Pulse Biosciences Inc - PLSE STOCK NEWS

Pulse Biosciences (PLSE) has appointed Jon Skinner as Chief Financial Officer, effective February 3, 2025. Skinner brings extensive healthcare sector experience, most recently serving as VP of FP&A and Investor Relations at Copeland. His prior roles include VP of Finance and Corporate Development at Imperative Care and VP of Finance – Interventional Urology at Teleflex, where he led 25 M&A transactions.

As part of his appointment, Skinner received inducement grants of options to purchase 300,000 shares at $20.93 per share. The options vest over four years, with half based on continuous employment and half tied to achieving product revenue and market capitalization milestones between $2 billion and $5 billion.

The appointment aims to support the company's operational excellence and commercialization of its CellFX nanosecond PFA Platform, which utilizes proprietary Nanosecond Pulsed Field Ablation technology.

Pulse Biosciences (PLSE) announced its nanosecond Pulsed Field Ablation (nsPFA) Percutaneous Electrode System will be featured at the North American Society for Interventional Thyroidology Annual Meeting in Washington D.C., January 31-February 1, 2025. The technology will be highlighted in both clinical science and video sessions.

The company recently obtained FDA 510(k) clearance for its nanosecond percutaneous electrode system for soft tissue ablation. According to CEO Paul LaViolette, the nsPFA technology's nonthermal mechanism limits scarring and fibrosis while sparing critical anatomical structures, making it potentially ideal for treating symptomatic benign thyroid nodules.

The scientific program includes presentations by Dr. Camila Mancera on clinical experience with nsPFA in thyroid nodule patients, and Dr. Stefano Spiezia presenting key nanopulse techniques. Pulse Biosciences will also maintain an exhibit booth at the Mayflower Hotel's East Room.

Pulse Biosciences (PLSE) presented late-breaking data from its Nanosecond PFA 360° Cardiac Catheter System first-in-human feasibility study at the AF Symposium 2025. The study, evaluating the system's safety and efficacy in treating atrial fibrillation, has treated 77 patients to date by six investigators.

Initial results from the first 30 patients showed a 92.4% success rate for pulmonary vein isolation (PVI) at ~3 months post-procedure. Key metrics include: total PVI ablation time of 11.6±4.5 minutes, procedure time of 88.3±30.1 minutes, and fluoroscopy time of 6.9±2.4 minutes. The study reported one primary SAE (cardiac perforation) and two AEs (vertigo and creatinine elevation), all resolved without sequelae.

The company remains on track to begin an IDE study this year for clinical validation, aiming for commercial approval.

Pulse Biosciences (PLSE) announced that its Nanosecond Pulsed Field Ablation (nsPFA) technology will be featured at the 30th Annual AF Symposium 2025 in Boston. The presentations include a late-breaking science session and a live case transmission featuring the nsPFA 360° cardiac catheter mapped with Abbott's Ensite X 3D Mapping System.

Dr. Vivek Reddy will present clinical data from the first 30 patients treated in a feasibility study using the nsPFA 360° Cardiac Catheter at Na Homolce Hospital. Additionally, Dr. Petr Neuzil will conduct a live case transmission from Prague demonstrating the catheter's workflow efficiency for pulmonary vein isolation.

The company plans to initiate a U.S. IDE pivotal clinical study for the catheter in mid-2025.

Pulse Biosciences (PLSE) has appointed Paul A. LaViolette, current Co-Chairman of the Board, as Chief Executive Officer. LaViolette brings extensive experience from his roles at Boston Scientific , where he served as Chief Operating Officer and various executive positions over 15 years. He also has significant venture investment experience as Managing Partner at SV Health Investors.

The company is developing its nano-PFA Cardiac Surgical System and nano-PFA 360° Cardiac Catheter, conducting first-in-human feasibility studies in Europe and a pilot program with FDA-cleared nsPFA Percutaneous Electrode Systems in the US. The company will present at the J.P. Morgan Healthcare Conference and the AF Symposium 2025.

Additionally, PLSE granted inducement awards of options to purchase 138,800 shares to eleven new employees, with an exercise price of $18.55 per share and various vesting schedules, including performance-based vesting tied to market capitalization milestones between $1-3 billion.

Pulse Biosciences (PLSE), a pioneer in Nanosecond Pulsed Field Ablation™ (nano-PFA) technology, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The company's management team is scheduled to deliver their presentation on Wednesday, January 15, 2025, at 3:45 PM Pacific Time.

Investors and interested parties can access both the live and recorded versions of the presentation through the company's investor relations website, specifically on the 'Events Calendar and Presentations' page at investors.pulsebiosciences.com.

Pulse Biosciences (PLSE) has announced plans to redeem its first tranche of common stock warrants ('150% Warrants') from its July 2024 rights offering. The redemption notice will be delivered around December 27, 2024, with a redemption date of February 5, 2025. Warrant holders can exercise their rights at $11.00 per share until the redemption date. Any unexercised warrants will be redeemed for $0.01 per warrant share.

The company's right to redeem these warrants was triggered as its volume weighted average price exceeded $16.50 for twenty consecutive trading days, averaging $18.85. The company received $60 million from its initial Rights Offering and could receive an additional $66 million if all warrants are exercised. The second tranche (200% Warrants) is not being redeemed at this time.

Pulse Biosciences (Nasdaq: PLSE), a bioelectric medicine company, announced on December 18, 2024, that its Co-Chairman and majority shareholder, Robert W. Duggan, exercised all of the warrants acquired in the company's 2024 rights offering. This transaction, valued at $58.4 million, resulted in the acquisition of 5,306,156 shares of common stock. Additionally, Mr. Duggan purchased another 156,714 shares of Pulse Biosciences between December 11 and December 13, 2024. These actions have increased Mr. Duggan's ownership in the company to approximately 70%.

Pulse Biosciences (PLSE) announced the publication of preclinical study results in the Journal of Thoracic and Cardiovascular Surgery, demonstrating advantages of their nano-PFA Cardiac Surgical System over radiofrequency technology for cardiac tissue ablation. The study showed the system's ability to create consistent, transmural ablations in all four heart chambers within 1.25 seconds per application, without damaging adjacent organs.

The system, which received FDA Breakthrough Device Designation in July 2024, operates approximately twenty times faster than current thermal ablation technologies. The company is conducting a multi-center, first-in-human atrial fibrillation feasibility study in three Netherlands centers, with preliminary results expected in late 2025.