Galvanize Aliya -Model INUMI -Aliya PEF System for Surgical Ablation of Soft Tissues
The Aliya PEF System is designed for the surgical ablation of soft tissues by delivering high voltage, short duration electrical energy. This targeted electrical energy alters the transmembrane potential, leading to the disruption of cellular homeostasis and inducing non-thermal programmed cell death. Utilizing technologies such as the Aliya Needle and the INUMI™ Flex Needle, the system enables precise ablation zones even in complex anatomical locations, minimizing collateral damage to surrounding healthy tissue. The non-thermal approach preserves the extracellular matrix, potentially activating an immune response that can complement existing treatment modalities. Though cleared by the FDA for soft tissue ablation, its application to immune response induction remains investigational and unproven for patient benefit beyond current indications.
The Aliya PEF System with the INUMI Flex Needle is the first endoscopic PEF ablation system. This unique technology offers precise ablation of targeted lesions by inducing non-thermal cell death and may offer a potential to activate an immune response. This endoscopic delivery empowers physicians to move beyond diagnosis and offer ablation in the same episode of care.
Predictable ablation zone, delivered endoscopically
Aliya PEF with INUMI Flex offers a consistent ablation
size, unaffected by heat sinks, to destroy target
tissues.
Demonstrates a favorable safety profile
Aliya PEF energy induces cell death through non-thermal mechanisms while preserving the extracellular matrix and surrounding tissues. This technology has been used safely near airways, pleural surfaces, and vessels. This technology allows for no cardiac cycle interference and low muscle stimulation.
Potential for Immune Activation
Galvanize’s preclinical and early clinical trial data suggest the non-thermal cell death induced by PEF may release antigens from the dying tumor cells that may stimulate an immune response for a system effect beyond focal ablation. This may be synergistic with and additive to standard of care therapies.