Redwood City, California, August,11, 2026
Galvanize Therapeutics, Inc. has announced the completion of the first commercial procedures using its FDA-cleared Aliya® EX System, marking an important milestone for the company’s pulsed electric field (PEF) technology platform. The first procedures represent the initial commercial clinical use of Aliya EX following its U.S. FDA 510(k) clearance in May 2026. The system expands the Aliya PEF platform across two primary delivery pathways, including percutaneous and endoscopic approaches, potentially allowing physicians to consider the technology across a broader range of clinical procedures involving soft-tissue ablation.
Aliya EX Expands PEF Treatment Capability
The Aliya EX System is designed as a next-generation generator for the Aliya PEF platform, delivering high-voltage, short-duration electrical energy during the surgical ablation of soft tissue. According to Galvanize Therapeutics, the system can provide up to 2x larger ablation diameter and as much as a 7x increase in ablation volume compared with the existing platform, while maintaining the core characteristics of Aliya PEF technology. The system uses pulsed electrical energy to induce non-thermal regulated cell death, with the goal of preserving surrounding tissue architecture. Galvanize said this approach remains compatible with existing oncologic diagnostic workflows and standard therapies.
The technology is being developed for applications in oncology and chronic lung disease, with the company focused on expanding the clinical capabilities of its PEF platform. The first commercial procedures were performed using both major delivery pathways. Joseph Mammarapallil, M.D., Associate Professor of Radiology at Duke University School of Medicine, performed the first percutaneous procedure, while Justin Thomas, M.D., Director of Interventional Pulmonology at Eisenhower Health, performed the first endoscopic procedure. Their initial use represents the transition of Aliya EX from FDA-cleared technology into commercial clinical practice in the United States.
Larger Ablation Zone Supports Broader Use
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A key feature of Aliya EX is its ability to create a larger ablation zone while maintaining the non-thermal energy delivery associated with the Aliya platform. Galvanize said the expanded capability may allow physicians to consider PEF for patients who previously may not have been candidates for the technology. Dr. Mammarapallil highlighted the system’s ability to provide a larger ablation zone while maintaining predictable non-thermal energy delivery. Dr. Thomas similarly noted that the technology could expand the range of patients considered for PEF ablation while retaining the characteristics of the Aliya platform that attracted clinical interest.
The company said physicians can use Aliya EX within a familiar workflow involving biopsy and ablation in a single procedure. The approach is intended to integrate with established diagnostic and therapeutic workflows rather than requiring major changes to existing procedural practices. Galvanize CEO Doug Godshall said the first commercial procedures demonstrate the performance the Aliya EX system was designed to provide. The company expects the larger ablation zone to potentially support broader clinical application and further evaluation of the platform.
FDA-Cleared Technology Enters Commercial Use
The completion of the first commercial procedures represents an important commercialization milestone for Galvanize Therapeutics and its Aliya PEF platform. The company is developing pulsed electric field technologies that are designed to harness biological processes for applications in oncology and chronic lung disease. Aliya PEF technology is based on the use of electrical pulses to induce non-thermal regulated cell death during soft-tissue ablation. Preclinical and early clinical data suggest that PEF treatment may promote antigen release that could activate the immune system. However, Galvanize states that the effectiveness of the Aliya System for inducing an immune response that results in patient benefit has not been established.
The Aliya PEF System is 510(k) cleared in the United States for surgical ablation of soft tissue. The company does not promote off-label use, and the system is not intended to treat, cure, prevent or mitigate any specific disease or condition. The first commercial use of Aliya EX marks another step in the development of PEF-based medical technology, combining expanded ablation capability with percutaneous and endoscopic delivery options. As commercial experience grows, further clinical use and evidence generation will help determine the broader role of the technology in soft-tissue ablation and future applications.
Source: Galvanize Therapeutics press release
