Pulse Biosciences eyes AFib breakthrough with nanosecond PFA platform. August 16, 2026 Key points. * 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. * MarketBeat previews the top five stocks to own by September 1st. 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. "I found in it something that I thought was absolutely exceptional," LaViolette said of Pulse's technology and opportunity. Nanosecond PFA technology. 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. AFib trial enrollment and prior data. 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." Discover more EV market analysis 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 that the results must be replicated in the IDE study and noted that U.S. patients may have different risk factors than the European population. LaViolette also said the technology could shorten procedures and reduce the number of ablation applications needed. He said conventional point-by-point radiofrequency procedures can require 100 to 125 ablations and take more than an hour, while first-generation pulsed field ablation systems have reduced procedures to roughly 45 to 50 minutes and 40 to 50 ablations. Pulse's approach, he said, has the potential to reduce that to 10 ablations and approximately seven to eight minutes from first to last ablation. * Pulse has added fewer than 20 patients to its IDE study. * LaViolette said the change followed an FDA-approved modification to anti-arrhythmic drug failure criteria. * Physicians sought the modification because the original protocol requirements did not reflect changing real-world practice, he said. Competitive landscape and commercial strategy. LaViolette said the AFib ablation market has shifted rapidly toward pulsed field ablation. He cited Boston Scientific's FARAWAVE launch as a major driver of PFA adoption and said Medtronic has gained share following the launch of its Sphere-9 system based on the Affera platform. Those market shifts demonstrate that physicians can switch PFA platforms quickly when new technology is introduced, he said. LaViolette argued that Pulse could be differentiated because it is pursuing nanosecond PFA rather than the microsecond PFA used by current competitors. Despite saying Pulse could feasibly build its own commercial channel, LaViolette said management and the board currently believe a partnership would be the best route to create value, reach physicians and bring the technology to patients. He cited the cost, execution risk and complexity of competing in a market involving mapping systems, ablation tools and related accessories. Additional applications. While AFib is the company's first cardiac indication and requires a Class III device premarket approval application, LaViolette said Pulse already has clearance for general soft-tissue ablation in non-cardiac uses. Its first planned use in that category is treatment of benign thyroid nodules. LaViolette said patients with benign thyroid growths currently may undergo complete thyroid removal, and he believes nsPFA could potentially shift treatment toward a less invasive approach that preserves more tissue. About Pulse Biosciences (NASDAQ:PLSE). Pulse Biosciences, Inc is a clinical-stage bioelectric medicine company that develops and commercializes medical devices based on its proprietary Tissue NanoPoration (TNP) platform. The company's core technology, NanoPulse Stimulation (NPS), delivers ultrashort, high-voltage electric pulses to targeted tissue, triggering cellular responses without the thermal damage associated with traditional energy-based devices. Pulse Biosciences focuses on applications in dermatology and aesthetic medicine, where controlled ablation of unwanted lesions is critical. The company's flagship product, the CellFX(R) System, is designed to treat a range of benign and malignant skin lesions, including seborrheic keratosis, non-melanoma skin cancers, and various epidermal and dermal lesions. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Continue following MarketBeat Before you consider Pulse Biosciences, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Pulse Biosciences wasn't on the list. 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Pulse Biosciences reported accelerated progress in its pivotal NanoPulse-AF cardiac ablation trial, enrolling over 82 patients and pushing completion to early Q4 2026—three months ahead of schedule. The company presented feasibility data showing 100% freedom from atrial fibrillation at six months and 96% at one year, with initial ablation times of seven to eight minutes. The company strengthened its balance sheet by raising $57.5 million through its ATM programme, ending Q2 with over $100 million in cash. However, GAAP net loss widened to $24.7 million from $19.2 million year-over-year, driven by increased clinical expenses. Pulse amended its study protocol to increase enrolment from 145 to 164 patients and broaden inclusion criteria. CE mark approval for the cardiac catheter is expected mid-2027, with US approval dependent on 12-month follow-up data.

As filed with the Securities and Exchange Commission on December 22, 2015