New Study Published on the Safety and Feasibility of Pulsed Electric Field Ablation for Early-Stage Non-Small Cell Lung Cancer Prior to Surgical Resection

Innovative technology offers promising non-thermal approach to soft tissue ablation without compromising sensitive structures.

REDWOOD CITY, Calif., May 20, 2025 /PRNewswire/ -- A new publication featuring Aliya^® PEF has been published in the Journal of Surgical Oncology. This publication features the INCITE-ES study, which evaluated the safety and feasibility of Aliya Pulsed Electric Field (aPEF) ablation in patients with Non-Small Cell Lung Cancer. The INCITE ES study (NCT04732520), sponsored by Galvanize, revealed no device- or procedure-related serious adverse events in 36 patients treated with Aliya PEF prior to surgical tumor resection.

Unlike traditional thermal ablation techniques, Aliya PEF uses short-duration, high-voltage electrical pulses to induce cell death without damaging the surrounding sensitive structures such as airways, blood vessels, or the pleura. This novel approach, delivered percutaneously or endoscopically, preserves the extracellular matrix and was well-tolerated among patients.

"Aliya PEF ablation showed 100% technical success and integrated seamlessly into existing care pathways," said Marcelo Jimenez, MD, PhD, professor of surgery, Thoracic Surgery Department, Salamanca University Hospital, Spain, investigator in the INCITE ES clinical study. "By performing ablation and biopsy in a single anesthetic event, this study showed that Aliya PEF offered the ability to integrate Aliya into existing clinical workflows without requiring a second anesthetic event for early-stage NSCLC."

The multi-center, two-arm, non-randomized treat and resect study enrolled 47 patients with suspected or confirmed NSCLC stage IA2-IB across Spain, the Netherlands, and Hong Kong. In 36 patients Aliya PEF energy was delivered to a solitary tumor either percutaneously or endoscopically at the time of biopsy. Surgical resection was performed a median of 19 days after aPEF. Eight patients were enrolled in the non-treated control group. The trial's design intentionally performed incomplete ablation prior to surgery, enabling direct histological comparisons between treated and untreated tumor tissue. Pathological analysis revealed tumor cellular depletion and the presence of tertiary lymphoid structures (TLS), indicating potential immune activation post-treatment.

Key findings include:

• No aPEF-related serious adverse events observed.
• Preservation of sensitive lung structures, including in tumors abutting pleural surfaces or fissures.
• Immune response indicators such as TLS found within and surrounding treated tissue and irrespective of tumor histology subtype.
• No impact on planned surgical resection, suggesting procedural compatibility with standard care.
• Clinical utility and ease of incorporating aPEF into current patient care pathways, facilitating the ability to diagnose and ablate in a single minimally invasive procedure.

"The study findings suggest that Aliya PEF could become a highly valuable tool, potentially for patients with tumors near sensitive structures where thermal techniques pose high risks," added Dr. Jimenez.

This study lays the groundwork for further exploration of Aliya PEF in oncology settings. Clinical trials evaluating aPEF in late-stage NSCLC, lung metastases, and systemic immune responses are currently underway.

For more information on this study and other Aliya PEF publications, visit https://galvanizetx.com/clinical-research/.

The Aliya PEF System and the INUMI Flex needle are 510(k) cleared in the United States for the surgical ablation of soft tissue. They are not currently commercially available in any other geography. 

Jimenez, M., Flandes, J., van der Heijden,et al. (2025), Safety and Feasibility of Pulsed Electric Field Ablation for Early-Stage Non-Small Cell Lung Cancer Prior to Surgical Resection. Journal of Surgical Oncology 2025, 1-14.

About Galvanize

Galvanize™ aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, including solid tumors, and chronic bronchitis symptoms. Formed by ATP (Apple Tree Partners), Galvanize is based in Redwood City, Calif., and is developing and commercializing its revolutionary Aliya^® PEF energy platform in the United States. For more information, please visit www.galvanizetx.com.

SOURCE Galvanize Therapeutics, Inc.