Pulse Biosciences Eyes AFib Breakthrough With Nanosecond PFA Platform

Pulse Biosciences is advancing nanosecond pulsed field ablation (nsPFA) as a non-thermal platform for atrial fibrillation and other treatments, with roughly 250 patents supporting its technology. The company is enrolling its U.S. Nano-Pulse AF IDE trial after promising European feasibility data, where management reported a reduction in the cited failure rate from 25% to 4%; however, the results still require confirmation in U.S. patients. Pulse believes nsPFA could substantially shorten AFib procedures and reduce ablation applications, while management favors partnering with an established medical-device company to commercialize the technology amid intense competition from existing PFA systems. Pulse Biosciences NASDAQ: PLSE is positioning its nanosecond pulsed field ablation technology as a potential next-generation treatment platform for atrial fibrillation and other conditions, President, CEO and Co-Chairman Paul LaViolette said during the Canaccord Genuity 46th Annual Global Growth Conference. LaViolette, who joined the company’s board in 2024 before quickly taking the CEO role, said his decision to lead Pulse followed diligence on the company’s technology, market opportunity and team. He previously held executive roles at C.R. Bard, Boston Scientific and other medical-technology organizations before becoming a venture capitalist and board member. Pulse is developing nanosecond pulsed field ablation, or nsPFA, an approach that uses electrical pulses to non-thermally ablate cells through irreversible electroporation. LaViolette contrasted the technology with traditional heat- and cold-based ablation methods, including radiofrequency ablation. According to LaViolette, the company’s platform creates biological effects including regulated cell death, in which cells trigger their own demise, while avoiding an inflammatory response. Because the approach is non-thermal, he said it may be used in tight anatomical spaces and near sensitive structures without causing damage. LaViolette said Pulse controls the technology through its development team, know-how and a portfolio of approximately 250 patents. He highlighted Darrin Uecker, David Danitz, the company’s chief technology officer and senior vice president of research and development, Chief Medical Officer David Kenigsberg, and Chief Operating Officer Liane Teplitsky as key members of the leadership team. The CEO also cited the involvement of Robert Duggan, whom he described as a major shareholder and investor in the company. LaViolette said Duggan has purchased shares as a public-equity investor and has funded the company’s development efforts because of his belief in nsPFA. Pulse’s primary cardiac opportunity is atrial fibrillation, or AFib, where catheter ablation is used to isolate pulmonary veins and treat abnormal heart rhythms. The company is enrolling its Nano-Pulse AF investigational device exemption, or IDE, study in the United States. LaViolette attributed the trial’s enrollment pace to physician interest and results from a European feasibility study involving more than 175 patients, including many followed for more than a year. He said the European study used the same endpoints planned for the IDE trial and generated efficacy results that he characterized as “completely unrivaled.” He said current AFib ablation technologies can deliver approximately a 75% probability of success, while Pulse’s European data reduced the cited 25% failure rate to 4%. He cautioned...