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:
Predictable Ablation Zone
• Non-thermal cell death of target tissues
• Consistent energy delivery
• Unaffected by heat sink effects
- Induces cell death through non-thermal mechanisms
- Preserves extracellular matrix and surrounding tissue and does not denature cellular and stromal proteins
- Has been used safely near airways, nerves, vessels and pleural surfaces1
Potential for Immune Activation
• Preclinical and early clinical data suggest that Aliya may promote antigen release that could activate the immune system1
• Compatible with standard-of-care therapies, preserving other treatment options including surgery1
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
- Preclinical and early clinical data suggest that Aliya PEF may promote antigen release that could activate the immune system1
- Compatible with standard-of-care therapies, preserving other treatment options including surgery1
References 1-6:
* 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.
- References on file.
Clinical Trials
Oncology
Support for Prior Authorization and Patient Access
The Galvanize Patient Access Program provides proactive support to help practices manage prior authorization, coordinate appeals, submit documentation, and track cases through a secure provider portal.