Wednesday, May 29, 2024
Galvanize has received FDA 510(k) clearance for its INUMI Flex endoscopic needle, which is designed for use with the Aliya® PEF System for soft tissue ablation.
This new addition to the Aliya Pulsed Electric Field (PEF) ablation portfolio allows for minimally invasive endoscopic procedures, complementing the previously approved percutaneous needle. Galvanize plans to commence commercial release in the U.S. soon.
The Aliya system, now enhanced with the INUMI Flex needle, is the first commercially available system to deliver PEF energy through an endoscope.
This enables physicians to reach and non-thermally ablate soft tissue lesions. During the ongoing AFFINITY clinical trial, clinicians administer energy immediately following an initial biopsy.
Aliya delivers high-voltage, short-duration electrical energy locally, which alters the transmembrane potential of cells, resulting in loss of homeostasis and non-thermal programmed cell death without denaturing cellular proteins or the extracellular matrix.
In addition to focal ablation, preclinical and clinical studies suggest that this process may release antigens from dying tumor cells, potentially stimulating an immune response with systemic effects beyond focal ablation.
The Aliya system can now be delivered using either an endoscopic or percutaneous approach.
As physicians increasingly shift from percutaneous to endoscopic access for target lesions, our team developed INUMI Flex to meet their needs.
Having demonstrated the effects of Aliya beyond focal ablation in early studies, we continue to explore the full potential of biologic activation and its unique immune response in clinical trials."
Endoscopic delivery of Aliya has been evaluated in two clinical feasibility studies involving patients with Non-Small Cell Lung Cancer (NSCLC).
Robotic-assisted bronchoscopy, and the other used navigation bronchoscopy. The INCITE-ES study, conducted outside the U.S., assessed the safety and feasibility of Aliya while examining immune activation in patients with early-stage IA
Source: prnewswire.com
