Pulse Biosciences Gets FDA IDE Nod for Atrial Fibrillation Study

Company Overview - Pulse Biosciences (PLSE) received FDA approval for its Investigational Device Exemption (IDE) to initiate the NANOCLAMP AF study, which evaluates its Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System for atrial fibrillation (AF) [1][8] - The IDE approval is a significant growth catalyst for the company, validating its technology and enhancing its potential for broader clinical adoption in the cardiac ablation market [2][4] Market Position and Financials - PLSE currently has a market capitalization of $1.01 billion [6] - Following the announcement of the IDE approval, PLSE shares closed flat, with a year-to-date decline of 15.2%, compared to the industry's decline of 10.9% and the S&P 500's gain of 11.9% [3] Study Details - The NANOCLAMP AF study will involve up to 136 patients across 20 global sites, including two outside the United States, to evaluate the effectiveness of the nsPFA Cardiac Surgical System during concomitant cardiac surgeries [9][10] - Early clinical data from the EU indicate rapid and consistent ablation, with the device designed to minimize collateral tissue damage due to its nonthermal mechanism [10][11] Industry Prospects - The global atrial fibrillation market was estimated at $26.89 billion in 2024 and is projected to reach $65.33 billion by 2033, with a compound annual growth rate (CAGR) of 10.44% from 2025 to 2033 [12]