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.
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.”
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® 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.
