Pulse Biosciences

Pulse Biosciences, Inc. is a bioelectric medicine company that was incorporated in 2014, initially as Electroblate, Inc., before adopting its current name in December 2015. The public company is significantly influenced by entrepreneur and investor Robert W. Duggan, who has served as Co-Chairman of the Board since 2017 and holds a majority of the company. Duggan's investment background is focused on breakthrough medical solutions, notably his successful leadership at Pharmacyclics, which was sold to AbbVie for $21 billion in 2015. The company is led by CEO Paul A. LaViolette, who brings four decades of experience in the global medical technology sector, including a 15-year tenure at Boston Scientific.

The core of Pulse Biosciences' operations is its proprietary Nano-Pulse Stimulation (NPS) technology, commercially known as Nanosecond Pulsed-Field Ablation (nsPFA). This platform delivers ultra-fast, nanosecond-duration electrical pulses to non-thermally clear targeted cells while preserving adjacent non-cellular tissue structures. This cell-specific mechanism is designed to offer a more precise and less damaging alternative to traditional thermal ablation methods, which can cause collateral damage to surrounding tissue and lead to scarring. The technology works by creating transient nanopores in cell membranes, disrupting intracellular functions and leading to regulated cell death.

The company's business model centers on the development and commercialization of the CellFX System, a multi-application platform that leverages the nsPFA technology. Initially, the CellFX system was launched for dermatological applications, targeting benign skin lesions. However, in 2022, the company strategically pivoted to focus on higher-value applications, primarily the treatment of atrial fibrillation (AFib) and soft tissue ablation in surgical settings. Its product pipeline now includes the CellFX nsPFA Percutaneous Electrode System for soft tissue ablation, a CellFX nsPFA Cardiac Clamp for surgical AFib treatment, and a CellFX nsPFA 360° Cardiac Catheter. The company has received FDA 510(k) clearance for its percutaneous system for soft tissue ablation and its CellFX nsPFA Cardiac Clamp has been granted Breakthrough Device designation by the FDA. Pulse Biosciences operates as a pre-revenue company since shifting its focus from dermatology, financing its extensive research and development and clinical trials through equity financing and warrant exercises.

Keywords: bioelectric medicine, Nano-Pulse Stimulation, nsPFA, Nanosecond Pulsed-Field Ablation, CellFX System, atrial fibrillation treatment, soft tissue ablation, electroceutical therapy, non-thermal ablation, medical device, cardiology, Robert Duggan, surgical instruments, dermatologic procedures, cell-specific treatment, regulated cell death, cardiac catheter, percutaneous electrode, medical technology, health innovation