Pulse Biosciences: Advances in Cardiac Surgery and Financial Development

Pulse Biosciences has reached a significant milestone in the field of cardiac surgery. As announced by President and CEO Burke T. Barrett, the first patients in Europe with atrial fibrillation (AF) have been successfully treated using the innovative Nano PFA system. This system has received a breakthrough device designation from the US FDA and benefits from the accelerated approval pathway of the TAP program. The company aims to commercialize its applications, with a focus on AF treatment. The third quarter of 2024 was financially challenging for Pulse Biosciences. Michael Koffler, Vice President of Finance, reported increased GAAP costs and expenses amounting to $13.7 million, primarily due to higher stock-based compensation. The GAAP net loss amounted to $12.7 million, while the non-GAAP net loss was reported at $9.4 million. A rights offering raised $60 million, and an additional $66 million could be generated through the exercise of warrants. Further progress was made in soft tissue ablation. The CellFX percutaneous electrode system received FDA 510(k) clearance for soft tissue ablation and has achieved positive results in the treatment of benign thyroid nodules. There are plans to expand the pilot program and begin a pivotal clinical study in mid-2025. In the area of catheter-based endocardial AF ablation, Pulse Biosciences is developing the 360-Cardiac Catheter. A feasibility study conducted in Prague with over 50 patients yielded promising results. A pivotal clinical study in the US is expected to begin in mid-2025, with the goal of submitting an FDA PMA application based on the study results. For the coming year, the company is strategically focusing on advancing the clinical understanding and regulatory processes for its three active indications. A team and the necessary infrastructure are being established to conduct pivotal clinical studies starting in 2025 and secure market approval for the approved devices.