Upgrade to SI Premium - Free Trial

Pulse Biosciences shifts focus to cardiac catheter program after AFib study

March 17, 2026 7:02 AM

Pulse Biosciences Inc. (NASDAQ: PLSE) announced a strategic realignment to prioritize its cardiac catheter ablation system following clinical data from a 150-patient European feasibility study for atrial fibrillation treatment.

The company will redirect capital allocation to accelerate development of its nPulse Cardiac Catheter Ablation System, which uses nanosecond pulsed field ablation technology. The decision follows clinical outcomes presented at the 31st Annual AF Symposium.

The European study showed 100% procedural success at six months among 75 evaluable patients who achieved acute pulmonary vein isolation. At 12 months, 96% of patients maintained sustained success, with 45 of 47 patients showing durable pulmonary vein isolation.

Procedural metrics included an average left atrial dwell time of 21.0 minutes, total procedure time of 65 minutes with 9.8 minutes of fluoroscopy, and an average of 16.1 applications per procedure. The study reported a 1.3% rate of serious adverse events related to the primary safety endpoint.

"The nPulse clinical performance demonstrates a clear potential to change clinical practice for the health treatment of millions of patients," said Bob Duggan, co-chairman of Pulse Biosciences.

The company will focus research and development investment on the cardiac catheter program's pivotal IDE study in the United States and Europe. It plans to reduce short-term market development investments in cardiac surgery while maintaining commitment to surgical clamp IDE enrollment.

Pulse Biosciences will streamline operations for its percutaneous soft-tissue ablation system, reducing sales and marketing spend while focusing on market development for thyroid nodule treatment.

Additional 12-month follow-up data from the cardiac catheter study will be presented at Heart Rhythm 2026 in Chicago on April 25 by Dr. Vivek Reddy of Mount Sinai Fuster Heart Hospital.

Categories

Corporate News

Next Articles