Galvanize Therapeutics Receives FDA Clearance for Aliya EX Generator, Expanding its Aliya Pulsed Electric Field Portfolio for Surgical Ablation of Soft Tissue

Next-generation generator delivers up to a 7x increase in ablation volume while preserving the core benefits of Aliya PEF energy

REDWOOD CITY, Calif., May 18, 2026 /PRNewswire/ -- Galvanize Therapeutics, Inc., a commercial-stage medical technology company pioneering pulsed electric field (PEF) therapies for oncology and chronic lung disease, today announced that it received U.S. Food and Drug Administration 510(k) clearance for the Aliya^® EX Generator for surgical ablation of soft tissue.

The Aliya EX Generator expands the Aliya PEF portfolio by enabling treatment of a broader range of lesion sizes. Compared with the previous‑generation system, Aliya EX produces up to a 2x larger ablation diameter, resulting in as much as a 7x increase in ablation volume, while maintaining the core attributes of Aliya PEF energy.

These attributes include predictable, non‑thermal ablation with a favorable safety profile; compatibility with existing biopsy workflows and standard oncologic therapies; and the potential for immune activation, which may allow Aliya PEF to function as a complementary primer for other therapeutic approaches.

"Aliya PEF allows me to offer an important additional option for patients who often have very limited alternatives," said Michael Pritchett, DO, MPH, Director of the Chest Center of the Carolinas at FirstHealth Moore Regional Hospital and Pinehurst Medical Clinic. "Aliya PEF has already changed the way we think about ablation, and with Aliya EX, flexibility in the size and shape of tissue that can be ablated creates opportunities to approach cases that historically may not have been eligible. That evolution allows us to think more broadly about how Aliya PEF contributes to longitudinal cancer care and multidisciplinary treatment planning."

Aliya PEF energy delivers high-voltage, short-duration electrical pulses to targeted tissue, inducing non-thermal regulated cell death. Preclinical and clinical studies suggest this process may promote antigen release and immune activation while preserving surrounding tissue architecture.

"Aliya EX is an important advancement for physicians and patients," said Doug Godshall, Chief Executive Officer of Galvanize Therapeutics. "This generator expands interventional options with Aliya PEF while preserving the biologic mechanism, procedural consistency, and workflow integration that define our platform."

Following clearance, the Aliya EX Generator will enter a limited commercial release in the United States.

About Aliya^® PEF Energy

Aliya EX delivers high-voltage, short-duration electrical energy locally to induce non-thermal regulated cell death. The System is intended for the surgical ablation of soft tissue. Preclinical and early clinical data suggest Aliya PEF may promote antigen release that could activate the immune system; however, the effectiveness of the Aliya System for the induction of an immune response resulting in patient benefit has not been established.

About Galvanize Therapeutics

Galvanize Therapeutics^® aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of patient populations, including soft tissue lesions and chronic bronchitis. Galvanize is based in Redwood City, California, and is developing and commercializing its Aliya^® PEF energy platform in the United States. For more information, please visit www.galvanizetx.com.

Regulatory Statement

The Aliya^® EX Generator is 510(k) cleared in the United States for the surgical ablation of soft tissue. The Aliya System is not intended to treat, cure, prevent, or mitigate any specific disease or condition.

SOURCE Galvanize Therapeutics, Inc.