Pulse Field Ablation Advances: New IDE Approval, $100M Funding, and Industry Expansion

Pulse Biosciences Receives IDE Approval for Cardiac Surgery PFA Study

Pulse Biosciences has secured Food and Drug Administration (FDA) approval to initiate a clinical study of its pulsed field ablation (PFA) system for treating atrial fibrillation during concomitant cardiac surgeries. The investigational device exemption (IDE) clears the way for the NANOCLAMP AF study, which will evaluate the company's nsPFA cardiac surgical device.

The single-arm prospective study aims to demonstrate the system's primary effectiveness and is expected to enroll up to 136 patients across 20 sites, including two outside the United States. Pulse Biosciences CEO Paul LaViolette emphasized that the company is the first to advance PFA technology into the cardiac surgical field for atrial fibrillation treatment.

Dr. Niv Ad, Pulse's chief science officer for cardiac surgery, highlighted the potential advantages of their proprietary nonthermal ablation mechanism, stating that it may offer significant improvements in safety, effectiveness, and speed compared to current thermal methods like radiofrequency ablation.

Galvanize Therapeutics Secures $100M Funding and New Leadership

Galvanize Therapeutics, a company developing pulsed electric field treatments for cancer and lung disease, has raised $100 million in a Series C funding round led by Sofinnova Partners. The investment, which included participation from Intuitive Surgical, Norwest Venture Partners, Fidelity Management & Research, T. Rowe Price, and Gilmartin Capital, will support the commercial expansion and continued development of Galvanize's Aliya platform for solid tumors and RheOx device for chronic bronchitis.

Concurrent with the funding announcement, Galvanize has appointed Doug Godshall as its new chairman and CEO. Godshall, formerly the CEO of Shockwave Medical and HeartWare International, brings extensive industry experience to the role. He succeeds Galvanize founder Jonathan Waldstreicher, who has transitioned to the position of president and chief strategy officer.

Godshall expressed enthusiasm for joining Galvanize, stating, "There are millions of patients who are underserved by today's largely pharmaceutical approaches, and I feel fortunate to be able to join the team as we seek to meaningfully improve the outcomes of those who are suffering with these chronic diseases."

PFA Pioneer Launches New Venture in Ablation Technologies

Steven Mickelsen, a pioneer in the field of pulsed field ablation, has announced the launch of Del Medtech, a seed-stage medical device company focused on developing ablation technologies beyond cardiac care. The company aims to create single-use ablation devices designed to improve efficiency and patient outcomes in specialties including gastroenterology, ear, nose and throat, men's and women's health, and oncology.

Mickelsen, who previously invented Boston Scientific's Farapulse PFA system, stated, "We are entering a period of rapid acceleration in ablative therapies, much like the rise of PFA in electrophysiology. Del Medtech is poised to lead this wave, and we welcome investors and partners who want to be part of shaping the future of ablation."

Founded in 2024 in Cardiff-by-the-Sea, California, Del Medtech is targeting market opportunities with annual revenues ranging from $1.4 billion to $7.4 billion and projected growth rates between 9% and 13%. This venture marks Mickelsen's second foray into PFA technology development, following his founding of Field Medical in 2022 to develop a PFA approach for ventricular tachycardia.