading publicly traded companies and venture-backed startups. Currently, she serves as President and CEO of Hyperfine, Inc., a medical technology company with a commercial stage portable brain MRI system. Previously, she served as President and CEO of Aegea Medical, President and CEO of CardioKinetix Inc., and as President and CEO of Concentric Medical. Prior to her CEO roles, Mrs. Sainz served in various leadership capacities at Guidant Corporation and Boston Scientific Corporation, including as Strategic Advisor to the COO, President of the Cardiac Surgery Division, Vice President of Global Marketing for Vascular Intervention, and Vice President for CRM and Cardiac Surgery in EMEA. In addition, she has served on the board of numerous companies including Shockwave Medical, Spectranetics Corp, Avanos Medical, Orthofix Medical Inc, Hyperfine, and several private medical device companies. Mrs. Sainz holds a Master of English from the Complutense University of Madrid and a Master of International Management from Thunderbird School of Global Management. Ankündigung • Jan 07
Pulse Biosciences Selects to Present Late-Breaking Data from the nPulse Cardiac Catheter Study at the AF Symposium Pulse Biosciences, Inc. announced that late-breaking data from the nPulse Cardiac Catheter Ablation System first-in-human feasibility study in Europe has been accepted for presentation at the 31st Annual AF Symposium 2026 meeting in February. This late breaking data will be presented by Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY, and include 6-month and 12-month follow-up data from the nPulse cardiac Catheter Ablation System First-in-human feasibility study conducted in Europe. The Company plans to provide specific on presentation times in late January. Ankündigung • Dec 18
Pulse Biosciences, Inc. Announces FDA Ide Approval to Initiate Its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation Pulse Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company's Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the initiation of its nPulse Cardiac Catheter Ablation System Study (NANOPULSE-AF) for the treatment of paroxysmal atrial fibrillation (PAF). This single-arm, multicenter, prospective study is designed to demonstrate primary safety and effectiveness of the nsPFA Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal AF. Up to 30 sites, including three sites outside the United States, are planned to enroll up to 145 patients. Additional details of the study are available on clinicaltrials.gov (NCT07018596). The nPulse Cardiac Cat catheter is designed to deliver a complete circumferential lesion in a single, brief energy application without the need to stack lesions, and eliminating the need to stop, rotate and reposition the catheter. The Company's ongoing feasibility study in Europe with the nPulse Cardiac catheter has now enrolled 150 patients by leading investigators with subject follow-up ongoing. Positive initial clinical outcomes support a strong foundation of real-world evidence to support broader global adoption of nsPFA treatments. Ankündigung • Oct 29
Pulse Biosciences, Inc., Annual General Meeting, Dec 09, 2025 Pulse Biosciences, Inc., Annual General Meeting, Dec 09, 2025. Ankündigung • Oct 24
Pulse Biosciences, Inc. Announces First Enrollment in the NANOCLAMP AF Study Pulse Biosciences, Inc. announced the enrollment of the first patient in its NANOCLAMP AF Study for the treatment of atrial Fibrillation (AF). The successful first procedure was completed at St. Helena Hospital in St. Helena, California, with the nPulse Cardiac Surgical Systemfollowing its recent FDA IDE approval. NANOCLAMP AF is a single-arm, prospective multicenter study designed to demonstrate the safety and effectiveness of the nPulse CardiacSurgical System for the treatment of AF in concomitant surgical procedures. Multiple sites, including two outside the United States, are planned for patient enrollment. This device offers an improved safety profile as a result of the nonthermal mechanism of action while enabling consistent, precise, contiguous and durable full-thickness lesions in a fraction of the time compared to existing technology. This should ultimately translate to improved outcomes for patients and expand treatment to more people in need. The nPulse Cardiac S surgical System is a next-generation, bipolar surgical device engineered to create continuous, full-thickness ablation lines during concomitant cardiac procedures. The system utilizes a nonthermal energy modality which is expected to provide significant safety and procedural advantages over conventional thermal ablation methods. The nsPFA Cardiac Surgical System was granted FDA Breakthrough Device Designation in July 2024 and is enrolled in the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP). These statements are not historical facts but rather are based on Pulse Biosciences' current expectations, estimates, and projections regarding Pulse Biosciences' business, operations and other similar or related factors. words such as "may, "will," " could," "would," "predict," "pot potential," continue," "intends," "projects," " believes," "estimates," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences' control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences' filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information may be available in the U.S. Ankündigung • Oct 23
Pulse Biosciences, Inc. to Report Q3, 2025 Results on Nov 05, 2025 Pulse Biosciences, Inc. announced that they will report Q3, 2025 results After-Market on Nov 05, 2025 Ankündigung • Oct 10
Pulse Biosciences, Inc. Announces Presentation of Late-Breaking Data from the nPulse Cardiac Surgical System First-In-Human Feasibility Study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting Pulse Biosciences, Inc. announced late-breaking clinical study results from the nPulse™? Cardiac Surgical System first-in-human feasibility study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark. The feasibility study is intended to assess the initial safety and efficacy of the nPulse Cardiac Surgical System for the treatment of Atrial Fibrillation (NCT06355063). Initial Cohort Study Results: All (100%) posterior box isolations were acutely successful in the high-dose cohort; Success rate of PVI (per vein) at 3 months was 94% (63/67); Average total ablation time of 50 seconds with average number of 13 applications; No reports of esophageal or phrenic nerve damage; No ablation-related severe or major adverse events. Also, at the EACTS annual meeting, a live-in-a-box case transmission featured the nPulse CardiacSurgical System in a recorded case performed and presented by Dr. Bart van Putte. The case highlighted the nPulse Cardiac surgical System's ability to rapidly achieve PVI and posterior box isolation with a fast, efficient procedure workflow. Recent Insider Transactions Derivative • Sep 17
CTO & Director exercised options and sold US$822k worth of stock On the 15th of September, Darrin Uecker exercised 75k options at a strike price of around US$4.00 and sold these shares for an average price of US$14.96 per share. This trade did not impact their existing holding. Since March 2025, Darrin's direct individual holding has decreased from 152.87k shares to 122.87k. Company insiders have collectively bought US$61m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Sep 14
Independent Co-Chairman recently bought US$2.6m worth of stock On the 10th of September, Robert Duggan bought around 180k shares on-market at roughly US$14.46 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Robert has been a buyer over the last 12 months, purchasing a net total of US$5.3m worth in shares. Ankündigung • Sep 08
Pulse Biosciences Announces Fda Ide Approval to Initiate Its Nspfa Cardiac Surgery System Study for the Treatment of Atrial Fibrillation Pulse Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company's Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the initiation of its nsPFA Cardiac Surgery System Study, NANOCLAMP AF, for the treatment of atrial fibrillation (AF). This single-arm, prospective study is designed to demonstrate primary effectiveness of the nsPFA Cardiac Surgical System for the treatment of AF in concomitant surgical procedures. Up to twenty sites, including two outside the United States, are planned to enroll up to 136 patients. Additional details of the study will be made available on clinicaltrials.gov. This FDA IDE approval is a major milestone for Pulse Biosciences. The study approval is a testament to the quality of the preclinical and human clinical data that has been generated in support of this breakthrough technology. The nsPFA Cardiac Clamp is designed to deliver continuous, linear, transmural ablations during concomitant cardiac surgeries. The bipolar device leverages the Company's proprietary nonthermal nsPFA technology, which early clinical data suggest may offer safety and performance advantages over traditional thermal ablation methods. Unlike thermal approaches, nsPFA energy minimizes the risk of collateral tissue damage due to its nonthermal mechanism of action. The nsPFA Cardac Surgical System received FDA Breakthrough Device Designation in July 2024 and is enrolled in the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP). Ankündigung • Sep 03
Pulse Biosciences, Inc. Announces First Successful Procedures in PRECISE Benign Thyroid Nodule (BTN) Study Pulse Biosciences, Inc. announced the first successful procedures in a multicenter IRB-approved study using Pulse Biosciences' nsPFA Percutaneous Electrode System for the treatment of benign thyroid nodules (BTNs). The PRECISE-BTN study is a prospective, single arm, multicenter, clinical study using the Pulse BiosciencesnsPFA™? Percutaneous Electrode System to safely and effectively treat benign thyroid nodules or cause significant nodule volume reductions, statements concerning whether any clinical study will show that the Company's novel nsPFA mechanism of action will deliver fast and precise ablations or effectiveness as a treatment for BTNs, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nsPFA Percutaneous electrode System, and Pulse Biosciences' expectations, whether stated or implied, regarding whether the Company's CellFX nsPFA technology will become a disruptive, superior and durable treatment option for treating benign thyroid nodules or any other medical condition or otherwise advance current medical standards of care, and other future events. Ankündigung • Aug 26
Pulse Biosciences, Inc. Announces Publication of First-In-Human Data for Treatment of Benign Thyroid Nodules in the Journal Thyroid Pulse Biosciences, Inc. announced a new publication in the Journal Thyroid. The First-in-Human Clinical feasibility study demonstrates the effectiveness of ablation of benign thyroid nodules using nsPFA energy. The study was designed to assess the ability of nsPFA energy to provide a safe and effective option for the treatment of symptomatic benign thyroid nodules with minimal side effects. The study was conducted by Professor Stefano Spiezia as a single-arm First-In-Human feasibility study at the Ospedale del Mare center in Naples, Italy. The CellFX nsPFA Percutaneous Electrode System was used under ultrasound guidance to ablate benign thyroid nodules, as either isolated ablations to assess tissue response (Cohorts 1 & 2) or for full treatment of thyroid nodules with therapeutic intent (Cohort 3). Results showed no intranodular fibrosis or scarring on follow-up ultrasounds and fully treated nodules (Cohort 3) had up to 93% reduction in size at 1 year on ultrasound assessment (average 86% reduction), with symptom relief and >48% reduction as early as 2 weeks. The results of this study are extremely compelling and demonstrate nsPFA's ability to offer advantages in treating benign thyroid nodules compared to other methods such as thyroidectomy or thermalablation. This technology provides a favorable safety profile, rapid symptom reduction, and lack of intranodular fibrosis and scarring. Ankündigung • Jul 30
Pulse Biosciences, Inc. to Report Q2, 2025 Results on Aug 12, 2025 Pulse Biosciences, Inc. announced that they will report Q2, 2025 results After-Market on Aug 12, 2025 New Risk • Jul 07
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 22% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 22% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$78m net loss next year). Significant insider selling over the past 3 months (US$486k sold). Recent Insider Transactions • Jun 18
CTO & Director recently sold US$486k worth of stock On the 13th of June, Darrin Uecker sold around 30k shares on-market at roughly US$16.19 per share. This transaction amounted to 20% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Despite this recent sale, insiders have collectively bought US$1.3m more than they sold in the last 12 months. Ankündigung • Apr 25
Pulse Biosciences, Inc. to Report Q1, 2025 Results on May 08, 2025 Pulse Biosciences, Inc. announced that they will report Q1, 2025 results at 4:00 PM, US Eastern Standard Time on May 08, 2025 Ankündigung • Mar 07
Pulse Biosciences, Inc. to Report Q4, 2024 Results on Mar 27, 2025 Pulse Biosciences, Inc. announced that they will report Q4, 2024 results After-Market on Mar 27, 2025 Recent Insider Transactions Derivative • Feb 12
Independent Director exercised options to buy US$1.3m worth of stock. On the 3rd of February, Mahkam Zanganeh exercised options to buy 60k shares at a strike price of around US$11.00, costing a total of US$663k. This transaction amounted to 7.4% of their direct individual holding at the time of the trade. Since March 2024, Mahkam's direct individual holding has increased from 752.99k shares to 813.23k. Company insiders have collectively bought US$60m more than they sold, via options and on-market transactions, in the last 12 months. Ankündigung • Feb 04
Pulse Biosciences, Inc. Announces the Appointment of Jon Skinner as Chief Financial Officer Pulse Biosciences, Inc. announced the appointment of Jon Skinner as Chief Financial Officer, effective February 3, 2025. Jon Skinner is an accomplished financial leader with experience across the healthcare sector. He most recently served as Vice President, FP&A and Investor Relations at Copeland, a private equity backed industrial company. Prior to this role, Mr. Skinner was Vice President, Finance and Corporate Development at Imperative Care. There, he spearheaded M&A, strategy, partnerships, and sales operations along with providing financial and strategic support for all development stage business units. While at Imperative Care, he also served as the interim CFO of Kandu Health during its spin-out and fundraising process. Prior to his time at Imperative Care, Mr. Skinner served as Vice President, Finance – Interventional Urology at Teleflex. There he led accounting, FP&A, customer service, and sales operations for the Interventional Urology Business Unit, following his role as Senior Director, Corporate Development, where he helped close 25 M&A transactions. Prior to Teleflex, Mr. Skinner spent time at Axalta Coating Systems working on its carve-out and IPO and at Duff & Phelps (now Kroll) in the Valuation Advisory Group. Mr. Skinner holds a Bachelor of Science and a Master of Business Administration from The Ohio State University. Ankündigung • Jan 21
Pulse Biosciences Announces Late-Breaking Data from its Nanosecond PFA 360° Cardiac Catheter System First-In-Human Feasibility Study Presented at the AF Symposium Pulse Biosciences, Inc. announced the late-breaking data from its Nanosecond PFA 360° Cardiac Catheter System first-in-human feasibility study, which data were recently presented at the 30th Annual AF Symposium 2025 meeting. The feasibility study is intended to assess the initial safety and efficacy of the Nanosecond PFA 360° Cardiac Catheter System for the treatment of AF (NCT06696170). To date, 77 patients have been treated by six investigators, including Dr. Vivek Reddy and Prof. Petr Neuzil, in cases performed at Na Holmolce Hospital in Prague and Dr. Johan Vijgen at Jessa Hospital in Hasselt. The initial cohort of the first 30 patients treated have been evaluated by remapping completed at ~3 months post ablation procedure. Initial Cohort Study Results: All (100%) lesions were acutely successful with conduction block. Success rate of PVI at ~3 months was 92.4% (109/118). Total PVI ablation time was 11.6±4.5 minutes. Total procedure and fluoroscopy times were 88.3±30.1 and 6.9±2.4 minutes, respectively. Left atrial dwell time was 29.6±15.3 minutes. 1 Primary SAE (cardiac perforation) and 2 AEs including vertigo (n=1; managed conservatively) and creatinine elevation (n=1; treated with IV saline). All AEs were resolved without sequelae. Also, at the AF Symposium, a live case transmission highlighted the nsPFA 360° Cardiac Catheter with 3D mapping and navigation on the Abbott Ensite X System. Prof. Petr Neuzil and Drs. Moritoshi Funasako and Jan Petru performed a successful live case highlighting the nsPFA 360° Cardiac Catheters’ ability to rapidly isolate the pulmonary veins with a fast, efficient procedure workflow. Ankündigung • Jan 10
Pulse Biosciences, Inc. Appoints Paul A. LaViolette as Chief Executive Officer Pulse Biosciences, Inc. announced the appointment of Paul A. LaViolette, current Co-Chairman of the Board, as Chief Executive Officer. Paul LaViolette has significant experience as a large-scale operator at global healthcare corporations as well as a leader to a diverse group of innovative medical technology startups as a venture investor and board member. As a Managing Partner at SV Health Investors, Paul invested in numerous portfolio companies and remains active on the Board of Directors of certain SV Health Investors portfolio companies. Before his investing career, he served in various executive capacities at Boston Scientific Corporation for 15 years, including as Chief Operating Officer; Group President, Cardiovascular; President, Cardiology; Group President, Endosurgery; and President, International. Prior to Boston Scientific, he also served as President, Cardiology, for CR Bard and various marketing roles at Kendall (Medtronic). Mr. LaViolette is currently a director for Edwards Lifesciences and Chairman of the Innovation Advisory Board at Mass General Brigham. Mr. LaViolette received his bachelor’s degree in psychology from Fairfield University and his Master of Business Administration from Boston College. Recent Insider Transactions Derivative • Dec 20
Executive Co-Chairman exercised options to buy US$94m worth of stock. On the 18th of December, Robert Duggan exercised options to buy 5m shares at a strike price of around US$11.00, costing a total of US$58m. This transaction amounted to 12% of their direct individual holding at the time of the trade. Since March 2024, Robert's direct individual holding has increased from 37.48m shares to 42.73m. Company insiders have collectively bought US$60m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Dec 16
Executive Co-Chairman recently bought US$972k worth of stock On the 11th of December, Robert Duggan bought around 56k shares on-market at roughly US$17.35 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Robert's only on-market trade for the last 12 months. Ankündigung • Nov 01
Pulse Biosciences, Inc. Announces Positive Clinical Data Presented At the American Thyroid Association Pulse Biosciences, Inc. announced positive preliminary results from its first-in-human feasibility study using Nanosecond Pulsed Field Ablation for the treatment of benign thyroid nodules. Dr. Stefano Spiezia presented these excellent results at the 2024 American Thyroid Association Annual Meeting. The preliminary data demonstrate that nano-PFA pulses effectively delivered by the Company's Percutaneous Electrode System reduced nodule sizes on average by over 50%, without evidence of residual fibrosis or scarring, and provided symptomatic relief within the first month of treatment. The nonthermal and minimally invasive nature of nano-PFA energy has shown potential to mitigate the risk of complications from thermal ablation procedures or surgical removal of benign thyroid nodules. Pulse Biosciences' nsPFA Percutaneous Electrode System is currently being investigated by Stefano Spiezia, Chief of Endocrine Surgery Division at Napoli Ospedale del Mare, Naples Italy. The study has completed enrollment in the 30-patient first-in-human feasibility clinical trial (NCT06117085) to support the initial safety and effectiveness profile of the nsPFA electrode or needle in treating and reducing the volume of benign thyroid nodules leading directly to a reduction in patient symptoms. The Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company's proprietary nano-PFA Console. The proprietary and novel electrode is designed to harness and deliver the key advantages of nano-PFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. This proprietary system is designed for non-cardiac applications. Ankündigung • Oct 31
Pulse Biosciences, Inc. Announces Appointment of David Kenigsberg, M.D. as Chief Medical Officer of Electrophysiology Pulse Biosciences, Inc. announced the appointment of David Kenigsberg, M.D. as Chief Medical Officer of Electrophysiology. Dr. Kenigsberg is a practicing cardiac electrophysiologist with a passion for treating atrial fibrillation over his career. He is the founder of Florida Heart Rhythm Specialists and Ft. Lauderdale Heart & Rhythm Surgical Center. He has been the Medical Director of the Electrophysiology Lab at HCA Westside Medical Center in Plantation, Florida, since 2007. He has published numerous scholarly articles in peer-reviewed medical journals. He has advised in the development and has been the primary investigator/co-investigator in a myriad of clinical trials involving ablation tools. Dr. Kenigsberg is a fellow of the American College of Cardiology and the Heart Rhythm Society. He is the President of the Florida Chapter of the American College of Cardiology and sits on the American College of Cardiology Board of Governors. Ankündigung • Oct 21
Pulse Biosciences, Inc. to Report Q3, 2024 Results on Oct 30, 2024 Pulse Biosciences, Inc. announced that they will report Q3, 2024 results After-Market on Oct 30, 2024 Ankündigung • Aug 16
Pulse Biosciences, Inc. announced delayed 10-Q filing On 08/15/2024, Pulse Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Ankündigung • Aug 13
Pulse Biosciences, Inc. Appoints Paul LaViolette to Its Board of Directors Pulse Biosciences, Inc. announced the appointment of Paul A. LaViolette to its Board of Directors. Mr. LaViolette has been appointed Co-Chairman of the Board alongside Co-Chairman Robert W. Duggan, serving as an independent director. Paul LaViolette has significant experience as a large-scale operator at healthcare corporations, as well as an advisor to a diverse group of innovative medical technology startups as a venture investor and board member. He is currently Managing Partner at SV Health Investors, investing in portfolio companies for its Medtech Convergence Fund. Before his investing career, he served in various executive capacities at Boston Scientific Corporation for 15 years, including as Chief Operating Officer; Group President, Cardiovascular; President, Cardiology; Group President, Endosurgery; and President, International. Prior to Boston Scientific, he also held general management and commercial leadership positions at CR Bard and various marketing roles at Kendall (Medtronic). Mr. LaViolette has experience in both chairman and director capacities for numerous private and public medical technology companies. He is currently a director for Edwards Lifesciences, Chairman of the Innovation Advisory Board at Mass General Brigham, and is a director or Chairman on multiple private medical device company boards. Mr. LaViolette received his bachelor’s degree in psychology from Fairfield University and his Master of Business Administration from Boston College. Ankündigung • Aug 08
Pulse Biosciences, Inc. Announces Successful Treatment of Patients in First-in-Human Study with its Nano-PFA Cardiac Surgery System Pulse Biosciences, Inc. announced treatment of the first two patients in the first-in-human feasibility study using its novel Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation. Dr. Bart Van Putte, Cardiothoracic Surgeon at St. Antonius Hospital, used the Company's Cardiac Surgery System to successfully treat two patients with atrial fibrillation at St. Antonius Hospital., Nieuwegein, The Netherlands. Pulse's Cardiac Surgery System with Surgical Clamp is designed to produce durable, continuous, transmural, ablation lesions during cardiac surgery procedures for the treatment of atrial Fibrillation. Also, due to the non-thermal mechanism of action of nano-PFA, there is no risk of thermal spread that may cause undesired injury to collateral tissues, which compares favorably to thermal radiofrequency ablation. The nano-PFA Cardiac Surgical System received FDA Breakthrough Device Designation in early July 2024. Recently the device was enrolled in the FDA's TAP program. The FDA's Center for Devices and Radiological Health (CDRH) launched the TAP program to help generate more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health. TAP's primary goal is to expedite patient access to innovative medical devices by providing early, frequent and strategic communications with the FDA and facilitating engagement with other key parties for developers of devices of public health importance. According to its website, the FDA has enrolled 46 devices in the TAP program to date, while there have been over 900 Breakthrough Device Designations granted. The Company plans to pursue FDA premarket approval (PMA) to commercialize its nano-PFA CardiacSurgical System in the United States as a treatment for atrial fibrillation. If granted by the FDA, a specific treatment indication would permit direct marketing of the device's treatment benefits. The Company intends to begin its pivotal clinical study of its nano-PFA Cardac Surgical System as a treatment for atrial Fibrillation in early 2025 and will provide additional details on the study and its regulatory and commercial implications later this year. Ankündigung • Jul 30
Pulse Biosciences, Inc. to Report Q2, 2024 Results on Aug 12, 2024 Pulse Biosciences, Inc. announced that they will report Q2, 2024 results After-Market on Aug 12, 2024 Ankündigung • Jul 16
Pulse Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $60 million. Pulse Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $60 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • Jul 08
Pulse Biosciences, Inc. Announces Receipt of FDA Breakthrough Device Designation for CellFX® nsPFA Cardiac Surgery System for the Treatment of Atrial Fibrillation Pulse Biosciences, Inc. announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company's Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation (AF). Pulse Biosciences' Cardiac Surgery System with Surgical Clamp is designed to produce durable, continuous transmural ablation lesions during cardiac surgery procedures for the treatment of atrial Fibrillation. The bipolar clamp utilizes the Company’s proprietary nanosecond PFA technology. Based on pre-clinical studies, a single application of less than 2 seconds with the Surgical Clamp creates a consistent, transmural ablation, which is significantly faster, requiring approximately one-twentieth the time of currently available thermal ablation technologies. Also, due to the non-thermal mechanism of action of nano-PFA, there is no risk of thermal spread that may cause undesired injury to collateral tissues, which compares favorably to thermal radiofrequency ablation. The Breakthrough Devices Program is a voluntary program for certain medical devices with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as atrial fibrillation. The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must still meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing. The Company now plans to pursue the premarket approval (PMA) application pathway for FDA approval to market as opposed to the 510(k) route, and once FDA PMA approved, commercialize the nsPFA Cardiac Surgical System in the United States as a treatment for atrial fibrillation. Once granted by the FDA, a specific treatment indication would permit direct marketing of the treatment benefits provided by the device. The Company expects to begin its pivotal clinical trial for AF in 2025 and will provide additional details on the study and its regulatory and commercial implications later this year. Ankündigung • Jun 10
Shelley D. Spray Does Not Stand for Reelection from the Board of Pulse Biosciences, Inc On June 6, 2024, Pulse Biosciences, Inc. held its 2024 Annual Meeting of Stockholders. Director Shelley D. Spray did not stand for reelection at the Annual Meeting. Recent Insider Transactions • May 24
President & CEO recently bought US$86k worth of stock On the 20th of May, Burke Barrett bought around 10k shares on-market at roughly US$8.56 per share. This trade did not impact their existing holding. This was the largest purchase by an insider in the last 3 months. This was Burke's only on-market trade for the last 12 months. Ankündigung • May 10
Pulse Biosciences, Inc. Announces First U.S. Procedure with the CellFX nsPFA Percutaneous Electrode System Pulse Biosciences, Inc. announced the first procedure with the CellFX nsPFA Percutaneous Electrode System in the United States has been completed. The successful case is the first in the Company's pilot program which follows the March 2024 U.S. FDA 510(k) clearance for the ablation of soft tissue in percutaneous and intraoperative surgical procedures with the system. The CellFX nsPFA Per cutaneous Electrode System consists of a percutaneous needle electrode for use with the Company's proprietary CellFX nsPFA Console. The proprietary and novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. This proprietary system is designed for non-cardiac applications. Thyroid nodule soft tissue ablation procedures were performed on 30 patients with the CellFX nsPFA Percutaneous System in Italy from April 2023 through January 2024. Per amended study protocols, patients were observed and evaluated in follow-up visits to assess the procedure as early as one week post procedure, and up to this point, as late as 180 days post procedure. Patient follow-ups were conducted weekly for the first 4 weeks, then at 30-, 90-, 180-, and 360-day timepoints following the procedures. No evidence of scarring or injury to surrounding tissue has been observed, and patient treatments have been judged to be successful. New Risk • May 08
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$34m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$34m free cash flow). Earnings have declined by 2.0% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (47% increase in shares outstanding). Ankündigung • Apr 26
Pulse Biosciences, Inc. to Report Q1, 2024 Results on May 07, 2024 Pulse Biosciences, Inc. announced that they will report Q1, 2024 results After-Market on May 07, 2024 Ankündigung • Apr 24
Pulse Biosciences, Inc., Annual General Meeting, Jun 06, 2024 Pulse Biosciences, Inc., Annual General Meeting, Jun 06, 2024, at 08:00 Pacific Standard Time. Agenda: To elect five directors from the nominees named in the accompanying Proxy Statement to hold office until 2025 annual meeting of stockholders and until their successors are duly elected and qualified, subject to their earlier resignation or removal; to ratify the appointment of Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; and to transact such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof. Ankündigung • Mar 15
Pulse Biosciences, Inc. to Report Q4, 2023 Results on Mar 28, 2024 Pulse Biosciences, Inc. announced that they will report Q4, 2023 results at 4:00 PM, US Eastern Standard Time on Mar 28, 2024 Ankündigung • Mar 09
Pulse Biosciences, Inc. Announces FDA 510(K) Clearance for its CellFX nsPFA Percutaneous Electrode System Pulse Biosciences, Inc. announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its novel CellFX nsPFA Percutaneous Electrode System for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. The CellFX nsPFA Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary CellFX nsPFA Console. The novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. This percutaneous electrode is designed for non-cardiac applications. Ankündigung • Jan 02
Pulse Biosciences Files 510(K) Submission with U.S. FDA for its CellFX nsPFA Cardiac Clamp Pulse Biosciences, Inc. announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel CellFX nsPFA Cardiac Clamp. Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information from the Company based on that review. FDA guidance suggests the goal is to complete 510(k) review within 90 calendar days, not including time required by the Company to respond to additional information requests. The time required to respond to any such requests will depend on the nature of the request. Pulse Biosciences' CellFX NSPFA Cardiac Clamp is designed to produce continuous linear transmural ablations during concomitant cardiac surgical procedures using the Company's novel CellFX system. The bipolar clamp utilizes the Company's proprietary nsPFA technology, a nonthermal ablation technology, and preclinical data suggest nsPFA may provide safety and performance benefits over the current thermal ablation technologies for cardiac ablation, such as the use of extreme heat or cold. A single CellFX nsPFA Cardac Clamp ablation can be done in one-twentieth of the time of current thermal ablation technologies and, due to the nonthermal mechanism of action, does not have the risk of thermal spread leading to unintended collateral damage to adjacent tissue and structures. Ankündigung • Dec 20
Pulse Biosciences, Inc. Announces First-In-Human Procedures with its Novel CellFX Nanosecond Pulsed Field Ablation Cardiac Catheter Pulse Biosciences, Inc. announced the completion of the first five procedures in its first-in-human feasibility study with its novel CellFX nsPFA cardiac catheter. All patients were successfully discharged by treating physicians. Patients will continue to be monitored and evaluated over the coming months to assess safety and effectiveness with the primary safety endpoint at 30 days. Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital, NY, and Dr. Pet Neuzil, Chief of Cardiology at Na Homolce Hospital, Prague, and colleagues used the Company's CellFX nsPFA 360 cardiac catheter integrated with 3D mapping and navigation technologies (iMap System, CardioNXT) to successfully treat five patients with atrial fibrillation (AF) at Na Homolce Hospital. Pulse Biosciences' CellFX nsPFA 360 cardiovascular catheter, which is still in the investigational stage, is uniquely designed to produce a nonthermal ablation, initially targeted for pulmonary vein isolation, using the Company's proprietary CellFX nsPFA energy in the treatment of atrial fibrillation. The Company expects to provide additional updates on the first-in-human procedures with the CellFX system in the upcoming months. Pulse Biosciences will inform stakeholders promptly if results differ materially from the stated expectations addressing safety and efficacy. The observations to date have been positive but the broad set of risks associated with cardiac surgery remain. The Company anticipates initiating the regulatory process with the U.S. FDA and appropriate regulatory authorities worldwide including Europe in the coming quarters and expects additional studies will be required. Recent Insider Transactions Derivative • Dec 08
Executive Chairman exercised options to buy US$382k worth of stock. On the 4th of December, Robert Duggan exercised options to buy 40k shares at a strike price of around US$10.66, costing a total of US$430k. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. Since March 2023, Robert's direct individual holding has increased from 20.47m shares to 36.81m. Company insiders have collectively bought US$18m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Dec 03
Executive Chairman recently bought US$1.1m worth of stock On the 28th of November, Robert Duggan bought around 124k shares on-market at roughly US$8.98 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Robert has been a buyer over the last 12 months, purchasing a net total of US$1.2m worth in shares. Ankündigung • Nov 22
Pulse Biosciences, Inc. Announces Filing of Premarket Notification 510(k) to U.S. Food and Drug Administration for its Novel CellFX nsPFA Percutaneous Electrode Pulse Biosciences, Inc. announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel CellFX nsPFA percutaneous electrode. The Company’s percutaneous electrode is an image-guided needle designed to harness CellFX nsPFA energy to deliver precise and complete nonthermal ablation of cellular tissue without damage to noncellular structures. The percutaneous electrode is designed for non-cardiac applications. Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information from the Company based on that review. FDA guidance suggests the goal is to complete 510(k) substantive review within 90 calendar days, not including time required by the Company to respond to additional information requests. The time required to respond to any such requests will depend on the nature of the request. Recent Insider Transactions • Nov 18
Chief Strategy Officer recently bought US$105k worth of stock On the 15th of November, Mitchell Levinson bought around 18k shares on-market at roughly US$5.90 per share. This transaction amounted to 24% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$140k more in shares than they have sold in the last 12 months. Recent Insider Transactions Derivative • Nov 12
Executive Chairman exercised options to buy US$68k worth of stock. On the 7th of November, Robert Duggan exercised options to buy 13k shares at a strike price of around US$5.95, costing a total of US$79k. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. Since March 2023, Robert's direct individual holding has increased from 20.47m shares to 36.25m. Company insiders have collectively bought US$12m more than they sold, via options and on-market transactions, in the last 12 months. Ankündigung • Oct 31
Pulse Biosciences, Inc. to Report Q3, 2023 Results on Nov 13, 2023 Pulse Biosciences, Inc. announced that they will report Q3, 2023 results After-Market on Nov 13, 2023 Ankündigung • Oct 25
Pulse Biosciences, Inc. Appoints Dr. Niv Ad as Chief Science Officer, Cardiac Surgery Pulse Biosciences, Inc. announced the appointment of Niv Ad, M.D. as Chief Science Officer, Cardiac Surgery. Dr. Ad is a leading authority in surgical treatment of atrial fibrillation, minimally invasive heart surgery and other advanced heart surgery techniques and transcatheter therapies. Dr. Ad has published more than 200 research articles in peer-reviewed publications. He has led the development of national and international clinical practice guidelines for the different cardiovascular societies for ISMICS, AATS and STS, and serves on multiple leadership positions and committees in the leading cardiothoracic societies. He is the past president of The International Society of Minimally Invasive Cardiothoracic and Vascular Surgery (MICS), the leading entity for minimally invasive procedures globally and he is the Editor in Chief of INNOVATIONS: Technology and Techniques in Cardiothoracic and Vascular Surgery. New Risk • Aug 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 1.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$45m net loss next year). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (48% increase in shares outstanding). Ankündigung • Jul 29
Pulse Biosciences, Inc. to Report Q2, 2023 Results on Aug 10, 2023 Pulse Biosciences, Inc. announced that they will report Q2, 2023 results After-Market on Aug 10, 2023 Recent Insider Transactions Derivative • Jul 10
Executive Chairman exercised options to buy US$881k worth of stock. On the 7th of July, Robert Duggan exercised options to buy 132k shares at a strike price of around US$2.19, costing a total of US$289k. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. Since March 2023, Robert's direct individual holding has increased from 20.47m shares to 36.10m. Company insiders have collectively bought US$12m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions Derivative • Jun 20
Executive Chairman exercised options to buy US$36m worth of stock. On the 14th of June, Robert Duggan exercised options to buy 6m shares at a strike price of around US$2.05, costing a total of US$12m. This transaction amounted to 19% of their direct individual holding at the time of the trade. Since March 2023, Robert's direct individual holding has increased from 20.47m shares to 30.41m. Company insiders have collectively bought US$12m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions Derivative • Jun 17
Independent Director exercised options to buy US$543k worth of stock. On the 9th of June, Mahkam Zanganeh exercised options to buy 87k shares at a strike price of around US$2.05, costing a total of US$178k. This transaction amounted to 10% of their direct individual holding at the time of the trade. Since March 2023, Mahkam has owned 590.30k shares directly. Company insiders have collectively bought US$303k more than they sold, via options and on-market transactions, in the last 12 months. Ankündigung • May 06
Pulse Biosciences, Inc. Appoints f Gansevoort 'Gan' Dunnington, M.D. as Its Chief Medical Officer Pulse Biosciences, Inc. announced the appointment of Gansevoort 'Gan' Dunnington, M.D. as its Chief Medical Officer. Dr. Dunnington is a cardiothoracic surgeon and the Director of Cardiothoracic Surgery at St. Helena Hospital (Napa Valley). He specializes in minimally invasive complex cardiothoracic procedures including the Hybrid Cox-Maze procedure for the treatment of atrial fibrillation (AF). Prior to his time at St. Helena Hospital, Dr. Dunnington was an assistant professor at Stanford University and assistant director of cardiothoracic surgery at El Camino Hospital, a Stanford University affiliate. Dr. Dunnington obtained his medical degree from the Medical College of Virginia. He completed his residency at Stanford University, where he served as Chief Resident of Surgery, and completed a fellowship in cardiothoracic surgery at the University of Virginia. Recent Insider Transactions • Oct 13
Chief Strategy Officer & Director recently bought US$70k worth of stock On the 7th of October, Mitchell Levinson bought around 31k shares on-market at roughly US$2.27 per share. This transaction amounted to 70% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$85k more in shares than they have sold in the last 12 months. Major Estimate Revision • Aug 17
Consensus revenue estimates fall by 31% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$2.10m to US$1.45m. Forecast losses increased from -US$1.71 to -US$1.90 per share. Medical Equipment industry in the US expected to see average net income growth of 11% next year. Consensus price target down from US$5.50 to US$4.00. Share price fell 6.4% to US$1.60 over the past week. Major Estimate Revision • May 18
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$3.99m to US$2.40m. EPS estimate increased from -US$1.83 to -US$1.71 per share. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target down from US$11.17 to US$5.50. Share price rose 10% to US$2.13 over the past week. Price Target Changed • Apr 27
Price target decreased to US$11.17 Down from US$24.67, the current price target is an average from 3 analysts. New target price is 325% above last closing price of US$2.63. Stock is down 87% over the past year. The company is forecast to post a net loss per share of US$1.83 next year compared to a net loss per share of US$2.28 last year. Major Estimate Revision • Apr 07
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$9.91m to US$3.99m. EPS estimate increased from -US$2.00 to -US$1.83 per share. Medical Equipment industry in the US expected to see average net income growth of 19% next year. Consensus price target down from US$24.67 to US$11.17. Share price fell 26% to US$3.59 over the past week. Price Target Changed • Jan 21
Price target decreased to US$35.33 Down from US$41.50, the current price target is an average from 3 analysts. New target price is 197% above last closing price of US$11.91. Stock is down 59% over the past year. The company is forecast to post a net loss per share of US$2.27 next year compared to a net loss per share of US$2.14 last year. Price Target Changed • Jan 19
Price target decreased to US$35.33 Down from US$38.00, the current price target is an average from 3 analysts. New target price is 194% above last closing price of US$12.02. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$2.27 next year compared to a net loss per share of US$2.14 last year. Breakeven Date Change • Jan 02
Forecast to breakeven in 2024 The 3 analysts covering Pulse Biosciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$41.1m in 2024. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Major Estimate Revision • Aug 12
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$1.26m to US$1.05m. EPS estimate increased from -US$2.88 to -US$2.37 per share. Medical Equipment industry in the US expected to see average net income growth of 19% next year. Consensus price target broadly unchanged at US$38.00. Share price rose 7.8% to US$24.25 over the past week. Price Target Changed • Jul 27
Price target decreased to US$37.95 Down from US$42.86, the current price target is an average from 3 analysts. New target price is 85% above last closing price of US$20.49. Stock is up 90% over the past year. Recent Insider Transactions • Jul 05
Independent Chairman of the Board recently bought US$50m worth of stock On the 30th of June, Robert Duggan bought around 3m shares on-market at roughly US$16.40 per share. This was the largest purchase by an insider in the last 3 months. This was Robert's only on-market trade for the last 12 months. Major Estimate Revision • May 17
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 expected loss increased from -US$2.03 to -US$3.13 per share. Revenue forecast of US$900.0k unchanged since last update. Medical Equipment industry in the US expected to see average net income growth of 39% next year. Consensus price target broadly unchanged at US$42.93. Share price was steady at US$17.45 over the past week. 