#USA #Redwood City #Galvanize Therapeutics #Aliya EX #pulsed electric field

Galvanize Therapeutics Celebrates Clinical Milestone with Aliya EX System

Galvanize Therapeutics, Inc., a pioneering medical technology company, has reached a significant milestone by completing the first commercial procedures using its newly FDA-cleared Aliya EX System. This notable advancement in healthcare, specifically in the realm of pulsed electric field (PEF) therapies, marks a pivotal moment not only for the company but also for patients with oncology and chronic lung disease conditions.

In a trailblazing effort to expand therapeutic options for patients, the Aliya EX System was utilized clinically for the first time after receiving its 510(k) clearance from the U.S. FDA in May 2026. This innovative system offers two primary delivery modes: percutaneous and endoscopic. The first percutaneous procedure was skillfully carried out by Dr. Joseph Mammarapallil, an Associate Professor of Radiology at Duke University School of Medicine, while the first endoscopic procedure was performed by Dr. Justin Thomas, the Director of Interventional Pulmonology at Eisenhower Health.

Dr. Mammarapallil expressed optimism regarding the capabilities of the Aliya EX System, stating, “This innovative platform allows us to provide PEF therapies to patients who may not have previously qualified for such treatments.” He emphasized the system's ability to achieve a larger ablation zone while ensuring a non-thermal energy delivery, a hallmark of the Aliya series.

Dr. Thomas echoed similar sentiments, mentioning, “Many of my patients have exhausted all available treatment options. The Aliya EX system widens the scope for patient eligibility for PEF ablation without compromising the established safety profile and the immunostimulatory potential that initially attracted me to this technology.”

The Aliya EX System markedly enhances the existing Aliya PEF platform by delivering an ablation diameter that is double that of previous versions, which translates to an increase in ablation volume by up to seven times. Its design cleverly employs electrical pulses to induce a regulated form of cell death that is non-thermal, thereby preserving the surrounding healthy tissues and maintaining compatibility with standard oncological diagnostic practices and treatments.

Doug Godshall, the Chief Executive Officer of Galvanize Therapeutics, remarked on the significance of these initial procedures, commenting, “The results we are seeing now exemplify the intended performance of the Aliya EX System. Physicians can now consider a greater number of patients for PEF treatments while continuing to integrate these procedures seamlessly into existing workflows for biopsy and ablation.” He noted that this wider ablation zone could positively affect clinical outcomes for patients undergoing these interventions.

Understanding Aliya PEF Technology

The Aliya EX System operates as a next-gen generator that delivers high-voltage, short-duration electrical energy essential for the surgical ablation of soft tissues. Preliminary data from clinical studies suggests that the PEF method may facilitate antigen release that activates the body's immune system. However, it is critical to note that the effectiveness of the Aliya System in generating a beneficial immune response is still under investigation.

A Glimpse into Galvanize Therapeutics

Based in Redwood City, California, Galvanize Therapeutics is at the forefront of innovating pulsed electric field technologies, aiming to leverage biologic processes for the treatment of cancer and chronic lung diseases. Through the Aliya PEF platform, the company seeks to expand therapeutic implementations beyond current capabilities in the United States and is continuously exploring other potential applications in oncology and chronic diseases.

For those seeking further insights into their revolutionary approach, additional information about the company and its products can be found on their official website, www.galvanizetx.com.

Regulatory Disclaimers

It is essential to understand that the Aliya PEF System is exclusively 510(k) cleared for surgical soft tissue ablation. Currently, there are no plans for commercial availability in other regions outside the United States. Furthermore, Galvanize Therapeutics does not promote any off-label usage of its products. The Aliya PEF System’s role is primarily as a tool for surgical procedures, not intended for the treatment, cure, prevention, or mitigation of any specific diseases.