The AliyaTM System is 510(k) cleared in the United States for the surgical ablation of soft tissue. It is 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.
Beyond direct cell death, Galvanize’s preclinical and early clinical trial data suggest that PEF may result in antigen release that could activate the immune system. This may be synergistic with and additive to standard of care therapies.3,4,5
- Internal data on file. TR-00107 Galvanize Preclinical Summary Report
- Internal data on file. TR-00158 Lab 90
- HMGB1 study – Lab 179
- M. Silvestrini et al. Local Treatment with Pulsed Electric Fields Generates a Tumor Specific Response. Journal of Vascular and Interventional Radiology. Vol. 33 Issue 6 Supplement S161–S162. June 2022.
- M. Jimenez, J. M. Fernandez, J. Flandes Aldeyturriaga, E. van der Heijden, W. Krimsky. Focal Treatment of Early Stage NSCLC Using Pulsed Electric Fields: INCITE ES Study. SIR 2022.