Galvanize Therapeutics completes first commercial procedures with FDA-cleared Aliya EX System

USA — Galvanize Therapeutics has completed the first commercial procedures using its recently U.S. FDA-cleared Aliya EX System, marking an important milestone for the company’s pulsed electric field (PEF) technology platform for cancer treatment and chronic lung disease.

The procedures represent the first clinical use of the Aliya EX System since it received U.S. Food and Drug Administration (FDA) 510(k) clearance in May 2026.

They also mark the first commercial procedures performed across the Aliya PEF platform’s two primary treatment approaches—percutaneous delivery and endoscopic delivery.

First commercial procedures completed

The first percutaneous procedure was carried out by Dr. Joseph Mammarapallil, Associate Professor of Radiology at Duke University School of Medicine.

Meanwhile, the first endoscopic procedure was performed by Dr. Justin Thomas, Director of Interventional Pulmonology at Eisenhower Health.

According to Dr. Mammarapallil, the new system enables physicians to treat patients who may previously have been unsuitable candidates for PEF therapy.

He added that the technology creates a larger ablation zone while maintaining the predictable, non-thermal energy delivery that has become a defining feature of the Aliya platform.

Dr. Thomas said many of his patients have already exhausted several treatment options.

He noted that Aliya EX broadens the range of patients who may benefit from PEF ablation while preserving the technology’s favourable safety profile and its potential to stimulate the immune system.

Expanded treatment capabilities

The Aliya EX System extends the capabilities of the existing Aliya PEF platform by producing up to twice the ablation diameter, resulting in as much as a sevenfold increase in ablation volume.

Despite the larger treatment area, the system retains the core characteristics of the company’s non-thermal PEF technology.

The device works by delivering controlled electrical pulses that trigger regulated, non-thermal cell death.

This approach preserves the surrounding tissue architecture while remaining compatible with established oncology diagnostic workflows and standard cancer therapies, allowing physicians to integrate the technology into existing clinical practice.

Company highlights clinical benefits

Doug Godshall, Chief Executive Officer of Galvanize Therapeutics, said the first commercial procedures demonstrate the performance the company intended when designing the Aliya EX System.

He explained that the technology enables physicians to consider a wider range of patients for Aliya PEF treatment while maintaining the familiar workflow of performing a biopsy and ablation during a single procedure.

Godshall added that the larger ablation zone is expected to further strengthen clinical response and expand treatment opportunities for patients requiring minimally invasive tumour ablation.