Aliya® PEF System
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.
Galvanize Therapeutics® does not promote the off-label use of its products and nothing herein is intended to promote an off-label use of the Aliya System. The Aliya System is a tool for the surgical ablation of soft tissues, and is not intended to treat, cure, prevent or mitigate any specific disease or condition.
The Aliya Pulsed Electric Field (PEF) System delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of a cell, disrupting cellular homeostasis and inducing non-thermal programmed cell death.
Aliya Needle for Percutaneous Ablation
INUMI™ Flex Needle for Endoscopic Ablation
Aliya PEF with the Aliya Needle
Key benefits:
Straightforward predictable ablation with a single 19-gauge needle and monopolar electrode for a precise and consistent ablation zone unaffected by heat sink effects.1,2
Preserves Surrounding Tissue
Aliya induces cell death through non-thermal mechanisms, leaving the extracellular matrix intact and preserving surrounding healthy tissue.1,2
Potential 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.*,3,4,5,6
Aliya PEF Animation
Aliya PEF with the INUMI™ Flex Needle
Energize your care with Aliya endoscopic ablation
Key benefits:
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.*,3,4,5,6
References:
* The Aliya System is cleared by the FDA for the surgical ablation of soft tissue and has not been cleared by FDA for any therapeutic indication, and the safety and effectiveness of the Aliya System for the induction of an immune response resulting in patient benefit has not been established. FDA clearance is restrictive, and we cannot promote the uses or properties of the Aliya System that fall outside the cleared intended use statement.
- Internal data on file. TR-00107
- Internal data on file. TR-00538
- Pastori et al. “Pulsed Electric Field Ablation versus Radiofrequency Thermal Ablation in Murine Breast Cancer Models: Anticancer Immune Stimulation, Tumor Response, and Abscopal Effects”. Journal of Vascular and Interventional Radiology35, no. 3 (March 1, 2024): 442-451.e7.
- Pastori et al. “Neoadjuvant Chemo-Immunotherapy Is Improved with a Novel Pulsed Electric Field Technology in an Immune-Cold Murine Model.”PLOS ONE19, no. 3 (March 25, 2024): e0299499
- J. Iding, et al. “Tertiary lymphoid structures (TLS) observed in non-small cell lung cancer (NSCLC) tumors treated with Pulsed Electric Fields”. Journal for Immunotherapy of Cancer 2022;10(Suppl 2):A1–A1595.
- M. Jimenez, et al. “Pulsed Electric Fields Induce a Stepwise Activation of Host Anti-Tumor Immunity in Patients with Early-Stage Non-Small Cell Lung Cancer”. Journal for Immunotherapy of Cancer 2023;11(Suppl 1):A1–A1686.)
