Galvanize Therapeutics, Inc., a commercial-stage medical technology company, has announced the online publication of six-month results from its U.S.-based AFFINITY clinical trial, which evaluates the safety and feasibility of Aliya® Pulsed Electric Field (PEF) ablation technology in patients with stage IV non-small cell lung cancer (NSCLC) or metastatic lung tumors. The findings published in the medical journal Cancers highlight an innovative advancement for oncology interventionalists and hospital administrators seeking new, non-thermal approaches to tumor ablation, with significant implications for future oncology service line strategy and investments.

The AFFINITY study is a multi-center, prospective, non-randomized, open-label and single-arm trial, involving 28 evaluable patients who received Aliya PEF ablation to lung tumors at the time of diagnostic biopsy. Depending on individual care plans and multidisciplinary team guidance, some patients received standard-of-care systemic therapies following ablation. The procedure is designed to deliver short-duration, high-voltage electrical pulses to cancerous tissue, thereby inducing tumor cell death without causing collateral thermal injury to delicate surrounding structures in the lung. This fundamental difference distinguishes the Aliya PEF platform from traditional radiofrequency or microwave ablation, expanding potential indications for patients previously ineligible for thermal-based interventions.

The six-month data demonstrate that Aliya PEF ablation is safe and logistically feasible within real-world U.S. cancer programs. The ablation procedure was completed successfully in 100% of patients, including those requiring bilateral lung ablation. Notably, there were no procedural delays in the subsequent administration of standard systemic therapies. Only a single procedure-related serious adverse event (pneumothorax) was observed, and it resolved without lasting effects, underscoring a favorable safety profile relevant for facility risk management and procedural planning.

From an efficacy perspective, the trial achieved a high rate of local control — defined as local stable disease, partial response, or complete response of ablated lung lesions — in 96% of all patients. In a significant subset of patients (n=12) who received only Aliya PEF ablation with no immediate follow-up therapy, the local control rate was 100%. These outcomes are clinically meaningful for hospital-based oncology programs treating patients who are not candidates for surgery or thermal ablation due to tumor location or comorbidities. Moreover, an intriguing finding was the robust systemic immune activation observed among these patients, which aligns with mechanisms of immunogenic cell death and potentially synergizes with emerging immunotherapies. Both innate and adaptive immune markers indicated heightened immune response after ablation-alone, suggesting that pulsed electric field energy may serve as an immune primer in otherwise difficult-to-treat metastatic disease.

For procurement professionals and healthcare technology committees, the commercial readiness of the Aliya PEF System and INUMI™ Flex needle — both cleared by the U.S. FDA via 510(k) pathway for surgical soft tissue ablation — marks an opportunity to expand ablation programs and close therapeutic gaps for ineligible NSCLC and metastatic patients. The procedure is applicable via percutaneous or endoscopic approaches, enhancing flexibility in scheduling and resource utilization. More than 2,000 patients have already been treated with Aliya ablation in commercial and clinical research settings across the United States, supporting confidence in scalability for larger hospital networks and cancer centers.

In summary, the AFFINITY trial provides a compelling business case for hospital administrators, oncology directors, and procurement leaders to explore pulsed electric field ablation, not only for direct tumor control but as an adjunct with immunotherapies to potentially improve patient outcomes. The favorable safety and efficacy profile, paired with systemic immunological benefits, strengthens the device's appeal amid the competitive oncology device landscape. Investments in this technology may further operational goals around advanced minimally invasive interventions and clinical research differentiation.